Structure Therapeutics’ GLP-1 receptor agonist GSBR-1290 achieved mean weight loss of 6.2% in overweight or obese patients. The company’s shares jumped to a six-month high on the news Monday.
Structure Therapeutics reported topline mid-stage results for its GLP-1 receptor agonist GSBR-1290 on Monday, with the experimental pill producing a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 6.2% in overweight or obese patients.
The oral small molecule was evaluated in a Phase IIa trial as well as a capsule to tablet pharmacokinetics (PK) study testing a new tablet formulation, both of which achieved their primary and secondary objectives. The 12-week Phase IIa study of 64 obese or overweight patients resulted in mean weight loss of 6.2%. At week 12, about two-thirds of patients lost 6% or more of their body weight and the other third lost 10% or more, compared to 0% for placebo.
The company also tested a new tablet formulation of the experimental drug, which outperformed the Phase IIa study. In this trial, patients achieved mean weight loss of 6.9% with the tablet at 12 weeks, with Structure noting that its future studies would likely use the new formulation.
The GLP-1 also demonstrated “generally favorable” safety and tolerability, the company said. The two most common adverse events reported were nausea and vomiting, resulting in study discontinuation in 5% of people in the Phase IIa trial and 11% in the capsule to tablet PK study. Neither study resulted in any drug-induced liver injury or persistent liver enzyme elevations.
The results suggest Structure’s GSBR-1290 is competitive with a once-daily GLP-1 drug currently being developed by Eli Lilly, orforglipron, an oral alternative to the company’s injectable Zepbound or to competitor Novo Nordisk’s injectable Wegovy. These oral formulations have the potential to be both easier to take and cheaper to produce than the injectable medications.
“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,” Structure CEO Raymond Stevens said in a statement. “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.”
Structure’s shares jumped 58% on the news with its stock price hitting $54.05 by midday Monday, the highest it’s been since December 2023 when disappointing results in a Phase IIa study of type 2 diabetes patients sent shares tumbling.
Structure is continuing to push forward with GSBR-1290. The company intends to submit an IND to the FDA by the fall, with the aim of launching a 36-week Phase IIb global obesity study involving 300 participants to be treated with multiple doses and dose titration regimens using the tablet formulation. Structure plans on initiating the study by the fourth quarter of 2024.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
