- Study will compare the acute subjective,
physiological, and endocrine effects of R-MDMA, S-MDMA, and racemic
MDMA in 24 healthy subjects -
NEW
YORK, Oct. 4, 2022 /PRNewswire/ -- Mind Medicine
(MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or
"MindMed"), a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders, today announced the
initiation of a Phase 1 investigator-initiated trial led by MindMed
collaborator Prof. Dr. Matthias
Liechti at University Hospital Basel (UHB). The study aims
to compare acute responses to R-MDMA, S-MDMA, and MDMA in healthy
subjects.
"MDMA is a racemic substance containing equal amounts of the
enantiomers S-MDMA and R-MDMA," said Prof. Dr. Liechti, principal
investigator of the trial. "Preclinical research indicates that
S-MDMA mainly releases dopamine, norepinephrine, serotonin, and
oxytocin while R-MDMA may act more directly on 5-HT2A receptors and
release prolactin. Animal studies indicate that R-MDMA may have
fewer adverse effects and have greater prosocial effects. But the
acute effects of S- and R-MDMA have never been validly examined in
a human study. We are excited for the opportunity to potentially
validate these findings in healthy human subjects."
Dr. Miri Halperin Wernli,
Executive President of MindMed, added, "Although we know from
animal studies that the two enantiomers act synergistically to
produce the subjective effects of MDMA, this study represents an
opportunity to validate the potential improved safety profile and
prosocial effects of the R-enantiomer of MDMA. Preclinical studies
of R-MDMA demonstrate its acute prosocial effects, while its
diminished dopaminergic activity suggest that it will exhibit less
stimulant activity, neurotoxicity, hyperthermia and abuse liability
compared to racemic MDMA or the S-enantiomer. MindMed is
developing MM-402 for the treatment of core symptoms of autism
spectrum disorder (ASD), which is a developmental disorder
characterized by atypical social communication and interactions,
repetitive patterns of behavior and restricted interests. Despite
its significant and growing prevalence, there are no therapies
approved to treat the core symptoms of ASD. We look forward to
exploring the exciting opportunities being unlocked by Dr.
Liechti's research."
The Phase 1 trial is a randomized, placebo-controlled,
double-blind, 5-period crossover study. The trial plans to enroll
24 healthy subjects, who will receive R-MDMA (125 and 250mg),
S-MDMA (125mg), MDMA (125mg), and a placebo. The primary outcome
measures for this trial will assess acute subjective effects using
the Visual Analog Scales (VAS) and the 5 Dimensions of Altered
States of Consciousness (5D-ASC). Secondary endpoints will assess
autonomic effects (blood pressure, heart rate, body temperature),
mood on the days following the administration, endocrine effects,
plasma concentration, and additional subjective effects (VAS, AMRS,
SCQ, PIQ). More information about this trial is available at
clinicaltrials.gov (identifier: NCT05277636) and at mindmed.co.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders, with a particular
focus on psychiatry, addiction, pain and neurology. 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 is 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 studies, results and timing of clinical
studies, and continuing collaborations and partnerships. 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, 2021 and its Quarterly Reports on
Form 10-Q for the period ended June 30,
2022 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.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.