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BOSTON and SAN DIEGO – Beacon Biosignals, a company specializing in home-based sleep monitoring, has announced a strategic collaboration with pharmaceutical company Skye Bioscience, Inc. (NASDAQ:SKYE) to enhance the CBEYOND™ Phase 2 clinical trial of the drug Nimacimab. The trial will now include sleep quality and sleep apnea assessments as part of its evaluation of Nimacimab's effects on patients with obesity.
Nimacimab is an investigational drug designed to inhibit the peripheral cannabinoid 1 (CB1) receptor and is currently being studied for its potential benefits in treating obesity and related cardiometabolic diseases. The collaboration with Beacon Biosignals will integrate sleep-related endpoints using the FDA 510(k)-cleared Dreem 3S EEG device and Beacon's analytics platform to provide a more in-depth understanding of the drug's impact on sleep patterns.
The inclusion of these sleep-related endpoints aims to develop a more comprehensive view of Nimacimab's therapeutic benefits, considering the strong relationship between metabolic health, disrupted sleep, and neurocognitive function. The Dreem 3S EEG headband and AI-powered analytics platform will be used to gather clinically-validated sleep data from patients in their own homes, focusing on metrics such as sleep efficiency and the apnea-hypopnea index (AHI).
Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals, expressed enthusiasm for the partnership, emphasizing the potential to improve sleep quality and reduce sleep apnea, which are common comorbidities with obesity and cardiometabolic disease. Punit Dhillon, CEO of Skye Bioscience, also highlighted the importance of understanding the multifaceted impact of Nimacimab on patients, especially given the prevalence of obstructive sleep apnea among the obese population.
Obstructive sleep apnea, a condition that affects up to 40 million Americans, is often undiagnosed and untreated, with many patients not adhering to traditional therapies like continuous positive airway pressure (CPAP). This collaboration represents a significant step in addressing the complexities of obesity and its comorbid conditions by potentially offering new, patient-centric clinical approaches.
The Phase 2 trial is scheduled to begin in the third quarter of 2024, with the goal of assessing the efficacy of Nimacimab as both a monotherapy and in combination with a GLP-1R agonist.
InvestingPro Insights
As Skye Bioscience, Inc. (NASDAQ:SKYE) embarks on its Phase 2 clinical trial for Nimacimab, investors may take a keen interest in the company's financial health and market performance. According to InvestingPro data, Skye Bioscience has a negative PEG Ratio of -0.12 for the last twelve months as of Q1 2024, indicating challenges in future earnings growth relative to its current price. Additionally, the company's Operating Income and EBIT both stand at a negative $16.57 million USD for the same period, reflecting operational challenges that the company faces.
InvestingPro Tips for Skye Bioscience reveal that while the company holds more cash than debt, suggesting a strong liquidity position, it is grappling with weak gross profit margins and is not expected to be profitable this year. Moreover, the stock has experienced significant volatility, with a large price uptick over the last six months, yet it has performed poorly over the last month and decade.
The strategic collaboration with Beacon Biosignals could potentially enhance the value proposition of Nimacimab, but investors should consider these financial metrics and analyst insights when evaluating the company's prospects. For those looking for more comprehensive analysis, there are additional InvestingPro Tips available at Investing.com/pro/SKYE. Use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, and gain access to valuable insights that could shape investment decisions.
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