Skye Bioscience Stock Plummets 60% on Failed Obesity Drug Trial
Nimacimab monotherapy misses primary weight-loss endpoint, though combination with semaglutide shows promise, raising questions for the drug's future.
Shares of Skye Bioscience (SKYE) in premarket trading after the company announced its experimental weight-loss drug, nimacimab, missed the primary goal in a mid-stage clinical trial.
The San Diego-based pharmaceutical company revealed that nimacimab, when used as a standalone therapy, of demonstrating a statistically significant reduction in body weight compared to a placebo after 26 weeks. Patients in the monotherapy arm of the Phase 2a study saw an average weight reduction of just 1.52%, a figure not meaningfully different from the 0.26% seen in the placebo group.
In its official announcement, suggesting the dose was likely too low, with pharmacokinetic analysis indicating a lower-than-expected drug exposure. The company stated that the 200 mg weekly dose was likely suboptimal for a monotherapy regimen.
Despite the monotherapy setback, Skye Bioscience highlighted a silver lining from a separate arm of the study. When nimacimab was administered in combination with semaglutide, the active ingredient in blockbuster weight-loss drugs like Wegovy and Ozempic, it showed a statistically significant benefit. Patients on the combination therapy achieved a 13.2% weight loss, compared to 10.25% for those on semaglutide alone. The company also noted that the combination showed no plateau in weight loss by the end of the 26-week period.
Critically, nimacimab maintained a favorable safety profile. The drug was designed as a peripherally-restricted CB1 inhibitor to avoid the severe neuropsychiatric side effects that plagued earlier drugs in this class, leading to their withdrawal from the market. Skye reported no such adverse events and noted placebo-like tolerability, even in combination with semaglutide.
Investors, however, focused on the headline failure of the monotherapy, triggering a massive sell-off that erased a significant portion of the company's market value. The path forward for nimacimab now appears to hinge on its potential as a combination therapy. Skye Bioscience management has stated they are evaluating the next steps, which may include exploring higher doses and further combination studies. Detailed results from the trial are expected to be presented at the ObesityWeek conference in November.