Adial Pharmaceuticals Announces Database Lock for the ONWARD™ Phase 3 Clinical Trial
27 June 2022 - 11:16PM
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
database lock for the Company’s ONWARD Phase 3 clinical trial. The
data sets have been transferred to the Company’s independent,
external statistical consultants who have initiated the analysis of
the data. Adial anticipates that it will provide top-line results
in July 2022.
“We are excited that data analysis has commenced
and we look forward to reporting the topline results of ONWARD this
July,” said Dr. Bankole Johnson, Chief Medical Officer of Adial.
“The primary endpoint of the ONWARD trial is reduction from
baseline in the monthly number of heavy drinking days experienced
by each patient during the last eight weeks of the 24-week
treatment period. Secondary endpoints include reduction in total
alcohol consumed and improvement as measured by the Patient Health
Questionnaire-9, a widely accepted tool for assessment of
depression. I am also pleased to reaffirm that no drug-related
serious adverse events were reported during the 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 and selected
polymorphisms in the serotonin transporter and receptor genes.
Patients were genetically screened prior to enrollment in the
ONWARD trial so that only genetically positive patients were
enrolled. Approximately one-third of the screened patients tested
genetically positive for the targeted genetics.
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.
The ONWARD trial is expected to serve as a basis
for approval of AD04 for the treatment of Alcohol Use Disorder in
patients identified as having the targeted genetics (i.e., a
pivotal Phase 3 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 ONWARD™ pivotal 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.
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 providing top-line results in July 2022, the ONWARD trial
serving as a basis for approval of AD04 for the treatment of
Alcohol Use Disorder in patients identified as having the targeted
genetics 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, the ability, our ability to provide
top-line results as planned, the ability of the ONWARD trial to
serve 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 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 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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