FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (“FSD
Pharma” or the “Company”), a biopharmaceutical company
dedicated to building a portfolio of innovative assets and biotech
solutions for the treatment of challenging neurodegenerative,
inflammatory and metabolic disorders, today announced completion of
the first-in-human (“FIH”) sentinel dosing of Lucid-21-302
(“Lucid-MS”) in the Company’s Phase I clinical trial evaluating its
novel drug candidate as an orally-administered treatment for
Multiple Sclerosis (“MS”). The sentinel dose was completed on
Sunday, April 16, 2023.
“Dosing the sentinel subject is a major achievement for our team
and culmination of more than a decade of very promising research by
a seasoned development team passionate about changing the future
treatment paradigm for patients dealing with the debilitating
effects of MS,” said Dr. Lakshmi Kotra, CEO of Lucid
Psycheceuticals, a wholly owned subsidiary of FSD Pharma. “Current
MS treatments are immunomodulatory and include repeated
subcutaneous or intramuscular injections for treating the symptoms
of MS. We envision a day where an oral medication will protect or
even help repair myelin in the central nervous system, a hallmark
feature of the disease. We are optimistic Lucid-MS has this type of
paradigm-shifting potential and the sentinel dosing is a critical
step in advancing this pipeline forward.”
The FIH clinical trial is evaluating the safety and tolerability
of Lucid-MS, a patented first-in-class New Chemical Entity (“NCE”)
and neuroprotective compound with a novel mechanism of action for
the treatment of MS. Lucid-MS. In preclinical models, Lucid-MS has
been shown to prevent myelin degradation (demyelination), a hall
mark pathology feature of MS and other neurogenerative diseases
characterized by damage to the myelin sheath surrounding nerve
fibers in the central nervous system. Preclinical evidence has
demonstrated Lucid-MS to promote functional recovery in
experimental animal models of MS
(https://fsdpharma.com/our-science/). Based upon current evidence,
Lucid-MS is non-immunomodulatory, an important distinction in the
potential for developing new, safe options for treating MS.
The Seriousness of MS
MS is a chronic inflammatory and degenerative disorder of the
central nervous system (brain and spinal cord). Presentation of
symptoms can be diverse, including fatigue, numbness and tingling,
muscle spasms, blurred vision, dizziness, pain, mobility problems,
cognitive impairment and decline, depression, anxiety, and more.
Although current treatments reduce the relapse rate, there remains
a significant unmet need to slow disease progression and address
the progressive stages of MS, which LUCID-MS may address.
The MS Society
(https://mssociety.ca/resources/news/article/atlas-of-ms-report-shows-28-million-people-worldwide-live-with-multiple-sclerosis)
shows that someone in the world is diagnosed with MS every five
minutes. According to MS International Foundation (Atlas of MS 2020
– Epidemiology report found at
www.msif.org/resource/atlas-of-ms-2020/), the number of people
diagnosed worldwide with Multiple Sclerosis in 2020 is estimated at
2.8 million, up significantly from 2.3 million in 2013. The U.S.
and Canada rank amongst the highest in the world in prevalence per
capita, with 288 cases per 100,000 people and 250 cases per 100,000
people, respectively. MS can occur at any age, but the average age
for diagnosis globally is 32 years. MS is also diagnosed in youths,
with at least 30,000 children under the age of 18 (or ~1.5% of the
total number of cases) living with the disease. MS is far more
frequent in females (69% of cases) than in males (31% of cases).
There currently is no cure for MS. Deaths attributed to MS are
commonly caused by infection (e.g., respiratory, urinary
tract-related); conditions associated with advanced disability and
immobility (e.g., aspiration pneumonia, chronic respiratory
disease). According to Allied Market Research, the global MS
therapies market was valued at $22.99 billion in 2018 and will grow
at a 2.5% compound annual growth rate to reach $28.0 billion by
2026 (www.alliedmarketresearch.com/multiple-sclerosis-market).
About FSD Pharma
FSD Pharma Inc. is a biotechnology company with three drug
candidates in different stages of development. FSD BioSciences,
Inc., a wholly owned subsidiary, is focused on pharmaceutical
research and development of its lead compound, FSD201, a
proprietary ultra-micronized PEA formulation, for the treatment of
inflammatory diseases. Lucid Psychss Inc., a wholly owned
subsidiary, is focused on the research and development of its lead
compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular
compound identified for the potential treatment of mental health
disorders, and expanding this category, the Company is
investigating other products addressing acute medical needs due to
the abuse of drugs such as alcohol. Lucid-MS is a molecular
compound identified for the potential treatment of
neurodegenerative disorders.
Forward Looking Information
This press release contains forward-looking statements and
forward-looking information (collectively, "forward-looking
statements") within the meaning of applicable securities laws.
Any statements that are contained in this press release that are
not statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements are often
identified by terms such as “plans”, “expects”, “expected”,
“scheduled”, “estimates”, “intends”, “anticipates”, “hopes”,
“planned” or “believes”, or variations of such words and phrases,
or states that certain actions, events or results “may”, “could”,
“would”, “might”, “potentially” or “will” be taken, occur or be
achieved. More particularly, and without limitation, this press
release contains forward-looking statements contained in this press
release include statements concerning the future of FSD Pharma Inc.
and are based on certain assumptions that FSD Pharma has made in
respect thereof as of the date of this press release. FSD Pharma
cannot give any assurance that such forward-looking statements will
prove to have been correct.
Since forward-looking statements relate to future events and
conditions, by their very nature they require making assumptions
and involve inherent risks and uncertainties. The Company cautions
that although it believes the expectations and material factors and
assumptions reflected in these forward-looking statements are
reasonable as of the date hereof, there can be no assurance that
these expectations, factors and assumptions will prove to be
correct and these risks and uncertainties give rise to the
possibility that actual results may differ materially from the
expectations set out in the forward-looking statements. These
forward-looking statements are not guarantees of future performance
and are subject to a number of known and unknown risks and
uncertainties including, but not limited to: the fact that the drug
development efforts of both Lucid and FSD BioSciences are at a very
early stage; the fact that preclinical drug development is
uncertain, and the drug product candidates of Lucid and FSD
BioSciences may never advance to clinical trials; the fact that
results of preclinical studies and early-stage clinical trials may
not be predictive of the results of later stage clinical trials;
the uncertain outcome, cost, and timing of product development
activities, preclinical studies and clinical trials of Lucid and
FSD BioSciences; the uncertain clinical development process,
including the risk that clinical trials may not have an effective
design or generate positive results; the potential inability to
obtain or maintain regulatory approval of the drug product
candidates of Lucid and FSD BioSciences; the introduction of
competing drugs that are safer, more effective or less expensive
than, or otherwise superior to, the drug product candidates of
Lucid and FSD BioSciences; the initiation, conduct, and completion
of preclinical studies and clinical trials may be delayed,
adversely affected, or impacted by COVID-19 related issues; the
potential inability to obtain adequate financing; the potential
inability to obtain or maintain intellectual property protection
for the drug product candidates of Lucid and FSD BioSciences; and
other risks. Accordingly, readers should not place undue reliance
on the forward-looking statements contained in this press release,
which speak only as of the date of this press release.
Further information regarding factors that may cause actual
results to differ materially are included in the Company’s annual
and other reports filed from time to time with the Canadian
Securities Administrators on SEDAR (www.sedar.com) and with the
U.S. Securities and Exchange Commission on EDGAR (www.sec.gov),
including the Company’s Annual Report on Form 20-F for the fiscal
year ended December 31, 2021, under the heading “Risk Factors.”
This list of risk factors should not be construed as exhaustive.
Readers are cautioned that events or circumstances could cause
results to differ materially from those predicted, forecasted or
projected. The forward-looking statements contained in this
document speak only as of the date of this document. FSD Pharma
does not undertake any obligation to publicly update or revise any
forward-looking statements or information contained herein, except
as required by applicable laws. The forward-looking statements
contained in this document are expressly qualified by this
cautionary statement.
Neither the Canadian Securities Exchange nor its regulation
services provider accept responsibility for the adequacy or
accuracy of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230417005534/en/
Zeeshan Saeed, Founder, President and Executive Co-Chairman of
the Board, FSD Pharma Inc. Email: Zsaeed@fsdpharma.com Telephone:
(416) 854-8884 Investor Relations: Email: ir@fsdpharma.com,
info@fsdpharma.com Website: www.fsdpharma.com
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