Skye Bioscience Achieves Over 50% Enrollment in Phase 2 Obesity Study

Skye Bioscience, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq under the symbol SKYE, announced on November 14, 2024, that it has surpassed 50% of its targeted patient enrollment for the CBeyond™ Phase 2 clinical trial. This trial is evaluating nimacimab, a CB1 inhibitor, in patients dealing with overweight or obesity issues. Skye anticipates releasing interim data for this trial in the second quarter of 2025, once the first batch of enrolled patients completes their 26-week treatment period.

Dr. Puneet Arora, Skye’s Chief Medical Officer, expressed gratitude towards the study participants and clinical investigators for their enthusiasm and efficiency. He noted that the current enrollment pace might allow the company to present topline data sooner than expected next year. He emphasized the importance of this rigorous clinical trial, which is evaluating several critical parameters, and looked forward to advancing nimacimab further.

Punit Dhillon, President and CEO of Skye, highlighted that CB1 inhibition has shown potential in preclinical and clinical studies to contribute significantly to sustainable anti-obesity drug regimens. He pointed out that nimacimab, Skye’s monoclonal antibody, stands out as the most peripherally restricted CB1 inhibitor compared to the most regulated small molecules. Recent preclinical data has shown that CB1 inhibition outside the brain can drive significant weight loss, which supports the potential of nimacimab in achieving metabolic benefits and fat loss without affecting CB1 receptors in the brain.

Dhillon further elaborated on nimacimab’s strong safety profile. In Phase 1 and preclinical studies, there were no instances of neuropsychiatric adverse events, a common issue with small-molecule CB1 inhibitors due to their unavoidable interaction with CB1 in the brain. Additionally, nimacimab demonstrated better gastrointestinal tolerability than GLP-1 receptor agonists. CB1 inhibition has also shown favorable outcomes with respect to preserving lean mass. With these qualities, nimacimab is well-positioned to play a groundbreaking role in realizing the therapeutic benefits of CB1 inhibition as a significant non-incretin alternative.

The CBeyond™ Phase 2 Clinical Trial is a randomized, double-blind study that aims to enroll 120 patients across four treatment groups. The primary goal is to evaluate the weight loss effects of nimacimab compared to a placebo. An exploratory endpoint will assess the combination of nimacimab and Wegovy® against a placebo and Wegovy®. Additionally, secondary and other exploratory endpoints will focus on safety and tolerability, neuropsychiatric and cognitive outcomes, changes in body composition using dual-energy X-ray absorptiometry (DEXA), metabolic parameters, and improvements in sleep patterns.

Skye Bioscience is dedicated to exploring new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. The company’s strategy involves leveraging biologic targets with substantial human proof of mechanism to develop first-in-class therapeutics that stand out clinically and commercially. Skye is currently conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) for nimacimab, a negative allosteric modulating antibody that inhibits CB1 peripherally. This study also examines the combination of nimacimab with a GLP-1R agonist (Wegovy®).

Skye’s approach aims to unlock new therapeutic pathways for metabolic health, and nimacimab represents a significant step forward in this mission, potentially offering a breakthrough treatment option for obesity with a promising safety profile.