Structure Therapeutics Inc. (NASDAQ: GPCR) has recently reported positive topline data from its phase 2a obesity study and capsule to tablet PK study for its oral non-peptide small molecule GLP-1 receptor agonist GSBR-1290. The results showed a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 6.2% in the phase 2a obesity study and up to 6.9% in the capsule to tablet PK study, both at 12 weeks.
In the phase 2a obesity study, GSBR-1290 demonstrated a placebo-adjusted mean decrease in weight of 6.2% at 12 weeks, with 67% of treated participants achieving ≥6% weight loss and 33% achieving ≥10% weight loss, compared to 0% for the placebo. The capsule to tablet PK study demonstrated a placebo-adjusted mean weight loss of up to 6.9% with the tablet formulation at 12 weeks.
The safety and tolerability results for GSBR-1290 were favorable, with low adverse event-related study discontinuations. The most common adverse events were gastrointestinal-related, with nausea and vomiting being the leading adverse events. There were zero cases of drug-induced liver injury or persistent liver enzyme elevations reported across the two studies.
The company plans to initiate a 36-week phase 2b study in obesity in the fourth quarter of 2024 and aims to submit an IND to the FDA in the third quarter of 2024 to support initiation of trials in chronic weight management.
GSBR-1290 is an orally-available, small molecule agonist of the glucagon-like-peptide-1 receptor, designed to be a biased GPCR agonist, selectively activating the G-protein signaling pathway. The company is also developing next-generation combination GLP-1R candidates together with GIP, amylin, glucagon, and apelin oral small molecules.
Structure Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions. The company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the manufacturing scalability limitations of traditional biologic and peptide therapies.
The company's CEO, Raymond Stevens, expressed satisfaction with the topline results, highlighting the substantial weight loss effect of GSBR-1290 and its potential to become a best-in-class oral small molecule GLP-1RA. The positive data from the phase 2 studies are encouraging for the development of GSBR-1290 as a potential future therapeutic for obesity and related diseases.
The press release also indicated that the global prevalence of obesity is expected to reach 1 billion by 2030, emphasizing the need for oral treatments, including small molecules, which are easier to manufacture at scale, more stable for transport and storage, and cost-effective.
The company plans to host a conference call and webcast to discuss the results further. As a result of these announcements, the company's shares have moved 60.4% on the market, and are now trading at a price of $54.84. For more information, read the company's full 8-K submission here.
