ROCKVILLE, MD and SHENZHEN, CHINA, June 21, 2024 – (ACN Newswire) – HighTide Therapeutics, Inc. (2511.HK), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced today that it will present at the American Diabetes Association’s (ADA) 84th Scientific Sessions, taking place from June 21-24, 2024 in Orlando, Florida. The presentation is a post-hoc analysis of the Phase 2 clinical study of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with type 2 diabetes mellitus (T2DM) (NCT06411275).

Based on the successful Phase 2 study, two Phase 3 studies (NCT06350890, NCT06353347) are currently ongoing to further evaluate the efficacy and safety of HTD1801 (as monotherapy and as add-on to metformin) in patients with T2DM and inadequate control. “We look forward to the results of our pivotal T2DM program which we expect to announce in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters Across the T2DM Disease Spectrum” (Abstract 847-P, Poster Presented June 23rd)

About the Abstract:

In a Phase 2, placebo-controlled, double-blind study in patients with T2DM, treatment with HTD1801 for 12 weeks resulted in significant dose-dependent improvements in key glycemic parameters. The objective of this post-hoc analysis was to evaluate the effectiveness of HTD1801 in patients with T2DM across the disease spectrum based on baseline HbA1c, with a particular emphasis on glycemic and lipid metabolism markers, along with indicators of liver injury. These data show that regardless of baseline disease severity, HTD1801 treatment resulted in significant improvements across these key parameters. The magnitude of improvement was greater in those with more severe disease. HTD1801 may offer a unique therapeutic approach for individuals with T2DM and other comorbidities (i.e. MASH and dyslipidemia), as managing these conditions effectively is crucial in controlling T2DM and reducing its associated complications.

About HighTide Therapeutics

HighTide Therapeutics, Inc. (2511.HK) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

Disclaimer

The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments.

For more information, please visit www.hightidetx.com 

Contact: pr@hightidetx.com 

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ROCKVILLE, MD and SHENZHEN, CHINA, June 5, 2024 – (ACN Newswire) – HighTide Therapeutics, Inc. (HKEX: 2511), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced that it will make multiple presentations at the European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy. The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxcyholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744).

“These data provide additional insight on the potential benefits of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with MASH and T2DM. The ongoing multi-regional Phase 2b study (CENTRICITY, NCT05623189), now fully enrolled, evaluates the histologic benefit of HTD1801 in this same patient population. We look forward to the results of CENTRICITY which is on track to read out in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract SAT-227, Poster Presented June 8)

About the Abstract: As GLP-1 Receptor Agonists (GLP-1RAs) are prominently used in patients with T2DM and gaining attention as a potential treatment for MASH, this post-hoc comparative efficacy analysis evaluated ongoing GLP-1RA use compared to newly initiated HTD1801 treatment. This analysis suggests that HTD1801 provides greater benefit across multiple cardiometabolic endpoints compared to ongoing GLP-1RA use. These findings are important as they suggest that patients with MASH and T2DM, on concomitant GLP-1RA treatment, could achieve additional benefit with HTD1801 in terms of further glucose and lipid lowering as well as weight loss.

“Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance” (Abstract SAT-225, Poster Presented June 8)

About the Abstract: Insulin resistance is a significant risk factor for T2DM, obesity and MASH. HTD1801 enhances the utilization of glucose and fats through activation of AMP-activated protein kinase (AMPK), thereby improving insulin sensitivity. As HTD1801 is under development as a treatment for patients with MASH and T2DM, the objective of this post-hoc analysis was to evaluate the effects of HTD1801 based on degree of insulin resistance. These data demonstrate that HTD1801 can alleviate the metabolic inhibitory effects caused by hyperinsulinemia, leading to even greater metabolic benefits in patients with MASH and more severe insulin resistance and therefore may offer a unique therapeutic approach for individuals with MASH and T2DM.

“Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM” (Abstract SAT-243, Poster Presented June 8)

About the Abstract: The most commonly occurring adverse events (AEs) in studies of HTD1801 across several indications have been mild to moderate gastrointestinal (GI) AEs, primarily diarrhea and nausea. The purpose of this post-hoc analysis was to characterize the time course and severity of GI AEs in patients with MASH and T2DM treated with HTD1801 for 18 weeks. Diarrhea and nausea, the most commonly occurring of GI AEs, followed a trend that was consistent with all reported GI AEs; they showed early onset (within the first 4 weeks), were mild or moderate in severity, and importantly, showed a decreasing incidence and prevalence over the course of treatment. These data demonstrate that with continued treatment with HTD1801, GI tolerability improves supporting its potential for long-term use for the treatment of chronic disease, such as MASH.

About HighTide Therapeutics

HighTide Therapeutics, Inc. (HKEX: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

Disclaimer

The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments.

For more information, please visit www.hightidetx.com.

Contact: pr@hightidetx.com 

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

WAKE FOREST, N.C. | ADELAIDE, AUS, June 4, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is sharing new data at BIO 2024 from Frost & Sullivan research showing biotechs save more than 30% in costs and halve start-up times with CROs that have in-house scientific and regulatory affairs.

Meet the team at BIO 2024 Booth #5601

DOWNLOAD THE REPORT HERE

According to the report key benefits for biotechs with CROs that have in-house scientific and regulatory affairs included:

• Decrease trial startup timelines by up to 50% by supporting sponsors in preparing the study protocols, reviewing essential documents and prepping site for activation. 
• Reduced compliance risk and achieve zero errors by preparing necessary regulatory documents, compile submission dossiers and manage responses with regulatory authorities 
• Decreased cost to sponsors by up to 30% by enabling sponsors to leverage benefits of full-service CRO services and avoiding standalone contracts with independent regulatory affairs agency. 

Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:

• Regulatory Strategy Development: We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals. 
• Liaison with Regulatory Authorities: We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
• Surrogate Development: Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.
• Streamlined Marketing Application: Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
• Adherence to GCP Standards: We utilize quality systems that uphold adherence to Good Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials. 

Avance Clinical recent news:

• Opened clinical operations in South Korea
• Signed an MOU with CNS specialist European CRO Julius Clinical

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to later phase trials.

Avance Clinical CEO, Yvonne Lungershausen said “It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs”.

“Our Australian and New Zealand operations have been delivering successful early phase clinical trials for decades, while our European and North American operations as well as our new Asia operations makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“Our global teams offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the EMA and FDA.” 

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,500 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials.”

Lungershausen said this is our GlobalReady program and we currently have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. “With a globalized strategy, we ensure efficiency every step of the way,” she said.

DOWNLOAD THE REPORT HERE

Find out more:

• Learn about the GlobalReady model
• For more information about the benefits of running your next study with Avance Clinical contact us
• Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

WAKE FOREST, N.C. |  ADELAIDE, AUS, May 31, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs has signed a Memorandum of Understanding (MOU) with Julius Clinical, a leading CNS, cardiometabolic, and rare diseases specialist CRO with extensive site relationships in the region.

Meet the Avance Clinical team at BIO 2024 – Book a meeting now.

Julius Clinical, established in 2008 and headquartered in Zeist, The Netherlands, specializes in CNS, cardiometabolic, and rare diseases. The non-exclusive MOU between Avance Clinical and Julius Clinical offers a streamlined global solution for biotech clients.

Avance Clinical CEO, Yvonne Lungershausen noted that Avance Clinical has expanded globally establishing operations now in Europe, Australia, New Zealand, Asia and North America.

She emphasized, “Avance Clinical is now a global CRO for biotechs. In addition to our existing operations, our specialist partner CROs work alongside our teams to ensure our biotech clients benefit from the most experienced scientific, regulatory, and clinical operations teams across various therapeutic areas and regions”.

“Julius Clinical are an ideal partner for Avance Clinical because they lead with scientific expertise and can support our biotech clients with specialist CNS, cardiometabolic and rare diseases clinical operations and site relationships in Europe,” Lungershausen said.

She added, “Julius Clinical clients can also leverage Avance Clinical operations in Asia, Australia, New Zealand, and North America for their expanded later phase trials”.

Julius Clinical has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

Lungershausen said that Avance Clinical teams across Europe, Australia, New Zealand, Asia, and North America provide world-class data and facilitate seamless geographic expansions to accelerate drug development programs, with study data accepted by regulatory authorities including the EMA and FDA. 

Martijn Wallert, CEO of Julius Clinical, added, “We are excited to be partnering with Avance Clinical. Biotechs seek partners that can start quickly with high-quality data accepted by regulatory agencies like the MHRA, EMA, and US FDA. Together with Avance Clinical, we offer a nimble, flexible, and scientifically robust service, providing a tailored global solution”.

Avance Clinical is committed to accelerating drug development for biotech clients from early to later phase trials, allowing clients to remain with one CRO throughout their clinical development program. “This is our GlobalReady program, currently utilized by more than 90 biotech clients. Our globalized strategy ensures efficiency at every step,” Lungershausen concluded.

Find out more:

• Learn about the GlobalReady model
• For more information about the benefits of running your next study with Avance Clinical contact us
• Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical consulting and regulatory services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

About Julius Clinical

Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a scientifically focused CRO providing end-to-end clinical trial service to pharmaceutical and biotechnology customers, as well as governments and academia. Julius Clinical’s renowned scientific leaders are at the forefront of their fields, which combine with operational excellence and a global network of research sites to deliver tailor-made solution for customers and their clinical trials. With a focus on the therapeutic areas of CNS, cardio-metabolic, renal, and rare diseases, Julius Clinical has grown to approximately 200 employees and has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

www.juliusclinical.com 

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Adelaide, AU & North Carolina, USA, May 8, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend BIO Korea (May 8-10, 2024) and formally open new clinical operations in Seoul, South Korea.

Meet with the team at BIO Korea

Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region’s scientific excellence and patient populations.

“In addition, feedback from a recent presentation of our GlobalReady drug development solution to more than 75 Korean biotechs and pharmaceutical companies in Seoul showed a real need for Korean clinical operations with a global pathway,” said Lungershausen.

“It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs. This makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“The new South Korean operations also offer a strategic presence for Avance Clinical’s CRO partners conducting multi-regional or global trials.

In addition, Korean biotechs are utilizing our Australian and United States clinical services as they progress their drug development programs,” said Lungershausen.

“Our Avance Clinical teams in APAC, Europe and the United States, offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA. In addition, the Therapeutic Goods Administration (TGA) in Australia and FDA recognises data generated in Korea.” 

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,000 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials,” she said.

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

Book a meeting with the team at the Australian Pavilion at BIO Korea to meet with our team of clinical trial experts.

Find out more:

• Learn about the GlobalReady model
• For more information about the benefits of running your next study with Avance Clinical contact us
• Request a Proposal here

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com 

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

North Carolina, USA & Adelaide, Australia, Apr 19, 2024 – (ACN Newswire) – Avance Clinical, the award-winning North American and Australian market-leading CRO for biotechs, will attend World Orphan Drug Conference in Boston (April 23-25, 2024) to share their rare diseases drug development expertise with biotechs (booth #730).

Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients’ lives.  

“Avance Clinical has deep therapeutic knowledge of this area, completing over 50 trials in rare and orphan diseases globally in the last five years, including Fragile X Syndrome, Duchenne Muscular Dystrophy, Rett Syndrome and Erythropoietic Protoporphyria,” she said. 

Central to the company’s success in this sector is collaboration with disease-specific advocacy groups, patient registries, and tailored recruitment strategies, to enhance patient enrolment and retention.  

Lungershausen said, “We have an extensive understanding of the unique challenges in managing small patient populations. Our patient-centric approach places patients at the heart of our operations, ensuring optimal care through the selection of experienced sites and clinics. 

“Avance Clinical engages with clients early in the planning process to tailor trial designs to accommodate the unique needs and challenges faced by patients with rare diseases, ultimately improving patient access to critical medicines,” she said. 

Avance Clinical is adept at crafting adaptive, patient-focused protocols that adhere to regulatory standards. The company’s innovative approach to study design, combined with over 26 years of experience in delivering FDA and EMA-quality data, positions Avance Clinical as a CRO capable of navigating the complexities of the regulatory landscape efficiently. 

Lungershausen describes Avance Clinical as a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for rare disease-focussed biotechs,” she said.  

“Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III,” she said. 

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said. 

“Biotechs are looking for a partner that can seamlessly help transition rapidly with high-quality data that is readily accepted by the FDA and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and support our clients with FDA, EMA and TGA submissions,” she said. 

“In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials, particularly in rare and orphan indications,” she said. 

New analysis by market research leader Frost & Sullivan shows one of the major challenges for biotechs was finding the right biotech aligned CRO partner. 

“More than 60% of US biotechs experience delays seeking the right CRO partner to accelerate their drug development programs,” Lungershausen said. (See report here). 

The comprehensive report underscores the increasing biotech preference to collaborate with the right sized CROs that can accommodate the fast-paced nature of biotech demands. 

Executive Vice President, North America Operations, John Mann, will attend the conference in Boston alongside Avance’s team of clinical trial experts, including Senior Vice President, Scientific and Regulatory Affairs Kevin Leach and Director of Business Development Clint Henry.

Visit Booth #730 to discuss your upcoming clinical trial, and find out more about the Avance Clinical Advantage, supporting biotechs globally in their clinical development programs.

Book a meeting with the team here 

Find out more: 

• Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/  
• For more information about the benefits of running your next study with Avance Clinical contact us  
• Visit Booth #730 to discuss your drug development program at the World Orphan Drug Congress in Boston, April 23- 25 

Media Contact:  
Avance Clinical 
media@avancecro.com  
Kate Thompson 

About Avance Clinical 

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services. 

Frost & Sullivan Awards 
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years. 

Pre-clinical through to mid to late phase 
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical consultancy through to Phase III clinical services leveraging global reach, supported by significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. 

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review. 

Technology 
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners. 

www.avancecro.com  

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Adelaide, AU & North Carolina, USA, Mar 28, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend World Vaccine Congress in Washington DC (April 1-4, 2024) and share the latest clinical trial client news including the Uvax Bio announcement. (Booth #267)

Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company’s US and Australian teams as they continue to excel in biotech vaccine CRO services.

Lungershausen said Avance Clinical is a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for vaccine focussed biotechs,” she said. Lungershausen said the company has had significant vaccine client successes in infectious diseases, including COVID-19 and RSV, as well as other diseases such as Hypertension and Psoriasis.

She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study. Mary Giffear, Uvax Bio’s Director of Clinical Operations reported, “we have completed enrollment in our Phase 1 study of the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, and the Australia-based trial is on schedule.”

Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

“Biotechs are looking for a partner that can seamlessly help transition them with the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration (FDA) and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and work to support our clients with FDA, EMA and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials,” she said.

Another key advantage for vaccine biotechs is that Avance Clinical is accredited as a gene technology CRO which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

The Office of the Gene Technology Regulator (OGTR) has developed globally compliant regulations and accreditations which are in line with international guidelines.

Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said: “This means that as an OGTR accredited CRO we can support our international biotech clients with extensive OGTR knowledge and experience to accelerate their clinical research. Indeed, we would argue the clarity around the OGTR regulations makes Australia one of the most attractive destinations for Cell and Gene Technology research,” he said.

Find out more:

• Learn about the GlobalReady model
• For more information about the benefits of running your next study with Avance Clinical contact us
• Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com
Kate Thompson

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Mar 18, 2024 – (ACN Newswire) – Essex Bio-Technology Limited (“Essex” or the “Group”, Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2023.

Financial Performance

The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023. During the year under review, the Group achieved a consolidated revenue of approximately HK$1,706.6 million, with an increase of 29.5% as compared to last year, which was contributed principally from Beifushu® unit-dose eye drops, Beifuxin® gel and Shilishun® (Iodized Lecithin Capsules). The Group achieved a net profit of approximately HK$275.3 million, representing an increase of 22.1% as compared to last year, which was exceptionally weighed down by the withholding tax incurred.

As of 31 December 2023, the Group had cash and cash equivalents of approximately HK$509.8 million (2022: approximately HK$543.5 million). The Board is pleased to propose a final dividend of HK$0.045 (2022: HK$0.025) per ordinary share to be approved at the upcoming annual general meeting of the Group. Together with the interim dividend of HK$0.045 per ordinary share paid on 13 September 2023, the total dividend for 2023 would be HK$0.09 (2022: HK$0.065) per ordinary share.

Revenue Growth in Ophthalmology and Surgical Segments

The Group’s turnover is primarily made up of the ophthalmology segment (“Ophthalmology”) and surgical (wound care and healing) segment (“Surgical”). For the year ended 31 December 2023, Ophthalmology contributed approximately HK$753.4 million to the Group’s turnover, representing an increase of 36.1% YoY, while Surgical recorded a total turnover of approximately HK$953.2 million, representing an increase of 24.7% YoY. The core products that are current growth drivers under each segment are:

1. Ophthalmology – Beifushu® series (Beifushu® eye drops, Beifushu® eye gel and Beifushu® unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops and Shilishun® (Iodized Lecithin Capsules); and

2. Surgical (wound care and healing) – Beifuji® series (Beifuji® spray, Beifuji® lyophilised powder and Beifuxin® gel), Carisolv® dental caries removal gel, Dr. YaDian mouth wash, Yi Xue An Granules and PELNACTM collagen-based artificial dermis.

Significant Business Development Milestones

During the year under review, the expansion of production capacity has progressed well. The second gel manufacturing line and the new freeze-drying (lyophilise) manufacturing line have been successfully commissioned and have passed the Good Manufacturing Practices (GMP) approval. The two additional manufacturing lines have been officially put into production. The core functional modules of the second phase of the quality management system (QMS) are officially launched, taking digitalisation, informatisation and intelligence to a new level in quality control.

Research and development (“R&D”) innovation continues to progress, with multiple pipelines advancing smoothly, and the global phase 3 clinical project of bevacizumab ophthalmic injection (EB12-20145P) has successfully enrolled patients in the PRC, Australia, European Union countries and the United States.

In addition, this year has been a fruitful year in promoting product diversification. We have obtained the exclusive agency rights for Osteopore’s innovative oral and maxillofacial products in Singapore, and released high-end home phototherapy brands PAINT® and EYESU+® dry eye care products. The business of medical devices such as FarFlex series of elastic bandages, PELNACTM absorbable dressings, Wlight eye adjustment training lights, etc. is of sound development. The Group’s new business segments have also made several breakthroughs. The Group’s wholly owned subsidiary, UNO Medical (Zhuhai) Co., Ltd. and Dymind Biotechnology Co., Ltd. (“Dymind”) have reached a strategic cooperation to jointly build an industry-leading digital cloud inspection platform, “Diyi Cloud Inspection”, for the point-of-care testing (POCT) equipment of Dymind.

Entrenched Market Access Capability

As of 31 December 2023, the Group maintains a network of 43 regional sales offices in the PRC with more than 1,260 sales and marketing representatives, covering more than 12,500 hospitals and medical providers, coupled with approximately 1,800 pharmaceutical stores, which are widely located in the major cities, provinces and county cities in the PRC. Sales to lower-tier cities are supplemented by on-line platform for e-consultation and e-prescription, which is further deployed for serving patients with chronic diseases.

The Group’s expansion of its market access into Southeast Asian countries via its base in Singapore has been gaining good traction since 2020.

Research and Development

During the period under review, the Group remains focused on executing its 5-year (2021 to 2025) R&D development plan. As at the date of this announcement, there are 16 R&D programmes in the pre-clinical to clinical stage, out of which the following 4 ophthalmology programmes are targeted as mid-term growth drivers:

— EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021. The continuation of the VISTA program is subject to the completion of the transfer of chemistry, manufacturing and controls (CMC), know-how and intellectual property rights relating to SKQ1 from Mitotech, following the acquisition on 13 Oct 2022.

— EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration (“NMPA”) in the PRC)

— EB12-20145P: Bevacizumab intravitreal injection for exudative (wet) age-related macular degeneration, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)

— EB11-21148P: Cyclosporine eye drops, phase 2 clinical trial (NMPA in the PRC)

The Group holds a total of 84 patent certificates or authorisation letters, which include 63 invention patents, 14 utility model patents and 7 design patents. The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (USA), London (UK) and Singapore which support not only our pursuit of new therapeutics but also our recruitment of global talents.

Honors and Awards Obtained In 2023

Zhuhai Essex Bio-Pharmaceutical Company Limited, a wholly-owned subsidiary of the Group, has been recognised as one of the 2022 top 100 innovative companies in Zhuhai, and has also been recognised as one of the 2022 top 100 chemical pharmaceutical companies in the PRC.

The Group’s Beifushu® has been awarded as one of the Chinese reputable medicine brands in five consecutive years. Also, the Group’s Beifuxin® gel has been recognised as 2023 Excellent Brand of Biochemical and Biological Enterprise. These awards are the testament to the recognition by the industry for the efficacy and quality of the Group’s flagship biologic drug.

In addition, the Company was awarded The Best Mid and Small Cap Company and further conferred with China Excellent IR – The Best Shareholder Relations Award and The Best Digitalised Investor Relations Award. 

Mr. Patrick Ngiam, Chairman of Essex, said, “The tenacity, resilience and solidarity are factors that have enabled the Group to weather the headwinds and achieved sound performances in FY23. Barring unforeseen circumstances, the Group remains focused on executing its plans and delivering progressive results.”

Full version of Essex’s FY2023 Annual Results Announcement can be downloaded at: https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0318/2024031801326.pdf

About Essex (1061.HK)

Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun® (Iodized Lecithin Capsules) etc. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 12,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.

Website: http://www.essexbio.com

Investor Enquiry:

Investor Relations: investors@essex.com.cn

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

KUALA LUMPUR, Feb 28, 2024 – (ACN Newswire) – LYC Healthcare Berhad (“LYC Healthcare” or the “Group”), a leading provider of comprehensive healthcare and specialist in mother and child care services, is pleased to announce the financial results for the third quarter ended 31 December 2023 (“Q3 FY2024”), demonstrating significant revenue growth and an improvement in operational results.

In Q3 FY2024, LYC Healthcare achieved a robust revenue of RM35.9 million, a notable increase from RM23.5 million in the same quarter of the previous year (“Q3 FY2023”). This growth is primarily attributed to the Group’s strategic focus on nutraceutical business and beneficial outcomes from lease modifications. Despite facing industry-wide challenges, LYC Healthcare successfully narrowed Loss Before Tax (“LBT”) to RM1.2 million, down from RM1.8 million in the corresponding quarter of the previous year, underscoring the effectiveness of the Group’s operational and strategic initiatives.

On a regional basis, Malaysia segment continues to contribute significantly to the Group’s performance, generating RM24.0 million in revenue for the quarter, up from RM13.4 million in the previous year’s quarter. The LBT in this segment decreased to RM2.0 million from RM3.2 million, reflecting improved outcomes from the nutraceutical business.

In Singapore, the healthcare operations continued to excel, generating revenue of RM11.9 million and a profit before tax of RM0.8 million. This performance is an improvement in revenue compared to the previous year, although there was a slight decrease in profit before tax from RM1.5 million, attributed to strategic investments in the region’s healthcare sector for future growth plans.

Cumulatively, for the nine months ended 31 December 2023 (“9M FY2024”), LYC Healthcare posted a revenue of RM95.0 million, up from RM66.6 million in the same period last year. The Group’s LBT improved significantly to RM2.9 million from RM6.4 million, driven by contributions from profit guarantee contributions, gains on lease modifications, and robust performance in both the Singapore healthcare businesses and the nutraceutical sector.

On a quarter-on-quarter basis, LYC Healthcare’s revenue increased from RM32.4 million in the preceding quarter to RM35.9 million, with LBT narrowing to RM1.2 million from RM2.0 million, further evidencing the Group’s strong performance momentum.

Mr. Sui Dong Hoe, Managing Director cum Group Chief Executive Officer of LYC Healthcare expressed optimism about the Group’s direction, stating, “The positive trends we are observing in Q3 FY2024 are a clear indication that LYC Healthcare is on the right trajectory towards profitability and sustained growth. Our strategic investments, particularly in T&T Medical Group Pte Ltd (“T&T”) and HC Orthopedic Surgery Pte Ltd (“HCOS”), and operational enhancements are beginning to bear fruit. The full acquisition of T&T and HCOS, coupled with our plans to list these entities under LYC Medicare (Singapore) Pte Ltd on the Catalist board of the Singapore Exchange (“SGX”), showcases our commitment to capitalizing on these opportunities. These steps are pivotal in further strengthening our market position and delivering value to our stakeholders.”

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com