Structure Therapeutics reported positive top-line results from a phase 2 trial of its GLP-1 pill, aleniglipron, at the American Diabetes Association meeting in New Orleans.
The drug, which has been touted as a potential competitor to Novo Nordisk's Wegovy and Eli Lilly's Foundayo pills, spurred up to 15.3% weight loss at 36 weeks with no signs of plateauing.
If replicated in late-stage testing, these results "could position aleniglipron as an alternative to Lilly's Foundayo," analysts at William Blair wrote today in a note to investors.
Trial participants who chose to remain on the treatment in the open-label extension study continued to lose weight after a median follow-up of 20 weeks. Weight loss reached 13.3%, 16.2% and 15.3% in the 45 mg, 90 mg and 120 mg dose groups, respectively.
Across the studies, the non-placebo-adjusted weight loss achieved with aleniglipron is around 15% between weeks 44 and 56, the analysts said.
While this percentage is greater than Foundayo's 12.4% in its Attain-1 study, it is comparable to the mid-stage results seen with the 36 mg dose of Lilly's drug, which triggered 14.2% weight loss in patients, according to the firm.
However, direct comparisons between the two drugs are challenging due to differences in trial design, the analysts noted.
For instance, higher doses were added later in the study, and the open-label portion is incomplete and has not been analyzed using a statistical model, the analysts said.
When it comes to aleniglipron's tolerability profile, "Structure is employing the 'start low and go slow' mantra, which theoretically should support an improved safety profile in the upcoming phase 3 study," the analysts added.
Although phase 3 testing is slated to begin in the third quarter of the year, William Blair analysts say it is too early to say if Structure's oral option is "differentiated against Foundayo" or could be a "best in class."
However, given the strong demand for a small-molecule GLP-1 pill, particularly in middle- and lower-income countries, there is a "considerable market opportunity" for Structure's oral option, analysts shared.
The biopharma is also developing other oral small-molecule treatments for metabolic diseases and is advancing its oral amylin receptor agonist pipeline.
Structures' lead amylin candidate, ACCG-2671, a dual amylin and calcitonin receptor agonist (DACRA), is currently in phase 1 testing and is expected to begin multiple-ascending-dose studies next quarter. Its other oral small molecule DACRA candidate, ACCG-3535, will begin clinical trials in the last quarter of the year.
Alivia Kaylor is senior editor of Xtelligent's Pharma Life Sciences, which she helped launch in 2023. She has spent nearly five years covering the biopharma industry, with a focus on GLP-1s and other obesity therapies, federal policy, clinical R&D and drug pricing.
Before becoming a full-time reporter, Alivia worked in drug manufacturing as a quality control microbiologist at a U.S. subsidiary of Daiichi Sankyo specializing in sterile injectables. She holds a bachelor of science in microbiology from Ohio State University and a master of science degree from Ohio University.
