Adial Pharmaceuticals Reaches Full Enrollment Target for ONWARD™ Phase 3 Trial of AD04 for the Treatment of Patients With Alcohol Use Disorder
August 20 2021 - 10:45AM
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
reached its full enrollment target of 290 subjects in the Company’s
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. ONWARD trial completion is expected in the first quarter of
2022.
William Stilley, Adial’s Chief Executive
Officer, stated, “Meeting our enrollment target is a major
achievement in our ONWARD™ Phase 3 trial. I would like to thank all
of the investigators involved in the trial that helped us reach
this important milestone in spite of the ongoing pandemic. Trial
engagement interest among patients continues to be strong, and
consistent with what was seen in previous clinical testing;
approximately 33% of those patients screened tested positive for
the genetics expected to indicate responsiveness to AD04. Our
confidence in the market potential of AD04 is bolstered by this
apparent confirmation of the percentage of the population with the
target genetics. We estimate the market potential for AD04 to be in
excess of $36 billion in the U.S. alone, and we are evaluating
marketing and distribution channel partners in the United States
and abroad.”
Mr. Stilley continued, “Due to increased demand
for entry into the study near the end of our trial recruitment
period, we still have additional patients that have been
genetically screened as positive for enrollment in the study but
have not yet been enrolled in ONWARD™. With this opportunity to
rapidly enroll additional patients to increase the statistical
power of the trial, and, we have determined to enroll these
additional, already screened patients through the end of this
month. This means total trial enrollment will exceed our enrollment
goal of 290 patients.”
“We are also encouraged by the high study
retention rate with more patients than expected continuing to
engage in the trial following enrollment. Moreover, no serious
adverse events have been reported to date that have been determined
to be study drug related, and the vast majority of adverse events
have been mild and also unrelated. The retention rate and safety
data are supportive of a well-tolerated therapy, differentiating
AD04 from other marketed AUD therapies.”
Conference Call
Adial will host a conference call at 11:00 A.M.
Eastern Time today, on Friday, August 20, 2021. The conference call
will be available via telephone by dialing toll free 844-369-8770
for U.S. callers or +1 862-298-0840 for international callers. A
webcast of the call may be accessed at
https://www.webcaster4.com/Webcast/Page/2463/42538 or on the
Company’s website at https://ir.adialpharma.com/.
An audio replay of the call will be available through September
3, 2021 and can be accessed by dialing 877-481-4010 for U.S callers
or +1 919-882-2331 for international callers and by entering the
access code: 42538.
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 the ONWARD trial completion being expected in the first
quarter of 2022, the target genetics expected to indicate
responsiveness to AD04 the market potential for AD04 being in
excess of $36 billion in the U.S. alone 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 achieve
key milestones for our pre-clinical adenosine program for
non-opiate pain relief, 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 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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