MindMed Completes Enrollment of Phase 2a Trial of MM-120 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
24 Oktober 2023 - 1:30PM
Business Wire
– 53 participants enrolled across two sites
–
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 of
Study MMED007, the Company’s Phase 2a study evaluating repeated
low-dose administration of MM-120 (lysergide D-tartrate) for the
treatment of adults with ADHD.
“We are pleased to announce the completion of enrollment of our
Phase 2a study in adults with ADHD,” said Robert Barrow, Chief
Executive Officer and Director of MindMed. “This proof-of-concept
trial is designed to evaluate the clinical effects of a
sub-perceptual dose of MM-120 administered in a repeated fashion.
The study's results will inform our ongoing work to establish new
clinical paradigms for this promising drug candidate. We anticipate
sharing topline data by the end of the first quarter of 2024.”
MMED007 is a multi-center, randomized, double-blind,
placebo-controlled Phase 2a study of MM-120 (20 μg) compared with a
placebo administered orally twice weekly for 6 weeks in adults
between the ages of 18 and 65 with ADHD. The primary endpoint in
this study is mean change from Baseline in ADHD symptoms, as
assessed by the Adult ADHD Investigator Symptom Rating Scale
(AISRS) after 6 weeks of treatment. Key secondary objectives,
measured up to 10 weeks after the initial dose, include assessments
of ADHD symptom severity, as well as safety and tolerability. More
information about MMED007 is available at mindmed.co or on
clinicaltrials.gov (identifier NCT05200936).
About MM-120
Lysergide is a synthetic tryptamine belonging to the group of
classic, or serotonergic, hallucinogens, which acts as a partial
agonist at human serotonin (5-hydroxytryptamine [5-HT]) 5-HT2A
receptors. MindMed is developing MM-120 (lysergide D-tartrate), a
tartrate salt form of lysergide, for generalized anxiety disorder
(GAD) and ADHD.
About ADHD
ADHD is a chronic and debilitating neuropsychiatric disorder
characterized by symptoms of inattention, hyperactivity and
impulsivity, resulting in significant impairment in school, social,
and work functions. While ADHD is often associated with children
and adolescents, adults living with the disease face numerous
challenges from chronic difficulties with time management and
impulsivity to mood swings and disorganization which contribute to
significant impairment in multiple functional domains.
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 2a 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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