MindMed Announces Enrollment Milestone in Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)
17 Maio 2023 - 5:01PM
Business Wire
– Over 50% of patients dosed across 20 active
clinical sites –
– On Track for Topline Results in late 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 the company’s Phase 2b study
evaluating MM-120 (lysergide D-tartrate) for GAD is over 50%
enrolled and dosed. The trial plans to enroll up to 200
participants who will receive a single administration of 25 µg, 50
µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are
expected to be announced in late 2023.
“We are thrilled by the quality and efficiency with which study
enrollment has progressed as we approach our expected topline data
release later this year. This progress is a testament to the
tireless work and dedication of all the individuals executing this
study and stands out as one of the fastest recruiting efforts for
this class of therapies in development,” said Robert Barrow, Chief
Executive Officer and Director of MindMed. “We have seen a
meaningful acceleration in enrollment over the last few months
since our full set of study sites were activated early this year
with 25 patients enrolled just in the last 30 days. I would like to
thank our team, the study investigators and their staff and the
many patients who have helped us achieve this important
milestone.”
The Phase 2b trial in patients diagnosed with GAD is a
multi-center, parallel, randomized, double-blind,
placebo-controlled, dose-optimization study. The trial plans to
enroll up to 200 participants who will be randomized to receive a
single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120
or placebo. The primary objective is to determine the reduction in
anxiety symptoms 4 weeks after a single administration of MM-120,
compared across the five treatment arms. 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 of results from the Phase 2b clinical trial 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
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.
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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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