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Skye Bioscience Surpasses 50% Patient Enrollment in CBeyond Phase 2 Trial for Nimacimab

18 Nov 2024
Admin
News Article

Skye Bioscience Surpasses 50% Patient Enrollment in CBeyond Phase 2 Trial for Nimacimab

Skye Bioscience surpasses 50% patient enrollment in CBeyond phase 2 trial of differentiated CB1 inhibitor, nimacimab to treat patients with overweight or obesity

Overview

Skye Bioscience, Inc., a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, announced that it has achieved more than 50% of targeted patient enrollment for its CBeyond phase 2 clinical trial assessing nimacimab, a differentiated CB1 inhibitor, in patients with overweight or obesity. Skye expects to report interim data for the CBeyond phase 2 clinical trial in Q2 2025 after this initial set of enrolled patients has completed the 26-week treatment period.

Words from the CMO: Skye

“We are grateful for the amazing motivation and responsiveness shown by our study participants and clinical investigators in the assessment of this first-in-class drug candidate for weight loss. The current pace of patient enrollment may also shorten our timeline to topline data next year. We will provide a further update after reaching full enrollment,” said Puneet Arora, MD, Skye’s chief medical officer.
“This is a rigorous clinical trial evaluating multiple important parameters. We look forward to advancing nimacimab through this program and getting this phase 2 data next year.”

Words from the CEO: Skye Bioscience

“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.
“Within the class, our monoclonal antibody, nimacimab, is the most peripherally restricted CB1 inhibitor, even compared to the most peripherally restricted small molecules. Importantly, our recently announced preclinical diet-induced obesity model data provides evidence for sufficiency of CB1 inhibition outside the brain to drive meaningful weight loss.”
“We believe the effects of nimacimab in the periphery cause metabolic gains and directly cause fat loss, while modulating hunger and increasing satiety without the need to inhibit CB1 receptors in the brain.
Dhillon added: “With virtually undetectable accumulation in the brain, we believe nimacimab has the best safety profile among CB1 inhibitors. In phase 1 and preclinical studies of nimacimab, there were no observations of neuropsychiatric adverse events, a risk and outcome that plagues small-molecule CB1 inhibitors with their to-date unavoidable engagement with CB1 in the brain.”
“Notably, nimacimab’s gastrointestinal tolerability far exceeds GLP-1 receptor agonists, and CB1 inhibition has displayed favourable outcomes with respect to lean mass preservation. With these attributes, we believe nimacimab is well-positioned to play a breakthrough role in realizing the therapeutic benefits of CB1 inhibition as an important non-incretin alternative.”

About the Trial

This clinical trial is a randomized, double-blind study designed to enroll 120 patients across four treatment groups.
The primary endpoint will evaluate the difference in weight loss of nimacimab compared to placebo.
An exploratory endpoint will assess a combination of nimacimab and Wegovy compared to placebo and Wegovy.
Secondary and other exploratory endpoints will assess safety and tolerability; neuropsychiatric and cognitive outcomes; change in body composition by dual-energy X-ray absorptiometry (DEXA); metabolic parameters; and improvement in sleep.

About the Company

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors.