– Trial met its primary endpoint with MM-120
demonstrating a statistically significant dose-dependent
improvement in HAM-A scores four weeks after a single-dose –
– MM-120 100 µg demonstrated a clinically and
statistically significant HAM-A reduction of 21.3 points,
representing a 7.6-point improvement over placebo at Week 4
(p=0.0004, Cohen’s d effect size = 0.88) –
– Clinical response rate of 78% in 100 µg and
200 µg dose groups and 50% clinical remission rate in the 100 µg
dose group at Week 4 –
– MM-120 was generally well-tolerated with
mostly mild-to-moderate adverse events that occurred on dosing day
–
– Company 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 a Phase 3 clinical program in the
second half of 2024 –
– Conference call and webcast to take place
today at 8:30 am EST –
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED),
(the “Company” or “MindMed”), a clinical stage biopharmaceutical
company developing novel product candidates to treat brain health
disorders, today announced positive topline results from its Phase
2b clinical trial of MM-120 (lysergide d-tartrate) in generalized
anxiety disorder (GAD). The trial met its primary endpoint, with
MM-120 demonstrating statistically significant and clinically
meaningful dose-dependent improvements on the Hamilton Anxiety
rating scale (HAM-A) compared to placebo at Week 4. MM-120 was
administered as a single-dose in a monitored clinical setting with
no additional therapeutic intervention.
MM-120 100 µg – the dose achieving the highest level of clinical
activity – demonstrated a 7.6-point reduction compared to placebo
at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s
d=0.88). Clinical Global Impressions - Severity (CGI-S) scores on
average improved from 4.8 to 2.4 in the 100 ug dose group,
representing a two-category shift from ‘markedly ill’ to
‘borderline ill’ at Week 4 (p<0.001). This clinical activity was
observed to be rapid and durable beginning on Day 2 and continuing
through Week 4 with no loss of activity observed on either HAM-A or
CGI-S.
“We are excited by the strong positive results for MM-120 in
GAD, particularly given that this is the first study to assess the
standalone drug effects of MM-120 in the absence of any
psychotherapeutic intervention. These promising findings represent
a major step forward in our goal to bring a paradigm-shifting
treatment to the millions of patients who are profoundly impacted
by GAD,” said Robert Barrow, Chief Executive Officer and Director
of MindMed. “We look forward to sharing additional study results in
the coming months – including topline 12-week results in the first
quarter of 2024 – and working closely with FDA as we finalize the
Phase 3 development program for MM-120 in GAD. I would like to
thank all of the participants in the study as well as the study
investigators and our clinical development team, whose dedication
made this important milestone possible.”
Daniel Karlin, MD, MA, Chief Medical Officer of MindMed said,
“Generalized anxiety disorder is a common condition associated with
significant impairment that adversely affects millions of people
and there remains a serious unmet need for this patient population.
The pharmaceutical industry has largely ignored GAD over recent
decades as it has proved extremely difficult to target. Few new
treatment options have shown robust activity in GAD since the last
new drug approval in 2004, making the strong, rapid, and durable
clinical activity of a single dose of MM-120 observed in the trial
particularly notable. We believe this study is the first to
rigorously assess the efficacy of a drug candidate in this class in
the absence of a concurrent therapeutic intervention, which brings
hope to the millions of people suffering from GAD and provides
additional evidence that MM-120 may play an important role in
revolutionizing the treatment of brain health disorders.”
Additional secondary and exploratory endpoints included in the
primary topline results included HAM-A response and remission rates
and Clinical Global Impressions - Severity (CGI-S) scores. Clinical
response (50% or greater improvement in HAM-A) at Week 4 was
achieved in 78% of participants treated with MM-120 (100 µg or 200
µg) compared to 31% for placebo. Clinical remission (HAM-A ≤ 7) at
Week 4 was achieved in 50% of participants treated with MM-120 100
µg. CGI-S scores demonstrated a statistically significant and
clinically meaningful improvement compared to placebo in the 100 µg
(p≤0.001) and 200 µg (p≤0.01) dose groups. On average, participants
receiving MM-120 (100 µg or 200 µg) experienced a 2-unit
improvement in the CGI-S score at Week 4, with statistically
significant improvements observed as early as one day after
treatment and continuing at all evaluated timepoints through Week
4.
MM-120 was generally observed to be well tolerated, with mostly
transient mild-to-moderate adverse events (AEs) that appear
consistent with the pharmacodynamic effects of MM-120. The overall
four-week completion rate in the trial was approximately 90% and
was 97.5% in the high dose groups, and no participants in the high
dose groups discontinued due to an adverse event through Week 4.
The most common adverse events (at least 10% incidence in the high
dose groups) occurred on dosing day and included illusion,
hallucinations, euphoric mood, anxiety, thinking abnormal,
headache, paraesthesia, dizziness, tremor, nausea, vomiting,
feeling abnormal, mydriasis and hyperhidrosis.
The Company expects that results of this study will support the
advancement of MM-120 into Phase 3 clinical development for GAD.
The Company plans to hold an End-of-Phase 2 meeting with the FDA in
the first half of 2024 and expects to initiate Phase 3 clinical
trials in the second half of 2024. The Company expects to present
additional topline 12-week data from the study in the first quarter
of 2024 and to present full results at a scientific meeting in
2024.
Conference Call and Webcast
MindMed management will host a conference call at 8:30 AM EST
today to discuss the results of MM-120 in GAD. Individuals may
participate in the live call via telephone by dialing (877)
407-3982 (domestic) or (201) 493-6780 (international). The webcast
can be accessed live here on the News & Events page in the
Investors section of the MindMed website, https://mindmed.co/. The
webcast will be archived on the Company’s website for at least 30
days after the conference call.
About Study MMED008
Study MMED008 is 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 MM-120 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 primary objective of the study was to
determine the dose-response relationship of four doses of MM-120
versus placebo as measured by the change in HAM-A from Baseline to
Week 4. Secondary objectives, measured up to 12 weeks after the
single administration, include assessments of anxiety symptoms,
safety and tolerability, as well as 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
(identifier NCT05407064).
About MM-120
Lysergide is a synthetic tryptamine 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 MM-120 (lysergide D-tartrate), the
tartrate salt form of lysergide, for GAD and ADHD.
About Generalized Anxiety Disorder
GAD is a brain health disorder that 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 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 MM-120; timing of a potential End-of-Phase-2
meeting with the FDA; timing of the initiation of a potential Phase
3 clinical trial of MM-120; and the potential benefits of the
Company’s product candidates. 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, 2022, the Company’s Quarterly
Reports on Form 10-Q for the periods ended March 31, 2023, June 30,
2023 and September 30, 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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For Media & Investor Inquiries, please contact: Maxim
Jacobs, CFA Vice President, Investor Relations and Corporate
Communications Mind Medicine (MindMed) Inc. ir@mindmed.co
media@mindmed.co
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