Skye Reports Positive CBeyond Phase 2a Extension Interim Study Results for Nimacimab in Combination With Semaglutide

Core Insights - Skye Bioscience announced interim 52-week data from the Phase 2a CBeyond study of nimacimab, a peripherally-restricted CB1 inhibitor antibody, showing promising weight loss results in combination with semaglutide [1][9] Study Design and Participant Details - The CBeyond extension study began in May 2025, involving participants who completed 26 weeks of treatment with either nimacimab plus semaglutide or placebo plus semaglutide [2] - A total of 19 participants from the combination cohorts entered the extension study, with 10 in the nimacimab plus semaglutide arm and 9 in the placebo plus semaglutide arm [2] Weight Loss Results - Participants in the nimacimab plus semaglutide arm experienced a mean weight loss of 14.4% at 26 weeks, with an additional 7.9% lost during the extension, totaling 22.3% after 52 weeks [3][8] - In the placebo plus semaglutide arm, mean weight loss was 13.9% at 26 weeks, with an additional 5.8% lost during the extension, resulting in a total of 19.7% after 52 weeks [4] Comparison with Previous Data - The combination of nimacimab and semaglutide achieved a clinically meaningful weight loss of -13.2% compared to semaglutide alone at 26 weeks [5] - The overall weight loss for all participants in the nimacimab plus semaglutide group was -13.6% at 26 weeks, with a follow-up weight regain of only 17.8% during a 13-week off-therapy period [6][10] Safety and Tolerability - The combination therapy demonstrated a strong safety profile, with no serious adverse events reported during the extension period [3][8] - The treatment was well tolerated at the tested doses, reinforcing the potential for nimacimab as a safe option in obesity treatment [9][11] Future Outlook - The company anticipates that further optimization of nimacimab dosing could lead to even greater weight loss and improved outcomes in future clinical trials [9][11] - Full topline reporting of the CBeyond Phase 2a extension data, including monotherapy data, is expected in Q3 2026 [11]