PharmaTher
Provides Update on Psychedelic Product Programs
TORONTO,
Canada -- April 15, 2021 -- InvestorsHub NewsWire -- PharmaTher
Holdings Ltd. (the "Company" or "PharmaTher") (CSE:
PHRM) (OTCQB:
PHRRF), a specialty psychedelic pharmaceutical company, is
pleased to provide an update on its psychedelic product
programs
as it
relates to the clinical and commercial development of ketamine and
the research and development of proprietary microneedle patch
delivery systems for psychedelics such as
ketamine, psilocybin,
N,N-Dimethyltryptamine ("DMT"), 3,4-Methylenedioxymethamphetamine
("MDMA") and lysergic acid diethylamide ("LSD").
"Over the
last 12 months, we have been focused on building our intellectual
property portfolio, which currently consists of 17 granted patent
and patent applications, advancing the clinical development of our
ketamine product pipeline
targeting Parkinson's disease, depression and Lou Gehrig's disease,
and developing novel microneedle patch delivery systems to unlock
the clinical value of psychedelics to treat neuropsychiatric,
neurodegenerative and pain disorders," said Fabio Chianelli, CEO of
PharmaTher. "With
the
recent
closing
of
the
sale
of our
psilocybin
program to Revive
Therapeutics for up to
CAD
$10
million, of which we
received $3 million in cash and $4 million in Revive common
stock upfront,
we are in a good
financial
position to advance our FDA
Phase 2 clinical studies with ketamine and to finalize the
development of our proprietary microneedle patch delivery systems
for clinical trials and to partner with life
sciences companies seeking a differentiated, safe and effective
delivery option for psychedelics."
Clinical
and Commercial Development Initiatives for Ketamine
Ketamine
is a rapid-acting, nonbarbiturate general anesthetic approved by
the Food and Drug Administration ("FDA") in 1970 and is clinically
used for analgesia, sedation, and anesthetic induction. Ketamine is
a generic drug classified by the Drug Enforcement Agency ("DEA") as
a Schedule III controlled substance. Published studies have
demonstrated ketamine's potential in major depressive disorder,
bipolar depression, depression with suicidal ideation,
post-traumatic stress disorder, drug addiction, Parkinson's
disease, and pain management.
PharmaTher is
planning on developing its own branded ketamine and is advancing
the clinical development of ketamine for Parkinson's disease,
depression and Amyotrophic lateral sclerosis ("ALS"), also known as
Lou Gehrig's disease under the FDA 505(b)(2) regulatory pathway.
The 505(b)(2) regulatory pathway provides for FDA approval based on
data (i.e.,
preclinical and
clinical data) previously reviewed by the FDA for the approval of a
separate drug application. PharmaTher seeks to leverage this
regulatory pathway to potentially accelerate the development
and lower
the clinical and regulatory risk of its ketamine-focused product
pipeline. The Company plans to have investigational new drug
("IND") applications with the FDA this year to evaluate ketamine in
Phase 2 clinical trials for Parkinson's disease, depression, and
ALS.
Commercialization
of Ketamine
PharmaTher plans to
commercialize its own branded ketamine product
to
support its growing ketamine-based product pipeline and meet the
increasing demand for ketamine globally. The Company is in
discussions with contract development and manufacturing
organizations ("CDMOs") for the
development and commercialization of ketamine and to file an
Abbreviated New Drug Application ("ANDA") to obtain FDA approval to
market ketamine in the U.S. An ANDA is a request to the FDA to
manufacture and market a generic drug in the U.S. The Company
will provide details on its commercialization strategy once a CDMO
is chosen.
Ketamine
for Parkinson's Disease
Parkinson's disease
is a debilitating disorder that affects over 1 million people in
the U.S. and more than 7 million people worldwide. There is
currently no cure for Parkinson's disease. The global Parkinson's
disease market is expected to grow from USD $5 billion in 2019 to
USD $7.5 billion by the end of 2025.
PharmaTher entered
into an exclusive license agreement with the University of Arizona
to develop and commercialize ketamine to treat Parkinson's disease
and movement disorders. Study results from preclinical
studies and case studies in Parkinson's disease patients from the
University of Arizona have shown that low-dose sub-anesthetic
ketamine infusion indicates tolerability, safety, and potential
long-term therapeutic benefit to reduce levodopa-induced
dyskinesia, improve on time, and reduce depression.
PharmaTher will file
its IND application with the FDA this month to evaluate the safety,
efficacy and pharmacokinetics of a low dose of ketamine for the
treatment of levodopa-induced dyskinesia ("LID") in individuals
with Parkinson disease ("PD") in a Phase 2 clinical trial. Assuming
the Phase 2 clinical trial is positive, the Company will request a
meeting with the FDA to discuss its plan and to obtain an agreement
to move to a pivotal Phase 3 clinical study under the 505(b)(2)
regulatory pathway.
KETABET™
for Major Depressive Disorder
Over 300
million people suffer from major depressive disorder, and 100
million people are resistant to available treatments worldwide.
Ketamine is emerging as a viable treatment option for depression.
Despite this, the potential for abuse and misuse of ketamine and
the adverse mental effects of ketamine uses
such as
dissociative, hallucinogenic, and amnesic effects leads to its
limited clinical use and discontinuation.
PharmaTher entered
into an exclusive worldwide license agreement with the National
Health Research Institutes to develop and commercialize a patented
combination formulation of FDA-approved ketamine and betaine
("KETABET™") as a potential next-generation ketamine product.
KETABET™ has shown in research studies to enhance the
antidepressant effect while having the potential to significantly
reduce the known negative side effects of ketamine.
In
Q2-2021, PharmaTher plans to file a pre-Investigational New Drug
("pre-IND") meeting request with the FDA to support the clinical
development of KETABET™ in depression. The pre-IND meeting will
provide valuable information for the Company to conduct a Phase 2
clinical study in the U.S. and obtain agreement that a 505(b)(2)
regulatory pathway is acceptable, allowing for the potential to
accelerate the clinical development for KETABET™ approval.
After the pre-IND meeting, PharmaTher will file an IND application
to conduct a Phase 2 clinical study.
Ketamine
for Amyotrophic Lateral Sclerosis (Lou Gehrig's disease)
Currently, there is
no known cure for Amyotrophic lateral sclerosis ("ALS"). ALS is a
progressive neuromuscular disease with a life expectancy of only 2
to 6 years after diagnosis. ALS affects approximately 50,000 people
in the U.S. and Europe, with over 5,000 new cases diagnosed
annually. As ALS advances, upper and lower motor neurons die,
causing the brain to lose its ability to control muscle movement.
Peak sales for a new drug to treat ALS can achieve over USD $1
billion.
PharmaTher entered
into an exclusive license agreement with The University of Kansas
to develop and commercialize the intellectual property of ketamine
to treat ALS. Inventors Dr. Richard J. Barohn, M.D., John A.
Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the
promising discovery that ketamine can be administered as an
effective treatment for ALS. Their preclinical research has shown
that the administration of ketamine preserves muscle function in
advancing ALS and increases life expectancy when given in the early
stages of muscle decline.
PharmaTher plans to
apply for orphan drug designation with the FDA in Q2-2021 and file
its IND with the FDA in Q3-2021 to support the clinical development
of ketamine in ALS.
Proprietary
Microneedle
Patch Delivery Systems
PharmaTher is
developing two novel microneedle patch delivery systems to support
KETABET™ and microdosing of psychedelics as part of its product
lifecycle strategy. PharmaTher believes that the microneedle patch
delivery systems for psychedelics may overcome the potential
drawbacks of oral administration, subcutaneous injections, topical
and nasal delivery systems.
PharmaTher is in
discussions with CDMOs to manufacture clinical-grade microneedle
patches to evaluate the delivery of psychedelic drugs, such as
ketamine, psilocybin, DMT, MDMA and LSD in human clinical
trials.
Hydrogel-Forming
Microneedle Delivery System for Ketamine
PharmaTher entered
into an exclusive worldwide patent and know-how license agreement
with The Queen's University of Belfast ("QUB") to develop and
commercialize a patented hydrogel-forming microneedle patch
delivery technology developed by Professor Ryan Donnelly to support
PharmaTher's product and clinical development initiatives involving
ketamine. The patented microneedle ("MN") patch delivery
system consists of hydrogel-forming MN arrays and an accompanying
reservoir which will overcome any limitations by the quantity of
drug that can be loaded into the needles or onto the needle
surfaces. The MN patch can significantly increase drug permeating
through the microneedle array and into the skin. This MN
patch is ideal for KETABET™ due to drug loading capacity and
combination.
Most
recently, Professor Donnelly's lab successfully completed research
and published a paper titled "Hydrogel-forming microneedle arrays
as a therapeutic option for transdermal esketamine delivery,"
validating the delivery of esketamine, the S(+) enantiomer of
ketamine, in a novel microneedle patch which may overcome the
drawbacks associated with ketamine administration in an intravenous
or nasal spray format.
PharmaTher will
continue developing the hydrogel-forming MN patch and evaluate it
with KETABET™. PharmaTher's proposed KETABET™ MN patch aims
to empower patients to dose their medication remotely, safely and
conveniently rather than under supervision by a healthcare provider
at a certified medical office. KETABET™ MN patch has the potential
for enabling continuous delivery of KETABET™ (without pain) with
minimal formulation manipulation into systemic circulation
while maintaining constant plasma levels for more than 24 hours
that will improve efficacy and compliance for patients. Also,
the KETABET™ MN patch will incorporate anti-tampering and
anti-abuse features and the product's delivery format that would
parallel the approach used for the tamper-resistant transdermal
fentanyl patch.
Development of the
ketamine hydrogel-forming MN delivery system at QUB is ongoing, and
development milestones will be made available as they
arise.
GelMA
Microneedle Delivery System for Psychedelics
The
Company entered into an exclusive license agreement for the
development and commercialization of a proprietary microneedle
delivery system, comprised of a biocompatible and biodegradable
gelatin methacryloy ("GelMA") composite developed in Khademhosseini
Lab at the University of California, Los Angeles ("UCLA"), for use
with psychedelic pharmaceuticals, including, but not limited
to, psilocybin, LSD,
MDMA, DMT, ibogaine and cannabinoids.
The GelMA
MN patch delivery system delivers both water-soluble and insoluble
drugs with desirable release profiles, efficiently penetrates the
stratum corneum layer (outer layer of the skin), and enables
flexible drug load capacity and combinations, and control-release
delivery. The GelMA patch delivery system focuses on the Company's
psychedelic microdosing program.
PharmaTher entered
into a sponsored research agreement with the Terasaki Institute to
further develop the GelMA MN patch for microdosing of psychedelics.
The results of certain development milestones will be made
available as they arise.
About
PharmaTher Holdings Ltd.
PharmaTher Holdings
Ltd. (CSE:
PHRM) (OTCQB:
PHRRF) is a specialty psychedelic pharmaceutical
company focused on the research, development and commercialization
of ketamine and novel microneedle patches for delivering
psychedelics to treat neuropsychiatric, neurodegenerative and pain
disorders.
Learn more at:
PharmaTher.com
and follow us on
Twitter
and
LinkedIn.
For more
information, please contact:
Fabio
Chianelli
Chief
Executive Officer
PharmaTher
Holdings
Ltd.
Tel:
1-888-846-3171
Email:
info@pharmather.com
Website:
www.pharmather.com
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