Ascletis Pharma Initiates Phase IIa Study for ASC30 Obesity Treatment

Ascletis Pharma has begun its Phase IIa study of ASC30, a once-monthly subcutaneous depot formulation of a small molecule GLP-1 receptor agonist for obesity treatment. The study aims to evaluate the safety, tolerability, and efficacy of ASC30, which has a 36-day half-life, supporting its monthly administration. This positions Ascletis as a competitive player in the obesity treatment market.

Ascletis Pharma Inc. has kicked off its Phase IIa study for ASC30, a once-monthly subcutaneous depot formulation of a small molecule GLP-1 receptor agonist aimed at treating obesity. The study, which began in the United States, involves participants with obesity or overweight and at least one weight-related comorbidity. The trial aims to evaluate the safety, tolerability, and efficacy of ASC30 over a 12-week period [1].

ASC30, an investigational GLP-1R biased small molecule agonist, is designed to be administered both orally and subcutaneously. Its unique properties allow for the same molecule to be used in both forms, providing flexibility in treatment options. The drug has a 36-day half-life, which supports its once-monthly administration and positions Ascletis as a competitive player in the obesity treatment market [1].

The Phase IIa study is a randomized, double-blind, placebo-controlled, and multi-center trial involving approximately 65 participants across three different dose cohorts. The trial's primary objective is to assess the safety and tolerability of ASC30, while also evaluating its efficacy in participants with obesity or overweight and at least one weight-related comorbidity. Topline data from the study are expected in the first quarter of 2026 [1].

Ascletis' proprietary Ultra-Long-Acting Platform (ULAP) technology has been instrumental in developing ASC30. This platform enables the creation of small molecule SQ compounds with extended half-lives, such as ASC30 and ASC47, which have half-lives of 36 days and 40 days, respectively, in participants with obesity. This technology avoids the limitations of albumin-dependent half-life extension technology, which limits half-life extension to the half-life of albumin (approximately 20 days) [1].

In order to achieve acceptable tolerability for SQ dosing of incretin drugs, the peak-to-trough ratio during the intended dosing interval should be equal to or less than 2:1. The peak-to-trough ratios of marketed semaglutide and tirzepatide are approximately 2:1 during their intended dosing interval. ASC30's peak-to-trough ratio is less than 2:1, supporting its optimal tolerability for once-monthly SQ administration [1].

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. The company utilizes its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and ULAP to develop multiple drug candidates in-house, including ASC30 [1].

References
[1] https://finance.yahoo.com/news/ascletis-announces-first-participants-obesity-001500073.html