Adial Pharmaceuticals, Inc.
(NASDAQ: ADIL)
(“Adial” or the “Company”), a clinical-stage biopharmaceutical
company focused on developing therapies for the treatment and
prevention of addiction and related disorders, recently hosted a
virtual key opinion leader webinar with addiction experts Joseph
Volpicelli, M.D., Ph.D., Executive Director and Founder of the
Volpicelli Center; and Jonathan Hunt-Glassman, MBA, Chief Executive
Officer and Co-founder of Oar Health, to discuss alcohol use
disorder (AUD), the current treatment landscape, and the need for
non-abstinence-based therapeutics. Both experts are nationally
recognized for their efforts in providing improved treatment
options to patients with AUD.
According to the National Institute on Alcohol Abuse and
Alcoholism (NIAAA) and other published research:
- AUD is a medical condition characterized by an impaired ability
to stop or control alcohol use despite adverse social,
occupational, and health consequences.1
- 28.6 million adults ages 18 and older had AUD in 2021.2
- An estimated 894,000 adolescents ages 12 to 17 had AUD in
2021.2
- Over 140,000 people die from alcohol-related causes annually,
making alcohol the fourth-leading preventable cause of death in the
United States.1
The key opinion leaders emphasized that there is a substantial
patient need for medications to treat AUD, yet current medications
are not being prescribed or utilized by most treating physicians.
There are only three FDA-approved medications for the treatment of
AUD, and of the approximately 30 million individuals with AUD, only
about 0.1% are given a prescription for one of these medications.
Among the patients in treatment with these medications, adherence
is a significant concern, with side effects being a common reason
given for stopping the medication.
To improve engagement in medical treatment, the key opinion
leaders expressed the belief that barriers to treatment could be
reduced by giving people additional options such as
non-abstinence-based therapies. A non-abstinence-based treatment
approach will provide patients with the power to choose more
realistic goals of reducing alcohol consumption rather than
abstinence. Reductions in excessive drinking, even without complete
abstinence, can have a major public health impact on morbidity and
mortality associated with AUD.
“In the AUD treatment community, there is a strong bias that
abstinence is the only legitimate goal. However, the academic
community has shown that non-abstinence-based approaches lead to
very beneficial results,” said Dr. Volpicelli. “Reduction in heavy
drinking is associated with improvements in day-to-day functioning,
socialization with peers, physical function, and self-esteem.
Recovery is more than abstinence. Recovery is about doing better in
life.”
“The biggest problem is that people don’t have access to
treatments that work for them,” said Mr. Hunt-Glassman. “For some
patients, currently available tools with the goal of lifelong
abstinence work terrifically, for others, these tools are
inconsistent with their goals and, consequently, may be a deterrent
to getting treatment. For many patients, the goal is moderation
rather than full sobriety. In other chronic disorders, there are
several classes of medications available to meet patients’ needs,
whereas for AUD we are limited to only a few options, making it
difficult to match patients with the best options that match their
goals and needs.”
Both Dr. Volpicelli and Mr. Hunt-Glassman acknowledged the
strides the research community is making towards recognizing
non-abstinence-based end goals for AUD treatment modalities,
including the NIAAA’s recent updates to the research definition of
‘recovery.’ They are optimistic that as physicians’ understanding
of addiction continues to grow and evolve, there will be a shift
away from the all-or-nothing approach currently applied to treating
AUD. They believe that with this shift, physicians will be more
empowered to recommend a broader spectrum of treatments, better
tailored to meet patients’ needs.
For more comments from Dr. Volpicelli and Mr.
Hunt-Glassman, a recording of the event is available on Adial’s
LinkedIn
page:https://www.linkedin.com/events/exploringtheunmetneedinalcoholu7112901068706996224/theater/
1https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/understanding-alcohol-use-disorder2SAMHSA,
Center for Behavioral Health Statistics and Quality. 2021 National
Survey on Drug Use and Health. Tables 5.6A & 5.6B.
About Adial Pharmaceuticals,
Inc.Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on the development of treatments
for addictions 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) in heavy drinking patients
and was recently investigated in the Company’s ONWARD™ pivotal
Phase 3 clinical trial for the potential treatment of AUD in
subjects with certain target genotypes (estimated to be
approximately one-third of the AUD population) identified using the
Company’s companion diagnostic genetic test. ONWARD showed
promising results in reducing drinking in heavy drinking patients,
and no overt safety or tolerability concerns. AD04 is also believed
to have the potential to treat other addictive disorders such as
Opioid Use Disorder, gambling, and obesity. Additional information
is available at www.adial.com.
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 need
for non-abstinence-based options being paramount,
non-abstinence-based treatment providing patients with the power to
choose more realistic goals of reducing alcohol consumption rather
than abstinence, the treatment having a major public health impact
on morbidity and mortality associated with AUD, there being a shift
away from the all-or-nothing approach currently applied to treating
AUD as physicians’ understanding of addiction continues to grow and
evolve, there will be a shift away from the all-or-nothing approach
currently applied to treating AUD, physicians being more empowered
to recommend a broader spectrum of treatments better tailored to
meet patients’ needs and 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 pursue our regulatory
strategy, our ability to advance ongoing partnering discussions,
our ability to execute on our business strategy and bring AD04 to
large markets in the most cost-effective and timely manner, our
ability to obtain regulatory approvals for commercialization of
product candidates or to comply with ongoing regulatory
requirements, our ability to develop strategic partnership
opportunities and maintain collaborations, our ability to obtain or
maintain the capital or grants necessary to fund our research and
development activities, our ability to retain our key employees or
maintain our Nasdaq listing, our ability to complete clinical
trials on time and achieve desired results and benefits as
expected, regulatory limitations relating to our ability to promote
or commercialize our product candidates for specific indications,
acceptance of our product candidates in the marketplace and the
successful development, marketing or sale of our products, our
ability to maintain our license agreements and the continued
maintenance and growth of our patent estate. 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, 2022, 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,
LLC David
Waldman / Alexandra
Schilt Tel:
212-671-1020 Email:
adil@crescendo-ir.com
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