Charlottesville, VA – July 20, 2022 – 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 successful results from the
Company’s ONWARD trial, a 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.
AD04 achieved statistically significant mean reduction in heavy drinking days
among the pre-specified group of “heavy drinkers” (defined below). AD04 also
showed safety and tolerability that compared favorably to placebo. Adial intends to
share the results of the ONWARD trial with the relevant health authorities to discuss
the appropriate next steps towards the expeditious development of AD04 and to
seek product approval.
Highlights of topline ONWARD data:
·AD04 patients, compared with placebo patients, achieved a statistically
significant reduction from baseline at month six in heavy drinking days for
the pre-specified patient group of heavy drinkers (avg. <10 drinks per
drinking day at baseline; p=0.03), which accounted for approximately two-
thirds of the trial population. A similar trend was seen in the combined
month five and six analysis in the reduction from baseline (p =0.07).
Notably, in the last month of the trial, AD04 heavy drinking patients had a
mean reduction of approximately 79% in heavy drinking compared with
baseline.
·AD04 patients, compared with placebo patients, showed a trend in the
reduction from baseline at month six in heavy drinking days for the
combined trial population of heavy and very heavy drinkers (p=NS), which
was influenced by the high placebo response among very heavy drinkers
(avg. ≥10 drinks per drinking day at baseline), due to both the AD04 and
placebo groups reducing mean heavy drinking days by more than 50%. A
similar, non-statistically significant trend was seen in the combined months
five and six analysis in the reduction from baseline, which was the pre-
specified primary efficacy analysis.
·At conclusion of the trial, compared with placebo patients, AD04 patients in
the heavy drinking group had an overall significant difference in the severity
of their AUD diagnosis (p=0.04) under the Diagnostic and Statistical Manual
of Mental Disorders, Fifth Edition (DSM-5). For the group of those who no
longer meet AUD criteria (<2 symptoms), the comparisons were 27.4% vs.
14.9% (i.e., an 84% decrease), of AD04 and placebo patients, respectively.
These data underscore the clinical relevance of the findings that heavy
drinking AUD patients that receive AD04 appear more likely to recover from
the disease by the end of the treatment regimen.
·Based on the levels of alcohol consumption reported in a meta-analysis of
83 prospective studies in primary care screening for those with AUD (Wood,
et. al., Lancet 2018), the Company estimates that a majority of potential
patients for AD04 would fall under the pre-specified group of heavy drinkers.
This finding underscores the potential broad applicability of the results to
general practice and that they could be the basis for potential regulatory
approvals.
Additionally, and consistent with the Phase 2b trial, AD04 had a safety and
tolerability profile that was similar to placebo:
·Serious Adverse Events (SAEs)
o No SAEs were determined to be related to AD04 treatment.
o More SAEs were reported in the placebo group compared with the
AD04 group (7 on placebo vs. 3 on AD04).
o There were two cardiac events in placebo group and none in the AD04
group.
·Side effects/Adverse Events (AEs)
oThe AE profiles between AD04 and placebo were similar.
oAEs reported with a frequency of 5% or more of patients in either
group were: headache (11% on placebo, 12% on AD04), insomnia (3%
on placebo, 7% on AD04), blood magnesium decreased (5% on
placebo, 6% on AD04), and fatigue (3% on placebo, 6% on AD04). All
of the above AE’s were reported as mild to moderate.
oImportantly, in the overall category of cardiac disorders, patients on
placebo showed a greater number of adverse events relative to AD04
(7% on placebo, 4% on AD04), in addition to greater number of
cardiac SAEs in the placebo group as reported above.
William Stilley, Chief Executive Officer of Adial, commenting on the trial results,
said, “Alcohol Use Disorder is an unmet medical need that affects tens of millions
of people each year, and, based on the strength of these ONWARD results in heavy
drinking patients that have the target genetics, and the fact that AD04
demonstrated an exceptional safety profile, and was well-tolerated during the trial,
we intend to advance AD04. We will work with regulatory authorities in Europe and
the U.S. to achieve this goal. We also plan to explore strategic partnerships.”
Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the
University of Helsinki and Principal Investigator for the ONWARD trial, stated,
“These study results may provide hope to millions of people worldwide suffering
from AUD, as well to the families of those impacted by this devastating disease.
Among heavy drinkers, which make up the majority of my practice, we saw a clear
and statistically significant reduction in heavy drinking days for those patients
receiving AD04 versus placebo. These results demonstrate the effectiveness of
AD04 for heavy drinker AUD patients.”
Professor. Dr. Bankole Johnson, Chief Medical Officer of Adial, said, “It has been my
life mission to develop new therapies that provide patients with a means to either
curb the impulse to drink, or abstain from alcohol entirely. AUD accounts for more
than 5% of deaths worldwide and is the number one indicator of death for men and
women ages 15 to 49, the prime of their lives. The ONWARD study reinforces that
AUD is a multi-factorial disease with a diverse set of neurobiological components.
The ONWARD data appears to support our earlier findings that AD04 is a
genetically targeted medical treatment addressing the biology of AUD. We believe
our finding that AD04 appears as safe as placebo should increase its acceptability
in general practice and eventually lead to widespread adoption of AD04 for
treatment of AUD.”
The Company is planning further communication regarding the ONWARD results
and its future plans for product development and regulatory interactions.
Conference Call
The Company will host a conference call at 1:00 P.M. Eastern Time on Wednesday,
July 20, 2022 to discuss the clinical results in more detail.
The conference call will be available via telephone by dialing toll free 888-506-
0062 for U.S. callers or +1 973-528-0011 for international callers and by entering
the access code: 810744. A webcast of the call may be accessed
at https://www.webcaster4.com/Webcast/Page/2463/46199 or on the Company’s
website at https://www.adial.com/newsroom/#section=adial-events.
A webcast replay of the call will be available on the Company’s Investor Relations
Section of the website (www.ir.adial.com) through July 20, 2023. An audio replay of
the call will be available through August 3, 2022 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: 46199.
About the ONWARD™ Trial
The ONWARD Phase 3 clinical trial was 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, and patients were stratified by the severity of
drinking into heavy drinkers and very heavy drinkers (determined by whether they
averaged less than ten, or greater than or equal to ten drinks per drinking day,
respectively, prior to enrollment). Approximately, two-thirds of the patients in the
ONWARD trial were in the heavy drinking group and one-third in the very heavy
drinker group.
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 was Professor Hannu E.R. Alho, Emeritus
Professor of Addiction Medicine at the University of Helsinki.
About Alcohol Use Disorder
According to an article in the widely respected publication The Lancet, alcohol is
the number one cause of death globally among both men and women ages 15 to
49 years. In the United States alone, approximately 35 million people have AUD
resulting in significant health, social and financial costs (NIAAA Alcohol Facts &
Statistics). AUD contributes to over 200 different diseases, and 10% of children live
with a person that has an alcohol problem. According to the American Society of
Clinical Oncologists, 5-6% of new cancers and cancer deaths globally are directly
attributable to alcohol. The Centers for Disease Control (CDC) has reported that
AUD costs the U.S. economy about $250 billion annually, with heavy drinking
accounting for greater than 75% of the social and health related costs. In addition,
according to the NIAAA, the problem in the United States appears to be growing
with an approximately 50% increase in AUD prevalence between 2002 and 2013.
Despite the high prevalence and high costs, according to an article in the JAMA
2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with
AUD are estimated to have been treated in any way and only 3.6% by a physician
(i.e., approximately 1.3 million people). The most common treatments for AUD are
directed at achieving abstinence, and typical treatments include psychological and
social interventions. Most therapies require abstinence even prior to initiating
therapy. Abstinence requires dramatic lifestyle changes often with serious work
and social consequences. Significant side effects of current pharmacologic
therapies include mental side effects, such as psychiatric disorders and depressive
symptoms and physical side effects, such as nausea, dizziness, vomiting,
abdominal pain, arthritis and joint fitness. These problems with the currently
available therapies appear to limit the willingness of people with AUD to seek
treatment and then to limit compliance with treatment requirements and,
therefore, the ultimate results for many people attempting currently available
therapies.
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) in heavy drinking
patients and was recently investigated in the Company’s ONWARD™ pivotal Phase
3 clinical trial for the potential treatment of AUD in subjects with certain target
genotypes (estimated to be approximately one-third of the AUD population)
identified using the Company’s proprietary companion diagnostic genetic test.
ONWARD showed promising results in reducing heavy drinking in heavy drinking
patients, and no overt safety or tolerability concerns. 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.adial.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 sharing the results of the ONWARD trial with the relevant
health authorities to discuss the appropriate next steps towards the expeditious
development of AD04 and to seek product approval, estimates that a majority of
potential patients for AD04 would fall under the pre-specified group of heavy
drinkers, the potential broad applicability of the results to general practice and
that they could be the basis for potential regulatory approvals, intent to advance
AD04 and working with regulatory authorities in Europe and the U.S. to achieve
this goal, plans to explore strategic partnerships, the study results providing hope
to millions of people worldwide suffering from AUD, AD04 appearing as safe as
placebo increasing its acceptability in general practice and eventually lead to
widespread adoption of AD04 for treatment of AUD, further communication
regarding the ONWARD results and future plans for product development and
regulatory interactions 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 of AD04 to be
approved by regulatory authorities for treatment of AUD, our ability to
commercialize 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, 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.
