PharmaTher Announces Positive
Research Results for Psilocybin Microneedle Patch
-
Delivering
psilocybin via microneedle patch unlocks potential
for desired dosage forms and pharmacokinetic profiles for
improved safety and
effectiveness.
-
Completing
microneedle patch research programs with other psychedelics before
year-end.
-
Pursuing Phase 2
clinical studies in 2022 with psilocybin and notable
psychedelics.
TORONTO, November 11, 2021 -- PharmaTher Holdings Ltd. (the
"Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company,
is pleased to announce that it has successfully completed its first
research study evaluating MicroDose-MN™,
a proprietary microneedle ("MN") patch for the intradermal delivery
of psychedelics, in delivering psilocybin.
These results provide
support to file for an IND application with the FDA to conduct
Phase 2 clinical studies in 2022 with psilocybin for various
indications.
The aim of PharmaTher's
research program was to develop a suitable prototype of
MicroDose-MN™ patch for transdermal (intradermal) drug
delivery to confirm compatibility and suitability to deliver
psilocybin. The research program scope included, full
characterization of psilocybin conjugated on the microneedle patch
backbone, establishment and demonstration of the loading capacity
for psilocybin, and release rate evaluations for the psilocybin
conjugated materials using appropriate models that will be used to
support the Company's IND application with the FDA.
The Company's research
program with psilocybin conjugated microneedles have been
successfully fabricated, optimized, and characterized. Both
structural aspects and ex-vivo skin insertion assessments of the
psilocybin conjugated microneedles have demonstrated successful
fabrication and acceptable performance. The incorporation of
psilocybin per microneedle without issue and the ability to
demonstrate complete ex vivo skin model release over several days
demonstrates potential for larger doses and modified release
profiles. With these results, the Company believes it has an
acceptable prototype for completing IND-enabling studies with the
aim to conduct clinical studies in 2022.
Details of the research
program will be published in a scientific journal.
The Company previously
announced that it has entered into a collaboration agreement with
Revive Therapeutics Ltd. ("Revive") (OTCQB: RVVTF)
(CSE: RVV) for the
evaluation of the psilocybin MicroDose-MN™
patch and is
currently in discussions with Revive in finalizing a definitive
agreement to advance the clinical and commercial
development.
There can be no assurance
that a definitive agreement will be entered into between PharmaTher
and Revive.
The Company believes that
its MicroDose-MN™ patch for delivering psilocybin and
other psychedelics may enable flexible drug load capacity and
combinations, controlled released delivery, and be
able to present desired pharmacokinetic and safety
profiles.
In addition, the MicroDose-MN™
patch for psychedelics 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 or hospital.
To achieve this, the Company
will incorporate anti-tampering and anti-abuse features that would
parallel the approach used for the tamper-resistant transdermal
fentanyl patch.
The Company is completing
its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine
("MDMA"), lysergic acid diethylamide ("LSD"), and N,
N-dimethyltryptamine ("DMT") and expects to provide results before
the end of this year and pursue clinical studies in
2022.
The Company is actively
engaged in partnering discussions for the use of its microneedle
patch system to deliver psychedelics including, but not limited to,
MDMA, LSD, DMT, ibogaine and mescaline.
As such, PharmaTher offers
potential partners a differentiated and validated delivery system
for psychedelics, desired pharmacokinetic profiles, intellectual
property protection, cGMP microneedle patches for IND-enabling and
clinical studies, and a clear clinical pathway towards clinical
studies in 2022.
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,
such as ketamine, to treat mental health, neurological and pain
disorders. PharmaTher is currently advancing an FDA
approved phase 2 clinical study with ketamine to treat Parkinson's
disease and is developing a novel microneedle patch for the
intradermal delivery of psychedelics and infectious disease
treatments.
Learn more
at:
PharmaTher.com and follow us on
Twitter and
LinkedIn.
For more business development opportunities or 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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the Canadian Securities Exchange nor its Regulation Services
Provider have reviewed or accept responsibility for the adequacy or
accuracy of this release.
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"Company") current belief or assumptions as to the outcome and
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("MD&A"), dated October 27, 2021, which
is available on the Company's profile at
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