Skye Bioscience presents Phase 1b data from nimacimab study

Skye Bioscience (SKYE) announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease at the European Association for the Study of Diabetes Annual Meeting. The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts. Importantly, there were no serious adverse events, no discontinuations due to adverse events, and no evidence of neuropsychiatric safety signals. Gastrointestinal side effects were infrequent and mild, underscoring the potential differentiated tolerability profile of this peripheral CB1-inhibiting antibody. “These Phase 1b results provide an early glimpse of the benchmark safety and tolerability profile that we believe sets nimacimab apart within the broader anti-obesity medicine landscape,” said Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye Bioscience. “Obesity is a multi-factorial disease with overlapping pathways across key organs including the liver, adipose tissue, and muscle. While our immediate focus is on the upcoming topline readout from our CBeyond Phase 2a obesity study, these favorable findings in an obese, diabetic MASLD population help establish nimacimab’s potential role in the treatment of metabolic diseases.” This Phase 1b study was previously conducted by Bird Rock Bio, Inc., which Skye acquired in 2023.