Core Insights - Ascletis Pharma Inc. presented promising results for its oral small molecule GLP-1 receptor agonist ASC30, demonstrating significant body weight reduction in participants with obesity during a 28-day multiple ascending dose study [3][4][9] Group 1: Study Results - ASC30 achieved a 6.5% placebo-adjusted mean body weight reduction from baseline in MAD cohort 2 after 28 days of treatment [4] - In MAD cohort 1, ASC30 showed a 4.5% placebo-adjusted mean body weight reduction from baseline after the same treatment duration [4] - The study indicated no signs of a plateau effect at Day 29, suggesting continued efficacy [4] Group 2: Safety and Tolerability - ASC30 was found to be safe and well tolerated, with only mild to moderate gastrointestinal adverse events reported [2][6] - No serious adverse events were recorded, and there were no Grade 3 or higher adverse events observed [7] - The titration strategy from 2 mg to 5 mg in MAD cohort 1 resulted in zero incidence of vomiting, indicating an appropriate escalation pace [6] Group 3: Pharmacokinetics - Higher doses of ASC30 (20 mg and 40 mg) demonstrated a superior pharmacokinetic profile, with a positive correlation between the area under the curve (AUC) and body weight reduction [5] - The pharmacokinetic data showed that the maximum concentration (Cmax) for MAD cohort 2 was 397 ng/mL, compared to 272 ng/mL for MAD cohort 1 [5] Group 4: Future Outlook - The company anticipates reporting topline results from the 13-week Phase IIa study of ASC30 in the fourth quarter of this year [9] - ASC30 is positioned as a differentiated treatment option for obesity, with both oral and subcutaneous administration routes [10][11]
Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting