Skye Bioscience announces clinical development plan in obesity for nimacimab

Skye Bioscience plans to develop nimacimab, the Company’s monoclonal antibody recently acquired from Bird Rock Bio, for weight loss and the treatment of obesity. The Company has filed an Investigational New Drug application with the U.S. Food and Drug Administration for the initiation of a Phase 2 clinical study of nimacimab in patients with obesity and chronic kidney disease. Nimacimab is a negative-allosteric modulating antibody targeting the cannabinoid 1 receptor, which has been implicated as an important target in multiple cardiometabolic diseases including obesity and renal complications. Obesity and kidney disease are highly correlated: 80% of patients who have kidney disease are also obese; 30% of obese patients have kidney disease. Moreover, the role of CB1 as an important regulator of appetite/satiety and diabetic renal complications has been demonstrated preclinically as well as clinically with a number of small molecule inverse agonists/antagonists. However, their efficacy has been hampered by mechanism-based safety issues related, in particular, to side effects of the central nervous system. Nimacimab effectively inhibits CB1 signaling and, based on preclinical and early clinical studies, is devoid of the CNS liabilities typically seen by small molecule drugs that target the CB1 receptor because it does not cross the blood-brain barrier. Skye owns the worldwide rights to nimacimab, with patents issued in the U.S. and other territories including claims to cannabinoid 1 receptor antibodies with inverse agonist function. The safety and tolerability assessments from the completed Phase 1b study of nimacimab in non-alcoholic fatty liver disease patients with diabetes or prediabetes demonstrated no serious adverse events, no early terminations of treatment due to adverse events, and no adverse events of concern occurring in a dose-dependent manner. Encouraging trends were observed in exploratory biomarkers of cholesterol, liver enzymes and liver function in patients receiving nimacimab versus placebo after the three-week dosing period. Moreover, pharmacokinetic assessment of nimacimab highlighted a half-life of approximately three weeks, potentially allowing for monthly dosing. The drug is formulated in pre-filled syringes enabling convenient patient self-administration.