ASCLETIS-B (01672) announced that ASC30's 13-week phase II study in diabetes subjects has received IND approval from the US FDA.

ASCLETIS-B (01672) announced that it has recently received approval from the Food and Drug Administration (FDA) for its new drug clinical trial (IND) of ASC30, an oral small molecule GLP-1, in diabetes patients. The phase II study is a 13-week, randomized, double-blind, placebo-controlled, and multicenter study designed to evaluate the efficacy, safety, and tolerability of ASC30 in type 2 diabetes patients. The primary endpoint of the phase II study is the average change in glycated hemoglobin (HbA1c) relative to baseline in the treatment group compared to the placebo group at 13 weeks. Secondary endpoints include the average change in fasting blood glucose relative to baseline, the average change in weight relative to baseline, and safety and tolerability compared to placebo at 13 weeks. The phase II study will enroll approximately 100 type 2 diabetes subjects at multiple centers in the United States. Subjects will be randomly assigned in a 2:3:3:2 ratio to the 40 mg, 60 mg, and 80 mg ASC30 tablet treatment groups and a matching placebo group. ASC30 will start at 1 mg and be titrated weekly to target doses of 40 mg, 60 mg, and 80 mg. Enrollment of subjects is expected to begin in the first quarter of 2026. ASCLETIS-B recently completed a 13-week phase II study (NCT07002905) evaluating the oral small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity. The study, conducted at multiple centers in the United States, included 125 obese subjects or overweight subjects with at least one weight-related comorbidity. At the primary endpoint at week 13, once-daily doses of 20 mg, 40 mg, and 60 mg ASC30 tablets achieved placebo-corrected average weight reductions of 5.4%, 7.0%, and 7.7%, respectively, with statistically significant, clinically meaningful, and dose-dependent weight loss. No weight loss plateau was observed. The vomiting rate of titrated ASC30 weekly was approximately half of that observed with titrated orforglipron. The gastrointestinal tolerability of titrated ASC30 weekly was comparable to the results of titrated orforglipron every four weeks in the phase III ATTAIN-1 study. The overall discontinuation rate due to adverse events in the phase II study of ASC30 for obesity or overweight was 4.8%. ASC30, developed by ASCLETIS-B, is the first and only small molecule GLP-1R biased agonist in clinical trials that can be taken orally once daily or administered subcutaneously monthly to quarterly for the treatment of obesity, diabetes, and other metabolic diseases. "As we continue to accumulate relevant research data on ASC30, the approval of the IND for the phase II study for diabetes treatment is an important milestone for ASCLETIS," said Dr. Jinzi Wu, founder, chairman, and CEO of ASCLETIS. "In addition, the FDA's approval of our IND application paves the way for ASC30 to enter the vast diabetes treatment market for clinical development."