ASCLETIS-B (01672.HK): Initiates US Phase I Study of Oral Amylin Receptor Agonist Peptide ASC36 for Obesity; Up to 13.2% Weight Loss in Non-human Primates

NewTimeSpace News: On 8 September 2026, Ascletis Pharma Inc. (stock code: 01672) issued a voluntary announcement stating that, following recent approval of an investigational new drug (IND) application by the US Food and Drug Administration (FDA), the company had initiated a Phase I study in the United States of ASC36 oral tablets, an oral amylin receptor agonist peptide, for the treatment of obesity. The study is the company's fourth peptide Phase I study this year.

According to the announcement, the Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of ASC36 in 86 subjects who are obese (BMI not lower than 30.0) or overweight (BMI not lower than 27.0). Preclinical data showed that in non-human primates, once-daily dosing of ASC36 oral tablets for seven days reduced mean body weight by up to 13.2% versus baseline and significantly reduced food intake; steady-state absolute oral bioavailability was 8% and 6% at doses of 10 mg and 25 mg, with elimination half-lives of 116 hours and 167 hours. In a head-to-head diet-induced obesity (DIO) rat model, subcutaneous ASC36 achieved approximately 32% and 91% greater weight reduction relative to eloralintide and petrelintide injections, respectively.

ASC36 is an amylin receptor agonist peptide independently developed using Ascletis's proprietary AI-assisted Structure-Based Drug Discovery (AISBDD) technology, and the oral tablet was developed and optimised using the company's proprietary Peptide Oral Transport ENhancement Technology (POTENT). Dr. Wu Jinzi, founder, chairman and chief executive officer of Ascletis, said that based on potentially superior oral bioavailability and efficacy, a lower dose of ASC36 oral tablets is expected, and the peptide's superior weight-loss effect per milligram may also lead to lower manufacturing costs at scale. The announcement contains the statement required under Rule 18A.05 of the Listing Rules, cautioning that there is no guarantee that ASC36 will ultimately be successfully developed, sold and/or commercialised.

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