PharmaTher
Announces
Submission of IND Application with
the FDA for
Phase
2 Clinical Trial Evaluating
Ketamine
in
the Treatment of Parkinson's Disease
TORONTO,
April 20, 2021 --
InvestorsHub NewsWire -- PharmaTher
Holdings
Ltd. (the "Company" or "PharmaTher") (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical
company, today announced it
submitted an Investigational New Drug ("IND") application with the
U.S. Food and Drug Administration ("FDA") for the initiation of a
Phase 2 clinical trial to evaluate the
safety, efficacy and pharmacokinetics of low-dose
ketamine
in
the treatment of levodopa-induced dyskinesia in patients with
Parkinson's disease ("LID-PD").
"The submission of our
IND application with the
FDA is an important milestone
as
it
provides
us
with a solid
foundation to
advance
our
ambition
in
commercializing
ketamine and unlocking
its
therapeutic
potential
through
novel uses, formulations and delivery methods in the treatment
of neurodegenerative
diseases
(ie. Parkinson's
disease and
Lou
Gehrig's disease), mental illness
(ie. Depression and
PTSD) and chronic
pain," said Fabio
Chianelli,
CEO of PharmaTher.
Ketamine
is an FDA-approved N-methyl-D-aspartate ("NMDA")
receptor-modulating drug that is widely used as an anesthetic agent
either alone or in combination with other anesthetic agents
[Smith et
al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of
low-dose ketamine on LID was noted in a retrospective analysis of
PD patients who received ketamine for pain relief. During this
analysis, it was observed that the patients experienced an
improvement in LID lasting several weeks beyond
treatment
[Sherman
et al, 2016]. These results were corroborated in a test of low-dose
ketamine in a rodent LID model, and this possible effect has also
been examined in a controlled study
[Bartlett
et al, 2016]. Ketamine may also have additional benefits in the
treatment of pain [Niesters
et al,
2014] and depression [Diamond et al, 2014; Murrough
et al,
2013], which are frequent comorbidities of Parkinson's
disease.
The clinical trial
is
titled "A
Multi-Center, Phase IIA, Randomized, Double-Blind, Prospective,
Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat
Levodopa-Induced Dyskinesia in Subjects with Parkinson's
Disease." It is
anticipated that up
to eight
clinical
sites in
the U.S. will randomize a total of up to 36 subjects to
the
investigational product (ketamine) or active control
(midazolam). The primary
end-point of the study
is the
change in the Unified Dyskinesia Rating Scale ("UDysRS")
total score from Baseline to Week 8. Secondary endpoints of
the study include the
change in
Total Objective Scores of the
UDysRS,
total
daily OFF times as assessed by subject-completed 24-hour
diaries and change in the
UPDRS total and sum scores
of
motor
and
dyskinesia
from
Baseline to Week 8. Because LID can
markedly affect a Parkinson
patient's
everyday activities, a reduction in LID could improve
the
patient's quality of life.
Assuming
the Phase 2 clinical trial is positive, the Company will request a
meeting with the FDA to discuss its plan and obtain an agreement to
move to a pivotal Phase 3 clinical study under the 505(b)(2)
regulatory pathway.
However,
there can be no assurance that the FDA will support any potential
request for an expedited path to approval or further
development.
About
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. Although the
etiology of PD is not fully understood, it is thought to result
from loss of pigmented dopaminergic neurons in the Substantia nigra
and their striatal projections, leading to dopamine deficiency in
the striatum [Schapira
and
Jenner, 2011]. This ultimately affects the cortico-striatal system
that controls movement.
As
a
progressive neurogenerative disorder of the central nervous
system that primarily
affects the motor nerve system, symptoms of
Parkinson's disease may emerge slowly and
include tremors, rigidity,
bradykinesia, and postural instability [Paulson and Stern,
2004]. Also,
patients
may experience non-motor symptoms such as autonomic dysfunction
(orthostatic hypotension,
constipation, bladder dysfunction), psychiatric (depression),
cognitive and sensory symptoms (pain)
[Olanow,
et al, 2009]. These non-motor symptoms become more common as
the disease progresses.
Treatments, including
levodopa and dopamine agonists, which restore the dopamine deficits
in
the
brain, have been employed
for almost 50 years. However, with continued treatment
using
levodopa,
dose-limiting motor side-effects often emerge. This includes the
emergence of
abnormal
involuntary movements termed Levodopa Induced
Dyskinesias, which can
be
identified in about
50% of patients within five years after initiation of levodopa
treatment and in
almost
all patients within ten
years
post-treatment initiation.
These side effects often limit further
dose
increases in dopaminergic therapy.
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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required by applicable securities laws. The foregoing statements
expressly qualify any forward-looking information contained herein.
Factors that could cause actual results to differ materially from
those anticipated in these forward-looking statements are described
under the caption "Risk Factors" in Company's management's
discussion and analysis for the period of November 30, 2020
("MD&A"), dated January 27, 2021, which is available on the
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