- Enrolling patients in proof-of-concept
exploratory trial conducted in collaboration with the University
Hospital Basel in Switzerland and
Maastricht University in the Netherlands –
-Trial led by Dr. Matthias Liechti and Dr. Kim Kuypers, pioneers and leading global experts
in the psychedelic landscape –
NEW YORK, Dec. 17, 2021 /CNW/ -- Mind Medicine (MindMed)
Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a
leading biotech company developing psychedelic-inspired therapies,
today announced the initiation of Phase 2a proof-of-concept (POC)
trial of lysergic acid diethylamide (LSD) in adult patients with
attention deficit hyperactivity disorder (ADHD). The first site has
been activated and patient enrollment is expected to start
imminently. The POC trial will be conducted in collaboration with
the University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate
the therapeutic utility of repeated low doses of LSD.
"We are pleased to activate our first site and excited to
initiate patient enrollment of our ADHD proof-of-concept trial,"
said Robert Barrow, Chief Executive
Officer and Director of MindMed. "The study builds on the growing
evidence demonstrating LSD has the potential to improve mood and
selective cognitive processes. Further, low doses of LSD have been
shown to be safe, well tolerated and have minimal effects on
physiological parameters. In collaboration with our renowned
clinical researchers and team of leading investigators, we look
forward to driving this exploratory trial forward as part of our
broader comprehensive LSD clinical development strategy."
Dr. Matthias Liechti, University
Hospital Basel and co-primary investigator of the trial commented,
"Psychedelics including LSD have shown beneficial and lasting
effects on mood when given at single doses producing psychedelic
effects. There is anecdotal evidence for possible benefits of low
to very low doses of psychedelics given repeatedly. This is the
first controlled study to validly evaluate therapeutic effects of
very low doses of a psychedelic in patients."
"We are very much looking forward to initiating our ADHD trial
with repeated low doses of LSD, which will be conducted at two top
European clinical therapeutic sites," said Dr. Miri Halperin Wernli, Executive President of MindMed.
"We have designed a robust, randomized clinical trial to replicate
and extend the promising findings of previously conducted smaller,
open-label trials. This trial will evaluate our therapeutic regimen
in a rigorously controlled setting and will help optimize the
dosing schedule, compound selection and clinical management.
Further, this trial will provide additional insight into the
mechanisms by which psychedelics exert their therapeutic
effects."
Phase 2a Trial Design
This is a multicenter, randomized, double-blind,
placebo-controlled Phase 2a trial evaluating the safety and
efficacy of low-dose LSD as treatment for ADHD in adults. The trial
plans to enroll a total of 52 patients that will receive 20µg of
LSD every (dose schedule) or placebo for 6 weeks (twice a week on a
3/4-day schedule [± 1 day]). The primary endpoints are mean change
from baseline in ADHD symptoms, as assessed by the AISRS after 6
weeks of treatment. The AISRS total score consists of 18 items from
the original Attention- Deficit/Hyperactivity Disorder - Rating
Scale (ADHD-RS), which were derived based on DSM-5 criteria for
ADHD. The ADHD-RS includes 9 items that address symptoms of
inattention, and 9 items that address symptoms of impulsivity and
hyperactivity. Each item is rated from 0 to 3. The AISRS total
score can range from 0 to 54. A higher score corresponds to a worse
severity of ADHD.
The trial will be led by Dr. Matthias
Liechti, at University Hospital Basel, Switzerland and Dr. Kim Kuypers at Maastricht
University, the
Netherlands.
About Adult ADHD
While ADHD is often associated with children and adolescents,
adults living with the disease face numerous challenges from
debilitating struggles with time management and impulsivity to mood
swings and disorganization. Of the estimated 10 million American
adults that have ADHD, it is projected that only 10.9% seek and
receive treatment for their condition. Between 2007 and 2016 alone,
the rate amongst adults increased by 123%. Adult ADHD comprises
over 46.5% of the total ADHD medication market in the United States. The total U.S. market size
for ADHD medications is currently valued at $12.9 billion annually.
About MindMed
MindMed is a clinical-stage psychedelic medicine biotech company
that seeks to discover, develop and deploy psychedelic-inspired
medicines and therapies to address addiction and mental illness.
The Company is assembling a compelling drug development pipeline of
innovative treatments based on psychedelic substances including
psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The
MindMed executive team brings extensive biopharmaceutical
experience to MindMed's approach to developing the next generation
of psychedelic-inspired medicines and therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the
symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
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
include, but are not limited to, statements regarding the start of
MindMed's Phase 1 clinical trial of dimethyltryptamine (DMT), the
business and the therapeutic potential of MindMed's product
candidates, the ability to successfully execute and delivery on the
R(-)-MDMA Program, the ability to achieve success with our
collaborations with Sphere Health and Forian, the successful
outcome of the Phase 1 clinical trial of DMT, the ability to
initiate a Phase 2 clinical trial of DMT, regulatory approvals, the
effects of DMT, subject enrollment and the administration method of
DMT. Although the Company believes that the expectations reflected
in such forward-looking information are reasonable, such
information involves risks and uncertainties, and undue reliance
should not be placed on such information, as unknown or
unpredictable factors could have material adverse effects on future
results, performance or achievements of the Company. 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 under the headings "Risk
Factors" in the Company's filings 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. Should one or more
of these risks or uncertainties materialize, or should assumptions
underlying the forward-looking information prove incorrect, actual
results and future events could differ materially from those
anticipated in such information. Although the Company has attempted
to identify important risks, uncertainties and factors that could
cause actual results to differ materially, there may be others that
cause results not to be as anticipated, estimated or intended.
These and all subsequent written and oral forward-looking
information are based on estimates and opinions of management on
the dates they are made and are expressly qualified in their
entirety by this notice. Except as required by law, the Company
does not intend and does not assume any obligation to update this
forward-looking information.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.