Skye Bioscience Initiates 400mg/600mg IV Expansion Study, Reports 22.3% Weight Loss
Skye Bioscience launched its 400mg and 600mg IV CBeyond Expansion cohorts to evaluate nimacimab safety and pharmacokinetics, with topline data due in Q4 2026. Interim 52-week data reveal 22.3% weight loss with nimacimab plus semaglutide and over 50% less weight regain in a 13-week follow-up versus semaglutide.
1. Expansion Study Initiation
Skye Bioscience has started the CBeyond Expansion Study Part C, enrolling 16 participants across two IV dose cohorts (400 mg and 600 mg) randomized 3:1 versus placebo to evaluate nimacimab’s safety and pharmacokinetics over 15 weeks plus a 12-week follow-up, with topline results due in Q4 2026.
2. Interim 52-Week Combination Results
In the February 2026 interim update, participants receiving 200 mg nimacimab plus 2.4 mg semaglutide achieved a mean 22.3% weight loss at 52 weeks with no plateau, maintained a placebo-like safety profile including no neuropsychiatric adverse events, and demonstrated over 50% less weight regain (17.8% vs. 37.3%) in a 13-week off-treatment follow-up compared to semaglutide alone.
3. FDA Feedback and Phase 2b Planning
Following a Type C meeting, Skye received written FDA minutes guiding the Phase 2b protocol design, focusing on dose selection, duration, endpoints and inclusion criteria for nimacimab monotherapy and combination arms, with an adaptive framework under evaluation to optimize peripheral exposure-response.
4. Preclinical APC Platform and Pipeline
Skye’s antigen-peptide conjugate program merges nimacimab’s CB1 inhibition with GLP-1 receptor agonists in a single unimolecular therapeutic; preclinical proof-of-concept data show the APC dosed every three days matches the efficacy of daily combination regimens, and the company licensed ENHANZE technology for high-volume subcutaneous delivery.