-A single oral administration of MM120 100 µg
met its primary and key secondary endpoints and maintained
clinically and statistically significant HAM-A reductions compared
to placebo at 12 weeks with a 65% clinical response rate and a 48%
clinical remission rate-
-MindMed also presents two new epidemiology
studies quantifying the burden of GAD in the US-
-APA Annual Meeting, the largest psychiatric
gathering in the world, is the first scientific presentation of
MM120 Phase 2b data-
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 presented data from MMED008, its Phase 2b study of
MM120 (lysergide d-tartrate) in the treatment of GAD in adults.
MM120 demonstrated clinically and statistically significant
efficacy compared to placebo at its primary week 4 and secondary
week 12 timepoints. The study was presented at the APA Annual
Meeting, the largest psychiatry-focused scientific meeting in the
world, in New York City being held May 4 – 8, 2024.
MM120 demonstrated rapid, clinically meaningful, and
statistically significant improvements on the Hamilton Anxiety
rating scale (HAM-A) compared to placebo at Week 4, the study’s
primary endpoint, and maintained durability of response to week 12.
MM120 was administered as a single dose in a monitored clinical
setting, with no additional therapeutic intervention, to
demonstrate the medication’s effect.
“On behalf of the 20 million people in the US – and millions
more worldwide – who are living with GAD, we are incredibly excited
for the therapeutic potential that MM120 shows based on its rapid
and robust efficacy, durably sustained for 12 weeks after a single
dose in this study,” said Daniel R. Karlin, MD, MA, Chief Medical
Officer of MindMed, who presented the Phase 2b MM120 study at APA.
“Few new 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.”
MM120 100µg – the dose with optimal clinical activity observed
in the study – 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 100µg
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.
In today’s presentation of the Phase 2b study with MM120,
investigators presented results from the assessment of several
additional secondary endpoints that were pre-specified. One such
endpoint was the change from baseline compared to placebo in
Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which
measures the severity of depression symptoms. Major Depressive
Disorder (MDD) and depressive symptoms are common co-morbidities in
people with GAD. MADRS score improvements in the 100 µg arm of the
study were clinically and statistically significant compared to the
placebo group, with a difference of 5.7 points (p≤0.05) at week 4
and a difference of 6.4 points (p≤0.05) at week 12.
In MMED008, MM120 was generally well-tolerated, with most
adverse events rated as mild to moderate, transient, and occurring
on the dosing day (day 1) and being consistent with the expected
acute effects of the study drug. The most common adverse events,
with at least 10% incidence on dosing day in the 100µg dose group,
included illusion, nausea, headache, hallucination, euphoric mood,
anxiety, mydriasis, hyperhidrosis, paresthesia, fatigue, blood
pressure increase, abnormal thinking, and altered state of
consciousness.
Prior to treatment with MM120, study participants were
clinically tapered and then washed out from any anxiolytic or
antidepressant treatments and were not provided 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 a
co-author 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.”
New Data on the Burden of GAD
Two additional studies with new epidemiological data were also
presented today by MindMed at the APA meeting. One study strongly
supports screening the general population for anxiety as
recommended by the US Preventive Services Task Force (USPSTF),
indicating that using the clinically validated GAD-7 screening tool
would identify about three-fold more people living with anxiety
than are currently diagnosed in the US.
The second study compared diagnosed and undiagnosed people with
GAD to determine the condition’s relative impact on their lives.
This study determined that clinically meaningful impact of GAD was
more significant among undiagnosed adults than their diagnosed
counterparts. This difference was consistently noted across
multiple factors: health-related quality of life, healthcare
resource utilization, substantial activity impairment and work
productivity loss.
“We are committed to addressing the unmet medical needs of
people with brain health disorders and particularly the growing
prevalence and dramatic underdiagnosis of GAD,” said Dr. Karlin.
“With seven presentations of new epidemiological studies at
scientific meetings this spring alone, we hope to augment the
understanding of the burden of GAD and the gaps in diagnosis and
treatment impacting people living with this debilitating
condition.”
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 Study 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 participants, those
that had at least one valid post-baseline Hamilton Anxiety rating
scale (HAM-A) score. Participants 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, included
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.
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; 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; the
prevalence of undiagnosed GAD patients; 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.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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