MindMed Announces Constructive End-of-Phase 2 Meeting with U.S. FDA for MM120 in Generalized Anxiety Disorder (GAD)
June 20 2024 - 7:00AM
Business Wire
-Aligned on requirements for Phase 3 clinical
development of MM120 for the treatment of GAD-
-Initiation of Phase 3 program remains on
schedule to begin in second half of 2024-
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or
“MindMed”), a clinical stage biopharmaceutical company developing
novel product candidates to treat brain health disorders, today
announced the completion of the End-of-Phase 2 (EOP2) meeting with
the U.S. Food and Drug Administration (FDA), supporting the
advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate)
into pivotal trials for the treatment of adults with GAD.
“Following a constructive End-of-Phase 2 meeting with the FDA,
we are pleased to have reached alignment on our Phase 3 development
strategy for MM120 in GAD,” said Rob Barrow, Chief Executive
Officer of MindMed. “This marks a significant milestone for MindMed
and for the millions of individuals affected by GAD. We are on
schedule to initiate our Phase 3 clinical program for MM120 oral
dissolving tablet (ODT) in GAD in the second half of this year and
look forward to sharing additional details on the design of our
pivotal program in the coming months.”
The EOP2 meeting was supported by results from MindMed’s
completed Phase 2b clinical trial, MMED008. The multi-center,
randomized, double-blind, parallel-group, dose-finding study was
designed to assess the effect of four doses of MM120 for the
treatment of anxiety symptoms in participants diagnosed with GAD.
In the trial, MM120 met its primary and key secondary endpoints and
demonstrated a rapid, clinically meaningful, and statistically
significant improvements on the Hamilton Anxiety rating scale
(HAM-A) at Week 4 and Week 12, with a 65% clinical response rate
and 48% clinical remission rate sustained to Week 12 in the MM120
100 µg cohort. MM120 was generally well-tolerated in this trial,
with most adverse events rated as mild to moderate, transient, and
occurring on the dosing day and being consistent with the expected
acute effects of the trial drug.
“On behalf of the 20 million people in the U.S. – and millions
more worldwide – who are living with GAD, we are incredibly excited
for the therapeutic potential that MM120 shows based on the data
from the previously completed Phase 2b MMED008 trial,” said Daniel
R. Karlin, MD, MA, Chief Medical Officer of MindMed. “Few treatment
options have shown robust activity in GAD, with the last new FDA
approval occurring in 2007. We are committed to bringing MM120 to
people living with GAD and are excited to move into the next phase
of our development program.”
About MM120
LSD (lysergide) is a synthetic ergotamine belonging to the group
of classic, or serotonergic, psychedelics, which acts as a partial
agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A])
receptors. MindMed is developing MM120, the tartrate salt form of
lysergide, for GAD and is exploring its potential applications in
other serious brain health disorders.
About Generalized Anxiety Disorder (GAD)
GAD is a common condition associated with significant impairment
that adversely affects millions of people. GAD results in fear,
persistent anxiety, and a constant feeling of being overwhelmed. It
is characterized by excessive, persistent, and unrealistic worry
about everyday things. Approximately 10% of U.S. adults,
representing around 20 million people, currently suffer from GAD.
This underdiagnosed and underserved indication is associated with
significant impairment, less accomplishment at work and reduced
labor force participation. Despite the significant personal and
societal burden of GAD, there has been little innovation in the
treatment of GAD in the past several decades, with the last new
drug approval occurring in 2007.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel product candidates to treat brain health disorders. Our
mission is to be the global leader in the development and delivery
of treatments that unlock new opportunities to improve patient
outcomes. We are developing a pipeline of innovative product
candidates, with and without acute perceptual effects, targeting
neurotransmitter pathways that play key roles in brain health
disorders. MindMed trades on NASDAQ under the symbol MNMD.
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, but is not limited to, statements regarding timing of the
initiation of a potential Phase 3 clinical trial of MM120 and the
potential benefits of the Company’s product candidates. There can
be no guarantees regarding the timing or results of the potential
Phase 3 clinical trials for MM120 for the treatment of GAD or that,
following any such trials, MM120 will receive the necessary
regulatory approvals. 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 its 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 in the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, under headings such as
“Special Note Regarding Forward-Looking Statements,” “Risk Factors”
and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations,” and other filings and furnishings made
by the Company with the securities regulatory authorities in all
provinces and territories of Canada which are available under the
Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S.
Securities and Exchange Commission on EDGAR at www.sec.gov. Except
as required by law, the Company undertakes no duty or obligation to
update any forward-looking statements contained in this release as
a result of new information, future events, changes in expectations
or otherwise.
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