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Yahoo
03-07-2025
- Business
- Yahoo
Ascletis begins dosing in Phase IIa trial of ASC30 for obesity treatment
Ascletis Pharma has dosed the first obese or overweight subjects in the 13-week, multi-centre US Phase IIa trial of ASC30. The dosing was performed in those identified with at least one weight-related comorbidity. The double-blind, randomised and placebo-controlled trial aims to assess the safety, tolerability, and efficacy of the oral treatment in individuals with a body mass index (BMI) of 30kg/m² or higher, or those overweight with a BMI of at least 27kg/m² but less than 30kg/m². Two oral formulations of the therapy, formulation one (ASC30 tablets) and formulation two (ASC30 tablets A1), both administered once a day, are under evaluation. The mean percentage change in body weight from baseline at week 13 is the trial's primary endpoint. The trial's design incorporates insights from previous Phase Ia and Ib studies, suggesting a lower starting dose and a slower titration strategy for the once-a-day administration of the oral therapy. Its protocol includes a lower starting dose of 1mg of both formulations, and will gradually increase the dosage to maintenance levels of 20mg and 40mg for formulation one, or 20mg, 40mg, and 60mg for formulation two, on a weekly basis. The Phase IIa trial's topline data are anticipated in the fourth quarter of this year. In earlier Phase Ia single ascending dose (SAD) studies, formulation two of ASC30 showed a flatter pharmacokinetic profile compared to formulation one. Ascletis Pharma CEO, chairman and founder Jinzi Jason Wu said: 'We are happy that we are ahead of the schedule of our US 13-week Phase IIa study since we have initiated screening of participants in June and recently completed dosing of the first participants. 'As a small molecule, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for obesity treatment, if approved.' ASC30, the in-house discovery of Ascletis, is a small-molecule glucagon-like peptide-1 receptor (GLP-1R)-biased agonist. This new chemical entity has patent protection in the US and globally until 2044, with no patent extensions. In April 2025, Ascletis reported early weight loss results from a Phase Ib trial of ASC30. "Ascletis begins dosing in Phase IIa trial of ASC30 for obesity treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-06-2025
- Business
- Yahoo
Ascletis Announces First Participants Dosed in U.S. Phase I Clinical Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor for the Treatment of Psoriasis
- The Phase I trial evaluates the safety, tolerability and preliminary efficacy of ASC50 for the treatment of psoriasis.- Preclinical data, including higher oral exposure, longer half-life and strong efficacy, support ASC50 as a potential best-in-class once-daily oral agent for the treatment of psoriasis. HONG KONG, June 17, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that the first healthy participants have been dosed in a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability and preliminary efficacy of ASC50 (NCT07024602) for the treatment of psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis. The Phase I clinical trial of ASC50 oral tablets, conducted at multiple sites in the U.S., is a randomized, double-blind, placebo-controlled, first-in-human study of both healthy participants and patients with mild-to-moderate plaque psoriasis. ASC50 oral tablets are developed in house at Ascletis. "We are pleased to announce completion of dosing of the first participants ahead of schedule and to begin clinical development of ASC50 for psoriasis." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "We are looking forward to the topline data from this study in the near future." About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange ( To learn more about Ascletis, please visit Contact: Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) pr@ ir@ View original content: SOURCE Ascletis Pharma Inc.


Associated Press
18-06-2025
- Business
- Associated Press
Ascletis Announces First Participants Dosed in U.S. Phase I Clinical Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor for the Treatment of Psoriasis
- The Phase I trial evaluates the safety, tolerability and preliminary efficacy of ASC50 for the treatment of psoriasis. - Preclinical data, including higher oral exposure, longer half-life and strong efficacy, support ASC50 as a potential best-in-class once-daily oral agent for the treatment of psoriasis. HONG KONG, June 17, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, 'Ascletis') announces that the first healthy participants have been dosed in a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability and preliminary efficacy of ASC50 ( NCT07024602 ) for the treatment of psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis. The Phase I clinical trial of ASC50 oral tablets, conducted at multiple sites in the U.S., is a randomized, double-blind, placebo-controlled, first-in-human study of both healthy participants and patients with mild-to-moderate plaque psoriasis. ASC50 oral tablets are developed in house at Ascletis. 'We are pleased to announce completion of dosing of the first participants ahead of schedule and to begin clinical development of ASC50 for psoriasis.' said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, 'We are looking forward to the topline data from this study in the near future.' About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange ( To learn more about Ascletis, please visit Contact: Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) [email protected] [email protected] View original content: SOURCE Ascletis Pharma Inc.