Skye Bioscience Doses First Patient in 400 mg and 600 mg IV Nimacimab Study Expansion
Skye Bioscience has dosed the first patient in its trial expansion testing weekly 400 mg and 600 mg IV nimacimab for 16 weeks. Two 3:1 cohorts versus placebo will define peripheral exposure thresholds for Phase 2b dose selection, with topline results due Q4 2026.
1. Study Design and Dosing
The Part C expansion enrolls two cohorts of eight participants each, randomized 3:1 to receive nimacimab 400 mg or 600 mg IV weekly versus placebo over a 16-week dosing period followed by a 12-week follow-up. These IV doses correspond to approximately 700 mg and 1,000 mg subcutaneous exposure equivalents and aim to challenge nimacimab’s peripheral restriction profile.
2. Objectives and Data Timeline
Primary objectives are to characterize safety and pharmacokinetics at higher exposures, with an independent Data Monitoring Committee overseeing participant safety. Enrollment in the 600 mg cohort requires a favorable safety review of the initial 400 mg cohort after four weeks, and topline safety and PK data are expected in Q4 2026.
3. Impact on Phase 2b Development
Data from these higher-dose cohorts will establish peripheral exposure benchmarks to inform optimal dosing in a planned Phase 2b combination trial with GLP-1 therapies. Regulatory feedback on dose, duration, endpoints and patient selection will be integrated into the final Phase 2b protocol design.