Beacon Biosignals Announces Strategic Collaboration with Skye Bioscience to Integrate Sleep Quality and Sleep Apnea Endpoints in CBEYOND™ Phase 2 Trial of Nimacimab for Obesity
July 24 2024 - 7:30AM
Beacon Biosignals, a leader in at-home sleep monitoring and
computational neurodiagnostics, today announced a strategic
collaboration with Skye Bioscience, Inc. (Nasdaq: SKYE), a
pharmaceutical company focused on unlocking new therapeutic
pathways for metabolic health, to enhance its upcoming
CBEYOND™ Phase 2 clinical trial of Nimacimab. This partnership
will incorporate sleep quality and sleep apnea endpoints via the
Beacon Platform and the FDA 510(k)-cleared Dreem 3S EEG device to
better understand the comprehensive impact of Nimacimab on patients
with obesity.
Nimacimab, a negative allosteric-modulating antibody that
inhibits the peripheral cannabinoid 1 (CB1) receptor, is currently
being investigated for its potential to address obesity and
cardiometabolic disease. Obstructive sleep apnea is an important
comorbidity associated with obesity, with apneic events and
intermittent hypoxia driving sympathetic activation and fragmented
sleep with nocturnal awakenings.
The addition of quantitative sleep-related endpoints aims to
establish a comprehensive view of the therapeutic benefits of
Nimacimab, given the linkage between metabolic conditions,
disturbed sleep, and neurocognitive function. By integrating
Beacon's advanced sleep monitoring technology platform, the planned
Phase 2 trial will assess and quantify improvements in sleep
patterns and apnea events, such as sleep efficiency and the
apnea-hypopnea index (AHI).
"We are thrilled to collaborate with Skye Bioscience to bring
our expertise in sleep monitoring and analysis to this important
clinical trial," said Jacob Donoghue, MD, PhD, CEO of Beacon
Biosignals. "Our FDA-cleared Dreem 3S EEG headband and AI-powered
analytics platform will enable the collection of
clinically-validated sleep assessments from patients in their own
homes. This will provide valuable insights into how Nimacimab may
improve sleep quality and reduce sleep apnea, conditions often
comorbid with obesity and cardiometabolic disease."
"Understanding the multifaceted impact of Nimacimab on our
target patient population is crucial because there is a growing
list of diseases that have demonstrated benefit from effective
treatment of obesity, including obstructive sleep apnea," said
Punit Dhillon, CEO of Skye Bioscience. "Collaborating with Beacon
Biosignals allows us to leverage their cutting-edge technology to
monitor sleep quality and apnea, providing a more comprehensive
assessment of Nimacimab's therapeutic potential early in the drug’s
development. This collaboration represents a significant step in
our commitment to addressing the complexities of obesity."
Obstructive sleep apnea affects up to 40 million Americans, with
an estimated 82-93% of individuals remaining undiagnosed. Of those
treated, up to 38% of patients are not adherent to traditional
continuous positive airway pressure (CPAP) therapy (Rotenberg et
al., 2016). Donoghue added, "There is tremendous unmet patient need
for those with obstructive sleep apnea. Next-generation weight loss
therapies hold the promise to catalyze new, patient-centric
clinical paradigms that can impact millions of people."
References
André, S., Andreozzi, F., Van Overstraeten, C. et
al. Cardiometabolic comorbidities in obstructive sleep apnea
patients are related to disease severity, nocturnal hypoxemia, and
decreased sleep quality. Respir Res 21,
35 (2020).
Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over
twenty years of data collection: a flattened curve. J Otolaryngol
Head Neck Surg. 2016 Aug 19;45(1):43.
About Beacon Biosignals
Beacon Biosignals is the leading at-home EEG platform for
precision drug development. Its FDA 510(k)-cleared Dreem 3S EEG
headband algorithms enable and accelerate research and development
of treatments that transform the lives of patients with
neurological, psychiatric, and sleep disorders. Beacon’s
Clinico-EEG database contains over 100,000 patients’ brain activity
data, and its cloud-native analytics platform empowers rapid
interrogation of brain activity to support retrospective and
prospective studies. For more information, visit
[beacon.bio](https://www.beacon.bio).
About Skye Bioscience
Skye is focused on unlocking new therapeutic pathways for
metabolic health. Backed by specialist life science investors,
Skye's strategy leverages biologic targets with substantial human
proof of mechanism for the development of first-in-class
therapeutics with clinical and commercial differentiation. Skye
plans to start a Phase 2 clinical trial in obesity in Q3 2024 for
Nimacimab, a negative allosteric modulating antibody that
peripherally inhibits CB1, comparing monotherapy and combination
arms of Nimacimab and a GLP-1R agonist. For more information,
please visit: https://www.skyebioscience.com.
For Beacon Biosignals media inquiries, please contact:
Dan FloreyBeacon BiosignalsEmail: info@beacon.bioX:
https://x.com/BiosignalsLinkedIn:
https://www.linkedin.com/company/beacon-biosignals
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/4457a080-bc24-4006-b2b8-395a3454f4ce
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