Full Press Release Details
Pharmaceuticals Provides Update on its ONWARD
Pivotal Phase 3 Trial of AD04 for Treatment of Alcohol Use Disorder
Projected to be Fully Enrolled During Q2 2021
VA - November 03, 2020 - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical
company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase
3 pivotal trial. ONWARD is investigating Adial's lead drug candidate, 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 highlights include:
are encouraged by the steady progress of our ONWARD Phase 3 trial and we are on track to complete enrollment during Q2
2021," commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "AUD accounts for nearly six percent
of all deaths worldwide and is the leading cause of death among men and women in their prime (ages 15 to 49). AUD also represents
a dramatically underserved market, as current therapies have limited efficacy and significant side effects. We believe AD04 may
represent a paradigm shift in treating this population. Among patients with the target genotype, we estimate the market for AD04
to be in excess of $35 billion in the United States where we are pursuing expedited review programs for AD04. The European market
is expected to be similar in size. It has also been reported that the AUD crisis continues to escalate given the prolonged nature
of the COVID-19 pandemic. We remain determined to advance ONWARD and look forward to providing further updates as we achieve
Adial Pharmaceuticals, Inc.
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 therapeutic agent for the treatment of Alcohol Use Disorder
(AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com
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 Trial being projected to be fully enrolled during Q2 2021, data readout being expected in Q4
2021 or earlier, AD04 representing a paradigm shift in treating the population afflicted with AUD, the market for AD04 being in
excess of $35 billion in the United States, the Company continuing its pursuit of U.S. expedited review programs for AD04, the
European market being similar in size to the market in the United States, the AUD crisis continuing to escalate given the prolonged
nature of the COVID-19 pandemic and providing further updates as the Company achieves key milestones, 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, our
ability to enroll patients 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 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, 2019,
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.
David Waldman / Natalya Rudman
Email: adil@crescendo-ir.com