FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort
10 Maio 2023 - 8:30AM
Business Wire
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 the
completion of dosing the first cohort of patients in the Company’s
Phase I clinical trial of Lucid-21-302 (“Lucid-MS”). The clinical
trial (ClinicalTrials.gov Identifier: NCT05821387), being conducted
by FSD Pharma through the Company’s wholly owned subsidiary Lucid
Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a
small molecule inhibitor of hypercitrullination, as a novel drug
candidate for the treatment of Multiple Sclerosis (“MS”).
“Our clinical development team and international advisory
committee are delighted at the progress of this milestone and
completing dosing the first cohort,” said Dr. Lakshmi Kotra, CEO of
Lucid Psycheceuticals. “The safety review committee has recommended
to move forward with the next cohort dosing, which we are thrilled
to say is expected to commence in the next few days.”
The clinical trial is a randomized, double-blind, placebo
controlled, single ascending dose (“SAD”) and multiple ascending
dose (“MAD”) study with the primary outcomes evaluating the safety,
tolerability, and pharmacokinetics of Lucid-MS in healthy
volunteers under fed and fasted conditions. Enrollment will be
comprised of five SAD cohorts and two MAD cohorts. Each SAD and MAD
cohort will enroll eight participants (for a total of 56
participants) randomized to six active and two placebo groups.
Participants in the active group will receive single or multiple
doses of Lucid-MS. For the SAD cohort with food effect, all eight
participants will receive Lucid-MS.
Lucid-MS is a patented first-in-class, New Chemical Entity
(“NCE”) and a neuroprotective compound with a novel mechanism of
action for the treatment of MS. In preclinical models, Lucid-MS has
been shown to prevent myelin degradation (demyelination), a
hallmark 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 on current evidence,
Lucid-MS is non-immunomodulatory agent, an important distinction in
the potential for developing new, safe options for treating MS.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230510005267/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 ClearThink Email: nyc@clearthink.capital
Telephone: (917) 658-7878
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