Trial enters pre-implementation stage having
met several key milestones towards expanding access to patients
with PTSD
VANCOUVER,
BC, Feb. 18, 2021 /CNW/ -
Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a
company creating an ecosystem of health solutions centered around
developing and supporting the safe, evidence-based, accessible use
of psychedelic-assisted psychotherapies, is pleased to share
that the single-arm, open-label, compassionate
access1 trial for MDMA-assisted therapy has made
significant progress towards treating patients with posttraumatic
stress disorder (PTSD). This trial is being pursued in
collaboration with MAPS Public Benefit Corporation (MAPS PBC), a
wholly-owned subsidiary of the Multidisciplinary Association for
Psychedelic Studies (MAPS), the leading developer of the treatment
protocols, research, and MDMA-assisted therapy training
programs.
"We are excited to share an update on the progress of our MDMA
compassionate access trial with the full recognition that existing
therapies for PTSD are inadequate," said Payton Nyquvest, CEO of Numinus. "At Numinus, we
are pleased to help foster a promising regulatory landscape that
will contribute to a better understanding that psychedelic-assisted
psychotherapies are a viable, safe, and necessary avenue for
expanding existing treatment options. We look forward to continued
collaboration with the Multidisciplinary Association of
Psychedelics for Studies (MAPS PBC) and will work together to
provide those experiencing PTSD with more treatment
options."
This first-of-its-kind trial in Canada has advanced and
successfully transitioned into the pre-implementation stage at
Numinus' Vancouver clinic. This
follows the successful completion of several milestones, starting
with the recruitment of therapists, physicians, and staff in
preparation for participant enrolment and the ultimate analysis of
therapy outcomes. The highly qualified cohort of medical staff will
be responsible for collecting safety data for Health Canada to
further implement key research that supports individuals living
with PTSD who have not benefited from existing treatment
options.
In November 2020, eight Numinus
therapists graduated from Part B of the MAPS MDMA therapist
training program. Through their roles within the trial, they will
complete the supervision requirement for certification as fully
qualified MDMA therapists.
A draft MDMA-assisted therapy protocol for PTSD has been adapted
for the trial, including clear guidance surrounding necessary
screening processes, patient health histories, and indications and
potential contraindications before accepting participants. Initial
regulatory meetings with Health Canada to define the trial's
implementation science strategy have been completed, and the next
steps will include obtaining ethical and Health Canada approvals to
allow the recruitment of participants according to COVID-19 public
health protocols.
"Developing a skilled workforce is a key challenge for the safe
delivery of psychedelic-assisted therapies, so we are pleased to
engage with Numinus to train therapists in the MDMA-assisted
therapy protocol for PTSD," said Amy
Emerson, CEO of MAPS PBC.
Numinus is also pleased to announce that its Medical and
Therapeutic Services Director, Dr. Devon
Christie, will serve as both the trial's Principal
Investigator and as a therapist. Dr. Christie is a family physician
with a focus in multidisciplinary pain management, is a certified
Relational Somatic Therapist, and is already MAPS-trained in the
delivery of the MAPS MDMA-assisted therapy for PTSD.
"I am thrilled to be involved in a long-awaited clinical program
that will help pave the way towards wider use of MDMA-assisted
psychotherapy for those experiencing PTSD," said Dr. Christie. "The
key milestones announced today are a true testament to our teams'
commitment to establishing the physical, technical, clinical, and
human resource infrastructure needed to swiftly move through the
trial's formal implementation stages and ultimately towards the
recruitment of the first participant."
NOTE
The safety and efficacy of MDMA-assisted psychotherapy is
currently under investigation. It has not yet been approved by
Health Canada or the 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 psychotherapy. These statements necessarily
involve known and unknown risks and uncertainties, which may cause
actual outcomes to differ materially from projections.
1Health Canada
recommends compassionate access open-label clinical trials when
drug manufacturers anticipate exceptional demand for a drug, "to
meet the needs of patients not eligible for enrollment in other
pivotal trials" (Special Access Program for Drugs: Guidance
document for industry and practitioners, Published 2020-10-14).
This program is not related to the U.S. FDA Expanded Access
program, sometimes referred to as "compassionate use" or the
Breakthrough Therapy designation.
About Numinus
Numinus Wellness Inc. (TSXV:NUMI) is a
health care and research company creating psychedelic-centred
solutions to treat mental illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics
and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic
protocols to use in treatments, in collaboration with research
partners and regulators.
Numinus Bioscience develops formulations and methods for
a safe supply, using Health Canada licences, scientific expertise
and cutting-edge technology.
Learn more at numinus.ca, and follow us on 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. Since its founding,
MAPS has raised over $100 million for
psychedelic therapy and medical marijuana research and
education.
www.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
www.mapspublicbenefit.org
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SOURCE Numinus Wellness Inc.