Skye Bioscience, Inc. has announced that its CBeyond phase 2 clinical trial evaluating nimacimab, a CB1 inhibitor, for the treatment of overweight and obesity has achieved over 50% of its targeted patient enrollment. The company anticipates reporting interim data in Q2 2025, pending the completion of the 26-week treatment period for the initial group of enrolled patients.
Nimacimab's Novel Approach to Weight Loss
Nimacimab is a monoclonal antibody designed to inhibit the CB1 receptor peripherally, with minimal accumulation in the brain. This approach aims to mitigate the neuropsychiatric adverse events observed with small-molecule CB1 inhibitors that engage with CB1 receptors in the brain. Preclinical data suggests that nimacimab's peripheral CB1 inhibition can drive meaningful weight loss, cause metabolic gains and directly cause fat loss, while modulating hunger and increasing satiety.
"CB1 inhibition has been shown in preclinical and clinical studies to have attributes with the potential to play a distinct role in achieving the goal of healthier, more sustainable anti-obesity drug regimens," said Punit Dhillon, president & chief executive officer of Skye Bioscience. "Within the class, our monoclonal antibody, nimacimab, is the most peripherally restricted CB1 inhibitor, even compared to the most peripherally restricted small molecules."
CBeyond Trial Design and Endpoints
The CBeyond trial is a randomized, double-blind study designed to enroll 120 patients across four treatment groups. The primary endpoint is the difference in weight loss between nimacimab and placebo. An exploratory endpoint will assess the combination of nimacimab and Wegovy compared to placebo and Wegovy.
Secondary and exploratory endpoints include assessments of safety and tolerability, neuropsychiatric and cognitive outcomes, changes in body composition via dual-energy X-ray absorptiometry (DEXA), metabolic parameters, and improvements in sleep.
Safety and Tolerability Profile
In phase 1 and preclinical studies, nimacimab has shown no neuropsychiatric adverse events. The company emphasizes that nimacimab's gastrointestinal tolerability exceeds that of GLP-1 receptor agonists, and CB1 inhibition has demonstrated favorable outcomes in preserving lean mass.
