Core Viewpoint - The approval of the IND for ASC30 by the FDA marks a significant milestone for the company, paving the way for clinical development in the large diabetes treatment market [3] Group 1: Clinical Trials and Research - The company has received FDA approval for the IND of ASC30, an oral small molecule GLP-1 for a Phase II clinical trial in diabetic subjects [1] - The Phase II study is a 13-week, randomized, double-blind, placebo-controlled, multi-center trial aimed at evaluating the efficacy, safety, and tolerability of ASC30 in type 2 diabetes patients [1] - Approximately 100 type 2 diabetes subjects will be enrolled across multiple centers in the U.S., with participants randomly assigned to treatment groups of 40 mg, 60 mg, and 80 mg of ASC30, as well as matching placebo groups [1] Group 2: Efficacy and Safety Results - The recently completed Phase II study for ASC30 in obesity showed significant weight loss results, with 20 mg, 40 mg, and 60 mg doses achieving weight reductions of 5.4%, 7.0%, and 7.7% respectively, all statistically significant and clinically meaningful [2] - The overall discontinuation rate due to adverse events in the obesity study was 4.8%, indicating a favorable safety profile [2] - The gastrointestinal tolerability of ASC30 was comparable to that of orforglipron, with a lower incidence of vomiting observed [2] Group 3: Product Development - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered both orally once daily and via subcutaneous injection monthly to quarterly, targeting obesity, diabetes, and other metabolic diseases [2]
歌礼制药-B(01672)宣布ASC30在糖尿病受试者中的 13周II期研究IND获美国FDA批准