Skye Bioscience's Investigational Drug Disappoints As Monotherapy For Weight Loss

Core Insights - Skye Bioscience Inc. (NASDAQ:SKYE) experienced a significant decline in stock price following the release of topline data from its 26-week Phase 2a CBeyond study of nimacimab, which did not meet its primary endpoint for weight loss compared to placebo [1][6] Study Results - The nimacimab monotherapy arm showed a weight loss of -1.52% compared to -0.26% for placebo, indicating a failure to achieve the primary endpoint [1] - In the combination cohort, nimacimab 200 mg plus semaglutide resulted in a weight loss of -13.2% compared to -10.25% for semaglutide alone, with statistical significance (p=0.0372) [2] - 100% of patients in the combination arm achieved >5% weight loss, while 67% achieved >10% weight loss, compared to 85% and 50% respectively for semaglutide alone [4] Safety Profile - Nimacimab 200 mg demonstrated a favorable safety profile with tolerability similar to placebo, and no increase in gastrointestinal (GI) adverse events when combined with semaglutide [3][5] - Rates of GI adverse events were 27% for nimacimab alone versus 29.5% for placebo, and 57.1% in combination with semaglutide versus 66.7% for semaglutide alone [5] - No neuropsychiatric concerns were reported, with no increases in anxiety, insomnia, or depression observed [6] Pharmacokinetics and Further Studies - Preliminary pharmacokinetic analysis indicated lower than expected drug exposure of nimacimab, suggesting the need for evaluation of higher dosing [1] - The findings support potential further studies to evaluate combinations of nimacimab and incretin-based therapies [2]