Adial Pharmaceuticals Provides Regulatory and Development Update
June 24 2021 - 5:07PM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW),
a clinical-stage biopharmaceutical company focused on the
development of treatments for addictions, today announced that it
has received correspondence related to its request for Fast Track
Designation from the U.S. Food and Drug Administration (FDA) for
its drug candidate, AD04, for the treatment of Alcohol Use Disorder
(AUD) in pediatric patients and adult patients with Alcoholic Liver
Disease (ALD) with select polymorphisms of the serotonin
transporter and receptor genes. While AD04 is being developed and
undergoing a pivotal Phase 3 trial to treat any adult with AUD with
the targeted genetics, Adial believes AD04 holds the potential
to effectively and safely treat AUD patients that are adolescents
or have ALD.
The Company is reporting that on June 23, 2021,
it received notice from the FDA that its request for Fast Track
Designation has been denied at this time. While the FDA did
acknowledge the unmet medical needs of adolescents and ALD patients
with AUD, the FDA stated in its letter that the Company has not yet
demonstrated that the product shows potential to address an unmet
medical need in the situation where other treatments are available.
Additionally, the FDA stated additional information would be
required regarding how AD04 might compare to other therapies if the
Company desires further consideration. Based on this feedback,
Adial will review the additional requirements and data requested by
the FDA for a Fast Track Designation.
The FDA’s Fast Track is a process designed to
facilitate development and expedite the regulatory review of drugs
that treat serious conditions and address unmet medical needs with
the purpose of getting important drugs to patients earlier. While
the FDA judges the seriousness of a condition on a case-by-case
basis, the FDA generally considers whether the drug will have an
impact on such factors as survival, day-to-day functioning, or the
likelihood that the condition, left untreated, will progress to a
more serious state.
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.
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, 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. The
Company is also developing adenosine analogs for the treatment of
pain and other disorders. Additional information is available at
www.adialpharma.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 ability to meet the requirements for approval of Fast
Track Designation in the future, 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 enroll
patients within the timelines anticipated and complete clinical
trials on time and achieve desired results and benefits as
expected, 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 our product candidates in the
marketplace and the successful development, marketing or sale of
our 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,
LLC David
Waldman / Natalya
Rudman Tel:
212-671-1021 Email:
adil@crescendo-ir.com
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