Structure Therapeutics’ oral obesity drug elicited a placebo-adjusted weight loss of 16.3% at 44 weeks in a Phase 2 trial. The biotech is planning to launch a late-stage program for the drug later this year.
Structure Therapeutics’ investigational GLP-1 pill achieved placebo-adjusted weight loss that analysts say could compete with the leaders in the space: Novo Nordisk’s oral Wegovy and Eli Lilly’s orforglipron.
A follow-up readout at 44 weeks from the Phase 2 ACCESS II study “shows what we believe to be a competitive profile vs. orforglipron and the Wegovy Pill,” BMO Capital Markets analysts wrote to investors in a Monday morning note.
Structure is trading at $59.49 before the opening bell on Monday, up 10.9% from its closing price on Friday.
ACCESS II enrolled 85 adults with obesity or who are overweight and suffering from at least one weight-related comorbidity. The trial tested three doses of Structure’s oral GLP-1 drug aleniglipron: 120 mg, 180 mg and 240 mg. At the 44-week follow-up, patients given the 180-mg dose hit a placebo-adjusted mean weight reduction of 16.3%, an effect that was highly statistically significant, according to the company’s press release.
The magnitude of weight loss was slightly lower with the 240-mg dose, hitting 16% at 44 weeks.
Structure also presented 56-week data from the ACCESS open-label extension study, showing up to 16.2% reduction in weight with a 120-mg dose at 56 weeks. Both ACCESS II and the open-label extension have yet to show signs of plateauing, according to the biotech.
“Even at the 180mg dose, efficacy looks to be highly competitive and better than orforglipron and the Wegovy pill,” BMO wrote.
As for safety, Structure detected one discontinuation in ACCESS II linked to an adverse event. In the open-label study, 2% of patients had to stop treatment due to side effects.
There might be some investor concern regarding these safety signals, BMO conceded, adding that while these cases are still relatively infrequent, they “are something we’re watching.” Structure “is working to further optimize dose titrations, using a low and slow method,” the analysts said.
With these data in hand, Structure aims to push aleniglipron into late-stage development later this year.
The oral obesity field is racing toward a pivotal moment, with an FDA greenlight for orforglipron expected to come on or before April 10. If approved, the drug will complete a GLP-1 trifecta for Lilly—alongside its tirzepatide brands Mounjaro and Zepbound—that analysts forecast could top $100 billion in peak sales. At the moment, however, Novo enjoys a monopoly on the weight loss pill market with oral Wegovy, approved late last year.
