Structure’s aleniglipron elicited over 11% weight loss in a Phase II trial, sending the biotech’s stock up nearly 103% as markets closed on Monday.
Structure Therapeutics’ investigational oral GLP-1 candidate aleniglipron elicited weight-loss of more than 11% in a mid-stage trial, efficacy that BMO Capital Markets declared “highly competitive” with leading oral obesity candidates in development.
In particular, the firm pointed to Eli Lilly’s orforglipron, noting that aleniglipron could serve as a “potential second oral small molecule entrant” in the obesity arena. “Strong weight loss, coupled with a tolerability profile comparable to Lilly’s Ph2 Orforglipron data,” the analysts added, “paint a clear path to Ph 3 and meaningfully de-risk the program in our view.”
Structure was trading at $69.98 at market close on Monday, representing a nearly 103% increase from its closing price of $34.57 on Friday.
In the Phase IIb ACCESS II study, patients on 120-mg aleniglipron achieved 11.3% placebo-adjusted weight-loss at 36 weeks, according to Structure’s Monday announcement. Lower doses of 45-mg and 90-mg elicited corresponding figures of 9.8% and 8.2%, respectively, over the same follow-up period. All three outcomes were highly statistically significant in favor of aleniglipron.
Additionally, an exploratory analysis testing a 240-mg dose of aleniglipron recorded 15.3% placebo-adjusted weight reduction at 36 weeks.
As for safety, aleniglipron’s side effects were consistent with those of the broader GLP-1 class, even at the highest tested dose level. ACCESS II did not detect episodes of drug-induced liver Injuries or persistent liver enzyme elevations. Across all doses tested, the most common adverse events were gastrointestinal.
Analysts at William Blair were similarly bullish about Structure’s data, writing in a Monday note to investors that they are “sufficient for aleniglipron to compete in the large and growing small-molecule GLP-1 receptor agonist class.” Like BMO, William Blair also compared aleniglipron to Lilly’s weight-loss pill, with the ACCESS II data nearing orforglipron’s “roughly 11%” weight loss in the Phase III ACHIEVE-1 study.
The analysts went one step further, saying that the recent bidding war between Pfizer and Novo Nordisk may have also contributed to Structure’s price movement on Monday. “The stock is currently trading up about 100% likely driven by the M&A prospect,” they wrote.
Still, William Blair believes it is “premature to declare aleniglipron as best-in-class,” especially given outstanding questions regarding the plateauing of its weight-loss effect after 36 weeks and the added benefits of higher doses.
Structure is working toward an end-of-Phase II meeting with the FDA early next year and will potentially kick off a late-stage program for aleniglipron by mid-2026, according to the Monday release.