Adial Pharmaceuticals Awarded U.S. and International Patents for the Treatment Of Alcohol and Opioid Use Disorders Using AD04
August 10 2021 - 8:30AM
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 provided an
update on recently issued patents for the use of Adial’s lead
asset, AD04, for the treatment of both Alcohol Use Disorder (AUD)
and Opioid Use Disorder (OUD). AD04 is currently being evaluated in
the Company’s ONWARD trial, a Phase 3 clinical study to evaluate
the efficacy, safety and tolerability of AD04 in patients with AUD,
which is being conducted in seven countries.
Recently issued patents:
- U.S. Patent
Number 16,807,379 covering the use of AD04 as a treatment for OUD
in patients with a specific genetic biomarker in the serotonin
transporter gene.
- Canadian Patent
Number 2716498 covering the use of AD04 for both OUD and AUD in
patients with specific genetic biomarkers in the serotonin
transporter gene.
- Israeli Patent
Number 262874 covering the use of AD04 as a treatment for OUD in
patients with specific genetic biomarkers in the serotonin
transporter gene.
- Brazilian Patent
Number PI09084258 covering the use of AD04 as a treatment for OUD
in patients with specific genetic biomarkers in the serotonin
transporter gene.
The Company believes AD04 may 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.
According to the U.S. Centers for Disease
Control and Prevention, an estimated 2 million people in the U.S.
had an opioid use disorder in 2018 and nearly 70% of drug overdose
deaths were attributed to opioids
Commenting on the patents, William Stilley,
Adial’s Chief Executive Officer, stated, “We are encouraged by our
recent patent activity, not only for obtaining patents for AD04 to
treat AUD and OUD patients, but also for having recently obtained a
Notice of Allowance on a patent for the use of our genetic
diagnostic panel in combination with AD04 for both AUD and OUD,
which represents another potentially significant business
opportunity for the Company. As we have done with the rest of our
patent estate, we continue our policy of pursuing patents
internationally in any jurisdictions where we believe a robust and
potentially profitable market exists, as demonstrated by not just
the U.S. patent issuance, but recent issuances in Brazil, Canada
and Israel. The use of AD04 for AUD is already covered by patents
issued in over 45 jurisdictions.”
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.
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.
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 holding 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, the potential
treatment of AUD in subjects with certain target genotypes, the use
of the Company’s genetic diagnostic panel in combination with AD04
for both AUD and OUD, representing another potentially significant
business opportunity for the Company 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 the ONWARD™ Phase 3 trial of AD04 as a genetically
targeted treatment for Alcohol Use Disorder through data read-out
as planned, our ability to achieve key milestones for our
pre-clinical adenosine program for non-opiate pain relief, 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, 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, LLCDavid
Waldman / Natalya RudmanTel: 212-671-1021Email:
adil@crescendo-ir.com
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