Adial Pharmaceuticals Achieves 50% Enrollment in ONWARD™ Phase 3 Trial
February 25 2021 - 9:30AM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW),
a clinical-stage biopharmaceutical company focused on the
development of treatments for addictions, today announced that it
has reached 50% enrollment in the Company’s landmark ONWARD™
pivotal Phase 3 clinical trial. ONWARD is investigating the
efficacy and safety of 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.
“We are pleased to have achieved this important
enrollment milestone in our ONWARD pivotal Phase 3 clinical trial,”
stated Schuyler Vinzant, Adial’s Vice President of Development. “We
have a high degree of confidence that ONWARD will be fully enrolled
this summer.”
Data Points – ONWARD Trial Patients
- 66% of
planned patient screening visits completed
- 830 patients
screened out of 1,254 patients expected to be required to achieve
full enrollment (more than 20 screened patients are currently
pending enrollment)
- 32% of
patients screened are genetically positive for treatment with
AD04
- Percentage of
genetically positive patients consistent with Phase 2b prevalence
and expected U.S. and European prevalence
- 75% of
patients screened as genetically positive have been
enrolled
- Patient
enrollment exceeds projected rate of 50% for genetically positive
patients
- 86%
ONWARD™ patient retention rate to date
- Retention rate
significantly greater than projected 70% retention rate
William Stilley, Adial’s Chief Executive
Officer, commenting on the ONWARD trial protocol, stated
“Telephonic pre-screening of potential study patients has allowed
us to successfully reduce non-genetic screen failure rates.
Moreover, streamlined site visits and patient follow-up processes
have resulted in better-than-expected retention rates to date.”
Mr. Stilley continued, “Adial would like to
express its genuine gratitude to all the ONWARD patients for their
participation in the study and appreciation for the commitment they
have made. We also appreciate the hard work of the more than 50
incredible frontline healthcare workers, including doctors, nurses
and their staff, who are caring for our patients and share Adial’s
commitment to improving outcomes for people suffering from Alcohol
Use Disorder.”
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 having the ONWARD™ trial fully enrolled this summer 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 enroll patients within the timelines anticipated 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 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,
LLC David
Waldman / Natalya
Rudman Tel:
212-671-1021 Email:
adil@crescendo-ir.com
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