FSD Pharma Subsidiary Lucid Psycheceuticals Files for Patent On Novel Formulations of Palmitoylethanolamide, Presents Preclinical Toxicology Results at an International Symposium
July 13 2022 - 8:30AM
Business Wire
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD
Pharma” or the “Company”), a life sciences holding
company dedicated to building a portfolio of assets and biotech
solutions, announced today that is wholly owned subsidiary, Lucid
Psycheceuticals Inc. (“Lucid”), filed a provisional patent
application on novel formulations of palmitoylethanolamide (PEA).
The new patent application is based on the results of completed
preclinical animal toxicology studies and phase 1 clinical trial
using FSD201 (ultramicronized PEA), sponsored by FSD Pharma. Patent
applications are important tools to protect intellectual property
of the company for commercialization and value proposition for the
shareholders.
FSD Pharma is diligently pursuing the clinical development of
FSD201 for various indications. On May 31, 2022, the Company
announced the submission of an Investigational New Drug application
with the U.S. Food and Drug Administration (“FDA”) and Health
Canada detailing a planned Phase 2 clinical trial of FSD201 for the
treatment of a yet-to-be-disclosed inflammatory disorder. FSD
Pharma is fortifying its intellectual property position through
additional novel formulations using PEA with superior
biopharmaceutical profiles to serve patients in need.
FSD Pharma presented their preclinical toxicology results on
FSD201 at the 32nd Annual Symposium of the International
Cannabinoid Research Society held in Galway, Ireland on June 25-30,
2022, in a scientific peer setting. FSD Pharma and Lucid were
represented at the conference by Dr. Lakshmi P. Kotra (CEO, Lucid
Psycheceuticals), Dr. Andrzej Chruscinski (Vice-President, Clinical
and Scientific Affairs, Lucid Psycheceuticals), and Dr. Mohammad
Ebrahimzadeh (Scientist, Lucid Psycheceuticals). The poster
presentation titled, "Preclinical Safety Pharmacology and
Toxicology of FSD201, A Palmitoylethanolamide Composition”
discussed the safety pharmacology and toxicokinetics of FSD201,
which were completed by FSD Pharma for regulatory filings with the
U.S. FDA. The poster presentation provided support for the clinical
development of FSD201, revealing well-tolerated doses of FSD201 in
two different animal species.
“New patent applications are a critical step for protecting our
assets in the development of effective therapeutics targeting brain
and inflammatory disorders,” said Dr. Kotra. “Novel, high-quality
treatments and intellectual property are important to us as an
innovation-driven company, and I am very pleased with our team’s
performance to stay on target towards the key milestones in 2022,
including the planned Phase 2 trial of FSD201.”
About FSD Pharma
FSD Pharma Inc. is a biotechnology company with three drug
candidates in different stages of development. FSD BioSciences,
Inc., a wholly owned subsidiary of FSD Pharma, is focused on
pharmaceutical research and development of its lead compound,
FSD201, an ultra-micronized PEA, for the treatment of inflammatory
diseases. Lucid Psycheceuticals Inc., a wholly owned subsidiary of
FSD Pharma, is focused on the research and development of its lead
compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular
compound identified for the potential treatment of mental health
disorders. Lucid-MS is a molecular compound identified for the
potential treatment of neurodegenerative disorders.
Forward Looking Information
Certain statements contained herein are “forward-looking
statements.” Often, but not always, forward-looking statement can
be identified by the use of words such as “plans”, “expects”,
“expected”, “scheduled”, “estimates”, “intends”, “anticipates”,
“hopes”, “planned” or “believes”, or variations of such words and
phrases, or states that certain actions, events or results “may”,
“could”, “would”, “might”, “potentially” or “will” be taken, occur
or be achieved. Forward-looking statements contained in this press
release include statements related to the Company’s subsidiary
Lucid Psycheceuticals filing for a patent on novel formulations of
PEA and presenting preclinical toxicology findings at a global
symposium. FSD cannot give any assurance that such forward-looking
statements will prove to have been correct. The reader is cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release.
Since forward-looking statements relate to future events and
conditions, by their very nature they require making assumptions
and involve inherent risks and uncertainties. The Company cautions
that although it is believed that the assumptions are reasonable in
the circumstances, these risks and uncertainties give rise to the
possibility that actual results may differ materially from the
expectations set out in the forward-looking statements. Factors
that may cause such material differences include without
limitation: the fact that the drug development efforts of both
Lucid and FSD BioSciences are at a very early stage; the fact that
preclinical drug development is uncertain, and the drug product
candidates of Lucid and FSD BioSciences may never advance to
clinical trials; the fact that results of preclinical studies and
early-stage clinical trials may not be predictive of the results of
later stage clinical trials; the uncertain outcome, cost, and
timing of product development activities, preclinical studies and
clinical trials of Lucid and FSD BioSciences; the uncertain
clinical development process, including the risk that clinical
trials may not have an effective design or generate positive
results; the potential inability to obtain or maintain regulatory
approval of the drug product candidates of Lucid and FSD
BioSciences; the introduction of competing drugs that are safer,
more effective or less expensive than, or otherwise superior to,
the drug product candidates of Lucid and FSD BioSciences; the
initiation, conduct, and completion of preclinical studies and
clinical trials may be delayed, adversely affected, or impacted by
COVID-19 related issues; the potential inability to obtain adequate
financing; the potential inability to obtain or maintain
intellectual property protection for the drug product candidates of
Lucid and FSD BioSciences; and other risks. Further information
regarding factors that may cause actual results to differ
materially are included in the Company’s annual and other reports
filed from time to time with the Canadian Securities Administrators
on SEDAR (www.sedar.com) and with the U.S. Securities and Exchange
Commission on EDGAR (www.sec.gov) under the heading “Risk Factors.”
Any forward-looking statement contained in this release speaks only
as of its date. The Company does not undertake to update any
forward-looking statements, except to the extent required by
applicable securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20220713005308/en/
Zeeshan Saeed, Founder, President and Executive Co-Chairman of
the Board, FSD Pharma Inc. Zsaeed@fsdpharma.com (416) 854-8884
For information: info@fsdpharma.com Investor Relations:
ir@fsdpharma.com Website: www.fsdpharma.com
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