By Fineline Cube 
China-based Ascletis Pharma Inc. (HKG: 1672) has announced positive top-line results from a Phase Ib multiple ascending dose (MAD) study for its investigational GLP-1R biased small molecule agonist, ASC30. The study was conducted in the US among participants with obesity (BMI: 30-40 kg/m²). These results highlight the potential of ASC30 as a promising treatment option for obesity.
ASC30: Unique Administration Flexibility
ASC30 is a novel chemical entity (NCE) with U.S. and global compound patent protection until 2044. A key feature of ASC30 is its unique administration flexibility, allowing it to be formulated as both an oral tablet and a subcutaneous injection. This versatility enhances its potential as a versatile treatment option for obesity.
Clinical Trial Results
In the study, participants who received ASC30 orally once daily for four weeks with weekly dose escalation (2 mg, 10 mg, 20 mg, and 40 mg) experienced an average body weight reduction of 6.5% relative to baseline after placebo calibration. Another cohort, receiving ASC30 at doses of 2 mg, 5 mg, 10 mg, and 20 mg, showed an average body weight reduction of 4.5%. Notably, no vomiting was reported in the 40 mg dose group. These results support the safety and efficacy profile of ASC30.
Future Development
The positive tolerability and efficacy data from the Phase Ib study have informed the design of a 13-week Phase IIa study for ASC30 as an oral once-daily tablet. The study protocol has been submitted to the U.S. Food and Drug Administration (FDA), adopting a “lower starting dose and slower titration” strategy.-Fineline Info & Tech