The Phase 3 ONWARD™ Trial Meets its Screening Target and Nears Enrollment Completion
July 06 2021 - 9:25AM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage
biopharmaceutical company focused on the development of treatments
for addictions, today announced that the Company has made
significant progress on its pivotal ONWARD Phase 3 clinical trial
having met 100% of its patient screening target and having achieved
90% of its patient enrollment target. The ONWARD trial is
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 Recent
highlights:
- 100% of the number of patients expected to fully enroll
ONWARD have been screened
- 1254 subjects have been screened which represents 100% of
anticipated subjects required to be screened based on the trial’s
historical screening-to-enrollment rates
- 90% of the number of patients projected for full
enrollment have been enrolled
- 261 of 290 (90%) subjects expected to be enrolled in ONWARD
have been enrolled
- 33% of evaluated patients tested positive for the
AD04-associated genotype
- This genetic data is consistent with Adial’s expectations for
U.S. prevalence of the target genotype and supports current
addressable market forecasts for AD04, estimated at $36 billion and
growing
- AD04 appears to be well-tolerated
- While the trial is still blinded so it is not known which
patients are taking AD04 or placebo, the vast majority of adverse
events reported across all study subjects are mild in
intensity
- No trial study drug-related serious adverse events have been
observed to date
- Study retention rate of 84% continues to exceed
expectations
- The 84% study retention rate continues to outpace the projected
70% retention rate
- The high retention rate is consistent with the encouraging
safety data observed and the Company believes retention is
correlated with AD04’s tolerance.
“We are on track to deliver trial data in the
first quarter of 2022,” said Schuyler Vinzant, Adial’s Vice
President of Development.
William Stilley, Adial’s Chief Executive
Officer, commented, “Full trial enrollment is expected in the
coming weeks as we drive toward generating data from ONWARD as we
advance our science with the goal of bringing help to those with
addiction. The ramifications for all addictions, and even other
mental health disorders, could be powerful and significant.”
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.
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.
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 there being a correlation between the high retention rate
and the AD04’s tolerance, the projected timeline for the provision
of data in the first quarter of 2022, having the ONWARD™ trial
fully enrolled in the coming weeks, the ramifications of the trial
being powerful and significant for all addictions, and even other
mental health disorders 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 continue to enroll patients
within the timelines anticipated and complete clinical trials on
time, provide data when anticipated 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 our product candidates in the
marketplace and the successful development, marketing or sale of
our 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.
Contact:Crescendo Communications, LLCDavid
Waldman / Natalya RudmanTel: 212-671-1021Email:
adil@crescendo-ir.com
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