SAN DIEGO – Skye Bioscience, Inc., a biotechnology company specializing in metabolic health therapeutics. (NASDAQ:SKYE) today announced that the Phase 2 CBeyond™ clinical trial evaluating nimacimab, a CB1 inhibitor, in overweight or obese patients has exceeded 50% enrollment. Interim data will be reported in the second quarter of 2025, following a 26-week treatment period in the initial patient population.
Dr Puneet Arora, Skye’s Chief Medical Officer, thanked the participants and clinical investigators for their dedication. He noted that the current pace of enrollment could advance the schedule for key data releases expected next year. Additional updates will be provided once full registration is complete.
Punit Dhillon, President and CEO, emphasized that nimacimab is uniquely positioned as the most peripherally localized CB1 inhibitor. This may provide a safer and more effective alternative for weight loss without affecting the brain’s CB1 receptors. According to Dhillon, nimacimab has been shown in phase 1 and preclinical studies to have no neuropsychiatric side effects and to be better gastrointestinal tolerable than GLP-1 receptor agonists.
The CBeyond™ Phase 2 trial will be a randomized, double-blind study that will enroll 120 patients across four treatment arms, with the primary endpoint focusing on weight loss comparison between nimacimab and placebo. The exploratory endpoint will compare the effectiveness of nimacimab in combination with Wegovy® versus placebo and Wegovy® alone. Secondary and exploratory endpoints include safety and tolerability, neuropsychiatric and cognitive outcome assessments, changes in body composition, metabolic parameters, and sleep improvement.
Skye Bioscience is dedicated to developing next-generation molecules that modulate G-protein coupled receptors, with a particular focus on developing first-in-class therapeutics. Currently, the company is conducting a Phase 2 clinical trial of nimacimab for the treatment of obesity, which is also examining its combination with Wegovy®, a GLP-1R agonist.
Information about Skye Bioscience’s ongoing clinical trials and the potential of nimacimab is based on a press release. Advances in this clinical trial represent an important step in the development of treatments for metabolic health diseases.
In other recent news, Skye Bioscience reported significant progress in its clinical trial of nimacimab, a CB1 inhibitor for the treatment of obesity. The company appointed Puneet S. Arora, MD, PhD, with more than 15 years of experience in clinical trials, regulatory submissions, and medical affairs, as its new Chief Medical Officer. Additionally, Skye Bioscience has appointed Paul Grayson as its new Chairman of the Board, a strategic move to strengthen the company’s governance and oversight capabilities.
Analyst firms including JMP Securities, Piper Sandler, Craig-Hallum, and Oppenheimer all maintain positive ratings on Skye Bioscience, reflecting confidence in the company’s prospects. Skye Bioscience has also partnered with Beacon Biosignals to include sleep-related assessments in its clinical trials, given the link between obesity and sleep disorders.
Interim weight loss data from the Phase 2 trial are expected in the second quarter of 2025, with final data expected in the fourth quarter of 2025. These recent developments demonstrate Skye Bioscience’s commitment to improving health outcomes for patients struggling with obesity.
InvestingPro Insights
Skye Bioscience’s announcement of achieving a 50% enrollment rate in its Phase 2 CBeyond™ clinical trial comes against a backdrop of exciting financial metrics and analyst forecasts. According to InvestingPro data, the company has posted a total stock return of 237.14% over the past year, indicating strong investor interest in the development of its obesity treatment nimacimab.
However, it’s important to note that Skye Bioscience is currently posting a loss. As of the third quarter of 2024, adjusted operating income for the past 12 months was -$23.62 million. This reflects the nature of the drug development process, where significant investments are made prior to potential commercialization.
Analysts aren’t expecting the company to be profitable this year, consistent with ongoing clinical trial costs, according to an InvestingPro tip. Stock prices can also be very volatile, so investors should take this into account when evaluating a company’s recent performance.
For those who would like to gain a deeper understanding of Skye Bioscience’s financial health and market position. InvestingPro offers 13 additional tips to provide comprehensive analysis for informed investment decisions.
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