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Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Submission of 13-week Phase IIa Study Protocol to FDA
GLPGlobal Partners LP(GLP) Prnewswire·2025-04-22 23:30

Core Insights - Ascletis Pharma Inc. announced positive topline results from its Phase Ib study of ASC30, an oral once-daily tablet for obesity treatment, demonstrating significant body weight reductions compared to placebo [3][10] - The study utilized three different weekly titration schemes, with the most effective showing a 6.5% placebo-adjusted mean body weight reduction after four weeks [4][5] Group 1: Study Design and Results - The Phase Ib study was randomized, double-blind, and placebo-controlled, conducted in the U.S. with participants having a BMI of 30-40 kg/m² [3] - Three dosing schemes were tested: - Scheme 1 (mid starting dose, slow titration) resulted in a 4.5% placebo-adjusted weight reduction - Scheme 2 (mid starting dose, normal titration) resulted in a 6.5% placebo-adjusted weight reduction - Scheme 3 (high starting dose, fast titration) resulted in a 5.0% placebo-adjusted weight reduction [4][5] - No serious adverse events were reported across all schemes, indicating a favorable safety profile [6] Group 2: Future Development Plans - Based on the Phase Ib results, the company plans to initiate a 13-week Phase IIa study with a "lower starting dose and slower titration" strategy, expected to begin in Q3 2025 [7] - The study protocol has been submitted to the U.S. FDA following preliminary consultations [7] Group 3: Product Information - ASC30 is a first and only investigational small molecule GLP-1 receptor biased agonist, designed for both oral and subcutaneous administration [8][11] - The compound has patent protection until 2044, highlighting its potential for long-term market exclusivity [11] Group 4: Company Overview - Ascletis Pharma Inc. is an innovative biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases and addressing unmet medical needs globally [12] - The company has multiple clinical-stage drug candidates in its pipeline, emphasizing its commitment to research and development [12]