Skye Bioscience Inc. (NASDAQ:SKYE) experienced a significant drop in its stock price on Monday following the release of disappointing results from its Phase 2a CBeyond proof-of-concept study on nimacimab, an investigational drug for weight loss.
The company reported that the nimacimab monotherapy did not meet its primary goal of achieving weight loss as compared to the placebo group, with weight loss results of -1.52% versus -0.26% for placebo based on the modified Intent-to-Treat (mITT) analysis. This lack of efficacy has raised concerns about the drug’s viability in the competitive obesity treatment market.
Preliminary analyses also indicated that nimacimab exposure levels were lower than anticipated, suggesting the need for further evaluation of higher doses. Despite these setbacks, data from the combination group involving 200 mg of nimacimab and the diabetes medication semaglutide showed more promising results. In this cohort, patients experienced a significant weight loss of -13.2%, compared to -10.25% with semaglutide alone, with a statistically significant p-value of 0.0372.
Notably, the weight loss observed in the combination therapy did not plateau over the 26 weeks of the study, indicating sustained effectiveness. This outcome paves the way for potential future studies focusing on the combinations of nimacimab with incretin-based therapies, which include semaglutide, an active ingredient in Novo Nordisk’s (NYSE:NVO) popular weight loss medications Wegovy and Ozempic.
In terms of safety, the combination therapy showcased a favorable profile with tolerability akin to that of placebo treatments. There was no increase in gastrointestinal (GI) adverse events reported when nimacimab was used with semaglutide, as well as no noted rise in neuropsychiatric side effects.
The data also revealed impressive results in a per-protocol analysis where all patients in the combination therapy group achieved more than 5% weight loss, while this figure stood at 85% for those receiving semaglutide alone. Furthermore, 67% of patients in the combination group lost over 10% of their weight, versus 50% for semaglutide alone.
Additionally, an improvement in the lean mass to fat ratio was observed by Week 26. Participants in the nimacimab and semaglutide combination group exhibited a ratio of 0.26, compared to 0.02 in the placebo group and 0.13 in the semaglutide-only group.
The safety profile for nimacimab as a monotherapy was reassuring, showing tolerability similar to placebo with no increase in GI adverse events. Among the safety analysis population, rates of GI issues were 27% for nimacimab alone, slightly lower than the 29.5% seen with the placebo. When combining with semaglutide, GI adverse event rates were 57.1% compared to 66.7% for semaglutide alone, indicating a better safety outcome.
Importantly, no neuropsychiatric issues were identified, and there were no increases in symptoms of anxiety, insomnia, or depression among patients taking nimacimab, whether as monotherapy or in combination.
Despite some positive findings in combination therapy, the overall discontinuation rate for the CBeyond study was notable at 27%. Many of these discontinuations were attributed to adverse events, with the placebo group accounting for 60% of these cases, raising valid discussions about the overall credibility of the results concerning the standalone nimacimab treatment.
As a result of the unfavorable news, Skye Bioscience’s stock plummeted significantly, down 60% to $1.90 during premarket trading on Monday. Investors will be keenly watching how the company handles this setback and any potential future developments regarding nimacimab and its positioning in the obesity treatment landscape.
