Reset Therapeutics, the leader in harnessing the power of the body's internal clocks to discover, develop, and commercialize high-value therapeutics for a variety of disease indications, today announced that it has been awarded a five-year cooperative agreement by the National Institutes of Health (NIH) to develop a new drug to treat narcolepsy. Reset's award includes up to $1 million in direct funding and access to contracted research services worth at least $10 million over the project's anticipated five-year period. The award was made through the NIH Blueprint Neurotherapeutics Network, which was established in order to bridge the gap in neuroscience-related drug development between academic and industry research.
Narcolepsy is the second leading cause of excessive daytime sleepiness and is estimated to affect nearly 500,000 people in the United States, Europe, and Japan. The majority of narcolepsy patients also experience cataplexy (brief but debilitating episodes of sudden-onset muscle weakness). None of the drugs marketed for narcolepsy address the underlying cause of the disease and full restoration of alertness remains a challenge for many narcolepsy patients. Additionally, agents approved for treating the symptoms of narcolepsy typically have limited duration of action and are associated with unwanted side effects. Reset is leveraging its expertise and leadership in circadian rhythms biology to develop orexin receptor agonists. Orexin proteins play a key role in the body's normal sleep/wake cycles. This approach is designed to address the molecular cause of narcolepsy.
“Reset is the leader in the biology of molecular clocks, and our technology and assets directly address the biological cause of narcolepsy,” said Ross Bersot, CFA, president and CEO of Reset Therapeutics. “Patients with narcolepsy are underserved by currently approved treatments, and we believe that our orexin receptor agonist program will enable new therapies that have improved efficacy, tolerability, and duration of action. We are pleased that the Blueprint Therapeutics Network has chosen to support Reset's innovative narcolepsy program. Funding from the Network will support key discovery and development activities designed to advance our narcolepsy program into phase 1 clinical trials. The grant complements our other projects focusing on compelling opportunities in conditions related to dysregulation of molecular clocks, such as diabetes, obesity, and cardiovascular disease.”
Orexin is expressed in a part of the brain that serves as the “on/off” switch for the body's internal clocks. The neurons that normally express orexin are missing in patients with narcolepsy, possibly due to autoimmune mechanisms. Consequently, narcolepsy patients have dramatically reduced levels of orexin A protein in their blood and spinal fluid, and 90% of narcolepsy patients have orexin deficiency.
Reset is developing orexin receptor agonists that are designed to mimic the effects of the orexin protein and restore normal balance to the body's sleep/wake cycles. Daily morning administration of an orexin receptor agonist is expected to prevent the daytime sleepiness and cataplexy that are typical of narcolepsy.
“The goal of the NIH Blueprint Neurotherapeutics Network is to support early-stage research on novel drugs so that pharmaceutical companies will advance their development and ultimately deliver new treatments to patients,” according to Rebecca Farkas, Ph.D., a program director at the NIH National Institute of Neurological Disorders and Stroke. “We look forward to working collaboratively with Reset to explore new treatments for narcolepsy, an important public health burden.”
About Reset Therapeutics
Reset Therapeutics is a privately held biopharmaceutical company focused on harnessing the power of the body's internal molecular clocks to discover, develop, and commercialize high-value therapeutics for a variety of disease indications. Molecular clocks are the foundation of the body's circadian system, which synchronizes many biological processes with cycles of light, activity, and nutrient status. Founded in 2008 by leaders in the field of molecular clock biology and Bay City Capital, the company has unparalleled expertise and intellectual property related to molecular clocks and the roles that they play in health and disease.
Reset has leveraged its leadership in molecular clocks to build a robust technology platform for discovering small molecule therapies that modulate circadian activity. The platform is also a powerful engine for identifying components of the circadian system that can be targeted to treat metabolic and related disorders, such as diabetes, obesity, and cardiovascular disease. A large and growing number of people are living with these conditions and are underserved by currently available therapies. Reset is uniquely positioned to address the underlying molecular cause of these diseases and to create clinical value for patients and commercial value for its shareholders.
Reset Therapeutics, Inc.
Ross S. Bersot, CFA, 415-835-9362
President & CEO
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