FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (FRA: 0K9A)
(“FSD Pharma” or the "Company") today announced that the U.S.
Food and Drug Administration (FDA) has given the company permission
to submit an Investigational New Drug Application (IND) for the use
of FSD-201 (ultramicronized palmitoylethanolamide, or
ultramicronized PEA) 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. FSD Pharma is focused on developing
FSD-201 for its anti-inflammatory properties to avoid the cytokine
storm associated with acute lung injury in hospitalized COVID-19
patients.
“FDA’s permission to design a proof-of-concept study in COVID-19
patients evaluating clinical doses of FSD-201 is a paradigm shift
for FSD Pharma and is the result of outstanding work conducted by
Dr. Edward Brennan, President FSD BioSciences, and his team,” said
Raza Bokhari, MD, Executive Co-Chairman & CEO. “We contacted
the FDA in late-March 2020 after becoming aware that several
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. Numerous studies over the past 40 years
also validate the efficacy and safety of ultramicronized PEA in the
treatment and prophylactic effects in respiratory infections. These
studies also pointed out that the ease of application of PEA offers
the possibility to have a quick therapeutic answer ready in case of
a flu epidemic.”
COVID-19 Trial Design
Based on the FDA feedback received to date, we expect the trial
will be a randomized, controlled, double-blind, U.S. multicenter
study to assess the efficacy and safety of FSD-201 dosed 600mg or
1200mg twice-daily plus standard of care (SOC) versus SOC alone in
symptomatic patients with clinical presentation compatible with
COVID-19. Eligible patients will present with symptoms consistent
with influenza/coronavirus signs (fever, dry cough, malaise,
difficulty breathing) and/or newly documented positive COVID-19
disease.
The primary endpoint is to determine if FSD-201 plus SOC
provides a significant improvement in clinical status (i.e.,
shorter time to symptom relief). Key secondary objectives include
determining if FSD-201 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 is expected to be 14 days. All patients who
experience clinical benefit are expected to continue to receive
their assigned treatment until study completion.
Rationale for Ultramicronized PEA in COVID-19
More than 600 scientific papers attest to the physiological
properties of PEA and its role as an endogenous modulator, as well
as its pharmacological and therapeutic effects, specifically its
anti-inflammatory profile.
PEA acts via multiple mechanisms either directly to activate
PPAR-α and GPR55 or indirectly through the inhibition of FAAH,
which increases endogenous levels of anandamide (AEA) and
2-arachidonoyl-glycerol (2-AG). These endocannabinoids directly
activate CB2 (or CB1) receptors and TRPV1 channels (entourage
effect). PEA may also activate TRPV1 channels via PPAR-α.
AEA has been shown to inhibit tumor necrosis factor-α-induced
NF-kappa B activation, independent of CB1 and CB2. Saturated
acylethanolamides such as PEA (an endogenous congener of AEA) may
act in an analogous fashion to modify chronic inflammation in
autoimmune disorders.
Nobel laureate Rita Levi-Montalcini described the importance of
the activation of the inflammatory cascade and in 1993 discovered
that PEA functions as a mast cell modulator by reducing mast cell
migration and degranulation; thus, PEA reduces the pathological
overactivation of these cells and the activity of proinflammatory
cytokines (such as TNF-α and IL6), cyclooxygenase and iNOS. It is
this excess immune response activity that contributes to the
physiologic derangement induced by influenza viruses and sets up
the pathogenesis of the “cytokine storm.”
In summary, PEA down regulates hyperactive mast cells, inhibits
iNOS expression and nuclear NF-kappa B translocation. It is
theorized that coronavirus activates the cellular IKK/NF-kappa B
signaling pathway for replication; therefore, PEA as a PPAR-α
agonist may ameliorate oxidative/nitrosative stress induced by
NF-kappa B and may be a suitable agent for antiviral
intervention.
In addition, PEA has repeatedly been shown to down-modulate
excess immune response activity that contributes to the physiologic
derangement induced by viruses and help mitigate the pathogenesis
of the “cytokine storm.”
The detailed description of the role of PEA in viral
pathogenesis via multiple mechanistic pathways can be found in Jan
MKH, Theca AMH (2017) Palmitoyl Ethanol Amide in Prophylaxis and
Treatment of Viral Infections. Infect Dis Diag Treat 2017:
J103.
Between 1969 and 1979, PEA was marketed as Impulsin by a
pharmaceutical manufacturer in the former Czechoslovakia to treat
influenza and the common cold. During this period, clinical trials
were conducted for these indications that involved nearly 4,000
patients and volunteers across six randomized, double-blind,
placebo-controlled trials. Together, these clinical trials
demonstrate that PEA has clear treatment and prophylactic effects
in respiratory infections, and is safe in its use. Side effects
were not reported, and study authors explicitly stated that “No
side effects were registered after several years of clinical
testing of Impulsin in military and civilian communities.” They
also pointed out that the ease of application of PEA offers the
possibility to have a quick therapeutic answer ready in case of a
flu epidemic.
In addition, since 2004 PEA has been dispensed in Italy and
Spain as a prescription-based medical food supplement. More
recently, the Company was made aware that several Italian
physician-scientists are advocating for the use of
ultramicronized-PEA for patients suffering from symptoms of
COVID-19, and that several are using ultramicronized PEA to treat
COVID-19 patients in Italy on a compassionate use basis.
Background on Ultramicronized PEA
FSD Pharma acquired worldwide rights (ex-Italy and Spain) to
ultramicronized PEA from Epitech Group, an Italian pharmaceutical
company that invented and holds the patents until 2034 for
ultramicronized PEA (defined as 0.6 -10µM particle size). PEA is a
naturally occurring fatty acid amide that was first discovered in
the yolks of chicken eggs. It is biosynthesized from a membrane
phospholipid and is degraded to palmitic acid and ethanolamine, and
serves as an anti-inflammatory modulator within the cell.
Epitech markets ultramicronized PEA as a prescription-based
“Food for Special Medical Purposes" in Italy under the brand name
Normast® 600mg oral tablets, for several chronic pain and
inflammatory conditions, including sciatic pain and diabetic
neuropathy.
FSD is focused on developing ultramicronized-PEA (FSD-201) for
its anti-inflammatory properties. A first-in-human safety and
tolerability study is currently progressing in Australia led by
principal researcher Jason Lickliter, MD, Chief Medical Officer of
Nucleus Network.
Many clinical trials assessing the safety and efficacy of
ultramicronized PEA on chronic pain have been published in the last
decade. A number of studies have demonstrated that ultramicronized
PEA at doses up to 2700mg/day administered to patients with various
chronic pain syndromes induced a significant decrease in pain
intensity, compared with control groups. In addition, clinical
studies have demonstrated that ultramicronized PEA is generally
very well tolerated. More than 1,500 patients have received either
ultramicronized or micronized PEA in clinical studies and no
serious adverse events were reported in the vast majority of these
studies at doses as high as 2700mg/day.
About FSD Pharma
FSD Pharma Inc. (Nasdaq: HUGE; CSE: HUGE.CN; FRA: 0K9A) is a
publicly traded holding company, since May 2018.
FSD BioSciences Inc., a wholly-owned subsidiary, is a specialty
biotech pharmaceutical R&D company focused on developing over
time a robust pipeline of FDA-approved synthetic compounds
targeting the endocannabinoid system of the human body to treat
certain diseases of the central nervous system and autoimmune
disorders of the skin, GI tract and the musculoskeletal system.
Through our acquisition of Prismic Pharmaceuticals in 2Q19, the
Company is also making an effort to help address the opioid crisis
by developing opioid-sparing prescription drugs utilizing the
ultramicronized formulation of palmitoylethanolamide (PEA).
The Company has a Phase 1 first-in-human safety and tolerability
trial for its lead candidate, FSD-201, currently underway in
Australia.
FSD’s wholly-owned subsidiary, FV Pharma, 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 release.
The Company’s subject area experts continue to review the
scientific evidence/claims/research relevant to the application of
PEA and ultra-micro PEA and thus far have no reason to doubt the
authenticity of the material reviewed that has been quoted in the
press release. 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.
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, including the approval of our IND
submission, the completion of any trials regarding the use of
FSD-201 to treat COVID-19 or whether FSD-201 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, development of any FDA approved synthetic compounds, the
successful treatment of diseases by such compounds, the ability to
address the opioid crisis, the development of opioid sparing
prescription drugs utilizing the micronized formulations of
palmitoylethanolamide (“PEA”), and the objectives and timing of the
initiation of Phase 1 first-in-human safety and tolerability trials
for FSD 201. micro-PEA. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200602005990/en/
Sandy Huard, Head of Communications, FSD Pharma, Inc.
sandy@fsdpharma.com (647) 864-7969
Zeeshan Saeed, President & Founder, FSD Pharma, Inc.
Zeeshan@fsdpharma.com (416) 854-8884
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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