FSD Pharma Announces First Patient Randomized in Phase 2 Trial of FSD201 for the Treatment of Hospitalized Patients with COVI...
December 15 2020 - 8:35AM
Business Wire
-----FDA has authorized randomized, controlled,
double-blind study on 352 patients. The Company is expected to
conduct this trial in 25-30 Medical Centers and Hospitals in North
America
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (“FSD Pharma” or the
“Company”) today announced the dosing of the first patient in its
Phase 2a clinical trial of FSD201 (ultramicronized
palmitoylethanolamide, or ultramicronized PEA) for the treatment of
hospitalized patients with COVID-19.
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.
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.
The Company filed an IND with the FDA on August 28, 2020 and was
approved on September 25, 2020 to initiate a phase 2 clinical trial
for the use of FSD201 to treat COVID-19, the disease caused by the
SARS-CoV-2 virus.
Severe COVID-19 is characterized by an over-exuberant
inflammatory response that may lead to a cytokine storm and
ultimately death. The Company is focused on developing FSD201 for
its anti-inflammatory properties to avoid the cytokine storm
associated with acute lung injury in hospitalized COVID-19
patients.
Forward-Looking Statements Neither the Canadian
Securities Exchange nor its regulation services provider accept
responsibility for the adequacy or accuracy of this press
release.
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, the
safety of FSD201 or whether FSD201 may be effective in treating
COVID-19, the costs associated with such planned trials and our
belief that we have sufficient cash to complete the Phase 2 study,
our ability to obtain required funding and the terms and timing
thereof, the ultimate development of any FDA approved synthetic
compounds, the expected insurance recovery related to the
settlement agreement, the completion of the settlement contemplated
in the settlement agreement and the timing and closing of the sale
of certain non-core real estate assets. 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 under 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/20201215005684/en/
For further information: Donal Carroll, Chief Financial
Officer, FSD Pharma Inc. Dcarroll@fsdpharma.com
Investor Relations IR@fsdpharma.com
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