Skye Bioscience announced that its experimental obesity drug nimacimab failed to achieve the primary goal of significantly reducing body weight in adults during a mid-stage Phase 2a trial, leading to a steep drop of over 60% in the company’s stock price. Nimacimab, a weekly subcutaneous injection designed to block the CB1 receptor involved in appetite regulation, produced only a 1.26% placebo-adjusted weight loss after 26 weeks, far short of the anticipated 5% to 8% reduction.
Despite the disappointing monotherapy results, nimacimab showed encouraging additive effects when combined with Novo Nordisk’s GLP-1 agonist Wegovy. Patients receiving the combination lost 13.2% of their body weight versus 10.25% for those on Wegovy alone, suggesting potential synergy worth further exploration. The drug was well tolerated with no increases in neuropsychiatric or gastrointestinal side effects typically associated with this drug class.
Skye attributed the failure largely to lower-than-expected drug exposure at the tested dose and indicated plans to explore higher doses to optimize efficacy. The trial enrolled 136 adults with overweight or obesity, and although the monotherapy did not meet statistical significance, experts remain cautiously optimistic about the combination’s potential.
The results represent a significant setback for Skye’s obesity pipeline but provide important clinical insights as the company evaluates next steps in developing nimacimab and combination therapies.
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