MindMed Announces Business Update and Anticipated Milestones for 2024
January 08 2024 - 7:45AM
Business Wire
-- Recently announced statistically significant
and clinically meaningful topline Phase 2b data for MM-120 in
Generalized Anxiety Disorder (GAD) position for multiple data
readouts and catalysts throughout 2024 including initiation of
Phase 3 clinical program --
-- Proof-of-Concept study evaluating repeated
sub-perceptual dose (20 μg) of lysergide in adults with
Attention-Deficit/Hyperactivity Disorder (ADHD) did not meet
primary endpoint; no further development activities planned for
sub-perceptual dose regimen --
-- Phase 1 Single Ascending Dose Study of
MM-402 in Healthy Participants initiated in Q4 2023 --
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 provided a corporate update and outlook for
2024.
“Our strong progress in 2023 culminated in the delivery of
statistically and clinically significant topline results for our
lead program (MM-120) in our Phase 2b study of GAD. These positive
results reinforce our scientific understanding of the mechanism of
action for MM-120 and emphasize the critical role we believe the
perceptual effects of MM-120 play in driving clinical outcomes,”
said Rob Barrow, Chief Executive Officer and Director of MindMed.
“We are excited to enter 2024 with an enhanced focus on our lead
program. In 2024, we plan to continue working diligently and
efficiently to advance our MM-120 program into Phase 3, bringing us
one step closer to potentially providing a new treatment option to
the millions of patients suffering from GAD. We anticipate several
key data milestones for our MM-120 program in 2024, including full
12-week results for MM-120 in GAD, results from our Phase 1
pharmacokinetics bridging study to support advancement of our
MM-120 ODT formulation into pivotal clinical trials and additional
results from our collaborator University Hospital Basel’s one-year
follow-up study of lysergide in anxiety disorders. We will be
working closely with the FDA to finalize our Phase 3 development
program for MM-120 in GAD and expect to hold our End-of-Phase 2
meeting with FDA in the first half of the year with initiation of
our Phase 3 clinical program in the second half of the year.”
Business Update
- MindMed's management team will participate in the BIO
Partnering at the J.P. Morgan Healthcare Conference in San
Francisco that is being held from January 8-11, 2024.
- The Company expects to host an analyst and investor day in the
first half of 2024, at which the Company plans for its senior
management, a physician expert and other leading key opinion
leaders to provide an update on the Company’s lead development
program MM-120 and discuss the treatment landscape, potential
market and commercial opportunity for MM-120 in GAD and other
psychiatric disorders.
Development Program Updates and
Anticipated Milestones
MM-120 (lysergide D-tartrate)
- Generalized Anxiety Disorder (GAD): In December 2023, the
Company announced statistically significant and clinically
meaningful topline 4-week results from the 198-patient Phase 2b
dose-optimization study of MM-120 for the treatment of GAD.
- MM-120 100 µg – the dose achieving the highest level of
clinical activity – demonstrated a 7.6-point reduction on the
Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4
(-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect
size=0.88), which is more than double the effect sizes seen with
the current standards of care1.
- 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.
- The Company plans to share topline 12-week results from the
Phase 2b study by the end of the first quarter of 2024, and present
full results at a scientific meeting in 2024.
- The Company intends to share results in the first quarter of
2024 from its pharmacokinetics bridging study of the MM-120 Zydis®
orally disintegrating tablet (ODT) formulation, its intended
commercial formulation of MM-120 formulation that may enhance
intellectual property and market protection with a potentially
differentiated biopharmaceutical profile.
- The Company plans to hold an End-of-Phase 2 meeting with the
FDA in the first half of 2024 and expects to initiate its Phase 3
clinical program in the second half of 2024.
- One-year follow-up data from a Phase 2 placebo-controlled
investigator-initiated clinical trial of lysergide in the treatment
of anxiety disorders is anticipated in 2024. This study was
conducted by the Company’s collaborators at University Hospital
Basel (UHB) in Switzerland.
- Attention-Deficit/Hyperactivity Disorder (ADHD): The Company’s
53-patient Phase 2a proof-of-concept trial in ADHD was designed to
assess the safety and efficacy of repeated sub-perceptual dose (20
μg) lysergide administration and did not meet its primary endpoint.
In conjunction with the findings from our study of MM-120 in GAD,
we believe that these results support the critical role of
perceptual effects of MM-120 in mediating a clinical response. The
Company intends to continue prioritizing development of its MM-120
program in GAD and other psychiatric indications, using the single
perceptual dose (100 μg or greater) regimen that has shown strong
positive results in numerous studies.
MM-402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
- The Company initiated its first clinical trial of MM-402
(R(-)-MDMA), a single-ascending dose study in adult healthy
volunteers in Q4 2023. This Phase 1 study is intended to
characterize the tolerability, pharmacokinetics and
pharmacodynamics of MM-402 and will enable further clinical studies
to characterize the effects of repeated daily doses of MM402 and
the exploration of early signs of efficacy in the ASD
population.
- In October 2023, the Company presented results from a MM-402
nonclinical study in a model of ASD, titled “MM-402 demonstrates
better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout
mice, an animal model of autism spectrum disorder” at the 36th
Annual European College of Neuropsychopharmacology (ECNP)
Congress.
- UHB is currently conducting a Phase 1 investigator-initiated
trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy adult
volunteers. This trial is designed to assess the tolerability,
pharmacokinetics and acute subjective, physiological and endocrine
effects of the three molecules. The Company anticipates topline
results to be presented in the first half of 2024.
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 other psychiatric
indications.
About MM-402
MM-402 is our proprietary form of R(-)-MDMA
(rectus-3,4-methylenedioxymethamphetamine), which we are developing
for the treatment of core symptoms of autism spectrum disorder
(ASD). MDMA is a synthetic molecule that is often referred to as an
empathogen because it is reported to increase feelings of
connectedness and compassion. Preclinical studies of R(-)-MDMA
demonstrate its acute pro-social and empathogenic effects, while
its diminished dopaminergic activity suggest that it has the
potential to exhibit less stimulant activity, neurotoxicity,
hyperthermia and abuse liability compared to racemic MDMA or the
S(+)-enantiomer.
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 drug
candidates, with and without acute perceptual effects, targeting
the serotonin, dopamine, and acetylcholine systems.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange 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, trials and studies; results and timing of and
reporting of topline data from clinical trials, the potential
benefits of the Company’s product candidates; potential additional
psychiatric indications for MM-120; the timing of a potential
End-of-Phase 2 meeting with the FDA; and the Company’s expectations
to publish data from the Phase 2b trial for MM-120 in a
peer-reviewed publication and present such data at a scientific
meeting in 2024. 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, 2022 and
its Quarterly Report 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," 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.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.
________________________ 1 Source: RB Hidalgo, J
Psychopharmacol. 2007 Nov;21(8):864-72.
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