PharmaTher Provides Product Pipeline Updates and Anticipated
Milestones for Q4-2021 and 2022
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10
clinical sites selected to participate in the FDA Phase 2 clinical
study evaluating ketamine for the treatment of Parkinson's
Disease
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Initiated
investigational new drug (IND) application to proceed to a Phase 2
clinical study for KETABET™ to treat depression
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Completed Phase 2
clinical study protocol for ketamine to treat ALS for IND
submission to the FDA
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Near
completion of research programs to advance novel
microneedle patches for the delivery of psychedelics
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Selected
U.S.-based CDMO to develop and supply proprietary ketamine products
for FDA Phase 3 clinical studies and commercialization
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Positioned
ketamine focused product pipeline for potential Phase 3 clinical
studies and commercial supply in 2022
TORONTO, September 13,
2021 -- InvestorsHub NewsWire -- PharmaTher Holdings Ltd. (the
"Company" or "PharmaTher") (OTCQB:
PHRRF) (CSE: PHRM),
a clinical-stage psychedelics biotech company, is pleased to
provide a product pipeline update and anticipated milestones for
Q4-2021 and 2022 including ongoing FDA Phase 2 clinical study
programs, microneedle patch delivery programs for psychedelics, and
clinical, commercial manufacturing and supply for its proprietary
ketamine and microneedle patch products.
Fabio
Chianelli, Chief Executive Officer of PharmaTher, said,
"I am very pleased with
the progress of our clinical programs for ketamine as a potential
treatment for Parkinson's disease, ALS and
depression. Our research programs for microneedle
patch delivery are nearing completion and preparations for FDA
Phase 1 and 2 clinical studies are on track. To support these and future programs,
we are securing manufacturing and supply of our proprietary
ketamine products and microneedle patches for planned FDA Phase 2
and 3 clinical studies and commercialization in 2022 and
beyond. We remain focused on achieving our
milestones in Q4-2021 and building a solid foundation that will
allow us to become a leader in the development and
commercialization of novel ketamine-based products. In addition,
our intradermal delivery of ketamine and psychedelics via our
proprietary microneedle patches position us for potential
next-generation therapeutic solutions for mental health,
neurological and pain disorders."
FDA
Phase 2 Clinical Study Programs
For the rest of 2021,
PharmaTher will focus on advancing three promising developments
through FDA Phase 2 clinical studies:
Ketamine
for Parkinson's Disease
The FDA's approval to
proceed with a Phase 2 clinical trial to evaluate the safety,
efficacy and pharmacokinetics of ketamine in the treatment of
levodopa-induced dyskinesia in patients with Parkinson's disease
triggered clinical program execution. The
Company has completed its clinical trial start-up activities and
selection of essential vendors including project
management, central laboratory, clinical supply kits and logistics,
data management and biostatistics, and clinical site management and
monitoring. Clinical trial drug product
(ketamine) and active placebo (midazolam) have also been
obtained.
More importantly, the
Company has selected ten (10) clinical sites in the U.S. to
participate in the Phase 2 clinical study. Patient screening has begun and the
Company expects patient enrollment to support the delivery of
clinical results in Q4-2021.
For further detail about
the study (ClinicalTrials.gov Identifier: NCT04912115), titled "A
Multi-Center, Phase II, Randomized, Double-Blind, Prospective,
Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous
Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in
Subjects with Parkinson's Disease," please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.
If the Phase 2 clinical
study is positive, the Company will request a meeting with the FDA
to discuss its plan and obtain an agreement to move to a Phase 3
clinical study under the 505(b)2 regulatory pathway in the first
half of 2022.
KETABET™
for Treatment-Resistant Depression
The Company has finalized
the Phase 2 clinical study protocol to evaluate KETABET™ for
treatment-resistant depression. The Company is working with its
scientific and clinical advisor, Dr. Maurizio Fava, MD, with the
aim to complete the IND and file it with the FDA in early
October. With the overlap of the clinical
operations from the Parkinson's disease study, the Company has
already activated start-up activities and identified potential
clinical sites to screen and enroll patients for the proposed Phase
2 clinical study in Q4-2021. The aim is to share initial clinical
results by the end of this year.
Assuming the Phase 2
clinical study is positive, the Company will request a meeting with
the FDA to discuss its plan and obtain an agreement to move to a
Phase 3 clinical study under the 505(b)2 regulatory pathway in the
first half of 2022.
KETABET™ is
the Company's patented combination formulation of FDA-approved
ketamine and betaine as
a potential next-generation treatment for neuropsychiatric
disorders.
More than
300 million people suffer from major
depressive disorder and of those, 100 million are resistant to
available treatments worldwide.
KETABET™ research has
shown potential enhancement of the antidepressant effect while
having the potential to significantly reduce the known negative
side effects of ketamine.1
Side effects such as
hallucinations, confusion, memory loss and abuse liability
compromise the compliance and potential therapeutic value of
ketamine.
Ketamine
for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's
Disease)
The Company has been
granted orphan drug designation by the FDA for ketamine to treat
ALS and along with its clinical advisors, has finalized the Phase 2
clinical study protocol. The IND application for this study is in
process and will be filed with the FDA in October 2021 with patient
enrollment targeting Q1-2022.
PharmaTher has an
exclusive license agreement with the University of Kansas for the
intellectual property protecting the potential use of ketamine to
treat ALS.
Preclinical research has
shown that the administration of ketamine preserves muscle function
in advancing ALS and could potentially increase life expectancy
when given in the early stages of muscle decline.
Proprietary
Microneedle Patch Delivery Programs for
Psychedelics
PharmaTher is working
with its research and development partners to advance next-generation microneedle
patches for the delivery of psychedelics:
Hydrogel-Forming
Microneedle Delivery Technology for Ketamine
PharmaTher has exclusive
worldwide development and commercial rights for the delivery of
ketamine, esketamine and KETABET™ using a patented hydrogel-forming
microneedle patch. The
Company is working with Professor Ryan Donnelly under a research
agreement with The Queen's University of Belfast to develop the
microneedle patch for the delivery of ketamine and
KETABET™. Foundational research is almost
complete and final research results will become available in
December 2021. To date, initial proof of concept
with ketamine and KETABET™ is very encouraging. The Company is currently preparing
for validation and tech transfer activities to support Phase 1 and
Phase 2 clinical studies in 2022. Development progress will be made
available as they arise for the remainder of the year.
The Company's microneedle
patch leverages the successful proof of concept achieved in
delivering esketamine, the S(+) enantiomer of ketamine, via the
microneedle patch, which may overcome the drawbacks associated with
ketamine administration in an intravenous or nasal spray
format.2
Details of the research
can be found in a published paper titled "Hydrogel-forming
microneedle arrays as a therapeutic option for transdermal
esketamine delivery."
GelMA
Microneedle Delivery Technology for Psychedelics
The Company is working
with the Terasaki Institute under a research agreement to finalize
the development of a proprietary microneedle delivery technology
comprised of a biocompatible and biodegradable gelatin methacryloy
(GelMA) composite for use with psychedelics such as psilocybin,
DMT, MDMA and LSD. The GelMA patch delivery technology
is the driving force of the Company's psychedelics microdosing
program. The research program is almost
complete and successful proof of concept with psilocybin and LSD
has been achieved. Full research results will be made
available in November 2021. The Company is currently preparing
for validation and tech transfer activities to support Phase 1 and
Phase 2 clinical studies in 2022.
Clinical and
Commercial Manufacturing and Supply
Initiatives
Proprietary
Ketamine
PharmaTher is focused on
building a specialty ketamine-based product
pipeline. The Company has selected a U.S.-based
GMP contract development and manufacturing organization (CDMO) with
extensive experience in the development, production and supply of
clinical and commercial controlled substance sterile
products. PharmaTher will work with the CDMO to
develop the Company's proprietary ketamine drug product(s) to
support future clinical studies and global commercial
supply.
It is expected that the
proprietary ketamine drug products will be available for FDA Phase
3 clinical studies and commercialization in H2-2022.
Proprietary
Microneedle Patch
The Company entered into
a co-development agreement with TSRL, Inc. to jointly develop the
patented hydrogel-forming microneedle patch delivery
technology. This
allows the Companies to control the manufacturing and supply of
microneedle patches for their respective clinical and commercial
drug programs.
PharmaTher is focused on
incorporating psychedelics and TSRL is focused on incorporating
antiviral medications in a microneedle patch with the potential to
improve the safety (i.e. fewer side effects), efficacy (i.e.
bioavailability, optimized dosing regimen including continuous
system delivery) and compliance (i.e. storage, distribution and
self-administration) of these compounds that currently must be
taken orally, inhaled, injected and intravenously.
Recent activities
included the tech transfer for scale-up and manufacturing of
clinical supplies to a GMP contract research lab and a pre-IND
meeting with the FDA that achieved agreement with the agency on
proposed 505(b)2 product development plans.
The Company aims to
validate non-clinical and clinical production of the microneedle
patch by October 2021 and begin non-clinical and clinical
manufacturing supply at the end of 2021. The Company expects to enter into
Phase 1 and 2 clinical studies in 2022 to evaluate its microneedle
patch in delivering ketamine, KETABET™, psilocybin, DMT, MDMA and
LSD.
About
PharmaTher Holdings Ltd.
PharmaTher
Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage
psychedelics biotech company focused on the research, development
and commercialization of novel uses, formulations and delivery
methods of psychedelics, including ketamine, to treat mental
health, neurological and pain disorders.
PharmaTher
is currently conducting an FDA approved phase 2 clinical study with
ketamine to treat Parkinson's disease and is developing novel
microneedle patches for the intradermal delivery of
psychedelics.
Learn more
at:
PharmaTher.com and follow
us on
Twitter and
LinkedIn.
For more information
about PharmaTher, 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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References:
-
J.-C. Lin,
M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances
antidepressant-like, but blocks psychotomimetic effects of ketamine
in mice, Psychopharmacology (Berl). 233 (2016)
3223–32.
-
Courtenay, et al.
Hydrogel-forming microneedle arrays as a therapeutic option for
transdermal esketamine delivery, Journal of Controlled Release,
Volume 322, 2020, Pages 177-186.
