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)
- No SAEs were determined to be
related to AD04 treatment.
- More SAEs were reported in the
placebo group compared with the AD04 group (7 on placebo vs. 3 on
AD04).
- There were two cardiac events in
placebo group and none in the AD04 group.
- Side effects/Adverse Events (AEs)
- The AE profiles between AD04 and
placebo were similar.
- AEs 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.
- Importantly, 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.
Contact:Crescendo Communications, LLCDavid
Waldman / Natalya RudmanTel: 212-671-1021Email:
adil@crescendo-ir.com
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