Distinguished Professor Markus Heilig
joins an accomplished assemblage of addiction specialists including
Dr. Giovanni Addolorato and Professors Hannu Alho, Tomas Zima and
Sebastian Mueller
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW)
http://www.adialpharma.com/, a clinical-stage
biopharmaceutical company focused on the development of medicines
for addiction, today announced that it has appointed Professor
Markus Heilig, MD, PhD as a Scientific Advisory Board (SAB) member.
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 Markus Heilig, MD, PhD, is a founding
director of the Center for Social and Affective Neuroscience at
Linköping Univ, in a joint initiative of the Swedish Research
Council, the University and the Region. Professor Heilig received
his MD and PhD from Lund University, Sweden, 1986 and 1989,
respectively, and was a post-doc at The Scripps Research Institute,
La Jolla, CA 1990 - 1992. Upon returning to Sweden and completing
clinical training in psychiatry, he served at the Karolinska
Institute, Stockholm, Sweden, in various clinical and academic
leadership capacities until 2004. Between 2004 – 2015, he was the
chief of intramural clinical and translational research at the U.S.
National Institute on Alcohol Abuse and Alcoholism.
Heilig's research is centered on regulation of
negative effect, as it applies to anxiety, addictive and affective
disorders. He has published more than 250 peer reviewed papers,
including in leading journals such as Science, Lancet, PNAS and
others. Current efforts in the Heilig lab are focused on
identifying novel mechanisms for pharmacotherapy of addiction, and
developing these from target discovery and validation to human
proof-of-concept trials. Currently pursued targets include systems
involved in stress, and negative effect such as neurokinins,
nociceptin, glutamate and cannabinoids. Recently, his laboratory
has expanded the scope of its research to incorporate the
neurobiology of choosing between alcohol and natural rewards, and
how social factors influence these behaviors.
Professor Heilig commented, “I am honored to
have the opportunity to join Adial Pharmaceuticals’ Scientific
Advisory Board. Alcohol use disorder is a global epidemic and
I look forward to supporting the development of AD04 that should
provide a viable option for patients with the targeted genotype,
versus the limited and often ineffective options currently
available in the marketplace today. There is a pent-up demand for a
therapeutic agent that can help patients reduce or perhaps
eliminate cravings for alcohol altogether through a simple and
tolerable oral formulation and I believe AD04 will be a safe and
effective solution.”
William Stilley, CEO of Adial Pharmaceuticals,
stated, “We continue to assemble the strongest possible team of
dedicated experts to help guide our efforts. We have world class
doctors on our SAB and we intend to rely on their expertise and
guidance to develop AD04 and take it through Phase 3 clinical
trials.”
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,
providing more viable options for patients with the targeted
genotype, the expected benefit AD04 will bring to patients and the
expected contribution of our SAB 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 contribution of our SAB in 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.
Contact:
Crescendo Communications, LLC David Waldman Tel: 212-671-1021
Email: dwaldman@crescendo-ir.com
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