- Voyage is the first-ever Phase 3 study of
lysergide D-tartrate (LSD) with the primary endpoint measuring the
change from baseline in the Hamilton Anxiety Rating Scale (HAM-A)
score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100
µg vs placebo -
- Study builds on positive Phase 2b study
results presented at the American Psychiatric Association’s Annual
Meeting in May 2024 -
- Topline data from the 12-week double-blind
period anticipated in the first half of 2026 -
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 that the first patient has been dosed in its Phase 3
Voyage study of MM120 ODT, a pharmaceutically optimized form of
lysergide D-tartrate (LSD) for the treatment of GAD. Voyage is the
first of two Phase 3 studies in GAD evaluating the efficacy and
safety of MM120 ODT versus placebo and is expected to enroll
approximately 200 participants in the United States. The Panorama
study, the second Phase 3 trial, will be conducted in the U.S. and
Europe and is on track to initiate in the first half of 2025.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20241216046321/en/
Representative Image of MM120
ODT/Courtesy of Catalent
“Today marks a pivotal moment in our journey towards advancing a
novel treatment option for the 20 million people1 in the U.S.
living with GAD. Building on our scientifically rigorous Phase 2b
study, which demonstrated efficacy that far exceeds today’s
standard of care and a favorable tolerability profile, our Phase 3
studies are designed to adhere to the highest clinical and ethical
standards and are in alignment with guidance from the U.S. Food and
Drug Administration,” said Daniel R. Karlin, M.D., M.A., Chief
Medical Officer of MindMed.
The 52-week Voyage study will be conducted in two parts: Part A,
a 12-week, randomized, double-blind, placebo-controlled, parallel
group period; and Part B, a 40-week extension period during which
participants will be eligible for open-label treatment with MM120
ODT based on symptom severity. The primary endpoint of Voyage will
measure the change from baseline in HAM-A at Week 12, which is
consistent with the durable clinical effect observed in the Phase
2b study.
“It is critical to continue to develop new and effective
treatment options for patients with GAD, a debilitating condition
where there is an urgent need for transformational innovation,”
said David Feifel, M.D., Ph.D., 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 Voyage study. “The design of the MM120 ODT
Phase 3 clinical program directly builds on the robust Phase 2b
study results and incorporates best-in-class methodologies to
mitigate the impact of functional unblinding, including the use of
independent central raters blinded to both treatment assignment and
visit number. The studies have also been designed to isolate the
standalone drug effect of MM120 ODT from other psychotherapeutic
intervention and follow industry best practices for safety
monitoring.”
About Generalized Anxiety Disorder (GAD)
GAD is a common condition associated with significant impairment
that adversely affects millions of people. GAD results in fear,
continuing 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 people1, currently suffer from GAD.
This underdiagnosed and underserved mental health disorder is
associated with 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 MM120 Orally Disintegrating Tablet (ODT)
MM120 ODT (lysergide D-tartrate or LSD) is a synthetic
ergotamine belonging to the group of classic, or serotonergic,
psychedelics which acts as a partial agonist at human serotonin-2A
(5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and
pharmaceutically optimized form of LSD. MM120 ODT is an advanced
formulation incorporating Catalent’s Zydis® ODT fast-dissolve
technology which has a unique clinical profile with more rapid
absorption, improved bioavailability and reduced gastrointestinal
side effects.
The MM120 ODT Phase 3 clinical development program includes the
Voyage and Panaroma studies in generalized anxiety disorder (GAD)
and the Emerge study in major depressive disorder (MDD). Additional
clinical indications are under consideration. MindMed’s Phase 2b
study, MMED008, met its primary and key secondary endpoints and
demonstrated 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 study,
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.
Based on the significant unmet medical need in the treatment of
GAD along with the initial clinical data from the Phase 2b study
and other research conducted by MindMed, the U.S. Food & Drug
Administration (FDA) has granted Breakthrough Therapy Designation
(BTD) for the MM120 program in GAD.
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.
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 the Company’s
anticipated topline readout for the Voyage study (Part A results)
in the first half of 2026; the Company’s expectation to enroll
approximately 200 participants in the Voyage study; the Company’s
expectation to initiate the Panorama Study in the first half of
2025; the Company’s beliefs regarding potential benefits of its
product candidates; anticipated upcoming milestones, trials and
studies; and potential additional indications for MM120 ODT. 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;
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," and "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.
References:
- Ringeisen, H., Edlund, M. J., Guyer, H., Geiger, P., Stambaugh,
L. F., Dever, J. A., Liao, D., Carr, C. M., Peytchev, A., Reed, W.,
McDaniel, K., & Smith, T. K. (2023). Mental and Substance Use
Disorders Prevalence Study: Findings report. RTI
International.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241216046321/en/
For Media: media@mindmed.co For Investors:
ir@mindmed.co
Mind Medicine MindMed (NASDAQ:MNMD)
Historical Stock Chart
From Dec 2024 to Jan 2025
Mind Medicine MindMed (NASDAQ:MNMD)
Historical Stock Chart
From Jan 2024 to Jan 2025
