Skye Bioscience Launches Phase 2 CBeyond Clinical Trial of its Differentiated CB1 Inhibitor, Nimacimab, in Patients with Obesity
CBeyond™ will assess nimacimab’s ability to safely induce weight loss, and will also evaluate a combination of a GLP-1 receptor agonist plus nimacimab
Excerpt from the Press Release:
SAN DIEGO, Aug. 22, 2024 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, has started screening patients for a Phase 2 clinical trial (CBeyondTM) of its novel peripheral CB1 inhibitor, nimacimab, a negative allosteric modulating antibody. The study will assess the ability of nimacimab as a next-generation weight loss therapeutic to safely and effectively reduce weight in patients with obesity. It will assess parameters increasingly viewed as important to the long-term quality and/or sustainability of weight loss, including gastrointestinal tolerability (GI) and lean mass retention.
“There is clearly a need for alternative mechanisms of action that can provide physicians and patients with improved overall health outcomes in the pursuit of weight loss beyond those achieved with GLP-1 and GIP drugs. We believe that peripheral CB1 inhibition, and nimacimab, a unique biologic drug within the class, have attributes that may help provide such outcomes, and we look forward to our goals of reporting interim data from this Phase 2 obesity trial in Q2 of 2025 and final data in Q4 of 2025,” said Punit Dhillon, Chief Executive Officer of Skye. “CB1 inhibition research has shown its potential to directly promote energy expenditure and fat breakdown1, improve leptin sensitivity2 , and peripherally modulate hunger and satiety 3. We are pleased to be assessing nimacimab as a monotherapy but to also undertake a preliminary evaluation of our peripheral CB1 inhibitor in combination with a GLP-1 drug.”
“As we evaluate CB1 inhibition as a possible alternative mechanism for weight loss, we believe it is important to consider health outcomes beyond GI intolerance and muscle loss, such as neuropsychiatric adverse events, that may compromise the long-term use of these drugs that is necessary for sustainable results,” added Tu Diep, Chief Development Officer of Skye.
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