Adial Pharmaceuticals Comments on Article in ‘The Atlantic,’ Highlighting the Second Pandemic of Addiction
June 07 2021 - 09:30AM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)
(“Adial” or the “Company”), a clinical-stage biopharmaceutical
company focused on developing therapies for the treatment and
prevention of addiction and related disorders, commends Kate Julian
and The Atlantic for highlighting the major crisis facing our
society in her article America Has a Drinking Problem. The article
highlights the complexity of the factors driving alcohol use and
its pervasiveness in human society and, particularly, in the United
States.
William Stilley, Chief Executive Officer of
Adial, commented, “We appreciate the spotlight that Ms. Julian and
The Atlantic have put on the increase in Alcohol Use Disorder
(AUD), which has been exacerbated by the COVID-19 induced
lockdowns—the ‘Second Pandemic of Addiction,’ as further
highlighted in my recent podcast interview with the Wall Street
Resource.”
Key statistics regarding Alcohol Use Disorder
include:
- In the United
States, approximately 35 million people each year suffer from AUD,
resulting in significant health, social and financial costs
according to the National Institute of Alcohol Abuse and Alcoholism
(“NIAAA”) and Journal of the American Medical Association
(“JAMA”).
- Excessive
alcohol use is the third leading cause of preventable death and is
responsible for 31% of driving fatalities in the United States
(NIAAA Alcohol Facts & Statistics).
- AUD contributes
to over 200 different diseases and 10% of children live with a
person that has an alcohol problem (NIAAA Alcohol Facts &
Statistics).
- 5-6% of new
cancers and cancer deaths globally are directly attributable to
alcohol (American Society of Clinical Oncologists).
- Alcohol is the
leading cause of death in people ages 15-49 globally (The
Lancet).
- AUD costs the
United States economy about $250 billion annually, with heavy
drinking accounting for greater than 75% of the social and health
related costs (The Centers for Disease Control).
- Only 7.7% of
patients, or approximately 2.7 million people, with AUD are
estimated to have been treated in any way and only 3.6% by a
physician, or approximately 1.3 million people (JAMA).
- AUD in the
United States appears to be growing with almost a 50% increase in
prevalence between 2002 and 2013 (JAMA).
About Adial Pharmaceuticals,
Inc.
Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on developing therapies for the
treatment and prevention of addiction and related disorders. The
Company’s lead investigational new drug product, AD04, is a
genetically targeted, serotonin-3 receptor antagonist, therapeutic
agent for the treatment of Alcohol Use Disorder (AUD) and is
currently being investigated in the Company’s landmark ONWARD™
pivotal Phase 3 clinical trial 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. 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). AD04 is
also believed to have the potential to treat other addictive
disorders such as Opioid Use Disorder, gambling, and obesity, and
the Company develops adenosine analogs for the treatment of pain
and other disorders. Additional information is available at
www.adialpharma.com.
About the Landmark ONWARD™ Pivotal Phase
3 Clinical Trial
The ONWARD trial is a 24-week, multicenter,
randomized, double-blind, placebo-controlled, parallel group, Phase
3 clinical study to evaluate the efficacy, safety and tolerability
of AD04 in patients with Alcohol Use Disorder (AUD) and selected
polymorphisms in the serotonin transporter and receptor genes.
Patients are genetically screened prior to enrollment in the ONWARD
trial so that only genetically positive patients are enrolled. The
primary endpoint for analysis of efficacy is the change from
baseline in the monthly number of heavy drinking days during the
last 8 weeks of the 24-week treatment period. ONWARD is currently
being conducted in 25 clinical sites in seven countries in
Scandinavia and Central and Eastern Europe (Sweden, Finland,
Poland, Latvia, Estonia, Bulgaria and Croatia). The principal
investigator is Professor Hannu E.R. Alho, Emeritus Professor of
Addiction Medicine at the University of Helsinki.
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. The forward-looking statements include statements
regarding the potential of AD04 to treat other addictive disorders
such as opioid use disorder, gambling, and obesity. Any
forward-looking statements included herein reflect our current
views, and they involve certain risks and uncertainties, including,
among others, our ability to leverage the acquisition of Purnovate
and our other expansion plans to position ourself as a leader in
the broader addiction market, our ability to enroll patients within
the timelines anticipated and complete clinical trials on time and
achieve desired results and benefits as expected, the ability of
AD04 to treat other addictive disorders such as opioid use
disorder, gambling, and obesity, 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 Annual
Report on Form 10-K for the year ended December 31, 2020,
subsequent Quarterly Reports on Form 10-Q and current reports on
Form 8-K filed with the Securities and Exchange Commission. 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, LLCDavid
Waldman / Natalya RudmanTel: 212-671-1021Email:
adil@crescendo-ir.com
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