MindMed Finalizes Clinical Development Approach for LSD
Targeting Generalized Anxiety Disorder as Initial
Indication
NEW YORK, May 17, 2021 /CNW/ -- MindMed (NASDAQ: MNMD)
(NEO: MMED) (DE: MMQ), a leading clinical stage psychedelic
medicine company, announces receipt of Type C Meeting Responses
from FDA leading to the finalization of the Company's clinical
development approach for Project Lucy by selecting Generalized
Anxiety Disorder as an initial indication. MindMed is on target to
formally submit its Investigational New Drug (IND) application for
Project Lucy in Q3 2021 and expects to launch its Phase
2b clinical trial shortly thereafter
in Q4 2021.
As an extension of the positive pre-IND meeting held with the
FDA in December 2020, MindMed sought
further agreement from the FDA on the Company's clinical approach
for the development of LSD in the treatment of anxiety disorders.
In line with positive FDA feedback, MindMed will pursue the
treatment of Generalized Anxiety Disorder as its first indication.
The clinical development program is scheduled to advance in late
2021 with the launch of Study MMED008, which is a Phase
2b dose-optimization study of LSD in
approximately 200 patients diagnosed with Generalized Anxiety
Disorder. This study, with clinical sites mainly in the United States, will assess improvements in
anxiety symptoms following a single administration of LSD and will
be the catalyst to select a final dose to be taken forward into
Phase 3 pivotal clinical trials.
"We are excited by the productive discussion with the FDA to
date and by the finalization of MindMed's clinical approach to
advance LSD in the treatment of anxiety disorders, beginning with a
Phase 2b clinical trial for
Generalized Anxiety Disorder. This approach both provides a clear
regulatory pathway to advance LSD to possible approval and
leverages the vast experience of Dr. Liechti and our UHB
collaborators, including the Phase 2 clinical trial studying LSD in
patients with anxiety." said Rob
Barrow, Chief Development Officer of MindMed. "Further, the
results of this Phase 2b dose
optimization study we believe could significantly advance our
scientific understanding of both the clinical effects of LSD and
the underlying mechanisms of action that predict clinical
response."
Generalized Anxiety Disorder is a chronic, often debilitating
mental health disorder that affects approximately 6% of US adults
in their lifetimes. Symptoms of Generalized Anxiety Disorder
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 Generalized Anxiety Disorder, Major
Depressive Disorder and other major mental health disorders, there
has been very little innovation focused on the treatment of
Generalized Anxiety Disorder in the past several decades.
MindMed Chief Medical Officer Dr. Dan
Karlin said: "Anxiety is a universal feature of the human
experience. At times, we all anticipate potentially uncomfortable
and unfortunate future events. Aversive anticipation is a central
and and distressing feature of daily life for many. Worse still is
the lurking awareness of our own mortality, and the existential
dread that this knowledge can carry with it. Though depression
syndromes, in particular Major Depressive Disorders, have been a
major focus of drug development activity in recent decades, we see
anxiety as being both core to the suffering of many diagnosed with
depression, and a symptom that cuts across a number of other
psychiatric disorders."
At present, most anxiolytics are oriented toward suppression of
the conscious experience of anxiety. Existing medications are taken
in anticipation of one's future anxiety, as a reaction to a
contemporaneous sense of heightened anxiety, and in anxiety's most
acute manifestation, to avert panic attacks.
"In studying the treatment of Generalized Anxiety Disorder
through Project Lucy, MindMed hopes to help patients address the
underlying sources of their anxieties to produce meaningful,
sustained improvement across all aspects of their lives," said
MindMed Chief Medical Officer Dr. Dan
Karlin.
About MindMed
MindMed is a clinical-stage psychedelic
medicine biotech company that discovers, develops and deploys
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. 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 includes statements regarding the
timing of the submission of the IND, the timing of the launch of
the Phase 2b clinical trial, the
ability to determine a final dose for a future Phase 3 clinical
trial or that a future Phase 3 clinical trial will occur, that
there is or will be a clear regulatory pathway to LSD approval,
that the Company's knowledge of the product or dosage will be
advanced by the Phase 2b study, the
ability of the Company to produce a product to address underlying
sources of anxiety and improve the lives of those suffering from
GAD and, if such a product is developed, that it will have the
desired effects. 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.
Media Contact: mindmed@150bond.com
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SOURCE Mind Medicine (MindMed) Inc.