FSD Pharma Inc. Announces Termination of FSD-201 Phase 2 Clinical Trial
August 24 2021 - 4:01PM
Business Wire
However, will continue to evaluate other
potential commercial opportunities with FSD-201
FSD Pharma Inc. (Nasdaq:HUGE) (CSE:HUGE) (FRA:0K9) (the
“Company” or “FSD”) announced today that it intends
to terminate the Phase 2 clinical trial of ultra-micronized
palmitoylethanolamide ("PEA"), or FSD-201, for use in treating
COVID-19.
FSD-201 stabilizes mast cells and down-regulates the
pro-inflammatory cytokines to effectuate an anti-inflammatory
response; it is also known to target the CB2 receptors of the
endocannabinoid system of the human body.
The Company has previously successfully completed a Phase 1
first-in-human safety and tolerability study for FSD-201 and the
compound to be safe with no serious adverse side effects. In June
2020, the United States Food and Drug Administration (the "FDA")
approved the submission of an Investigational New Drug Application
("IND") for the use of FSD-201 to treat COVID-19 and in September
2020, a randomized, controlled, double-blind, multicenter Phase 2
clinical study was approved by the FDA. The Company is working to
complete and publish these findings in the near future.
As previously disclosed, following the May 14, 2021 annual
general and special meeting of shareholders, the Company retained
Bloom Burton Securities Inc. (“Bloom Burton”) to undertake a review
of its Phase 2 clinical program to assist the Company in
determining its viability and, more broadly, evaluating the general
current commercial viability of FSD-201. In particular, the Company
was concerned with the pace of progress in advancing the Phase 2
clinical study during a period in which COVID-19 treatments evolved
significantly and competitive products were being successfully
advanced. Bloom Burton recently reported its findings and the
Company concluded that, while there are potential commercial
opportunities for FSD-201, specifically the treatment of COVID-19
by FSD-201 is unlikely to be commercially viable. Based on this
information, the Company has elected to terminate the current Phase
2 clinical study in order to concentrate its resources on more
commercially viable opportunities.
“We remain committed to fulfilling the strategic and operational
goals outlined in our communications to shareholders prior to the
May 14, 2021 shareholder meeting. Objectively evaluating the
commercial viability of this Phase 2 study of FSD-201 was one of
our immediate priorities. While we are disappointed that the Phase
2 study commenced under the Company’s prior management was not
productive, we are pleased that the independent review did support
the belief that there are other viable commercial opportunities for
FSD-201,” said Zeeshan Saeed, the Company’s President. “We will
continue to explore these potential opportunities to advance the
commercialization of FSD-201 and it’s potential on the human
endocannabinoid system,” he added.
About FSD Pharma
FSD Pharma Inc. (www.fsdpharma.com) is a publicly-traded holding
company.
FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty
biotech pharmaceutical R&D company focused on developing
multiple applications of its lead compound, ultramicro PEA by
down-regulating the cytokines to effectuate an anti-inflammatory
response.
Forward Looking Information
Certain statement 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” or
“believes”, or variations of such words and phrases, or states that
certain actions, events or results “may”, “could”, “would”, “might”
or “will” be taken, occur or be achieved. Forward-looking
statements contained in this press release include the comments
made with respect to the Company’s clinical trial, the evaluation
of the commercial viability of its principal drug compound, and the
statements made by Zeeshan Saeed regarding the commercial
opportunities the Company’s principal drug compound and other
commercial opportunities and fulfilling strategic and operational
goals outlined in prior communications to shareholders. 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 document.
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version on businesswire.com: https://www.businesswire.com/news/home/20210824005813/en/
Anthony Durkacz 1-844-978-3540 adurkacz@fsdpharma.com
Zeeshan Saeed 1-844-978-3540 zsaeed@fsdpharma.com
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