Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)
(“Adial” or the “Company”), today announced that Purnovate, Inc., a
subsidiary of Adial focused on developing novel molecules targeting
the adenosine receptors for the treatment of major unmet medical
needs, achieved positive in-vivo data from its study with mice
treated with Purnovate’s PNV-6005 as a potential treatment for
inflammatory bowel diseases.
PNV-6005 is a selective adenosine 2A receptor
agonist designed to have anti-inflammatory properties and
protective effects against colitis and other inflammatory bowel
diseases (IBD). In the study, PNV-6005 demonstrated statistically
significant effect against both primary study endpoints, which are
pre-clinical endpoints expected to indicate potential efficacy
against ulcerative colitis in humans. Specially, PNV-6005 (i)
significantly prevented weight loss as compared to the control
group (greater than 50% inhibition of weight loss) and (ii)
significantly prevented colon damage as evidenced by reduction of
shortening of colon lengths in the PNV-6005 treated group (almost
total prevention), as well as a decrease in inflammation as
assessed histologically.
The study was conducted by Dr. Peter Ernst, DVM,
PhD, Professor of Pathology at the University of California San
Diego (UC San Diego), an expert in the fields of immunology,
inflammation and infectious diseases.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/1664150a-b1eb-4bc6-874a-e7462f47b19d
Study Design
- The study utilized a DSS- induced
colitis model, which is widely used because of its simplicity and
similarities with human ulcerative colitis
- PNV-6005 was administered
intraperitoneally twice a day at 6µg/kg dose for 7 days
- DSS was administrated at 4%
concentration via drinking water
- The study included four groups of 5
mice: (i) one group with normal drinking water; (ii) one group with
DSS 4% volume concentration in drinking water; and (iii) two
treated groups receiving PNV6005 intraperitoneal injections
The positive results follow a recent research
collaboration agreement between Purnovate and UC San Diego, a
leading education and research university, to evaluate the
Company’s proprietary adenosine analogs as a potential treatment
for inflammatory diseases, including IBD and infectious diseases
where a large immune response (i.e., cytokine storm) plays a
significant role.
Dr. Ernst stated, “We are encouraged by these
results, which demonstrate both in-vivo efficacy and the ability of
Purnovate’s adenosine compounds to effectively address the
historical challenges of solubility and biodistribution. We look
forward to further advancing this research in ulcerative colitis as
well as broader IBD indications and other inflammatory
conditions.”
William Stilley, CEO of Purnovate, stated, “We
appreciate the support of Dr. Ernst and UC San Diego in supporting
this important study, and look forward to advancing PNV-6005
towards first-in-human clinical trials. Ulcerative colitis is the
most common form of IBD and causes inflammation and ulcers in the
digestive tract, affecting an estimated 1 million people in the
U.S. alone. According to QY Research Medical, the ulcerative
colitis market was valued at $6.2 billion in 2020 and it is
expected to reach $10.8 billion by 2030. In addition to advancing
PNV-6005 for ulcerative colitis and IBD, we believe this research
reinforces the broad potential of our Purnovate adenosine platform
for other inflammatory conditions.”
"These additional data strengthen our belief in
the potential for our Purnovate platform and diverse
opportunities," said Cary Claiborne, CEO of Adial. "We will
continue to provide updates on our progress with Purnovate as we
advance the first drug candidates from this program toward clinical
development. Furthermore, we see good synergies between Adial's
work in bringing AD04 toward the market and that of Purnovate, with
a focus on building upon our addiction and pain treatment
pipeline."
About Purnovate, Inc.
Purnovate, Inc., a wholly owned subsidiary of
Adial Pharmaceuticals, Inc., is a pharmaceutical development and
chemistry company focused on inventing and developing selective,
potent, stable, and soluble drug candidates targeting the adenosine
receptors to treat diseases and disorders such as pain, asthma,
cancer, diabetes, non-alcoholic steatohepatitis (NASH), and
inflammatory diseases and disorders such as burn/wound healing,
inflammatory bowel disorder and infectious disease. For more
information, visit www.adial.com/purnovate/.
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 Purnovate’s PNV-6005 as a potential treatment for
inflammatory bowel diseases, PNV-6005 having anti-inflammatory
properties and protective effects against colitis and other
inflammatory bowel diseases, advancing this research in ulcerative
colitis as well as broader IBD indications and other inflammatory
conditions, advancing PNV-6005 towards first-in-human clinical
trials, the ulcerative colitis market reaching $10.8 billion by
2030, the broad potential of Purnovate’s adenosine platform for
other inflammatory conditions and diverse opportunities 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
further validate the potential of PNV-6005 to have
anti-inflammatory properties and protection against colitis and
other inflammatory bowel diseases in human clinical trials, our
ability to validate the potential of adenosine compounds as an
alternative or adjunct therapy, our ability to 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, 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,
LLC David
Waldman / Natalya
Rudman Tel:
212-671-1021 Email:
adil@crescendo-ir.com
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