Adial to File Fast Track Application for AD04 with the FDA
February 23 2021 - 1:00PM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)
(“Adial” or the “Company”), a clinical-stage biopharmaceutical
company focused on the development of treatments for addictions,
today announced that it will be filing an application for “Fast
Track” with the U.S. Food and Drug Administration (FDA) for its
lead drug candidate, AD04, which is a therapeutic agent for the
treatment of Alcohol Use Disorder (AUD) in persons with certain
target genotypes.
Adial previously announced on September 25,
2020, that the Company had submitted a formal request to the FDA in
support of Adial’s position that AD04 should be considered eligible
for an FDA expedited review program. Adial and its regulatory
advisors had previously concluded that AD04, which is being
developed for a serious condition that is an unmet medical need, is
a candidate for this FDA program.
“Adial’s correspondence and consultation with
the FDA following its expedited review filing in September 2020,
leads us to believe that AD04 qualifies for Fast Track
consideration,” said Adial’s Head of Regulatory, Dr. Jack Reich. “I
am confident Alcohol Use Disorder qualifies as a serious condition
and that there is an unmet medical need, based on our communication
with the FDA and as set forth in the FDA’s Guidance for Industry
Expedited Programs for Serious Conditions – Drugs and
Biologics.”
“We are working with our regulatory counsel to
prepare our Fast Track submission after consultation with the FDA,”
commented Adial’s CEO, William Stilley. “Following our submission,
the FDA is expected to review the request and make a decision
within 60 days.”
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. Depression is one such disease that is
considered to be a serious condition for Fast Track purposes, and
Adial believes that Alcohol Use Disorder will be treated
similarly.
When reviewing a Fast Track application where
there are available therapies, the Fast Track drug must demonstrate
advantages over the available therapy currently approved for the
indication in order to be considered as meeting an unmet medical
need. Examples of advantages considered by the FDA that Adial
believes are applicable to AD04 include: (1) has an effect on a
serious outcome of the condition in patients who are unable to
tolerate or failed to respond to available therapy; (2) decreases a
clinical significant toxicity of an available therapy that is
common and causes discontinuation of a treatment; (3) provides
safety and efficacy comparable to those of available therapy but
has a benefit that is expected to lead to an improvement in serious
outcomes; and (4) has the ability to address emerging or
anticipated public health need.
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™ Phase 3 Pivotal 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.
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 AD04 qualifying for Fast Track consideration, the FDA
treating AD04 similarly to depression for Fast Track designation
purposes, Alcohol Use Disorder qualifying as a serious condition
and being an unmet medical need and the timing of the FDA review
and decision process for the Company’s Fast Track Designation
request 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, to the FDA determining that AD04 qualifies for Fast
Track Designation, 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 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, 2019, 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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