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

Structure Therapeutics Inc. (GPCR), a global biopharmaceutical company in the clinical-stage phase that specializes in metabolic and cardiopulmonary conditions, has unveiled promising 12-week topline obesity data from its Phase 2a study of GSBR-1290. Additionally, they reported positive topline outcomes from a pharmacokinetic (PK) study comparing their capsule and tablet forms.

The company confirmed that both studies met their primary and secondary goals, and they are now proceeding to a Phase 2b study targeting overweight and obese individuals.

In pre-market activity on the Nasdaq, Structure shares surged about 16.6%, reaching $39.86.

Looking ahead, Structure announced plans to submit an Investigational New Drug (IND) application to the FDA by the third quarter of 2024. This submission aims to support the initiation of trials focused on chronic weight management. Subsequently, they intend to launch a Phase 2b obesity study of GSBR-1290 in the fourth quarter of 2024.

This 36-week global study will utilize the tablet formulation of GSBR-1290 and will include approximately 300 participants, treated with various doses and dose titration regimens.

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

In the Phase 2a obesity study, GSBR-1290 achieved a significant placebo-adjusted mean weight reduction of 6.2% at 12 weeks. By Week 12, 67% of participants treated with GSBR-1290 reached at least a 6% weight loss, and 33% reached at least a 10% weight loss, compared to 0% in the placebo group.

Furthermore, a capsule-to-tablet PK study demonstrated that the new tablet formulation of GSBR-1290 achieved a placebo-adjusted mean weight loss of up to 6.9% at 12 weeks.

Structure also noted that GSBR-1290 showed generally favorable safety and tolerability profiles with repeated daily dosing up to 120mg.

Raymond Stevens, Founder and CEO of Structure, commented, "These topline results highlight the significant weight loss potential of GSBR-1290 and its promise as a leading oral small molecule GLP-1 receptor agonist (GLP-1RA), positioning it as an ideal foundation for future combination therapies for obesity and related conditions. Designed for once-daily dosing, we are encouraged by the competitive treatment effect observed at 12 weeks, dose-proportional exposure, and 24-hour target engagement."

Stevens further added that, as a non-peptide small molecule, their large-scale manufacturing process is expected to sufficiently meet the anticipated global demand for GSBR-1290.

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