Skye Bioscience’s Nimacimab Fails Mid-Stage Obesity Trial, Stock Plummets

Nimacimab, Skye Bioscience’s experimental CB1-targeting obesity drug, failed to meet its primary endpoint in a Phase 2a clinical trial, with patients on the drug achieving only 1.5% weight loss—marginally above placebo (0.26–0.3%) and far below the 10.25% seen with semaglutide alone135.

When combined with semaglutide (the active ingredient in Novo Nordisk’s Wegovy), nimacimab showed improved efficacy, with patients losing an average of 13.2% of body weight compared to over 10% with semaglutide alone135.

Skye attributed the disappointing monotherapy results to potentially suboptimal dosing (200 mg weekly subcutaneous injection), and plans to explore higher doses in future studies135.

The drug demonstrated a favorable tolerability profile, with no increase in gastrointestinal or psychiatric side effects—a notable concern for drugs in its class13.

Skye’s stock fell by up to 60% in early trading following the announcement135.

The company now plans to focus resources on its metabolic program, with further development of nimacimab as a potential adjunct therapy for obesity4.

Sources:

1. https://www.biopharmadive.com/news/skye-bioscience-nimacimab-cb1-obesity-drug-results/802002/

3. https://www.fiercebiotech.com/biotech/skyes-shares-crater-cb1-blocker-fails-reduce-weight-phase-2-obesity-study

4. https://www.fiercebiotech.com/biotech/skye-bioscience-ends-eye-disease-rd-after-glaucoma-drugs-phase-2-fail

5. https://www.gurufocus.com/news/3131951/skye-biosciences-skye-shares-plunge-after-trial-setback

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