All subjects completed the trial per protocol,
no safety concerns found up to the highest dose tested of 2400
mg/day
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (FRA: 0K9A)
(“FSD Pharma” or the "Company") today announced favorable
topline results from its Phase 1 randomized, double-blind,
placebo-controlled study of ultramicronized palmitoylethanolamide
(PEA), or FSD201. This single-site study was conducted at the
Alfred Hospital, part of the Alfred Health group of hospitals
serving the state of Victoria in Australia and enrolled 48 healthy
adult men and women.
The trial sequentially tested single ascending doses ranging
from 600 mg to 2400 mg tablets and multiple ascending doses ranging
from 600 mg to 1200 mg tablets administered twice daily for 7
consecutive days. The single ascending dose subjects also were
tested for food effect.
The study found ultramicronized PEA to be safe and well
tolerated. Mild and self-limiting side effects were reported and
were deemed unlikely to be related to study drug. There were no
abnormal laboratory findings or ECGs observed during the study and
no serious adverse events were reported. No subjects withdrew due
to an adverse event and all eligible subjects completed all doses.
The pharmacokinetic profile of FSD201 in this study is still being
analyzed.
The study was led by principal researcher Jason Lickliter, MD,
Chief Medical Officer of Nucleus Network, Australia.
“We are delighted to be reporting favorable topline findings
from our Phase 1 first-in-human safety and tolerability study with
FSD201. I congratulate our pharmaceutical team, led by Dr. Edward
Brennan. This study has also successfully validated the
considerable scientific literature published over the years in
Europe that claims safety and tolerability of micro-PEA,” said Raza
Bokhari, MD, Executive Co-Chairman & CEO.
“Our immediate plans for FSD201 include submitting these Phase 1
trial results for publication in a peer-reviewed journal and
advancing this compound into a Phase 2a proof-of-concept trial for
the treatment of COVID-19,” continued Dr. Bokhari. “The U.S. Food
and Drug Administration recently gave the Company permission to
submit an Investigational New Drug application for the use of
FSD201 to treat COVID-19. We contacted the FDA after becoming aware
that Italian physicians and scientists were advocating for use of
ultramicronized PEA for patients suffering from symptoms of
COVID-19, based on the drug’s mechanism of action as a potent and
safe anti-inflammatory agent that reduces the production of
pro-inflammatory cytokines and may help mitigate a cytokine
storm.”
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. (Nasdaq: HUGE; CSE: HUGE.CN; FRA: 0K9A) is a
publicly traded holding company, since May 2018.
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, ultramicronized palmitoylethanolamide (PEA), by
down-regulating the cytokines to effectuate an anti-inflammatory
response.
The Company has successfully completed a Phase 1 first-in-human
safety and tolerability study for FSD201 that found the compound to
be safe with no serious adverse side effects. This study also
validated considerable scientific literature published in Europe
that claims safety and tolerability of micro-PEA. Ultra-micronized
PEA has been dispensed in Italy and Spain as a prescription
anti-inflammatory medical food supplement since 2004, with no
serious adverse side effects reported.
On June 1, 2020, the Company received permission from the U.S.
Food and Drug Administration (FDA) to submit an Investigational New
Drug (“IND”) application 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.
FV Pharma, a wholly-owned subsidiary, is a licensed producer
under Canada’s Cannabis Act and Regulations, having received its
cultivation license on October 13, 2017 and its full Sale for
Medical Purposes license on June 21, 2019. The Company is licensed
to cultivate cannabis in approximately 25,000 square feet of its
facility in Cobourg, Ontario.
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 U.S. Food and Drug
Administration ("FDA") approvals, the costs associated with such
planned trials, our ability to obtain required funding and the
terms and timing thereof, development of any FDA-approved synthetic
compounds, and the successful treatment of diseases by such
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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200621005031/en/
For further information: 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 www.fsdpharma.com or
LHA Investor Relations Sanjay M. Hurry shurry@lhai.com (212)
838-3777
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