FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome
September 06 2022 - 08:30AM
Business Wire
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD
Pharma” or the “Company”), a biopharmaceutical company
dedicated to building a portfolio of innovative assets and biotech
solutions to address ailments affecting millions worldwide, today
announces that it received “Study May Proceed” letter for the
Investigational New Drug (“IND”) application from the U.S. Food and
Drug Administration (“FDA”) and “Notice of Authorization” from
Health Canada for its Phase 2 clinical trial of FSD201. The
corresponding study protocol is titled “A Randomized, Double-Blind
Placebo Controlled Parallel Group Study of Safety and Efficacy of
FSD201 in Patients with Chronic Widespread Musculoskeletal
Nociplastic Pain Associated with Idiopathic Mast Cell Activation
Syndrome (Disorder)”.
“We are delighted to receive authorization to proceed with our
planned efficacy clinical trial of FSD201 from both FDA and Health
Canada. We are working with our clinical sites in the U.S. and
Canada to initiate the study and intend to release more details on
the study very soon,” said Dr. Lakshmi Kotra, CEO of FSD Pharma
subsidiary Lucid Psycheceuticals. “Our regulatory and clinical
teams led by Dr. Andrzej Chruscinski, Vice-President for Clinical
and Scientific affairs, worked tirelessly with our expert advisors
developing the protocols, and we are looking forward to the next
stage of clinical development of FSD201. We believe FSD201 is a
compelling drug candidate, and we are actively exploring
opportunities for development partners and other synergistic
collaborations that will maximize shareholder returns.”
FSD201 is a proprietary formulation of ultra-micronized
palmitoylethanolamide (PEA). FSD Pharma’s successfully completed
Phase 1 clinical trial showed FSD201 to be safe and well tolerated.
This is especially important as chronic inflammatory diseases are
the leading cause of death globally and the World Health
Organization ranks chronic disease as the greatest threat to human
health.1 This immense problem has limited treatment options.2 This
is why FSD Pharma continues to work relentlessly to bring a new and
safe inflammatory treatment option to market.
1 Chronic Inflammation - StatPearls - NCBI Bookshelf (nih.gov);
https://www.ncbi.nlm.nih.gov/books/NBK493173/ 2 50 of 2021’s
best-selling pharmaceuticals | Drug Discovery;
https://www.drugdiscoverytrends.com/50-of-2021s-best-selling-pharmaceuticals/#:~:text=(Look%20out%20for%20more%20insights,generated%20%2420.7%20billion%20in%20sales.
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, 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, 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 relating to the FDA and Health Canada
Approval of IND for FSD Pharma to Proceed with Phase 2 Trial of
FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell
Activation Syndrome. 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/20220906005664/en/
Zeeshan Saeed, Founder, President and Executive Co-Chairman of
the Board, FSD Pharma Inc. Email: Zsaeed@fsdpharma.com Telephone:
(416) 854-8884
Investor Relations: Email: ir@fsdpharma.com, info@fsdpharma.com
Website: www.fsdpharma.com
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