Clinical TrialMay 20, 2026, 07:02 AM
Skye Bioscience Advances Nimacimab to 600 mg IV Dose in Obesity Study
AI Summary
Skye Bioscience announced that its Cohort Review Committee (CRC) unanimously approved opening the second cohort (600 mg IV) of the CBeyond Part C Expansion Study for nimacimab. This decision follows a favorable safety review of participants who completed 4 weeks of treatment in Cohort 1 (400 mg IV), with no neuropsychiatric adverse events reported. The expansion study aims to gather preliminary safety and pharmacokinetic data at higher doses of nimacimab, a potential treatment for obesity and metabolic health disorders.
Key Highlights
- CRC approved opening Cohort 2 (600 mg IV) for nimacimab in CBeyond Part C Expansion Study.
- Approval based on favorable safety review of Cohort 1 (400 mg IV) participants.
- No neuropsychiatric adverse events reported at 400 mg IV dose to date.
- Expansion Study evaluates nimacimab monotherapy (400 mg IV, 600 mg IV) vs. placebo.
- Nimacimab administered weekly for 15 weeks (16 doses) with 12-week follow-up.
- Each cohort randomizes 8 participants (6 nimacimab, 2 placebo).
- Goal is to obtain additional safety and PK data at higher drug exposures.
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