Core Insights - Ascletis Pharma Inc. is set to present data from its Phase Ib clinical study of the oral GLP-1 receptor agonist ASC30 at the 61st EASD Annual Meeting in Vienna, Austria [1][2] - The company is on track to report topline data from a Phase IIa clinical study of ASC30 in participants with obesity or overweight by the fourth quarter of 2025 [1] Group 1: Clinical Study and Presentation - The 28-day multiple ascending dose study of ASC30 demonstrated superior weight loss in participants with obesity [2] - The short oral discussion will take place on September 16, 2025, from 12:00 to 13:00 CEST, with presentation number 827 [2] Group 2: Product Information - ASC30 is a new chemical entity (NCE) with unique properties allowing for both oral tablet and subcutaneous injection administration, protected by U.S. and global patents until 2044 [3] Group 3: Company Overview - Ascletis Pharma Inc. focuses on developing and commercializing therapeutics for metabolic diseases, utilizing its proprietary AI-assisted drug discovery platform [5] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [5]

Core Insights - Ascletis Pharma Inc. announced promising efficacy results from a study combining ASC47, a muscle-preserving weight loss drug candidate, with tirzepatide in diet-induced obese (DIO) mice [3][9] Group 1: Efficacy Results - The combination of ASC47 low dose with tirzepatide resulted in an 87% greater reduction in body weight compared to tirzepatide monotherapy, with average total body weight reductions of 38.1% versus 20.4% respectively [1][5] - ASC47 low dose combined with tirzepatide demonstrated a statistically significant increase in efficacy compared to ASC47 low dose combined with semaglutide, achieving 87% weight loss versus 55% [1][5] Group 2: Body Composition Restoration - The combination therapy restored the body composition of obese mice to levels similar to healthy non-obese mice, with total muscle mass percentages of 60.4% for the combination group compared to 62.0% for healthy controls [2][8] - Tirzepatide monotherapy did not restore body composition to healthy levels, indicating the potential superiority of the ASC47 and tirzepatide combination [8] Group 3: Drug Properties - ASC47 is a first-in-class, adipose-targeted, once-monthly subcutaneously injected thyroid hormone receptor beta (THRβ) selective small molecule agonist, developed in-house by Ascletis [4] - The drug's unique properties allow for high drug concentrations in adipose tissue, which may contribute to its efficacy in weight loss [4]

Core Insights - Ascletis Pharma Inc. has completed enrollment for its 13-week Phase IIa study of ASC30, a small molecule oral GLP-1 receptor agonist aimed at treating obesity, with 125 participants enrolled in just over one month [2][3]. Group 1: Study Details - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, focusing on participants with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² but < 30 kg/m²) who have at least one weight-related comorbidity [3][4]. - Two oral formulations of ASC30 are being evaluated: formulation 1 (ASC30 tablets) and formulation 2 (ASC30 tablets A1), with a primary endpoint of mean percentage body weight change from baseline at Week 13 [3][4]. - The study protocol starts with a low dose of 1 mg for both formulations, with weekly titrations to maintenance doses of 20 mg and 40 mg for formulation 1, and 20 mg, 40 mg, and 60 mg for formulation 2 [3]. Group 2: Product Information - ASC30 is a first and only investigational small molecule GLP-1R biased agonist, designed for both once-daily oral and once-monthly subcutaneous injection dosing options for obesity treatment [4][5]. - The compound has U.S. and global patent protection until 2044, ensuring its exclusivity in the market [5]. Group 3: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary platforms for drug discovery [6]. - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6].

Core Insights - Ascletis Pharma Inc. has initiated a 12-week Phase IIa study in the U.S. for its once-monthly subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30, targeting participants with obesity or overweight and at least one weight-related comorbidity [3][6] - The ASC30 formulation has demonstrated a 36-day half-life in a Phase Ib study, supporting its monthly administration [4][5] - Topline data from the Phase IIa study is expected in the first quarter of 2026 [2][6] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) [9][10] - ASC30 is a unique investigational GLP-1R biased small molecule agonist that can be administered both orally and subcutaneously, with patent protection until 2044 [8][10] Study Details - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, involving approximately 65 participants with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² but < 30 kg/m²) [6] - The study consists of three cohorts with different doses to evaluate safety, tolerability, and efficacy [6] Technical Insights - The ultra-long-acting SQ depot formulation of ASC30 has a peak-to-trough ratio of less than 2:1, which is critical for achieving acceptable tolerability for SQ dosing of incretin drugs [2][5] - ASC30 is the only once-a-month incretin in clinical development with a half-life greater than the intended dosing interval, which is essential for optimal tolerability [5]