Skye Bioscience, Inc. (NASDAQ:SKYE), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that the Cohort Review Committee (CRC) responsible for reviewing safety data generated from the CBeyond Part C Expansion Study, and for approving the opening of enrollment in Cohort 2 has unanimously approved opening the second cohort of the CBeyond Part C Expansion study. The CRC focuses exclusively on the safety of the Part C Expansion Study and does not conduct efficacy assessments. The independent Data Monitoring Committee (DMC) continues to have safety oversight for the study.

The Expansion Study comprises two cohorts of nimacimab monotherapy (400 mg IV and 600 mg IV) compared with placebo, administered weekly over 15 weeks (16 doses), with a 12-week follow-up period, to generate preliminary safety and PK data with higher doses. Within each dose cohort, 8 participants will be randomized in a 3:1 ratio to nimacimab (n=6) or placebo (n=2). The CRC approved enrollment in Cohort 2 (600 mg IV) based on a favorable safety review of the first participants who completed 4 weeks of treatment in Cohort 1 (400 mg IV).