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]

Core Insights - Ascletis Pharma Inc. has initiated a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting interleukin-17 (IL-17), aimed at treating psoriasis [2][3] - The trial is randomized, double-blind, and placebo-controlled, involving both healthy participants and patients with mild-to-moderate plaque psoriasis [3] - Preclinical data suggests that ASC50 has higher oral exposure, a longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [1] Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing innovative therapeutics for metabolic diseases [4] - The company utilizes its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) to develop drug candidates in-house [4] - Ascletis is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [4]

Core Insights - Ascletis Pharma Inc. has received FDA clearance for the investigational new drug (IND) application for ASC50, an oral small molecule IL-17 inhibitor aimed at treating mild-to-moderate plaque psoriasis [3][6] - ASC50 shows promising preclinical data, including higher oral exposure, longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [2][4] Company Overview - Ascletis is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic and other diseases while addressing unmet medical needs globally [7] - The company utilizes an Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform for drug development, with ASC50 being the first oral small molecule candidate in immunology from this platform [6] Clinical Development - The Phase I clinical trial for ASC50 will be a randomized, double-blind, placebo-controlled study conducted at multiple sites in the U.S., with patient dosing expected to start in the third quarter of 2025 [5][6] - Preclinical studies indicate that ASC50 has a lower clearance rate compared to existing oral IL-17 inhibitors currently in clinical development, suggesting a potentially advantageous pharmacokinetic profile [4]