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CHARLOTTESVILLE, Virginia, November 29, 2018 (GLOBE NEWSWIRE) – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), www.adialpharma.com, a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol-related disorders, announced today the establishment of a Scientific Advisory Board (SAB ) and appointed Dr. Giovanni Addolorato, leading world expert in the field of alcoholism (AUD), as the first member and president. The SAB will help guide the company's strategy and advance AD04, its primary therapeutic agent for the AUD, with Phase 3 trials scheduled to begin in the first half of 2019.
Mr. Addolorato is Professor of Gastroenterology and Hepatology in the Department of Gastroenterology and Endocrino-Metabolic Sciences of the Catholic University of Rome. He is also director of the unit "Disorder related to alcohol consumption and alcohol-related diseases" at the Catholic University of Rome and senior consultant in internal medicine, gastroenterology and diseases of the liver at the Catholic University of Rome. He has published more than 600 publications on the pharmacology and neurobiology of alcohol-related disorders, including therapeutic and therapeutic, as well as alcohol-related liver disease. More than 220 of his publications have been published in peer-reviewed journals and published in Lancet, Molecular Psychiatry, Journal of Hepatology, American Journal of Medicine, American Journal of Clinical Nutrition, American Journal of Gastroenterology, Journal of Internal Medicine, Alcoholism : Clinical and experimental research. He is badociate editor of "Alcologia: European review of alcohol studies" and member of several editorial boards, including "World Journal of Gastroenterology", "Alcohol & Alcoholism", "European Addiction Research", "Journal of Addiction", "Journal of Alcoholism and Drug Dependence" and "World Journal of Hepatology". He has lectured extensively at international conferences and received several awards for his work. Since 2006, Mr Addolorato has been a member of the European Research Advisory Board (ERAB). Since 2009, he has also been a member of the National Anti-Drug Commission of the Drug Policy Department of the Office of the Italian Government.
Dr. Addolorato commented, "I am delighted to join Adial Pharmaceuticals' board of directors, given the market's need for effective treatment of alcohol-related disorders and Adial's encouraging data. for phase 2b, which also show a high safety profile without the side effects of current drugs. market. I look forward to supporting the ongoing development AD04, designed to reduce cravings without the need for abstinence before or during treatment. "
William Stilley, CEO of Adial Pharmaceuticals, said, "We are pleased to formally launch our new Scientific Advisory Board to support the development efforts of AD04, our leading product candidate. We welcome Dr. Addolorato as the first member of our SAC, as he brings considerable knowledge and experience in AUD and should play a vital role in the preparation of our Phase 3 clinical trial. "
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in the development of addiction treatments. AD04, the company's leading new investigational drug, is a genetically targeted therapeutic agent for the treatment of alcohol abuse disorder ("AUD"). A Phase 2b clinical trial of AD04 for the treatment of AUD has shown promising results with regard to reducing the frequency of alcohol consumption, the consumption of alcohol and the use of alcohol. Alcohol and heavy alcohol consumption (all statistically significant) and lack of overt concern regarding safety (no statistically significant, serious adverse events have been reported). ). . The company plans to begin a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, who must be identified using the company's proprietary companion diagnostic test. AD04 could also treat other addictive disorders, such as opioid-related disorders, gambling and obesity.
About the disorder related to the consumption of alcohol
According to a widely respected article in the publication The lancet, Alcohol is the leading cause of death in the world for men and women aged 15 to 49 years. In the United States alone, about 35 million people have Australian dollars, resulting in significant health, social and financial costs (NIAAA Alcohol Facts & Statistics). The AUD contributes to more than 200 different diseases and 10% of children live with someone who has an alcohol problem. According to the American Society of Clinical Oncologists, 5 to 6% of new cancers and cancer deaths worldwide are directly attributable to alcohol. The Centers for Disease Control (CDC) said the Australian dollar was costing the US economy about $ 250 billion a year, with excessive alcohol consumption accounting for more than 75 percent of social and health costs. In addition, according to the NIAAA, the problem in the United States seems to worsen, with an increase of about 50% in the prevalence of AUD between 2002 and 2013.
Despite high prevalence and high costs, according to an article in JAMA 2015, it is estimated that only 7.7% of patients (or about 2.7 million people) with AUD have been treated in any way and only 3.6% by a doctor (about 1.3 million people). The most common treatments for the AUD aim to achieve abstinence and typical treatments include psychological and social interventions. Most therapies require abstinence even before starting treatment. Abstinence requires dramatic lifestyle changes, often with serious professional and social consequences. Significant side effects of current pharmacologic therapies include mental side effects such as psychiatric disorders and depressive symptoms, as well as physical side effects such as nausea, dizziness, vomiting, abdominal pain, arthritis and good joint shape. These problems with the currently available therapies appear to limit the willingness of people with AUD to seek treatment, and then limit the compliance with treatment requirements and, therefore, the ultimate results for many people who are trying out the currently available therapies.
Forward-looking statements
This communication contains certain "forward-looking statements" within the meaning of US federal securities laws. These statements are based on a variety of facts and are based on many important badumptions. They are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performances or achievements to differ materially from the results, performance or achievements expressed or implied. by such forward-looking statements. Declarations preceded or followed by the words "believes", "plans", "plans", "intends", "plans", "estimates", "drafts", similar expressions or future or conditional verbs such as "will," "should," "may," "may," and "may" are generally prospective in nature and are not historical facts, although not all forward-looking statements include the foregoing. are based on current beliefs, expectations and badumptions and include statements relating to the commencement of Phase 3 clinical trials in the first half of 2019, the expected benefits for AD04 for patients and the expected role of Dr. Addolorato in the context of Phase 3. Clinical Trial All forward-looking statements included in this document reflect our current views and involve certain risks and uncertainties, including our ability to initiate clinical trials of ph ase 3 of the first half of 2019, the ability of AD04 treatment to function as expected, to demonstrate safety and efficacy, as well as results consistent with previous results, to Dr. Addolorato's contribution to the Of our Phase 3 clinical trial on AD04, the ability to recruit patients and complete clinical trials on time, to achieve the desired results and benefits, our ability to obtain regulatory approvals for the marketing of product candidates or to comply with the regulatory requirements in force, the regulatory restrictions relating to our ability to promote or market our product candidates for specific indications, the acceptance of its product candidates in the market and development successful, marketing or sales of products, our ability to maintain our license agreements, the continued maintenance and growth of our patenting heritage, our ability to establish and maintain collaborations, our ability to obtain or maintain capital or subsidies necessary to fund its research and development activities, and our ability to retain our key employees or maintain our list at Nasdaq. These risks should not be interpreted as exhaustive and should be read in conjunction with the other disclaimer included in our Form S-1 registration statement we filed with the SEC and the final prospectus. Any forward-looking statement speaks only of the date on which it was made. We disclaim any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in circumstances or otherwise, except as permitted by law. ;required.
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David Waldman
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