Adial Pharmaceuticals Receives Notice of Allowance on U.S. Patent for the Treatment for Opioid Use Disorder Using AD04
January 24 2022 - 9:25AM
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 the
U.S. Patent and Trademark Office (USPTO) has mailed a Notice of
Allowance for US Patent Application No. 16/784,051, a patent
application for the treatment for opioid use disorder (OUD) using
AD04. This patent application covers treatment of patients with a
specific genetic biomarker for the serotonin-3 receptor.
AD04 is currently being evaluated in the
Company’s ONWARD trial, which is designed as a Phase 3 clinical
study to evaluate the efficacy, safety and tolerability of AD04 in
patients with alcohol use disorder (AUD). The Company believes AD04
may also hold significant potential for the treatment of OUD since
the physiology and neurotransmitters involved in opioid addiction
are similar to alcohol and could be expected to be modulated by a
serotonin-3 receptor antagonist.
William Stilley, Adial’s Chief Executive
Officer, stated, “We continue to build the patent estate around
AD04, and, including expected extensions, we believe AD04 will have
robust, long-term patent protection of our intellectual property
through 2036. Specifically, this represents our ninth U.S. patent,
in addition to numerous international patents, covering AUD, OUD,
or both. OUD remains a significant, yet underserved market.
According to the CDC’s National Center for Health Statistics, there
were an estimated 93,000 drug overdose deaths in the United States
alone during 2020, an increase of nearly 30% from the prior year.
The Centers for Disease Control and Prevention estimates that the
total economic burden of prescription opioid misuse alone in the
United States is $78.5 billion a year, including the costs of
healthcare, lost productivity, addiction treatment, and criminal
justice involvement.”
A Notice of Allowance is issued after the USPTO
makes a determination that a patent can be granted from an
application. The issued patent would have a term that expires no
earlier than July 1, 2031.
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 through its wholly owned subsidiary,
Purnovate, Inc. 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 potential of AD04 for the treatment of OUD since the
physiology and neurotransmitters involved in opioid addiction are
similar to alcohol and could be expected to be modulated by a
serotonin-3 receptor antagonist, the patent estate around AD04
having robust, long-term patent protection of our intellectual
property through 2036, the estimated total economic burden of
prescription opioid misuse alone in the United States is $78.5
billion a year, 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 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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