- Panorama is the second Phase 3 trial 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 -
- Panorama builds on positive Phase 2b study
results presented at the American Psychiatric Association’s Annual
Meeting in May 2024 and will be conducted at sites in the US and
Europe -
- Topline data from the 12-week double-blind
period anticipated in the second half of 2026 -
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or
"MindMed"), a late-stage clinical biopharmaceutical company
developing novel product candidates to treat brain health
disorders, today announced that the first patient has been dosed in
Panorama, its second Phase 3 study evaluating MM120 ODT, a
proprietary, pharmaceutically optimized form of LSD for the
treatment generalized anxiety disorder (GAD). The Panorama study
will evaluate the efficacy and safety of MM120 ODT versus placebo,
will be conducted in the United States and Europe, and is expected
to enroll approximately 250 participants.
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Image of MM120 Orally Disintegrating
Tablets (Photo: Business Wire)
“This is an incredible time for MindMed, and we are optimistic
about what lies ahead as we embark on our second Phase 3 study for
MM120 ODT in GAD only weeks after the successful launch of our
first Phase 3 study, Voyage,” said Dan Karlin, M.D., M.A., Chief
Medical Officer of MindMed. “MM120 ODT represents a potentially
life-changing treatment for people living with GAD, and if our
Phase 3 development program is successful, it could offer a
differentiated and compelling option for one of the most
significant unmet needs in psychiatry. We aspire to deliver a truly
transformational treatment that we believe has the potential to
change the trajectory of the ongoing brain health epidemic.”
The clinical trial design of the 52-week Panorama study is
aligned to Voyage and 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. Participants will be
randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg, or
placebo. The 50 µg arm serves to confound participants’ ability to
accurately assess the dose condition to which they have been
randomized. This approach builds on the MM120 Phase 2b study, which
the Company believes demonstrated that the clinical activity of
MM120 was not attributable to functional unblinding and aligns with
FDA guidance regarding the use of complementary designs across our
Phase 2 and 3 studies. The primary endpoint of Panorama will
measure the change from baseline in HAM-A at Week 12 between MM120
ODT 100 µg and placebo, which is consistent with the durable
clinical effect observed in the MM120 Phase 2b study.
“GAD is a common and debilitating disorder, as we have shown
that it impairs various cognitive abilities, and many patients are
not sufficiently helped by currently available treatments.1 There
is an urgent need for different approaches. The Panorama study
builds on the results of MindMed’s Phase 2b study, which showed a
rapid and sustained response to a single dose of MM120,
demonstrating its potential as a promising treatment for GAD,” said
Philip Gorwood, M.D., Ph.D., Professor of Psychiatry at Sainte-Anne
Hospital and Paris Cité University, France. “Panorama, which is
consistent with the design of the Phase 2b study, has the potential
to be a transformative change in the way we understand and treat
brain health disorders, offering acute but also lasting benefits to
patients who have long been frustrated with current standards of
care.”
About Generalized Anxiety Disorder (GAD)
GAD is a common disorder 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 people2, currently suffer from GAD.
This underdiagnosed and underserved mental health disorder 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 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 and Drug
Administration has granted Breakthrough Therapy Designation for the
MM120 program in GAD. MindMed has also been granted an Innovation
Passport for the potential treatment of GAD under the United
Kingdom Innovative Licensing and Access Pathway (ILAP) by the U.K.
Medicines and Healthcare products Regulatory Agency. The Innovation
Passport is the entry point to the ILAP, which aims to accelerate
time to market and facilitate patient access to medicines in the
U.K.
About MindMed
MindMed is a late-stage clinical 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 Panorama study (Part A results)
in the second half of 2026; the Company’s expectation to enroll
approximately 250 participants in the Panorama study; 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:
- Baussay A, Di Lodovico, Poupon D, Doublet M, Ramoz N, Duriez P,
Gorwood P (2024) The capacity of cognitive tests to detect
generalized anxiety disorder (GAD), a pilot study. J Psychiatr Res,
Jun; 174: 94-100.
- 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20250127889062/en/
For Media: media@mindmed.co For Investors:
ir@mindmed.co For Medical Affairs: medaffairs@mindmed.co
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