- Last subject completed study in late 2021 with topline
results expected in early 2022 -
- Results to inform design of Phase 2a study in individuals
undergoing supervised opioid withdrawal -
NEW YORK, Jan. 4, 2022 /PRNewswire/ -- Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ)
(the "Company"), a leading biotech company developing
psychedelic-derived therapies, today announced the completion of
its Phase 1 clinical trial of 18-MC, the Company's
non-hallucinogenic proprietary derivative of ibogaine, being
developed for the treatment of indications linked to opioid use
disorder. The trial was completed in December 2021 with topline results expected in
early 2022.
"This is an exciting milestone, and we look forward to
announcing the results of our Phase 1 study in the coming months,"
said Robert Barrow, Chief Executive
Officer and Director of MindMed. "The growing opioid crisis claims
over 75,000 lives each year and impacts more than we'll ever know.
While ibogaine has been used and studied as a treatment for opioid
addiction, its efficacy, while promising, has been overshadowed by
significant safety concerns. Our proprietary molecule, 18-MC, has
indicated an encouraging safety profile and preclinical efficacy
data setting the stage for our Phase 2a proof-of-concept study in
individuals undergoing opioid withdrawal. We expect to initiate
this study in early 2022, which will evaluate the safety,
tolerability and efficacy of 18-MC in mitigating the symptoms of
opioid withdrawal."
Phase 1 Trial Design
This Phase 1 single and multiple ascending dose trial conducted
at a single clinical research site in Perth, Australia, evaluated the safety,
tolerability, pharmacokinetics, and effects on cognitive activity
of 18-MC in healthy volunteers. Subjects either received
doses between 4 and 325 milligrams twice per day (for one day; n=5
per arm) or doses between 2 and 90 milligrams twice per day (for up
to 7 days, n=5 per arm).
About 18-MC
18-MC is an alpha-3-beta-4 nicotinic receptor antagonist with a
differentiated mechanism of action that modulates excessive
dopamine fluctuations in the mesolimbic system of the brain. 18-MC
is a synthetic organic molecule designed around a coronaridine
chemical backbone common to a number of plant-based medicinal
compounds, including ibogaine. In preclinical efficacy models,
18-MC has demonstrated strong activity in reducing both withdrawal
symptoms and self-administration of opioids, stimulants and other
substances of abuse. Extensive preclinical characterization has
shown 18-MC to have a strong safety and tolerability profile.
Importantly, 18-MC has the potential to overcome safety limitations
of ibogaine and has not demonstrated proarrhythmic or neurotoxic
activity.
About MindMed
MindMed is a clinical-stage biotech company that seeks to
discover, develop and deploy psychedelic-inspired medicines and
therapies to address mental health and addiction. 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. Although the Company believes that the expectations
reflected in our 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 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mindmed-successfully-completes-phase-1-clinical-trial-of-18-mc-301453240.html
SOURCE Mind Medicine (MindMed) Inc.