- FDA has issued a clinical hold on initial IND submission
required to initiate Phase 2b trial
of LSD for the treatment of generalized anxiety disorder -
NEW YORK, Dec. 21, 2021 /CNW/ -- Mind Medicine (MindMed)
Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a
leading biotech company developing psychedelic-inspired therapies,
today announced that the U.S. Food and Drug Administration (FDA)
has placed a clinical hold on its IND submission intended to
support the initiation of a Phase 2b
trial of lysergic acid diethylamide (LSD) for the treatment of
generalized anxiety disorder (GAD). Additional detail regarding the
FDA's decision is expected within 30 days.
"Our team has a tremendous sense of urgency to bring new
treatments, such as LSD, to the many patients in need, particularly
given the growing mental health epidemic," said Robert Barrow, Chief Executive Officer and
Director of MindMed. "We remain highly confident in the therapeutic
potential of LSD to usher in a new treatment paradigm for these
disorders and we look forward to working closely with FDA to
satisfy all outstanding concerns as rapidly as possible."
About GAD
GAD is a chronic, often debilitating mental
health disorder that affects approximately 6% of U.S. adults in
their lifetimes. Symptoms of GAD include excessive anxiety and
worry that persists for over six months, which can lead to
significant impairments in social, occupational and other
functioning, according to the National Institute of Mental Health
(NIMH). While there is substantial diagnostic overlap between GAD,
Major Depressive Disorder and other major mental health disorders,
there has been very little innovation focused on the treatment of
GAD in the past several decades.
About MindMed
MindMed is a clinical-stage biotech
company that seeks to discover, develop and deploy
psychedelic-inspired medicines and therapies to address mental
health and addiction. The Company is assembling a compelling drug
development pipeline of innovative treatments based on psychedelic
substances including psilocybin, LSD, MDMA, DMT and an ibogaine
derivative, 18-MC. The MindMed executive team brings extensive
biopharmaceutical experience to MindMed's approach to developing
the next generation of psychedelic-inspired medicines and
therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the
symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
Forward-Looking Statements
Certain statements in this
news release related to the Company constitute "forward-looking
information" within the meaning of applicable securities laws and
are prospective in nature. Forward-looking information is not based
on historical facts, but rather on current expectations and
projections about future events and are therefore subject to risks
and uncertainties which could cause actual results to differ
materially from the future results expressed or implied by the
forward-looking statements. These statements generally can be
identified by the use of forward-looking words such as "will",
"may", "should", "could", "intend", "estimate", "plan",
"anticipate", "expect", "believe", "potential" or "continue", or
the negative thereof or similar variations. Forward-looking
information in this news release include, but are not limited to,
statements regarding the therapeutic potential of LSD and the
ability to initiate a Phase 2b trial
of LSD for the treatment of GAD, the expected timing of additional
information regarding the FDA's decision and working closely with
the FDA to satisfy all outstanding concerns as rapidly as possible.
Although the Company believes that the expectations reflected in
such forward-looking information are reasonable, such information
involves risks and uncertainties, and undue reliance should not be
placed on such information, as unknown or unpredictable factors
could have material adverse effects on future results, performance
or achievements of the Company. There are numerous risks and
uncertainties that could cause actual results and the Company's
plans and objectives to differ materially from those expressed in
the forward-looking information, including history of negative cash
flows; limited operating history; incurrence of future losses;
availability of additional capital; lack of product revenue;
compliance with laws and regulations; difficulty associated with
research and development; risks associated with clinical trials or
studies; heightened regulatory scrutiny; early stage product
development; clinical trial risks; regulatory approval processes;
novelty of the psychedelic inspired medicines industry; as well as
those risk factors discussed or referred to herein and the risks
described under the headings "Risk Factors" in the Company's
filings with the securities regulatory authorities in all provinces
and territories of Canada which
are available under the Company's profile on SEDAR at www.sedar.com
and with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov. Should one or more of these risks or uncertainties
materialize, or should assumptions underlying the forward-looking
information prove incorrect, actual results and future events could
differ materially from those anticipated in such information.
Although the Company has attempted to identify important risks,
uncertainties and factors that could cause actual results to differ
materially, there may be others that cause results not to be as
anticipated, estimated or intended. These and all subsequent
written and oral forward-looking information are based on estimates
and opinions of management on the dates they are made and are
expressly qualified in their entirety by this notice. Except as
required by law, the Company does not intend and does not assume
any obligation to update this forward-looking information.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.