FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder
March 22 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 that its
Australian entity, FSD Pharma Australia Pty Ltd. received the
certificate of approval from The Alfred Ethics Committee in
Australia to proceed with a Phase 1 clinical trial of Lucid-201
(“Lucid-Psych”) as a novel drug candidate for the potential
treatment of Major Depressive Disorder (“MDD”). Lucid-Psych is
being developed outside of Australia by Lucid Psycheceuticals,
Inc., a wholly owned subsidiary of FSD Pharma, and in Australia by
FSD Pharma Australia Pty Ltd
Lucid-Psych is a psychoactive molecule selected as a potential
therapeutic for MDD based upon the compound’s pharmaceutical and
metabolic properties including employing machine learning
algorithms, as well as for its potential proprietary position.
“Psychoactive molecules as new therapeutics for depression and
other mental disorders represent some of the most exciting areas of
clinical research in healthcare today,” said Dr. Lakshmi Kotra, CEO
of FSD Pharma Australia Pty Ltd. “Today’s standard of care is
prescribing antidepressants that merely mask the symptoms and are
well documented to have a bevy of potential negative side effects.
Hundreds of millions of people globally need new, safer, accessible
and more effective options to redefine the front-line approach by
getting to the root of the disorder and how it is currently
treated. As we initiate the clinical stage for Lucid-Psych, our
clinical team is optimistic that our novel drug candidate in a
unique dosage form will be safe and tolerated.” Dr. Kotra further
added, “We are also very cognizant of mental health challenges
faced by those suffering from neurodegenerative disorders, such as
multiple sclerosis, Alzheimer’s among others. As a company pursuing
total brain health, we see Lucid-Psych a strategic fit for clinical
development with our other pipeline programs.”
Major Depressive Disorder, sometimes called clinical depression,
is a serious mental health disorder categorized by feelings of
sadness or worthlessness, depressed mood, lack of motivation, and
anhedonia, or reduced interest in activities once considered
enjoyable. MDD can be a chronic condition with multiple periods of
regression and relapse over a lifetime. Different types of MDD
include Seasonal Affective Disorder (SAD), Postpartum depression,
psychotic depression, melancholic depression, and catatonic
depression. Broadly speaking, the National Institute of Health
considers depression one of the most common mental disorders in the
United States.1 An estimated 21.0 million adults in the U.S. had at
least one major depressive episode in 2020, representing 8.4
percent of the country’s adults. In the same year, an estimated 4.1
million adolescents aged 12 to 17 in the U.S. had at least one
major depressive episode, representing 17.0 percent of people in
the age group. According to Allied Market Research, the global
antidepressant drugs market size was valued at $15.65 billion in
2020 and is projected to reach $21.0 billion by 2030.2
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.
1 https://www.nimh.nih.gov/health/statistics/major-depression 2
https://www.alliedmarketresearch.com/antidepressants-drugs-market
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version on businesswire.com: https://www.businesswire.com/news/home/20230322005337/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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