Skye Bioscience Hosts Virtual Event on CB1 Inhibition and Details Phase 2 Nimacimab Trial with Sleep Apnea Endpoints

Skye Bioscience, Inc. (Nasdaq: SKYE), a clinical-stage biopharmaceutical company, is set to host a virtual event titled “Metabolic Rewiring with CB1 Inhibition,” focusing on its drug candidate Nimacimab. The event, scheduled for July 24, 2024, will feature discussions on the scientific foundations of Nimacimab, a peripheral CB1 inhibitor, and the design of the CBeyond™ Phase 2 clinical trial. Additionally, Skye will introduce its collaboration with Beacon Biosignals to assess sleep quality and sleep apnea in the Phase 2 trial.

The event will be conducted online, and registration is needed to join the webcast. A replay of the presentation will also be available on Skye’s website. The event aims to provide insights from obesity experts and Skye’s management team on current obesity treatments, the potential of peripheral CB1 inhibition, and the preliminary and Phase 1 clinical data on Nimacimab. Other topics include the finalized goals and design of the CBeyond™ Phase 2 trial, the introduction of the collaboration focused on sleep disturbances, and an overview of Nimacimab’s clinical development plan. A Q&A session will allow for further discussion.

Tu Diep, Chief Development Officer at Skye, emphasized the potential of Nimacimab as a unique and complementary treatment for obesity, particularly in comparison to existing treatments like GLP-1 receptor agonists. The event will highlight the expertise of key opinion leaders in obesity research.

The CBeyond™ Phase 2 Clinical Trial is designed to begin screening patients in August 2024, with interim data expected by Q2 2025 and topline data by Q4 2025. The trial will involve 120 patients divided into four treatment groups. Eighty patients will receive either Nimacimab or a placebo weekly in a double-blinded design, while another forty patients will receive either Nimacimab combined with Wegovy® or a placebo combined with Wegovy® in a partially-blinded design. The Wegovy® administration will follow a titration protocol up to a maximum dose of 2.4 mg weekly. The participants will undergo treatment for 26 weeks, followed by a 13-week safety monitoring period. The primary endpoint is weight loss evaluation in the Nimacimab group compared to the placebo group. Secondary endpoints include safety, tolerability, neuropsychiatric and cognitive assessments, changes in body composition, and key metabolic parameters. Exploratory endpoints will examine the combination of Nimacimab and Wegovy®, differences in weight loss and body composition between the two drugs, and improvements in sleep.

The trial will target patients with obesity or those overweight with at least one weight-related co-morbidity such as dyslipidemia, cardiovascular disease, obstructive sleep apnea (OSA) syndrome, or controlled arterial hypertension. Patients with diabetes will be excluded from the study. The trial will be conducted at 18 clinical sites in the U.S.

In relation to OSA and sleep disturbances, Skye has partnered with Beacon Biosignals to use their EEG analytics platform. This collaboration aims to enhance the assessment of sleep quality in the Phase 2 trial. The trial will employ Beacon’s Dreem Headband to collect sleep data from a subset of 40 patients across all study arms. Multi-night data collection will occur during screening and at several points throughout the trial to measure sleep patterns and apnea events, such as sleep efficiency and the apnea-hypopnea index (AHI).

Nimacimab is a humanized monoclonal antibody that inhibits CB1 signaling in the periphery, showing potential for treating various conditions, including obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH). Skye’s strategic focus on developing novel therapeutic pathways for metabolic health is supported by life science investors, aiming to create first-in-class therapeutics with both clinical and commercial potential.

Skye plans to initiate the Phase 2 clinical trial for Nimacimab in obesity by Q3 2024, comparing the effects of Nimacimab alone and in combination with a GLP-1R agonist.