Structure Posts Positive Topline Results From GSBR-1290 Trials In Obesity; Stock Up In Pre-market

(RTTNews) - Structure Therapeutics Inc. (GPCR), a clinical-stage global biopharmaceutical company focused on metabolic and cardiopulmonary diseases, announced Monday positive 12-week topline obesity data from its Phase 2a study of GSBR-1290, along with positive topline results from its capsule to tablet PK study.

The company noted that both studies achieved their primary and secondary objectives, and that it would move into a Phase 2b study in overweight and obese individuals.

In pre-market activity on the Nasdaq, Structure shares were gaining around 16.6 percent to trade at $39.86.

Structure said it plans to submit an IND to the FDA in the third quarter of 2024 to support initiation of trials in chronic weight management and thereafter 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 include around 300 participants to be treated with multiple doses and dose titration regimens.

The double-blind, 12-week placebo-controlled Phase 2a clinical trial enrolled 64 healthy overweight or obese participants that were randomized to GSBR-1290 120mg or placebo, dosed once daily with weekly dose titrations.

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.

Further, the company noted that 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.

According to Structure, GSBR-1290 demonstrated generally favorable safety and tolerability results following repeated, daily dosing up to 120mg.

Raymond Stevens, Founder and CEO of Structure, said, "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. 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."

Stevens added that as a non-peptide small molecule, the company's large-scale manufacturing process is expected to be more than capable of meeting the anticipated global demand of a product with the profile of GSBR-1290.

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