Skye Says CBeyond Phase 2a Study Of Nimacimab Monotherapy Did Not Meet Primary Endpoint

(RTTNews) - Biotechnology company Skye Bioscience, Inc. (SKYE) announced Monday the topline data from its 26-week Phase 2a CBeyond proof-of-concept study of nimacimab, its peripherally-restricted CB1 inhibitor antibody.

In CBeyond, the nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo. Preliminary pharmacokinetic analysis showed an association between exposure and response, suggesting that the 200 mg, subcutaneous weekly dose was suboptimal as a monotherapy.

In the combination cohort, nimacimab 200 mg (subcutaneous, weekly) plus semaglutide demonstrated a clinically meaningful magnitude of weight loss compared to semaglutide alone, with no plateau being observed through Week 26. At the tested dose and exposure levels, nimacimab 200 mg demonstrated a favorable safety profile with placebo-like tolerability. In combination with semaglutide, there was no increase in gastrointestinal (GI) adverse events. Importantly, there were no increases in neuropsychiatric adverse events reported resulting from treatment with nimacimab.

In Monday's pre-market trading, SKYE shares are plummeting $2.75 or 57.9 percent to $2.00.