FSD Pharma Reports Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultramicronized PEA
June 22nd, 2020
All subjects completed the trial per protocol, no safety concerns found
up to the highest dose tested of 2400 mg/day
TORONTO (June 22, 2020) – 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
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
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
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.
For further information:
Sandy Huard, Head of Communications, FSD Pharma, Inc.
Zeeshan Saeed, President, FSD Pharma, Inc.
LHA Investor Relations
Sanjay M. Hurry
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