Skye Completes 26-week Treatment Phase in Phase 2a CBeyond™ Study

Core Insights - Skye Bioscience, Inc. has completed the treatment phase for the last patient in its Phase 2a CBeyond™ clinical trial evaluating nimacimab for obesity, with topline data expected in late Q3/early Q4 of 2025 [1][3] Group 1: Clinical Trial Details - The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study focusing on weight loss, safety, tolerability, and metabolic biomarkers in adults with obesity and overweight [2] - The primary endpoint of the trial is to compare weight change from baseline to 26 weeks between nimacimab and placebo [2] - An exploratory arm of the trial is assessing the combination of semaglutide (Wegovy®) with nimacimab versus semaglutide with placebo [2] Group 2: Study Progress and Future Plans - Skye has completed enrollment for a 26-week extension of the Phase 2a trial, which aims to provide data on 52 weeks of treatment with nimacimab, either as monotherapy or in combination with semaglutide [5] - Patients who completed the initial 26 weeks were eligible for the extension, potentially leading to a total treatment duration of 52 weeks followed by a 12-week follow-up [5] - Data from the extension study is expected to be reported in Q1 2026 [5] Group 3: Company Strategy and Market Context - Skye is focused on developing new therapeutic pathways for metabolic health, particularly through the modulation of G-protein coupled receptors [6] - The company believes that peripheral CB1 inhibition via an antibody presents a promising alternative to existing GLP-1 weight loss drugs, which may not meet all patients' needs [4] - Skye aims to advance nimacimab as a potential new therapeutic option for obesity and overweight, addressing limitations of current treatments [4]