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Subject: TRI

Eolas Therapeutics Announce Initiation of a Phase I Clinical Trial for AZD4041, an Orexin-1 Receptor Antagonist for Smoking Cessation


NEW YORK, Dec. 4, 2019  Eolas Therapeutics Inc. today announced the initiation of a Phase I study of AZD4041 for treating tobacco use and dependence. The study will investigate safety and pharmacokinetics (PK) of AZD4041 in healthy volunteers. AZD4041 is a central nervous system (CNS) penetrant antagonist of orexin-1 (hypocretin-1) receptors that is being developed in collaboration with AstraZeneca.

"Smoking-related diseases are directly responsible for the deaths of hundreds of thousands of people in the United States each year," said Paul Kenny, PhD, co-founder of Eolas Therapeutics and Chair of the Nash Family Department of Neuroscience at the Icahn School of Medicine at Mount Sinai. "We are committed to advancing AZD4041 through clinical development as rapidly as possible to help treat tobacco use and dependence."

Approximately 80% of smokers relapse within the first month of quitting. The orexin-1 receptor is thought to play an important role in the addiction-related actions of nicotine and other drugs of abuse, and blockade of this receptor reduces nicotine-seeking behaviors in rodents and primates.

"Addictive behaviours relating to tobacco use and, more broadly, to disorders such as opioid use disorder affect not only individuals but also their families, and there is potential for new medicines to help address these behaviors. The Phase I trial for AZD4041 is an exciting opportunity to investigate the potential of this molecule," said Iain Chessell, Head of Neuroscience, BioPharmaceuticals R&D, AstraZeneca.

AZD4041 is being developed in partnership with the Blueprint Neurotherapeutics (BPN) Network and with substantial support from the National Institute on Drug Abuse (NIDA) under grant number U01NS083614. The BPN network is a National Institutes of Health (NIH) initiative managed by the National Institute of Neurological Disorders and Stroke (NINDS) that provides non-dilutive support for small molecule drug discovery and development. Healthy volunteers will be treated initially with a single dose of AZD4041. The study endpoints will be safety, tolerability and pharmacokinetics.

"There are opportunities for new therapeutics for people with addiction to nicotine and other drugs. The orexin antagonists show promise and AZD4041 will move ahead on the clinical development pathway" said Charles L. Cywin, Ph.D., NINDS Program Director of BPN.

About tobacco use and dependence
Tobacco use and dependence is a chronic, relapsing disorder driven by addiction to nicotine. Though a majority of adults who smoke report wanting to quit, less than 10% report successful quitting in the last year. The burden of disease and negative economic impact of tobacco use on society is staggering. It is predicted that ~0.6 billion current smokers worldwide will die from smoking-related illnesses, such as chronic obstructive pulmonary disorder (COPD), lung cancer, and cardiovascular disease.

About Eolas Therapeutics
Eolas Therapeutics is a biopharmaceutical company developing novel drug candidates for the treatment of substance use disorder and other psychiatric disorders. The company's lead drug candidate, AZD4041, is a novel orexin-1 receptor antagonist that is being developed for the treatment of addiction to nicotine and other drugs of abuse. If shown to be safe and with a favorable PK profile, AZD4041 will be advanced to a Phase 2 pivotal study to determine its actions on core symptoms of tobacco use disorder. For more information please visit: http://eolastherapeutics.com

SOURCE Eolas Therapeutics


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