FSD Pharma Signs Agreement with Covar Pharmaceuticals to Support the Development of Lucid-PSYCH
October 19 2021 - 8:30AM
Business Wire
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9) (“FSD
Pharma” or the “Company”), a life sciences holding
company dedicated to building a portfolio of assets and biotech
solutions, announced today it has entered into an agreement with
Covar Pharmaceuticals Inc. (“Covar”), a contract development and
manufacturing services organization (“CDMO”), to commence work on
providing research quantities of FSD’s drug candidate, Lucid-PSYCH,
on an exclusive basis for further clinical evaluation.
A psychoactive compound, Lucid-PSYCH (formerly Lucid-201) has
been selected by FSD to advance its research into the treatment of
major depressive disorders based on analysis of the drug
candidate’s pharmaceutical and metabolic properties processed via
machine learning algorithms, as well as for its potential
proprietary position.
Clinical development of Lucid-PSYCH is continuing under the
leadership of Dr. Lakshmi P. Kotra, B.Pharm.(Hons), Ph.D., the
Chief Executive Officer of Lucid Psycheceuticals Inc., of FSD’s
wholly-owned subsidiary, with Investigational New Drug (“IND”)-
enabling studies currently underway, and preclinical efficacy
studies being conducted in collaboration with the University Health
Network, the largest health research organization in Canada.
Covar’s R&D facility is licensed to handle psychoactive
compounds such as Lucid-PSYCH, which are Controlled Substances
listed under the Controlled Drugs and Substances Act, Canada.
Pursuant to the agreement, Covar will produce Non-GMP and GMP
Lucid-PSYCH for use in FSD’s planned pre-clinical and Phase 1
clinical trials, respectively.
“This agreement with Covar continues our momentum in completing
advanced preclinical studies and scale-up activities,” commented
Anthony Durkacz, Interim CEO of FSD Pharma. “This potentially sets
the stage for us to achieve our goal of moving Lucid-PSYCH from
bench to clinic by obtaining IND approval and initiating a Phase 1
clinical study.”
About FSD Pharma
FSD Pharma is a life sciences holding company with two
wholly-owned subsidiaries dedicated to building a portfolio of
diversified therapeutic assets and innovative healthcare and
biotech services.
FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty
biotech pharmaceutical R&D company focused on developing
applications of its lead compound, ultramicronized PEA, by
down-regulating the cytokines to effectuate an anti-inflammatory
response.
Lucid Psycheceuticals Inc., a wholly-owned subsidiary, has
exclusive worldwide rights to novel compounds shown to prevent and
potentially reverse the biochemical mechanisms of progressive
multiple sclerosis in multiple preclinical animal models.
Additionally, FSD is seeking to develop a unique psychoactive
(psychedelic-based) therapeutic aimed at addressing
neurodegenerative disorders, a multibillion-dollar mental
health market. The Company hopes to quickly advance its lead drug
candidates through clinical trials.
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 the comments made with respect to advancing the
Company’s research into Lucid PSYCH, including the anticipated
production and clinical development of Lucid-PSYCH and the
advancement of Lucid PYSCH from research into clinical trials and
any potential commercially viable therapeutic application, the
efforts to advance ultramicronized Palmitoylethanolamide and
develop of applications therefor evaluation of the commercial
viability of its principal drug compound, and the statements made
by Anthony Durkacz regarding the Company’s goal of rapidly moving
Lucid-PSYCH from bench to clinic by obtaining IND approval and
initiating a Phase 1 clinical study future development of Lucid
PYSCH. 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/20211019005062/en/
For further information: Zeeshan Saeed, President,
Founder and Director, FSD Pharma Inc. Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8888 Investor Relations: Email:
ir@fsdpharma.com, Website: www.fsdpharma.com
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