NEW
YORK, Jan. 25, 2022 /CNW/ -- Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ)
(the "Company"), a clinical-stage biopharmaceutical company
developing psychedelic-inspired therapies for the treatment of
brain-based disorders, announced today that the U.S. Food and Drug
Administration (FDA) has cleared MindMed's Investigational New Drug
(IND) application, allowing the Company's Phase 2b dose-optimization trial of MM-120 for the
treatment of generalized anxiety disorder (GAD) to proceed.
The previously announced clinical hold on the IND was lifted
following MindMed's rapid responses for additional information
related to the participant monitoring protocol in the upcoming
study. The Company is working with study investigators and clinical
trial sites to prepare for participant enrollment, which is
expected to start in early 2022.
"FDA clearance of our Phase 2b
clinical trial represents a major milestone, for MindMed and for
the industry as a whole," said Robert
Barrow, Chief Executive Officer and Director of MindMed.
"This trial, the first commercial study of LSD in more than 40
years, builds on productive discussions with FDA and provides an
opportunity to explore improvements in anxiety symptoms following a
single administration of MM-120. Further, the results of this trial
will guide the dose selection and development strategy for our
pivotal Phase 3 clinical trials, as well as deepen our scientific
understanding of the clinical effects of MM-120 and its underlying
mechanisms of action."
Mr. Barrow continued, "With a clear regulatory path, we look
forward to building on this momentum and advancing this trial as
quickly and efficiently as possible, bringing us significantly
closer to transforming the treatment landscape for patients who
suffer from anxiety."
About Study MMED008
Study MMED008 is a
multicenter, randomized, double-blind, placebo-controlled,
dose-optimization Phase 2b trial in
patients with GAD. The trial plans to enroll a total of 200
participants who will receive a single administration of up to 200
µg of MM-120 or a placebo control. The primary objective of the
study is to determine the reduction in anxiety symptoms for up to
twelve weeks after a single administration of MM-120, compared
across five treatment arms.
About Generalized Anxiety Disorder (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 (MDD) and
other major mental health disorders, there has been very little
innovation focused on the treatment of GAD in the past several
decades due to the shift in focus from anxiety disorders like GAD
toward depressive disorders like MDD, driven by the marketing of
serotonin reuptake inhibitors starting in the 1990s.
About MM-120
MM-120 is MindMed's proprietary
drug candidate, a pharmacologically optimized form of LSD being
developed for GAD and other brain-based disorders. LSD was first
synthesized in 1938 and its psychoactive properties were discovered
in 1943. From 1949 to 1966, LSD was used by psychiatrists and
researchers to gain insights into the world of brain health and to
assist psychotherapy. LSD has been investigated for its
applications in the treatment of anxiety associated with terminal
cancer, alcoholism, opioid use disorder, and depression, among
other conditions.
About MindMed
MindMed is a clinical-stage
psychedelic medicine biotech company that seeks to discover,
develop and deploy psychedelic-inspired medicines and therapies to
address addiction and mental illness. 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. 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.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.