Skye Bioscience Forms Advisory Board for Nimacimab Development

15 July 2024

Skye Bioscience (Nasdaq: SKYE), a biotechnology company focused on innovative therapeutic drugs targeting the endocannabinoid system, has announced the formation of a Clinical Advisory Board (CAB). This board consists of esteemed academics and experts in metabolic diseases, particularly obesity, and will provide strategic and scientific guidance for the development of Skye's lead candidate, Nimacimab. Nimacimab is a cannabinoid 1 (CB1) receptor inhibitor slated to begin a Phase 2 clinical trial for obesity treatment in the third quarter of 2024.

Punit Dhillon, Chief Executive Officer and Chairman of Skye, expressed enthusiasm about the advisory board's formation. "We are honored to unite these world-class obesity experts as we continue to advance the clinical development of Nimacimab for the treatment of obesity," Dhillon said. He highlighted the critical role the advisory board's members would play in offering strategic oversight and aiding Skye as it prepares to launch the Phase 2 trial.

The Clinical and Scientific Advisory Board comprises several prominent figures:

- Lee Kaplan, MD, Ph.D.: Professor of Medicine and Chief of the Division of Obesity Medicine at the Geisel School of Medicine at Dartmouth, Dr. Kaplan also directs the Dartmouth Weight and Wellness Center. He chairs the U.S. Obesity Medicine Fellowship Council and has contributed significantly to the understanding of obesity through over 250 published papers.

- Louis Aronne, MD: A leading authority on obesity treatment, Dr. Aronne is the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medical College. He directs the Center for Weight Management and Metabolic Clinical Research and has authored over 60 papers on obesity.

- Rekha Kumar, MD, M.S.: Associate Professor of Clinical Medicine at Weill Cornell Medical College, Dr. Kumar specializes in endocrine and metabolic disorders, including obesity and type 2 diabetes. She is also the Chief Medical Officer of Found Health.

- Marcus DaSilva Goncalves, MD, Ph.D.: An Associate Professor of Medicine and Director of Systemic Metabolism Research at NYU Langone Health, Dr. Goncalves focuses on the systemic regulation of body weight and metabolism. His research aims to develop novel treatments for obesity and related metabolic diseases.

- Beverly Tchang, MD: A triple board-certified physician in obesity medicine, Dr. Tchang is an Assistant Professor of Clinical Medicine at Weill Cornell. She has extensive experience in treating obesity and training professionals in the field.

- Eduardo Muñoz, MD, Ph.D.: A Professor of Immunology at the University of Córdoba in Spain, Dr. Muñoz leads research on the mechanisms of action of cannabinoids and endocannabinoids. He has published nearly 200 articles and holds several patents.

- Giovanni Appendino, Ph.D.: Professor of Organic Chemistry at the University of Eastern Piedmont in Italy, Dr. Appendino's research has led to the discovery of over 200 novel compounds, including phytocannabinoids. He has authored over 400 peer-reviewed articles and numerous patents.

Nimacimab, a humanized monoclonal antibody, acts as a negative allosteric modulator inhibiting CB1 signaling in the periphery. This inhibition has shown promise in addressing diseases with significant unmet needs, such as obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).

Skye Bioscience is dedicated to exploiting the pharmaceutical potential of the endocannabinoid system to tackle diseases involving metabolic, inflammatory, and fibrotic processes. The company aims to commence a Phase 2 clinical trial for Nimacimab in obesity during Q3 2024, comparing its efficacy as a monotherapy and in combination with a GLP-1R agonist.

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