Core Insights - Skye Bioscience announced topline data from its 26-week Phase 2a CBeyond™ study of nimacimab, a CB1 inhibitor antibody targeting obesity and metabolic disorders [1][2] Study Results - The nimacimab monotherapy did not meet the primary endpoint for weight loss, showing a placebo-subtracted weight loss of -1.26% at week 26 [6][7] - In the combination cohort, nimacimab 200 mg plus semaglutide resulted in a significant weight loss of -13.2% compared to -10.25% with semaglutide alone, with a p-value of 0.0372 [3][12] - The combination therapy did not show a plateau in weight loss through Week 26, indicating potential for continued efficacy [3][12] Safety Profile - Nimacimab demonstrated a favorable safety profile, with tolerability similar to placebo and no increase in gastrointestinal adverse events when combined with semaglutide [4][9] - No neuropsychiatric adverse events were reported with nimacimab, indicating a clean safety profile [4][13] Pharmacokinetics and Dosing Insights - Preliminary pharmacokinetic analysis indicated that the 200 mg weekly dose of nimacimab was suboptimal as a monotherapy, suggesting the need for higher dosing [2][5] - The company is considering higher dosing strategies based on preclinical data and safety margins observed in the study [5][18] Future Directions - Skye plans to evaluate the next stage of development for nimacimab, including potential follow-on Phase 2 studies to optimize dosing [5][18] - Detailed results from the 26-week treatment period will be presented at ObesityWeek in November [19]