Continuation patent would allow for
broader protection beyond claims protected under current
patents
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL;ADILW), a
clinical-stage biopharmaceutical company focused on the development
of medicines for addiction, today announced that it has submitted a
continuation patent application with U.S. Patent and Trademark
Office to broaden the claims relating to the use of AD04 for opioid
dependence and abuse, commonly referred to as Opioid Use Disorder
(OUD). The continuation patent claims priority to and therefore
retains the filing date of the original patent.
William Stilley, CEO of Adial Pharmaceuticals,
stated, “Given the progress we are making advancing towards our
Phase 3 trial for AD04 in Alcohol Use Disorder (AUD), we are now
accelerating our efforts to expand into other indications. We
believe this program has significant potential since the physiology
and neuro-transmitters involved in opioid addiction are similar to
alcohol and could be expected to be modulated by a serotonin-3
receptor antagonist. In the past, we have filed claims and received
patents globally that broadly recite addictive related
disorders. This is the first time we have filed a
continuation patent application specifically drawn to OUD.”
Mr. Stilley continued, “In addition to our
continuation patent application, we are also exploring non-dilutive
grant funding opportunities, as OUD represents an underserved
market and is a high priority with significant backing among both
governmental and non-governmental organizations. Since fentanyl is
a synthetic opioid, we believe AD04 represents a potential
treatment option for these patients as well.”
According to the Centers for Disease control, in
2017 alone, more than 72,000 people in the US died of drug
overdoses, at least two-thirds of which were linked to opioids.
This marked the highest number of Americans that have died of drug
overdoses in a single year—more than those killed by guns, car
crashes, or HIV/AIDS—with alcohol being one of the only other
causes responsible for more deaths.
According to the National Institute on Drug
Abuse (NIDA), among opioids, fentanyl is the biggest driver of
overdose deaths in America, as it is roughly 100 times more potent
than morphine and 50 times stronger than heroin. In 2016, synthetic
opioids (primarily illegal fentanyl) passed prescription opioids as
the most common drugs involved in overdose deaths in the United
States.
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 therapeutic agent for the
treatment of alcohol use disorder (AUD). 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). The Company plans to commence a Phase 3 clinical
trial using AD04 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. AD04 is
also believed to have the potential to treat other addictive
disorders such as opioid use disorder, gambling, and obesity.
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.
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. These statements are based upon current beliefs,
expectations and assumptions and include statements regarding the
beliefs that the program may have significant potential since the
physiology and neuro-transmitters involved in opioid addiction are
similar to alcohol and could be expected to be modulated by a
serotonin-3 receptor antagonist and that AD04 represents a
potential treatment option for OUD patients, the plans to commence
a Phase 3 clinical trial using AD04 for the potential treatment of
AUD in subjects with certain target genotypes, and the belief that
AD04 has the potential 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 a serotonin-3 receptor antagonist AD04 to modulate
the physiology and neuro-transmitters involved in opioid addiction;
the ability of AD04 to provide a potential treatment option for OUD
patients; our ability commence the Phase 3 clinical trials in the
first half of 2019, the ability of AD04 therapy to perform as
designed, to demonstrate safety and efficacy, as well as results
that are consistent with prior results, the contribution of our SAB
in advancing our Phase 3 clinical trial of AD04, the ability to
enroll patients and complete the clinical trials on time and
achieve desired results and benefits, 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 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 registration statement on Form S-1 that we have
filed with the SEC and the final prospectus and our Current Report
on Form 10-Q for the quarter ended September 30, 2018. 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 Tel: 212-671-1021
Email: dwaldman@crescendo-ir.com
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