Skye Bioscience (Nasdaq: SKYE) has commented on Novo Nordisk's Phase 2a top-line data for monlunabant, a small-molecule oral CB1 inverse agonist. The study met its primary endpoint, showing at least 6% placebo-adjusted weight loss at 16 weeks. However, dose-dependent neuropsychiatric side effects were observed.
Skye highlights the advantages of their large-molecule CB1 inhibitor, nimacimab, over small-molecule approaches. Nimacimab has shown minimal brain accumulation in preclinical studies and no neuropsychiatric adverse events in Phase 1 trials. Skye believes nimacimab offers a potential safety advantage due to its peripheral restriction.
Skye's Phase 2 trial of nimacimab in obesity, launched in August 2024, is expected to report interim weight loss data in Q2 2025 and top-line data in Q4 2025. The company remains confident in nimacimab's development plan and its potential for a wider therapeutic indexcompared to small-molecule CB1 inhibitors.