-A single oral administration of MM120 100 µg
met its key secondary endpoint and maintained a clinically and
statistically significant HAM-A reductions compared to placebo at
12 weeks with a 65% clinical response rate and 48% clinical
remission rate-
-MindMed plans to hold an End-of-Phase 2
meeting with the U.S. Food & Drug Administration (FDA) in the
first half of 2024 and initiate its Phase 3 clinical program in the
second half of 2024-
-MindMed will host a webcast to discuss data
from its Phase 2b study at 8:00 am ET-
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (Cboe Canada
MMED), (the “Company” or “MindMed”), a clinical stage
biopharmaceutical company developing novel product candidates to
treat brain health disorders, today announced that FDA has granted
breakthrough designation to its MM120 (lysergide d-tartrate)
program for the treatment of generalized anxiety disorder (GAD).
The Company also announced that its Phase 2b study of MM120 in GAD
met its key secondary endpoint, and 12-week topline data
demonstrated clinically and statistically significant durability of
activity observed through Week 12.
MindMed previously announced rapid, clinically meaningful, and
statistically significant improvements on the Hamilton Anxiety
rating scale (HAM-A) compared to placebo at Week 4, which was the
trial’s primary endpoint. MM120 was administered as a single dose
in a monitored clinical setting with no additional therapeutic
intervention.
“I’ve conducted clinical research studies in psychiatry for over
two decades and have seen studies of many drugs under development
for the treatment of anxiety. That MM120 exhibited rapid and robust
efficacy, solidly sustained for 12 weeks after a single dose, is
truly remarkable,” stated David Feifel, MD, PhD, Professor Emeritus
of Psychiatry at the University of California, San Diego and
Director of the Kadima Neuropsychiatry Institute in La Jolla,
California and an investigator in the MM120 study. “These results
suggest the potential MM120 has in the treatment of anxiety, and
those of us who struggle every day to alleviate anxiety in our
patients look forward to seeing results from future Phase 3
trials.”
MM120 100 µg – the dose with optimal clinical activity observed
in the trial – demonstrated a 7.7-point improvement over placebo at
Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81),
with a 65% clinical response rate and a 48% clinical remission rate
sustained to Week 12. Clinical Global Impressions - Severity
(CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg
dose group, representing a two-category shift from ‘markedly ill’
to ‘borderline ill’ at Week 12 (p<0.004). This clinical activity
was rapid, observed as early as study day 2, and durable with
further improvements observed in mean HAM-A or CGI-S scores between
Weeks 4 and 12.
Based on the significant unmet medical need in the treatment of
GAD – especially in patients who do not respond to or tolerate
currently available medications – along with the initial clinical
data from Phase 2b and other research conducted by MindMed, the
U.S. Food & Drug Administration (FDA) has designated MM120 for
GAD as a breakthrough therapy. The Company plans to hold an
End-of-Phase 2 meeting with the FDA in the first half of 2024 and
initiate a Phase 3 clinical program in the second half of 2024.
“The FDA’s decision to designate MM120 as a breakthrough therapy
for GAD and the durability data from our Phase 2b study provide
further validation of the important potential role this treatment
can play in addressing the huge unmet need among individuals living
with GAD,” said Robert Barrow, Chief Executive Officer and Director
of MindMed. “We are committed to bringing MM120 to people living
with GAD and delivering on the potential of our pipeline to treat
serious brain health disorders.”
In the Phase 2b study, known as MMED008, MM120 was generally
well-tolerated with most adverse events rated as mild to moderate,
transient and occurring on dosing day, and being consistent with
expected acute effects of the study drug. The most common adverse
events (at least 10% incidence in the high dose groups) on dosing
day included illusion, hallucinations, euphoric mood, anxiety,
abnormal thinking, headache, paresthesia, dizziness, tremor,
nausea, vomiting, feeling abnormal, mydriasis and
hyperhidrosis.
Prior to treatment with MM120, study participants were
clinically tapered and then washed out from any anxiolytic or
antidepressant treatments and did not receive any form of
study-related psychotherapy for the duration of their participation
in the study.
“As a clinician and clinical researcher, I applaud the way this
study was designed by MindMed to isolate the effect of MM120 by
removing confounding variables like additional medications and
psychotherapy,” said Reid Robison, MD, Psychiatrist and Chief
Clinical Officer at Numinus (TSX:NUMI) who has served as adjunct
faculty at the University of Utah for the last 12 years and was an
investigator in the MM120 study. “It gives me confidence in the
data and the positive results give me hope that this may translate
into meaningful benefits for my patients.”
The primary data analyses from MMED008 have been accepted for
presentation at the American Psychiatric Association’s annual
meeting, which will be held in New York on May 4-8, 2024. The study
is also being submitted for publication in a leading medical
journal.
Conference Call and Webcast
MindMed management will host a webcast at 8:00 am ET today to
discuss the Phase 2b results of MM120 in GAD. The webcast and
slides will be accessible live under “News & Events” on the
Investors page of the Company’s website at https://ir.mindmed.co/
or by clicking here. A replay of the event will be available on
MindMed’s website. The webcast will be archived on the Company’s
website for at least 30 days after the conference call.
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,
an underdiagnosed and underserved indication that 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 2004.
About MMED008
MMED008 was a multi-center, parallel, randomized, double-blind,
placebo-controlled, dose-optimization study. The trial enrolled 198
participants who were randomized to receive a single administration
of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The full
analysis set (FAS) for the trial included 194 subjects, those that
had at least one valid post-baseline Hamilton Anxiety rating scale
(HAM-A) score. Subjects enrolled in the trial presented with severe
GAD symptoms (average baseline HAM-A scores of approximately 30).
The study's main objective was to determine the dose-response
relationship of four doses of MM120 versus placebo as measured by
the change in HAM-A from Baseline to Week 4. The key secondary
objective of the study was to determine the dose-response
relationship of four doses of MM120 versus placebo as measured by
the change in HAM-A from Baseline to Week 8. Secondary objectives,
measured up to 12 weeks after the single administration, include
assessments of anxiety symptoms, safety and tolerability, and other
measures of efficacy and quality of life. More information about
the trial is available on the MindMed website (mindmed.co) or on
clinicaltrials.gov (NCT05407064).
About MM120
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 (lysergide D-tartrate), the
tartrate salt form of lysergide, for GAD and is exploring its
potential applications in other serious brain health disorders.
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 and on the Cboe
Canada (formerly known as the NEO Exchange, Inc.) under the symbol
MMED.
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 anticipated
upcoming milestones, and progress of trials and studies; results
and timing of and reporting of full data from the Company’s Phase
2b clinical trial of MM120; timing of a potential End-of-Phase-2
meeting with the FDA; 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 results of the potential Phase 3 clinical trial or that,
following any such trial, 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 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.sedar.com 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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