Numinus will manage two new clinics in
Montreal and Vancouver to host trials.
VANCOUVER, BC, Nov. 10, 2021 /CNW/ - Numinus Wellness
Inc. ("Numinus" or the "Company") (TSXV: NUMI), a leader
in psychedelics-focused mental healthcare, is pleased to announce
that it has secured two new Canadian psychedelic clinics that will
host the Canadian sites of the MAPS Public Benefit Corporation
(MAPS PBC) study "A multi-site open-label extension study of
MDMA-assisted psychotherapy for PTSD (MAPPUSX)."
In addition to managing the two new clinics, which are fully
compliant with Health Canada regulations and ready to provide
MDMA-assisted therapy as part of the trial, Numinus will host the
Montreal and Vancouver sites in MAPPUSX, which will
continue to study the safety and efficacy of MDMA in treating
severe PTSD, under the leadership of MAPS PBC as study organizer.
Numinus will also financially support costs relating to therapists
who deliver the therapeutic intervention in Numinus clinics during
the trial.
"We are honored to host the Canadian sites of the MAPPUSX trial
as we continue to examine the important findings around
MDMA-assisted therapy for PTSD," said Dr. Joe Flanders, VP, Psychology, Numinus and
therapist for the Montreal site of
the trial. "Our clinical and research teams are well positioned to
implement MAPS' research and, ultimately, to work with MAPS on the
translation of research findings into mainstream clinical practice.
We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX
study supports expanded collaboration in the future."
To date, 25 Numinus-affiliated therapists have gone through
MAPS' training program for delivery of MDMA-assisted therapy and a
number of these therapists will have roles in the trial. The trial
will be open to eligible participants who were previously enrolled
in the placebo arm of the parent study (MAPP1) or who were not able
to receive treatment due to COVID-19 restrictions.
"We are happy to work with a trusted ally to quickly complete
the extension trial at the Canadian sites" said Rick Doblin, Ph.D. the founder and executive
director of the Multidisciplinary Association for Psychedelic
Studies (MAPS). "As we get closer to our goal of making
MDMA-assisted therapy a reality, it is critical that we work with
clinics who will advance making this treatment widely accessible in
real-world settings."
To accomplish this next step in the MAPPUSX study, Numinus has
assumed the leases of two new clinics, the Vancouver and Montreal psychedelic-assisted psychotherapy
clinics that were previously used to conduct MAPS PBC's earlier
study "A multi-site phase 3 study of MDMA-assisted psychotherapy
for PTSD (MAPP1)." In that trial, 88% of participants
experienced a clinically meaningful reduction in symptoms and
67% no longer qualified for a PTSD diagnosis. The highly
statistically significant results and excellent safety record
suggest MDMA-assisted therapy will be an effective treatment for
severe, chronic PTSD
Payton Nyquvest, CEO, Numinus,
added, "We are thrilled that our two new locations, which are
purpose-developed for psychedelic-assisted therapy, regulatorily
compliant and leading in industry standards, can be used to help
advance this crucial work on psychedelic medicine. We look forward
to deepening our collaboration with MAPS while expanding the
resources and solutions available to those suffering from
PTSD."
Securing the Canadian sites will further allow Numinus to expand
its clinical activities in Quebec
and BC, including its ketamine-assisted psychotherapy program,
which is available in both provinces.
NOTE
The safety and efficacy of MDMA-assisted therapy is currently under
investigation. It has not yet been approved by Health Canada or the
U.S. Food and Drug Administration (FDA), does not work for
everyone, and carries risks even in therapeutic settings. These
statements are no guarantee of future Health Canada or FDA approval
or availability of MDMA-assisted therapy. These statements
necessarily involve known and unknown risks and uncertainties,
which may cause actual outcomes to differ materially from
projections.
About Numinus
Numinus Wellness (TSXV: NUMI) helps
people to heal and be well through the development and delivery of
innovative mental health care and access to safe, evidence-based
psychedelic-assisted therapies. The Numinus model - including
psychedelic production, research and clinic care - is at the
forefront of a transformation aimed at healing rather than managing
symptoms for depression, anxiety, trauma, pain and substance use.
At Numinus, we are leading the integration of psychedelic-assisted
therapies into mainstream clinical practice and building the
foundation for a healthier society.
Learn more at www.numinus.com and follow us on LinkedIn,
Facebook, Twitter, and Instagram.
About MAPS
Founded in 1986, MAPS is a 501(c)(3)
non-profit research and educational organization that develops
medical, legal, and cultural contexts for people to benefit from
the careful uses of psychedelics and marijuana. MAPS is sponsoring
the most advanced psychedelic therapy research in the world: Phase
3 clinical trials of MDMA-assisted therapy for PTSD. Since its
founding, MAPS has raised over $130
million for psychedelic and marijuana research and education
and has earned both the Guidestar Platinum Seal of Transparency and
a 4-Star Rating from Charity Navigator. Learn more at
maps.org
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS
Public Benefit Corporation (MAPS PBC) catalyzes healing and
well-being through psychedelic drug development, therapist training
programs, and sales of prescription psychedelics while prioritizing
public benefit above profit. Founded in 2014, MAPS PBC is a wholly
owned subsidiary of the Multidisciplinary Association for
Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
Learn more at www.mapspublicbenefit.org
Forward-looking statements
This press release
contains forward-looking statements within the meaning of
applicable securities laws. All statements that are not
historical facts, including without limitation, statements
regarding future estimates, plans, programs, forecasts,
projections, objectives, assumptions, expectations or beliefs
regarding future performance are "forward-looking
statements". Forward-looking statements can be identified by
the use of words such as "expects", "does not expect", "is
expected", "intends", "anticipates", "does not anticipate",
"believes" or variations of these words, expressions or statements,
that certain actions, events or results "may", "could", "would",
"might" or "will be" taken, will occur or will be
realized. Such forward-looking statements involve risks,
uncertainties and other known and unknown factors that could cause
actual results, events or developments to differ materially from
the results, events or developments expected and expressed or
implied in such forward-looking statements. These risks and
uncertainties include, but are not limited to, dependence on
obtaining and maintaining regulatory approvals, including the
acquisition and renewal of federal, provincial, municipal, local or
other licenses, and any inability to obtain all necessary
government authorizations, licenses and permits to operate and
expand the Company's facilities; regulatory or policy changes
such as changes in applicable laws and regulations, including
federal and provincial legalization, due to fluctuations in public
opinion, industry perception of integrative mental health,
including the use of psychedelic-assisted therapy, delays or
inefficiencies or any other reason; any other factor or
development likely to hamper the growth of the market; the
Company's limited operating and profitability track
record; dependence on management; the Company's need for
additional financing and the effects of financial market conditions
and other factors on the availability of
capital; competition, including that of more established
and better funded competitors; the continued impact of the
COVID-19 pandemic; and the need to build and maintain alliances and
partnerships, including with research and development companies,
customers and suppliers. These factors should be carefully
considered, and readers are cautioned not to place undue reliance
on forward-looking statements. Despite the Company's efforts
to identify the main risk factors that could cause actual measures,
events or results to differ materially from those described in
forward-looking statements, other risk factors may cause measures,
events or developments to materially differ from those anticipated,
estimated or intended. There can be no assurance that
forward-looking statements will prove to be accurate, as
actual results and future events could differ materially from those
anticipated in forward-looking statements. The Company does
not undertake to revise forward-looking statements, even if new
information becomes available as a result of future events, new
facts or any other reason, except as required by applicable
laws.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this news release.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/numinus-to-host-extension-of-maps-sponsored-mdma-assisted-therapy-for-ptsd-trials-301420678.html
SOURCE Numinus Wellness Inc.