Adial Pharmaceuticals Confirms Scheduling of Meetings with FDA and European Regulatory Agencies to Advance Clinical Development of AD04 for Alcohol Use Disorder
2023年2月21日 - 11:00PM
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, today announced that
it has secured meetings with regulatory authorities in the U.S. and
Europe to discuss and develop plans for the clinical advancement of
AD04 for alcohol use disorder toward potential approvals.
In the United States, Adial has secured a Type C
meeting with the Food and Drug Administration (FDA) in the second
quarter of this year. This meeting will allow Adial and the FDA to
discuss the clinical development program for AD04 in the U.S. and
the most appropriate path toward possible approval. In Europe,
Adial has meetings scheduled or planned with five national
regulatory authorities in France, Sweden, Finland, the United
Kingdom and Germany. Adial intends to seek from the agencies a
clear understanding and direction toward the most expeditious path
to approval.
Cary Claiborne, Adial’s President and Chief
Executive Officer, said, “These meetings are the next step in our
plan to complete clinical development of AD04 and bring to market a
much-needed treatment for alcohol use disorder. In parallel, we are
discussing opportunities with prospective pharmaceutical company
partners that can help us to fund clinical development while also
creating go-to market commercial strategies in the U.S. and Europe.
We will provide an in-depth update on all AD04 program activities
in the coming weeks.”
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) 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 heavy
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, meetings allowing Adial and the FDA to discuss the
clinical development program for AD04 in the U.S. and the most
appropriate path toward approval, scheduled or planned meetings
with five national regulatory authorities in France, Sweden,
Finland, the United Kingdom and Germany, discussing opportunities
with prospective pharmaceutical company partners that can help us
to fund clinical development while also creating go-to market
commercial strategies in the U.S. and Europe, AD04 being approved
and brought to market, Adial partnering with another pharmaceutical
company, Adial obtaining from agencies a clear understanding and
direction toward the most expeditious path to regulatory approval,
AD04 appearing to be well tolerated 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 develop
plans for the clinical advancement of AD04 for alcohol use disorder
toward potential approvals with regulatory authorities in the U.S.
and Europe, our ability to partner with prospective pharmaceutical
companies to help the Company to fund clinical development while
also creating go-to-market commercial strategies in the U.S. and
Europe, our ability to 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 our 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, 2021, 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
Adial Pharmaceuticals (NASDAQ:ADILW)
過去 株価チャート
から 12 2024 まで 1 2025
Adial Pharmaceuticals (NASDAQ:ADILW)
過去 株価チャート
から 1 2024 まで 1 2025