Core Insights - Ascletis Pharma Inc. announced positive topline results from its 13-week Phase II study of ASC30, an oral GLP-1 receptor agonist for obesity treatment, showing statistically significant weight loss compared to placebo [3][4][12] - ASC30 demonstrated a dose-dependent mean body weight reduction of 5.4%, 7.0%, and 7.7% for doses of 20 mg, 40 mg, and 60 mg respectively, with no observed plateau in weight loss [4][5] - The study included 125 participants with obesity or overweight and at least one weight-related comorbidity, achieving a placebo-adjusted mean weight loss of 7.7% at the highest dose [3][4] Efficacy and Safety - 80% of participants taking 60 mg of ASC30 lost at least 5% of their body weight, compared to 4.2% in the placebo group, and 45% lost 7% of their body weight [5] - ASC30 also met secondary endpoints, showing reductions in cardiovascular risk markers such as total cholesterol, LDL-C, triglycerides, and blood pressure across all doses [6] - No significant gastrointestinal adverse events were reported, with a total treatment discontinuation rate due to adverse events at 4.8% [7][8] Tolerability - The vomiting rate for ASC30 was approximately half that of orforglipron, indicating better gastrointestinal tolerability [7][10] - All gastrointestinal adverse events were mild to moderate, with no severe events reported [8][9] - The company anticipates further improvement in gastrointestinal tolerability in Phase III studies when titration is adjusted to every four weeks [9][10] Future Plans - Ascletis plans to submit the Phase II study data to the U.S. FDA and request an End-of-Phase II meeting in Q1 2026 [10] - The company is focused on developing ASC30 as a potential best-in-class treatment for chronic weight management, with ongoing research and development efforts [14]

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]