Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)
(“Adial” or the “Company”), today issued the following letter to
its shareholders from the Company’s CEO, William Stilley.
Dear Shareholders,
It continues to be my great honor to serve you
as CEO of Adial Pharmaceuticals, especially at this momentous time
when you and I, anxiously yet optimistically, await top-line
results from the ONWARD™ Phase 3 clinical trial. Yesterday, we
announced database lock for ONWARD, and today, I want to take this
opportunity to personally write to you.
Great care was taken to verify and validate the
integrity of all data collected during ONWARD, all of which
remained blinded throughout. Now that database lock is complete,
meaning the dataset has been permanently set, the data has been
transferred to the Company´s outside, professional statisticians.
At this point, only these statisticians have access to the
unblinded ONWARD data, and they are now conducting their
review.
When their analyses is complete, the
statisticians will share the unblinded trial data and results with
Adial. Adial will then review the unblinded data. In the next
several weeks, and most likely by mid-July, we expect to publicly
announce the top-line results. Following the announcement, Adial
plans to further expand its review of the trial data to determine
what other information may be useful to support an application for
approval of AD04 to the FDA.
As Adial investors, we know the world needs a
drug with the characteristics that AD04 demonstrated in the Phase
2b study. After more than three years of work and substantial
investment, we seek to confirm and expand on the Phase 2b findings
with revelation of the ONWARD results.
Nearly all of us have been impacted by alcohol
addiction in some way. Precision medicine by genetic targeting
could revolutionize the way addiction patients are perceived and
treated. Adial is committed to advancing the science of addiction
through medicine to achieve better outcomes.
Finally, thank you for your support. We could
not have made it this far without you, and with you, we are
advancing the battle against addiction.
Sincerely yours,William Stilley, CEO
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.
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.
ONWARD 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™ 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 publicly announcing the top-line results by mid-July,
plans to further expand ours review of the trial data to determine
what other information may be useful to support an application for
approval of AD04 to the FDA, confirming and expanding on the Phase
2b findings with revelation of the ONWARD data, precision medicine
by genetic targeting revolutionizing the way addiction patients are
perceived and treated, 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 (i.e., a
pivotal Phase 3 trial) 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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