Structure Therapeutics has reported encouraging new data from a midstage clinical trial and pharmacokinetics study, bolstering the case for their once-daily oral treatment for
obesity. The biotech company revealed a 6% weight reduction during a phase 2a trial, a significant improvement that has positively influenced investor sentiment.
Back in December 2023, Structure Therapeutics faced skepticism from investors when they presented initial data on their oral
GLP-1 candidate, which aims to reduce blood sugar and weight. At the time, investors were unimpressed, especially when comparing the results to leading competitors like
Eli Lilly’s Zepbound and
Novo Nordisk’s Wegovy. Consequently, Structure's shares plummeted to $29. However, the recent data release has reversed some of these losses, with the company's stock rising 16% to $39.65.
The phase 2a trial of
GSBR-1290 demonstrated a placebo-adjusted mean weight reduction of 6.2% over 12 weeks. Notably, 67% of the patients treated with GSBR-1290 achieved a weight loss of at least 6%, while 33% saw a reduction of 10% or more, a stark contrast to the placebo group, which saw no significant weight loss. In a separate pharmacokinetics study focusing on a tablet formulation of GSBR-1290, participants experienced a placebo-adjusted mean weight loss of up to 6.9% over the same period. This study also indicated that the tablet form offers comparable bioavailability to the capsule, supporting the feasibility of a once-daily dosing regimen.
Safety remains a critical concern in the development of GLP-1 therapies, a market segment dominated by
Eli Lilly and Novo Nordisk. These leading treatments have shown substantial weight loss but are often accompanied by gastrointestinal side effects and muscle loss. Structure Therapeutics reported that GSBR-1290 generally exhibited favorable safety and tolerability profiles. In the phase 2a study, the most common side effects were gastrointestinal, such as nausea and vomiting, yet these were mostly well managed. The discontinuation rates were relatively low at 5% in the obesity study and 11% in the pharmacokinetics study. Importantly, there were no reported cases
of liver injury, a problem observed with some earlier oral GLP-1 treatments, including one from
Pfizer.
Raymond Stevens, Ph.D., CEO of Structure Therapeutics, expressed optimism about the results, stating, “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 treating obesity and related diseases.”
Looking ahead, Structure Therapeutics plans to apply the insights from the dosing studies to a phase 2b trial. The safety findings suggest that a higher dose could be safely tested. This upcoming trial, expected to commence in the fourth quarter, will involve 300 participants and will utilize the tablet formulation of GSBR-1290. The company aims to submit an investigational new drug application to the FDA in the third quarter to facilitate this 36-week study.
This new data brings renewed optimism to Structure Therapeutics' efforts to carve out a space in the competitive obesity treatment market, potentially offering a safer and effective oral alternative to current therapies.
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