MindMed Completes Enrollment of Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)
12 September 2023 - 1:30PM
Business Wire
– 198 participants dosed across 20 clinical
sites –
– On track for topline results 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, announced today that it has completed enrollment and
dosing in Study MMED008, the Company’s Phase 2b study evaluating
MM-120 (lysergide D-tartrate) for the treatment of GAD.
“Completion of enrollment of this study is a significant
milestone for MindMed and moves us one step closer to our goal of
transforming the treatment of GAD for the millions suffering from
the disorder,” said Robert Barrow, Chief Executive Officer and
Director of MindMed. “Thanks in large part to the enthusiasm we
have seen regarding MM-120 among investigators and patients, as
well as the strong execution of our team, we were able to enroll
almost 200 participants in this trial in just over a year. We
anticipate sharing topline results during the fourth quarter of
this year.”
Study MMED008 is a multi-center, parallel, randomized,
double-blind, placebo-controlled, dose-optimization study. The
trial has enrolled 198 participants who were randomized to receive
a single administration of 25 µg, 50 µg, 100 µg or 200 µg of
MM-120, or placebo. The primary objective of the study is to
determine the dose-response relationship of four doses of MM-120
versus placebo as measured by the change in Hamilton Anxiety Rating
Scale (HAM-A) from baseline to week 4. Key secondary objectives,
measured up to 12 weeks after the single administration, include
assessments of anxiety symptoms, safety and tolerability, as well
as other measures of efficacy and quality of life. More information
about the trial is available on our website (mindmed.co), the
trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov
(identifier NCT05407064).
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
disorders.
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
timing and results from the Phase 2b clinical trial of MM-120] and
the potential benefits of the Company’s product candidates. 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, 2022,
the Company’s Quarterly Report on Form 10-Q for the fiscal quarter
ended June 30, 2023 under headings such as “Special Note Regarding
Forward-Looking Statements,” “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.
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For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA Vice President, Investor Relations and
Corporate Communications Mind Medicine (MindMed) Inc. ir@mindmed.co
media@mindmed.co
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