- Positive safety and tolerability results
support the advancement of MM-110 and guide the Phase 2a dose
design in individuals undergoing supervised opioid withdrawal
-
- Phase 2a trial remains on track to initiate
in Q2 2022 -
NEW
YORK, May 19, 2022 /CNW/ -- Mind Medicine
(MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the "Company" or
"MindMed"), a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders, today announced
topline results from the Phase 1 placebo-controlled trial designed
to assess the safety, tolerability, pharmacokinetics and
neurocognitive effects of MM-110 in 108 healthy volunteers.
The results showed favorable safety and tolerability, support
the advancement of MM-110, and have guided the Phase 2a dose,
schedule, and design in individuals undergoing supervised opioid
withdrawal. MM-110 (also known as zolunicant HCl or 18-MC) is an
α3β4 nicotinic cholinergic receptor antagonist and
non-hallucinogenic proprietary congener of ibogaine.
"As there is a major unmet need to address the ongoing and
ever-growing opioid crisis, we are very pleased with the results
from our Phase 1 trial, which underscore the potential clinical
utility of MM-110 to safely mitigate symptoms of opioid
withdrawal," said Daniel R Karlin, MD MA, Chief Medical Officer of
MindMed. "These data build on extensive pharmacology and toxicology
studies, as well as encouraging results from preclinical studies
that showed reductions in translational markers of opioid
withdrawal and multi-day reductions in opioid self-administration
following a single-dose administration of MM-110. Together, the
data generated to date support our clinical development program and
bring us one step closer to potentially providing an effective
treatment solution with an optimized dosing schedule for withdrawal
management. We look forward to leveraging these findings in the
upcoming Phase 2a, gated two-part study, which will provide an
opportunity for early signs of efficacy and inform the randomized
proof-of-concept trial. The Phase 2a trial remains on track to
initiate in the second quarter of 2022."
A total of 72 participants received up to 325 mg of MM-110
(n=51) twice on a single day or placebo (n=21), and 36 participants
were administered up to 90mg of MM-110 (n=26) twice daily for seven
days or placebo (n=10). The topline results and observations
include the following:
- MM-110 was well-tolerated up to 500mg per day in the
single ascending dose (SAD) arm and 60 mg per day for seven days in
the multiple-ascending dose (MAD) arm of the trial.
- A linear pharmacokinetic profile was maintained across
the tested doses and frequencies.
- Observed clinical effects demonstrated alignment with
potent CNS engagement.
- No serious adverse events were reported. Treatment
emergent adverse events were mild or moderate in severity and
resolved without sequelae.
- Clinical laboratory parameters and electrocardiograms
were also assessed with no findings of clinical concern across the
administered dose ranges.
- Next steps: Consistent with the Phase 1 trial and
aligned with the preclinical data, an every-other-day dose regimen
is planned for the Phase 2a trial. This dose schedule offers the
potential to be a better option than existing treatments for
supervised opioid withdrawal.
About the Phase 1 Trial Design
The 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 the neurocognitive
activity of MM-110 in 108 healthy volunteers.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders, with a particular
focus on psychiatry, addiction, pain and neurology. 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 drug
candidates, with and without acute perceptual effects, targeting
the serotonin, dopamine and acetylcholine systems.
MindMed trades on the 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, including
statements regarding the perceived benefits of MM-110 and its
potential to address the needs of the opioid crisis and the
expectations on timing and outcomes for our Phase 2a trial for
MM-110. 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. 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 year ended
December 31, 2021 and its Quarterly
Report on Form 10-Q for the period ended March 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.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.