Structure Therapeutics Announces Positive Results from Phase 2a Obesity and PK Study for GSBR-1290
Structure Therapeutics Inc., a clinical-stage biopharmaceutical company, has announced promising results from its 12-week Phase 2a study evaluating GSBR-1290 for obesity, along with positive outcomes from its capsule to tablet pharmacokinetics (PK) study. The company, listed on NASDAQ as GPCR, is recognized for developing novel oral small molecule treatments targeting metabolic and cardiopulmonary diseases.
Key Findings from Phase 2a and PK Studies:
In the Phase 2a obesity study, GSBR-1290 achieved a statistically significant and clinically meaningful placebo-adjusted mean weight loss of 6.2% (p<0.0001) over 12 weeks. Notably, 67% of participants treated with GSBR-1290 experienced a weight loss of over 6%, while 33% saw a reduction of 10% or more, as opposed to none in the placebo group.
Additionally, the capsule to tablet PK study, aimed at assessing a new tablet formulation, demonstrated a placebo-adjusted mean weight reduction of up to 6.9% (p<0.0001) within the same period. Pharmacokinetic data indicated that the tablet formulation had comparable exposure to the original capsule form, supporting its once-daily dosing regimen.
Safety and Tolerability:
GSBR-1290 showcased favorable safety and tolerability, with low discontinuation rates due to adverse events (AEs). Common AEs were primarily gastrointestinal issues, including nausea and vomiting, which typically appeared early and subsided after dose titration. No cases of drug-induced liver injury or persistent liver enzyme elevations were reported across the studies.
Forward Plans:
Structure Therapeutics anticipates initiating a 36-week Phase 2b obesity study in the fourth quarter of 2024, using the tablet formulation of GSBR-1290. This upcoming global trial will involve approximately 300 participants and will explore various dosing and titration regimens.
Dr. Raymond Stevens, Founder and CEO of Structure Therapeutics, highlighted the significance of these findings, stating, "These topline results underscore the substantial weight loss potential of GSBR-1290, positioning it as a leading oral small molecule GLP-1 receptor agonist. The once-daily dosing and robust target engagement over 24 hours are particularly promising."
Industry Context:
The need for effective oral treatments for obesity is growing, with global prevalence expected to reach 1 billion by 2030. Oral small molecules like GSBR-1290 offer advantages in terms of manufacturing scalability, stability, and cost-effectiveness, potentially broadening treatment accessibility.
Dr. Ania Jastreboff from Yale School of Medicine emphasized the importance of these factors, noting, "The phase 2 data with GSBR-1290 are encouraging, demonstrating both safety and clinically meaningful weight reduction after 12 weeks of treatment."
Future Prospects:
Structure Therapeutics plans to submit an Investigational New Drug (IND) application to the FDA in the third quarter of 2024 to facilitate the initiation of trials in chronic weight management. The company is also preparing for a Phase 2 development plan for type 2 diabetes mellitus (T2DM), set to be determined in the second half of 2024.
GSBR-1290, an orally-available small molecule targeting the glucagon-like-peptide-1 (GLP-1) receptor, represents a key component of Structure's metabolic franchise. Beyond GSBR-1290, the company is exploring next-generation combination GLP-1 receptor candidates alongside other oral small molecules.
About Structure Therapeutics:
Structure Therapeutics is committed to developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary diseases. Leveraging its structure-based drug discovery platform, the company has built a pipeline of GPCR-targeted compounds designed to overcome the limitations of traditional biologic and peptide therapies, making them more accessible globally.
These promising developments signal a significant step forward in the fight against obesity, offering hope for more effective, scalable, and accessible treatments in the near future.
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