Adial Pharmaceuticals to Announce Topline Results of ONWARD™ Phase 3 Trial for AD04 in Patients With Alcohol Use Disorder
18 July 2022 - 11:25PM
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 plans to report topline results from the Company’s ONWARD™ Phase
3 clinical trial on Wednesday, July 20, 2022. The Company plans to
host a conference call at 1 PM Eastern Time on Wednesday (dial-in
instructions to follow).
About the ONWARD™ Trial
The ONWARD Phase 3 clinical trial is a 24-week,
multicenter, randomized, double-blind, placebo-controlled, parallel
group, clinical study to evaluate the efficacy, safety and
tolerability of AD04 in patients with Alcohol Use Disorder and
selected polymorphisms in the serotonin transporter and receptor
genes. Patients were genetically screened prior to enrollment in
ONWARD so that only genetically positive patients were enrolled.
Approximately one-third of the screened patients tested genetically
positive for the targeted genetics, and patients were stratified by
the severity of drinking into heavy drinkers and very heavy
drinkers (determined by whether they averaged less than ten, or
greater than or equal to ten drinks per drinking day, respectively,
prior to enrollment). Approximately, two-thirds of the patients in
the ONWARD trial were in the heavy drinking group and one-third in
the very heavy drinker group.
ONWARD was conducted in 25 clinical sites in six
countries in Scandinavia and Central and Eastern Europe (Sweden,
Finland, Poland, Latvia, 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 was recently investigated in the Company’s
landmark ONWARD™ 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 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 plans to report topline results from the Company’s
ONWARD™ Phase 3 clinical trial on Wednesday, July 20, 2022 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
provide top-line results from the ONWARD™ Phase 3 clinical trial as
planned, our ability to use the ONWARD trial as a basis for
approval of AD04 for the treatment of Alcohol Use Disorder in
patients identified as having the targeted genetics, our ability to
enroll patients in future trials within the timelines anticipated
and complete clinical trials on time, our ability to 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 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, 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
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