Skye Bioscience Inc.(US:SKYE) Globenewswire·2025-11-05 12:05Core Insights - Skye Bioscience, Inc. announced positive topline data from its Phase 2 study of nimacimab, showing that it effectively reduces weight regain when combined with semaglutide compared to semaglutide alone [1][2] Study Results - In a 12-week post-treatment analysis, participants receiving nimacimab 200 mg weekly plus semaglutide experienced only 18.1% weight regain, significantly lower than the 49.8% regain observed in the semaglutide-only group [2] - The combination group maintained significant weight loss compared to the placebo group (p=0.006), while the semaglutide-only group lost significance (p=0.12) [2] - The combination therapy resulted in a weight loss of -13.2% compared to -10.25% for semaglutide alone (p=0.0372) [2] Waist Circumference Changes - The combination of nimacimab and semaglutide led to a reduction in waist circumference of -11.26 cm compared to -8.09 cm for semaglutide alone, with a statistically significant difference of -3.17 cm (p=0.0492) [3] Future Development Plans - The company plans to conduct a dose-ranging study to determine the optimal dosing of nimacimab in both monotherapy and combination settings, despite initial monotherapy results not showing significant weight loss [3][4] - Skye aims to position nimacimab as a versatile treatment option in the obesity treatment paradigm, potentially addressing multiple needs beyond just being a non-incretin add-on [3] Company Overview - Skye Bioscience focuses on developing next-generation therapeutics for metabolic health, particularly through the modulation of G-protein coupled receptors [4] - The company is currently conducting a Phase 2a clinical trial for nimacimab, which is designed to assess its efficacy in combination with GLP-1R agonists [4][5]