- First-in-human trial to investigate the tolerability,
pharmacology, and pharmacokinetics of novel MDMA-like compounds
versus a placebo in healthy subjects
- Acute effects of equivalent doses will be compared across
the following compounds: MDMA, MDA, Lys-MDMA and Lys-MDA
NEW
YORK, Sept. 20, 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 first patient has been dosed in a Phase 1
investigator-initiated study led by MindMed collaborator Prof. Dr.
Matthias Liechti at University
Hospital Basel (UHB). The study aims to evaluate the effects of
MDMA-like substances, including MDA, Lys-MDMA, Lys-MDA, versus a
placebo in healthy volunteers.
"Although amphetamines like MDMA and MDA induce mainly positive
subjective and mood-enhancing effects, they may also produce
negative subjective drug effects, particularly at the onset of
response," said Prof. Matthias
Liechti, principal investigator of the trial. "Lys-MDMA and
Lys-MDA are prodrugs that are slowly metabolized to MDMA and MDA,
offering a novel and controlled delivery system of these active
substances with potentially improved pharmacological properties. By
using pharmacokinetics and modern psychological and psychometric
tests, this study will investigate the potential to better control
the bioavailability, slow the effect onset and reduce possible
adverse effects of MDMA and MDA by using these prodrugs. The study
will also investigate effects of MDA in direct comparison with MDMA
for the first time in humans."
Dr. Miri Halperin Wernli,
Executive President of MindMed, added, "This study represents an
exciting opportunity to investigate the pharmacokinetic and
pharmacodynamic activity of MDMA-like compounds within the same
subject. Through our collaboration with the Leichti Lab at UHB, we
have exclusive rights to the data from this study which will
enhance our understanding of the therapeutic properties involved in
the induction of positive mood in a way that may help optimize the
treatment model for our R(-)-MDMA drug candidate."
The Phase 1 clinical trial is a randomized, placebo-controlled,
double-blinded, 5-period crossover study. The trial plans to enroll
24 healthy subjects who will receive MDMA (100mg), MDA (93.9mg),
Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg), and placebo. The primary
outcome measures for this study will assess acute subjective
effects using Visual Analog Scales (VAS) assessing the intensity
and duration of subjective effects on a scale (0-100 percent) with
higher scores representing more intense effects as well as plasma
levels of MDMA and MDA at each study day across the 18-month study
period. More information about the trial is available on our
website (mindmed.co) or on clinicaltrials.gov (identifier
NCT04847206).
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel products 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 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.