Ultra-Long-Acting Platform

Search documents
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
Prnewswire· 2025-07-28 00:15
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]
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
Prnewswire· 2025-06-18 00:00
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]