On Friday, Skye Bioscience, Inc. (NASDAQ:SKYE) announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.
The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts.
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.
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The Phase 1b study was previously conducted by Bird Rock Bio, Inc., which Skye acquired in 2023.
“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.”
Investment firm William Blair expects Phase 2a CBeyond 26-week topline data of nimacimab by the end of the month or early next quarter in obesity and overweight.
Skye management has guided to placebo-adjusted weight loss expectations of 5%-8% for monotherapy and additive weight loss for the Wegovy combination, with no occurrences of neuropsychiatric events, forming the basis of the base case assumption.
Analyst Andy Hsieh writes that cannabinoid receptor 1 (CB1R) inverse agonism/antagonism represents a promising modality that could serve as either an alternative or combination partner for GLP-1 receptor agonists, and first-generation CB1R antagonists and inverse agonists provide clinical validation for the approach.
Specifically, negative modulation of CB1R appears to induce weight loss with a lower degree of adverse gastrointestinal events and muscle mass retention.
While development of first-generation versions was halted due to psychiatric adverse events, the analyst writes that this headwind is mitigated by nimacimab's preferential targeting of peripherally located CB1 receptors through the use of an antibody, and initial Phase 1 data, along with recent preclinical experiments, support this hypothesis.
William Blair recognizes that competition is fierce in the obesity space, owing in large part to the unprecedented success of GLP-1 receptor drugs, such as Novo Nordisk's (NYSE:NVO) Ozempic and Eli Lilly's (NYSE:LLY) Zepbound.
However, given the sizable addressable market and the increasing focus on tolerability and maintaining patients on therapy, the analyst says that nimacimab's clinical success could translate into significant upside for investors. William Blair maintains the Outperform rating on Skye shares.
Price Action: SKYE stock was trading higher by 0.76% to $3.97 at last check Friday.
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