Benzinga - by Vandana Singh, Benzinga Editor.
Structure Therapeutics Inc. (NASDAQ:GPCR) unveiled 12-week topline obesity data from its Phase 2a study of GSBR-1290.
In the Phase 2a obesity study, GSBR-1290 demonstrated a clinically meaningful and statistically significant placebo-adjusted mean decrease in weight of 6.2% at 12 weeks.
At Week 12, 67% of GSBR-1290 treated participants achieved ≥6% weight loss, and 33% achieved ≥ 10% weight loss, compared to 0% for placebo.
A capsule-to-tablet PK study designed to explore a new tablet formulation of GSBR-1290 demonstrated a placebo-adjusted mean weight loss of up to 6.9% with the tablet formulation at 12 weeks.
In addition, the tablet formulation demonstrated comparable exposure to the prior capsule formulation, and pharmacokinetic data support dose-proportional exposure and a once-daily dose profile of GSBR-1290.
GSBR-1290 demonstrated generally favorable safety and tolerability results following repeated, daily dosing of up to 120mg.
As expected for the GLP1-RA drug class, leading adverse events (AEs) were gastrointestinal (GI)-related and the two most common AEs were nausea and vomiting.
Structure plans to submit an investigational new drug application (IND) to the FDA in the third quarter of 2024 to support the initiation of trials in chronic weight management and initiate a Phase 2b obesity study of GSBR-1290 in the fourth quarter of 2024.
The 36-week global study is expected to use the tablet formulation of GSBR-1290 and includes approximately 300 participants who will be treated with multiple doses and dose titration regimens.
“These topline results demonstrate the substantial weight loss effect of GSBR-1290 and its potential to become a best-in-class oral small molecule GLP-1RA as well as an ideal backbone for future combination therapeutics for the treatment of obesity and related diseases,” said Raymond Stevens, Founder and CEO of Structure. “We designed GSBR-1290 to be dosed once a day and are pleased to see the competitive treatment effect at 12 weeks, dose-proportional exposure, and target engagement over 24 hours.”
Price Action: GPCR shares are up 15.2% at $39.41 at last check Monday.
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