CHARLOTTESVILLE, Va., Jan. 17, 2019 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of medicines for addiction, today announced that it has appointed Professor Tomáš Zima, MD, DSc, Dr.h.c. and Professor Sebastian Mueller, MD, PhD as its next two Scientific Advisory Board (SAB) members. Doctors Zima and Mueller bring broad and diversified experience in areas such as addiction, genetics and the diagnosis and treatment of alcohol related diseases. They join Dr. Giovanni Addolorato, a leading global expert in the field of alcohol use disorder (AUD), who was selected as Adial’s first SAB member and Chairperson in November 2018. The SAB is charged with helping to guide the Company’s strategy and advance AD04, its lead therapeutic agent for AUD, with Phase 3 trials expected to commence in the first half of 2019.
Professor Tomáš Zima, MD, DSc. Dr.h.c. is the Rector (Chancellor) of Charles University of Prague and the President of the Czech Rectors’ Conference. He was the Dean of the First Faculty of Medicine at Charles University between 2005-2012 and served as a professor of medical chemistry and biochemistry since 2001 and head of the Institute of Medical Biochemistry and Laboratory Medicine at Charles University since 1999. Prof. Zima is also a specialist in clinical chemistry and specialist in laboratory medicine, as well as internal medicine and nephrology. He graduated from the First Faculty of Medicine, Charles University of Prague in 1990, is author of more than 450 articles, has conducted hundreds of lectures, and belongs to a number of leading societies, including Academia Europea, the Czech Medical Academy, and the Czech Learned Society. Prof. Zima is also an executive board member of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), a member of the Congresses and Congresses Committee of EFLM, and is a member of the European Commission’s Scientific Panel for Health (SPH).
Sebastian Mueller is Professor of Medicine and the current Vice Head of the Department of Internal Medicine at Salem Medical Center and the Co-Director of the Center for Alcohol Research at the University of Heidelberg. Since 2017, he has served as president of the European Society of Biomedical Research on Alcoholism (ESBRA). Prof. Mueller studied medicine in Leipzig, Denver and Strasbourg and obtained a PhD in biophysics, was a gastroenterology resident and consultant in Heidelberg, postdoctoral Humboldt fellow at USC in Los Angeles, and lecturer at the BIDMC/Harvard Medical School. Prof. Mueller’s translational research includes the pathophysiology, genetics, diagnosis and treatment of liver diseases, including alcoholic liver disease, and he has published more than 100 original papers.
Professor Zima commented, “Joining the Adial Pharmaceuticals’ Scientific Advisory Board is both an honor and an opportunity to impact the global epidemic of alcohol use disorder alongside some of the greatest and most progressive minds working to find solutions. I look forward to helping the Company as it strives to capitalize on its encouraging phase 2 results that have set the stage for the upcoming phase 3 clinical trials.”
Professor Mueller stated, “As a member of the Scientific Advisory Board, I look forward to actively supporting the continued development of a new pharmacological solution for AUD. Through the continued development of AD04 we aim to provide more viable options for patients with the targeted genotype, versus the limited and often ineffective options currently available in the marketplace. There is a large unmet need for a therapeutic agent that can help patients reduce or perhaps eliminate cravings for alcohol altogether through a simple and tolerable oral formulation. I am excited to work with my other esteemed colleagues in playing an integral role in this important work.”
William Stilley, CEO of Adial Pharmaceuticals, stated, “Our goal has been to assemble the strongest possible team of dedicated experts to help guide our efforts. With the selection of doctors Addolorato, Zima and Mueller we are executing on our plan. We expect that our SAB will be active and critical in the effort to further develop AD04 through our upcoming clinical trials and beyond, and we will rely on their expertise and guidance to enhance our development activities.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted therapeutic agent for the treatment of alcohol use disorder (“AUD”). A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity.
About Alcohol Use Disorder
According to an article in the widely respected publication, The Lancet, alcohol is the number one cause of death globally among both men and women ages 15 to 49 years. In the United States alone, approximately 35 million people have AUD resulting in significant health, social and financial costs (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases, and 10% of children live with a person that has an alcohol problem. According to the American Society of Clinical Oncologists, 5-6% of new cancers and cancer deaths globally are directly attributable to alcohol. The Centers for Disease Control (CDC) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. In addition, according to the NIAAA, the problem in the United States appears to be growing with an approximately 50% increase in AUD prevalence between 2002 and 2013.
Despite the high prevalence and high costs, according to an article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). The most common treatments for AUD are directed at achieving abstinence and typical treatments include psychological and social interventions. Most therapies require abstinence even prior to initiating therapy. Abstinence requires dramatic lifestyle changes often with serious work and social consequences. Significant side effects of current pharmacologic therapies include mental side effects such as psychiatric disorders and depressive symptoms and physical side effects such as nausea, dizziness, vomiting, abdominal pain, arthritis and joint fitness. These problems with the currently available therapies appear to limit the willingness of people with AUD to seek treatment and then to limit compliance with treatment requirements and, therefore, the ultimate results for many people attempting currently available therapies.
Forward Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward- looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements are based upon current beliefs, expectations and assumptions and include statements regarding commencing Phase 3 clinical trials in the first half of 2019, capitalizing on encouraging phase 2 results, providing more viable options for patients with the targeted genotype, the expected benefit AD04 will bring to patients and the expected role Drs. Zima and Mueller will play in connection with the Phase 3 clinical trial. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability commence the Phase 3 clinical trials in the first half of 2019, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the contributions of Drs. Zima and Mueller to advancing our Phase 3 clinical trial of AD04, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our registration statement on Form S-1 that we have filed with the SEC and the final prospectus and our Current Report on Form 10-Q for the quarter ended September 30, 2018. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
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