Skye Bioscience, Inc. (NASDAQ:SKYE) ("Skye") a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, has treated the first patient in its Part C expansion study of the CBeyond Phase 2a trial to characterize safety and pharmacokinetics (PK) at exposures designed to challenge the peripheral restriction of nimacimab through intravenous (IV) administration over 16 weeks of treatment. These doses will set the benchmark for the safety profile of nimacimab and support higher dosing in combination with incretin therapies.
The expansion study comprises two cohorts of nimacimab monotherapy (400 mg IV and 600 mg IV) compared to placebo administered weekly over 15 weeks (16 doses), with a 12 week follow-up period, to generate preliminary safety and PK data with administration of higher doses. Based on the Company's translational work, 400 mg IV and 600 mg IV correspond to approximately ~700 mg and 1,000 mg subcutaneous dosing, respectively, and are projected to achieve substantially higher peripheral tissue exposure than the 200 mg subcutaneous dose tested in the Phase 2a study. Within each dose cohort, 8 participants will be randomized in a 3:1 ratio to nimacimab (n=6) or placebo (n=2). Enrollment in Cohort 2 (600 mg IV) is contingent on a favorable safety review of the first participants completing four weeks of treatment in Cohort 1 (400 mg IV) by an independent Cohort Review Committee. We expect to report topline data from the expansion study in the fourth quarter of 2026.