Adial Pharmaceuticals, Inc. (NASDAQ: ADIL;
ADILW), a clinical-stage biopharmaceutical company focused
on developing therapies for the treatment and prevention of
addiction and related disorders, today announced positive data in a
pre-clinical model of pain reduction. Based on this positive data,
Purnovate, Inc., a wholly owned subsidiary of Adial
Pharmaceuticals, Inc., has selected PNV-5030 as the lead compound
for its program to develop a drug for the treatment of pain.
PNV-5030 has been tested to be more than
1000-fold selective over the adenosine A1 receptor, which is known
to have cardiovascular and central nervous system effects across
several therapeutic indications. Historically, when selectivity has
been achieved over the A1 receptor, water solubility has decreased,
making effective tissue distribution in the human body (made
largely of water) difficult to achieve. However, PNV-5030 has
demonstrated solubility more than 50 times greater than other known
selective adenosine compounds of the same class. Solubility is
often an important characteristic of successful drug candidates,
and Purnovate believes solubility is a particularly important
characteristic in determining the drug development potential of
molecules of this class.
In the most recent study, PNV-5030 was tested in
a mouse model of somatic nociceptive pain where discomfort was
initiated using a laser focused on the mouse’s tail, with the time
before the mouse flicked its tail away being measured by a sensor.
Response groups of 12 mice were analyzed with a control group
receiving vehicle alone (i.e., liquid dosing solution without any
drug) and other groups receiving either 1mg/kg or 2mg/kg doses of
morphine, a common opioid pain relief medication, alone; PNV-5030
alone; or morphine plus PNV-5030.
PNV-5030 alone exhibited a significant pain
reduction as compared to the control group and a similar effect to
1mg/kg morphine. Importantly, PNV-5030 demonstrated a significant
effect when administered with 1 mg/kg morphine as compared to
administering 1 mg/kg morphine alone. Interestingly, when combined
with 1 mg/kg morphine, PNV-5030 achieved a similar level of pain
reduction to the reduction obtained with 2mg/kg morphine. These
results could indicate the possibility of lowering the opioid dose
to achieve a similar pain reduction level by combining an opioid
with PNV-5030 or even eliminating the use of an opioid for pain
relief in favor of a higher dose of PNV-5030.
Notably, certain mice in both the PNV-5030 plus
morphine groups achieved results at the maximum time allowed under
the study (15 seconds), and, therefore, may have shown even greater
pain reduction results had the protocol allowed continuation of the
test beyond the time limit. The data are shown in the following
chart:
A Media Snippet accompanying this announcement
is available by clicking on the image or link below:
Dr. Julien Dimastromatteo, Purnovate’s Vice
President, Research, commented, “We are highly encouraged by what
we consider to be robust pre-clinical data demonstrating that
PNV-5030 should be advanced as a drug candidate for treating
somatic nociceptive pain. We have conducted an additional battery
of both in vitro and in vivo screening and believe that PNV-5030
has the characteristics to successfully complete the required
toxicity and toxicology studies to allow us to proceed with testing
in humans. With our lead compound selection made, we expect to
efficiently advance PNV-5030 into clinical trials in 2022.”
William Stilley, Adial’s Chief Executive
Officer, stated, “The Purnovate adenosine platform continues to
exceed expectations, and PNV-5030’s success in an oral model of
pain, after demonstrating pain reduction effects when administered
interperitoneally, is a validation of our belief that the platform
has the ability to underpin a drug development program addressing
pain and a number of other prevalent ailments such as diabetes,
asthma, cancer, Parkinson’s Disease, inflammatory bowel disease,
and infectious diseases where a cytokine storm is a significant
contributing factor, including COVID-19. We are highly encouraged
by this data, which suggests PNV-5030 may help reduce the need for
morphine and perhaps other opioids when used as either a standalone
or combination therapy or eliminate the need for the use of an
opioid altogether.”
About Adial Pharmaceuticals,
Inc.
Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on developing therapies for the
treatment and prevention of addiction and related disorders. 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.
About Purnovate, Inc.
Purnovate, Inc., a wholly owned subsidiary of
Adial Pharmaceuticals, is a pharmaceutical development and
chemistry company focused on inventing and developing selective,
potent, stable, and soluble adenosine analogs to treat diseases and
disorders such as pain, cocaine addiction, inflammation, infectious
disease, cancer, asthma, and diabetes. Additional information is
available at www.purnovate.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 solubility being a particularly important characteristic
in determining the drug development potential of this class of
adenosine compounds, PNV-5030 having the characteristics to
successfully complete the required toxicity and toxicology studies
to allow the Company to proceed with testing in humans, advancing
PNV-5030 into clinical testing in 2022, the Purnovate adenosine
platform having the ability to underpin a drug development program
addressing pain and a number of other prevalent ailments such as
diabetes, asthma, cancer, Parkinson’s Disease, inflammatory bowel
disease, and infectious diseases where a cytokine storm is a
significant contributing factor, including COVID-19 , 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
provide for effective oral administration of adenosine analog
compounds, our ability to successfully complete the required
toxicity and toxicology studies to allow us to proceed with testing
in humans and, advancing PNV-5030 into clinical trials in 2022 ,
our ability to demonstrate that PNV-5030 has broad implications as
a replacement therapy for opioids or, when used in combination, as
a way to support lower dose administration of opioids, our ability
to unlock the potential of adenosine analogs as a therapy
addressing pain and other prevalent ailments where a cytokine storm
is a significant contributing factor, 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 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 our 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, 2020, 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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