- FDA has authorized randomized, controlled,
double-blind, multicenter study on 352 patients
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (“FSD
Pharma” or the “Company”) announced that the U.S. Food
and Drug Administration (“FDA”) has authorized the
initiation of a Phase 2 study for the use of FSD201
(ultramicronized palmitoylethanolamide, or ultramicronized PEA) to
treat COVID-19, the disease caused by the SARS-CoV-2 virus (the
“FSD201 COVID-19 Trial”). The company is expected to start
dosing patients in October 2020. We believe FSD201 may have the
potential to address the over-exuberant inflammatory response
characterized by COVID-19 infection that may lead to a cytokine
storm and ultimately death.
“Commencing a phase 2 clinical trial to treat hospitalized
COVID-19 patients is a major milestone achieved by our
pharmaceutical team led by Dr. Edward Brennan and a huge step
forward for FSD Pharma,” said Dr. Raza Bokhari, Executive
Co-Chairman & CEO. We are joining the global fight against the
deadly SARS-CoV-2 virus with a hope to demonstrate down-regulation
of the over-expressed immune response in COVID-19 patients leading
to better treatment outcome. FSD201 is formulated as a tablet for
oral dosing and is a safe compound with no known serious adverse
side effects. Numerous studies over the past 40 years have
validated micronized PEA for its efficacy and safety in the
treatment of, and prophylactic effects with respect to, other
respiratory infections.”
COVID-19 Trial Design
The FSD201 COVID-19 Trial is a randomized, controlled,
double-blind, multicenter study, conducted on 352 patients to
assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg
twice-daily, together with standard of care ("SOC") compared
to SOC alone in hospitalized patients with documented COVID-19
disease. Eligible patients will present symptoms consistent with
influenza/coronavirus signs (fever, dry cough, malaise, difficulty
breathing) and newly documented positive COVID-19 disease.
The primary objective of the FSD201 COVID-19 Trial is to
determine whether FSD201 plus SOC provides a significant
improvement in the clinical status of patients (e.g., shorter time
to symptom relief). Secondary objectives of the FSD201 COVID-19
Trial include determining whether FSD201 plus SOC demonstrates
additional benefit in terms of safety, objective assessments such
as length of time to normalization of fever, length of time to
improvement of oxygen saturation and length of time to clinical
progression, including time to mechanical ventilation or
hospitalization, and length of hospital stay. The exploratory
endpoint is cytokine clearance as measured by Enzyme Linked
Immunosorbent Assay (ELISA). The treatment period for patients in
the FSD201 COVID-19 Trial is 14 days and the primary end point is
determined at 28 days.
The Company is not making any express or implied claims that its
product has the ability to eliminate, cure or contain the COVID-19
(or SARS-2 Coronavirus) at this time.
Board of Directors Update
FSD Pharma announces the departure of Mr. David Urban from the
Board of Directors effective October 31, 2020. Mr. Urban has
advised the Chairman of the Board that he is stepping down because
of external contractual obligations. We thank David Urban for his
significant leadership and services as a valuable board member and
we wish him much success in his present and future endeavors.
About FSD Pharma
FSD Pharma Inc. is a publicly-traded holding company.
FSD Pharma BioSciences, Inc., a wholly-owned subsidiary, is a
specialty biotech pharmaceutical R&D company focused on
developing over time multiple applications of its lead compound,
FSD201, by down-regulating the cytokines to effectuate an
anti-inflammatory response.
Forward-Looking Statements
Neither the Canadian Securities Exchange nor its regulation
services provider accept responsibility for the adequacy or
accuracy of this release.
The Company's subject area experts continue to review the
scientific evidence/claims/research relevant to the application of
PEA and ultramicronized-PEA.
The duration and cost of Phase 2 clinical trials can vary
significantly depending on multiple factors, including the
enrollment rate of patients, country in which trials are conducted,
and specific trial protocols required. The process of developing
pharmaceutical products and receiving the necessary regulatory
approvals for commercialization typically takes several years.
Accordingly, no near-term revenues from product sales or services
are expected from our ultramicronized-PEA candidate(s). The
milestones described above represent customary inflection points
for financing by clinical-stage biotech companies. However, there
is no assurance that the Company will be able to achieve these
clinical milestones, nor, if successful in doing so, that the
Company will be able to access additional financing on terms or
timing acceptable to the Company.
Certain statements contained in this press release constitute
"forward-looking information" and "forward-looking statements"
within the meaning of applicable Canadian and U.S. securities laws
(collectively, "Forward-Looking Information"). Forward-Looking
Information includes, but is not limited to, information with
respect to FSD Pharma's strategy, plans or future financial or
operating performance, receipt of any FDA approvals, the completion
of any trials regarding the use of FSD201 to treat COVID-19 or
whether FSD201 may be effective in treating COVID-19, the costs
associated with such planned trials, our ability to obtain required
funding and the terms and timing thereof and the ultimate
development of any FDA approved synthetic compounds. The use of
words such as "budget", "intend", "anticipate", "believe",
"expect", "plan", "forecast", "future", "target", "project",
"capacity", "could", "should", "focus", "proposed", "scheduled",
"outlook", "potential", "estimate" and other similar words, and
similar expressions and statements relating to matters that are not
historical facts, or statements that certain events or conditions
"may" or "will" occur, are intended to identify Forward-Looking
Information and are based on FSD Pharma's current beliefs or
assumptions as to the outcome and timing of such future events.
Such beliefs or assumptions necessarily involve known and unknown
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied in such Forward Looking
Information. Certain of these risks and uncertainties are described
in the Company's continuous disclosure filings available under the
Company's SEDAR profile at www.sedar.com and on the Company’s EDGAR
profile at www.sec.gov. Forward Looking Information is not a
guarantee of performance. The Forward-Looking Information contained
in this press release is made as of the date hereof, and FSD Pharma
is not obligated to update or revise any Forward-Looking
Information, whether as a result of new information, future events
or otherwise, except as required by law. Because of the risks,
uncertainties and assumptions contained herein, investors should
not place undue reliance on Forward Looking-Information. The
foregoing statements expressly qualify any Forward-Looking
Information contained herein.
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version on businesswire.com: https://www.businesswire.com/news/home/20201005005194/en/
Sandy Huard, Head of Communications, FSD Pharma Inc.
sandy@fsdpharma.com (647) 864-7969
Zeeshan Saeed, President, FSD Pharma Inc.
zeeshan@fsdpharma.com
Investor Relations IR@fsdpharma.com
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