PharmaTher
Announces
FDA Approval of Ketamine IND In The Treatment of Parkinson's
Disease
TORONTO,
May
17,
2021 --
InvestorsHub NewsWire -- PharmaTher
Holdings Ltd. (the
"Company" or "PharmaTher") (CSE: PHRM) (OTCQB: PHRRF), a psychedelics
biotech
company,
is
pleased to announce
that
the U.S. Food and Drug Administration ("FDA") has approved the
Company's Investigational New
Drug ("IND") application 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
("LID-PD").
PharmaTher
expects
to begin enrolling
patients in the Phase 2
clinical trial in Q3-2021.
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
Phase 3 clinical study under the 505(b)(2) regulatory
pathway next
year.
Fabio
Chianelli, Chief Executive Officer of PharmaTher,
said, "The FDA's acceptance of
our IND application for ketamine to treat
Parkinson's disease
is a
significant milestone for
us.
The
FDA
IND
is our
first of many we
will
aim
to obtain,
and
we are
one of the few psychedelics-focused
biotech companies that have
an
IND approved
by
the FDA
for
a recognized
psychedelic
drug. The
IND paves the
way for us
to
expeditiously evaluate
ketamine and other
psychedelics via the FDA
regulatory pathway in
various
mental
illness, neurological
and
pain disorders.
We
are
committed to building a
rich
product
pipeline of
novel
uses, formulations and
delivery methods of
psychedelics,
and
with
our FDA
IND
in
place,
we now
have the foundation in
making
PharmaTher
a
global
leader
in psychedelic-based
therapeutics."
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 some drug
combinations are used to treat the disease symptoms. 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 [360iResearch
2020] and it is estimated
that the potential market opportunity for LID-PD to be over USD $3
billion in the U.S. alone.
About
the Phase
2 Clinical Trial
The
clinical trial is titled "A Multi-Center, Phase II, 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.
The
Company has assembled a prolific scientific and clinical team
experienced in Parkinson's disease, including Dr. Scott Sherman and
Dr. Torsten
Falk
from the University of Arizona, Dr. Alberto Espay
from
the University of Cincinnati and Dr. Robert Hauser from the
University of South Florida.
Ketamine's
Potential In Parkinson's Disease
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.
About
Parkinson's Disease
There
is currently no cure for Parkinson's disease. Although the etiology
of Parkinson's
disease 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.
There
can be no assurance that the FDA will support any potential request
for an expedited path to approval or further
development for ketamine in
the treatment of Parkinson's disease.
About
PharmaTher Holdings Ltd.
PharmaTher Holdings
Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a psychedelics
biotech
company
focused on the research, development and commercialization of
ketamine and novel microneedle patches for the delivery
of psychedelics to
treat mental
illness,
neurological
and
pain disorders.
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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