Skye Bioscience Advances to 600mg Nimacimab Cohort After Safe 400mg Dosing
Skye Bioscience’s safety committee approved enrollment in Cohort 2 of its CBeyond Part C Expansion Study after four participants completed four 400 mg IV nimacimab doses with no serious or special-interest adverse events. Cohort 2 will test 600 mg IV weekly in six active and two placebo participants over 15 weeks.
1. CRC Approval and Safety Findings
The Cohort Review Committee unanimously approved the initiation of Cohort 2 after four participants in Cohort 1 received weekly 400 mg IV doses without reporting any serious adverse events or adverse events of special interest over four weeks of treatment.
2. Study Design and Cohort 2 Details
The Part C Expansion Study will randomize eight participants in Cohort 2 in a 3:1 ratio to receive 600 mg IV nimacimab or placebo weekly for 15 weeks (16 doses), followed by a 12-week follow-up to gather safety and pharmacokinetic data.
3. Development Implications
Advancing to the 600 mg dose expands safety and PK profiling for nimacimab’s potential as a CB1-targeting therapy for obesity and metabolic disorders, supporting comparisons with small-molecule inhibitors and combination strategies with GLP-1 receptor agonists.