SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE), a biopharmaceutical company specializing in metabolic health therapies, announced today that it has reached over 50% enrollment for its Phase 2 CBeyond™ clinical trial. The trial is evaluating nimacimab, a CB1 inhibitor, in patients with overweight or obesity issues. The interim data from the trial is expected to be reported in the second quarter of 2025, following a 26-week treatment period for the initial patient group.
Dr. Puneet Arora, Skye’s Chief Medical (TASE:PMCN) Officer, expressed gratitude for the dedication of participants and clinical investigators. He noted that the current enrollment pace could potentially accelerate the timeline for topline data, which is anticipated next year. Further updates are promised upon completion of full enrollment.
Punit Dhillon, President & CEO, highlighted nimacimab's unique position as the most peripherally restricted CB1 inhibitor, potentially offering a safer and more effective alternative for weight loss without affecting the brain's CB1 receptors. According to Dhillon, nimacimab has shown promising results in Phase 1 and preclinical studies, including no neuropsychiatric adverse effects and better gastrointestinal tolerability compared to GLP-1 receptor agonists.
The CBeyond™ Phase 2 trial is a randomized, double-blind study set to enroll 120 patients across four treatment groups, with the primary endpoint focused on weight loss comparison between nimacimab and a placebo. An exploratory endpoint will examine the combined effect of nimacimab with Wegovy® against placebo and Wegovy® alone. Secondary and exploratory endpoints include safety and tolerability, as well as assessments of neuropsychiatric and cognitive outcomes, body composition changes, metabolic parameters, and sleep improvement.
Skye Bioscience is dedicated to developing next-generation molecules that modulate G-protein coupled receptors, with a focus on first-in-class therapeutics. The company is currently conducting a Phase 2 clinical trial for nimacimab in obesity, which is also examining the drug's combination with a GLP-1R agonist, Wegovy®.
The information regarding Skye Bioscience's ongoing clinical trial and the potential of nimacimab is based on a press release statement. The company's progress in the trial represents a significant step in the development of new treatments for metabolic health conditions.
In other recent news, Skye Bioscience has reported significant progress in its clinical trials for nimacimab, a CB1 inhibitor aimed at treating obesity. The company has appointed Dr. Puneet S. Arora as its new Chief Medical Officer, bringing over 15 years of experience in clinical trials, regulatory submissions, and medical affairs. Furthermore, Skye Bioscience has appointed Paul Grayson as the new Chairman of the Board, a strategic move aimed at enhancing the company's governance structures and oversight capabilities.
Analyst firms JMP Securities, Piper Sandler, Craig-Hallum, and Oppenheimer have all maintained positive ratings on Skye Bioscience, reflecting confidence in the company's prospects. Skye Bioscience has also partnered with Beacon Biosignals to incorporate sleep-related assessments into the trial, given the link between obesity and sleep disorders.
Interim weight loss data from the Phase 2 trial is expected in Q2 2025, with top-line data anticipated in Q4 2025. These recent developments highlight Skye Bioscience's commitment to improving health outcomes for patients struggling with obesity.
InvestingPro Insights
Skye Bioscience's recent announcement of reaching 50% enrollment in its Phase 2 CBeyond™ clinical trial comes amid a backdrop of intriguing financial metrics and analyst perspectives. According to InvestingPro data, the company has seen a remarkable 237.14% price total return over the past year, indicating strong investor interest in its potential. This aligns with the company's focus on developing nimacimab, a promising CB1 inhibitor for obesity treatment.
However, it's important to note that Skye Bioscience is currently operating at a loss, with an adjusted operating income of -$23.62 million over the last twelve months as of Q3 2024. This reflects the company's stage in the drug development process, where significant investments are made before potential commercialization.
InvestingPro Tips highlight that analysts do not anticipate the company to be profitable this year, which is consistent with the ongoing clinical trial expenses. Additionally, the stock price movements are quite volatile, which investors should consider when evaluating the company's recent performance.
For those seeking a deeper understanding of Skye Bioscience's financial health and market position, InvestingPro offers 13 additional tips, providing a comprehensive analysis for informed investment decisions.
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