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Highlights

  • Phase 1b trial showed nimacimab was safe, well-tolerated, and predictable.
  • No serious adverse events, discontinuations, or neuropsychiatric safety concerns reported.
  • Gastrointestinal side effects observed were infrequent and mild across dose cohorts.

Skye Bioscience, Inc. (Nasdaq:SKYE), a clinical-stage biotechnology company developing therapies for obesity and metabolic health disorders, presented results from its Phase 1b study of nimacimab at the European Association for the Study of Diabetes (EASD) Annual Meeting. The trial evaluated nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD), an increasingly recognized condition linked to obesity and metabolic dysfunction.

The study demonstrated that nimacimab, a peripheral CB1-inhibiting antibody, was safe and well-tolerated across multiple ascending dose cohorts. The drug showed predictable pharmacokinetics and low immunogenicity, supporting further clinical development. Importantly, researchers reported no serious adverse events, no trial discontinuations due to adverse events, and no evidence of neuropsychiatric safety signals, which have been a concern with earlier-generation CB1 inhibitors.

Mild gastrointestinal effects were noted in some participants, but these side effects were infrequent, suggesting a potentially differentiated tolerability profile. This distinction may be important as therapeutic development continues in the anti-obesity and metabolic disease space, where treatment adherence is often influenced by tolerability.

Commenting on the trial results, Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye Bioscience, stated:

“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. 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.”

The Phase 1b study was initially conducted by Bird Rock Bio, Inc., a company Skye Bioscience acquired in 2023. With this acquisition, Skye integrated nimacimab into its clinical pipeline, expanding its portfolio of metabolic disease programs.

The upcoming topline data from the CBeyond™ Phase 2a obesity study will provide further insight into nimacimab’s clinical profile and potential therapeutic applications. For now, the Phase 1b results presented at EASD highlight a favorable early safety and tolerability foundation as the investigational therapy advances through later-stage clinical testing.