Adial Pharmaceuticals Exceeds Enrollment Target in ONWARD™ Phase 3 Trial of AD04 for the Treatment of Patients with Alcohol Use Disorder
August 31 2021 - 9:30AM
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, announces it has
successfully enrolled 302 patients across 25 clinical sites and has
now closed enrollment for its ONWARD™ Phase 3 trial evaluating AD04
as a therapeutic agent for the treatment of Alcohol Use Disorder
(AUD) in persons with certain target genotypes related to the
serotonin transporter and receptor genes.
William Stilley, Adial’s Chief Executive
Officer, stated, “I am pleased to report we have exceeded our
enrollment target of 290 subjects. Given patient interest and
because a larger patient population to evaluate AD04 enhances the
statistical power of the trial and reduces the risk of not
achieving the target number of fully completed patients in the
trial, we extended our enrollment period by one month and now, with
twelve additional patients enrolled, enrollment of ONWARD is now
closed. Our appreciation goes out to the ONWARD clinical
investigators across Scandinavia and Central and Eastern Europe,
including clinical sites in Sweden, Finland, Poland, Latvia,
Bulgaria and Croatia. Our team is highly encouraged by the trial
retention rate and safety data to date. This data preliminarily
suggests a well-tolerated therapy, which may place Adial’s AD04 at
a significant advantage to other currently marketed AUD therapies.
Importantly, we remain on target to complete patient dosing in the
first quarter of 2022 and look forward to reporting our top line
data as soon as practical.”
For more information regarding ONWARD, please
visit the National Institute of Health’s Clinical Trials website,
which should be updated shortly to reflect full enrollment of the
trial.
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 pivotal ONWARD™ Phase 3 clinical trial for the potential
treatment of AUD in subjects with certain target genotypes, which
are 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,
pivotal 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
six countries in Scandinavia and Central and Eastern Europe
(Sweden, Finland, Poland, Latvia, Bulgaria and Croatia). The
Coordinating 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 the expectation that the ONWARD trial will be complete in
the first quarter of 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 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 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,
LLC David
Waldman / Natalya
Rudman Tel:
212-671-1021 Email:
adil@crescendo-ir.com
Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Apr 2023 to Apr 2024