Structure Therapeutics Inc. (GPCR) on Monday announced positive topline data from the ACCESS clinical program of aleniglipron for the treatment of people with obesity and/or overweight with at least one weight related co-morbidity. The company's shares were more than 14% up in pre-market trading.
The results include 44-week data from the Phase 2 ACCESS II study and interim findings from the ongoing body composition study and the ACCESS open-label extension (OLE) study. In the Phase 2 ACCESS II study, aleniglipron achieved placebo-adjusted mean weight loss of 16.3% at the 180 mg dose and 16% at the 240 mg dose at 44 weeks, meeting both clinically meaningful and statistically significant thresholds. In the ACCESS OLE study, the drug showed continued weight loss from 36 weeks to 56 weeks, reaching 16.2% weight loss with the 120 mg dose, with no evidence of a weight-loss plateau in either study.
Updated interim data from the ACCESS OLE and Body Composition studies also indicated improved tolerability, with low discontinuation rates of 2% to 3.4% due to adverse events using a lower 2.5 mg starting dose.
Structure Therapeutics said it has scheduled a Type B End-of-Phase 2 meeting with the U.S. Food and Drug Administration in the second quarter of 2026 to finalize the design of the Phase 3 program.
The company expects to initiate the Phase 3 program in the second half of 2026.
Structure Therapeutics shares closed at $53.75 on Friday, down 1.52%.
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