Optimi Health Celebrates Encouraging Results from the MAPS Phase 3 MDMA-Assisted Therapy Clinical Trial
September 14 2023 - 1:59PM
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a
Canadian psychedelics drug research and formulation company, is
pleased to see the positive and encouraging outcomes from the MAPS
Phase 3 MDMA-Assisted Therapy (MDMA-AT) Clinical Trial published
today on Nature Medicine. The Company considers the results to be a
substantial step forward in the treatment of individuals grappling
with moderate to severe Post-Traumatic Stress Disorder (PTSD). The
study, conducted across multiple sites, showcases the potential of
MDMA-AT to significantly reduce PTSD symptoms and functional
impairment, indicating it as a promising therapeutic avenue.
The randomized, double-blind, confirmatory Phase
3 study focused on the assessment of the efficacy and safety of
MDMA-assisted therapy in comparison to placebo with identical
therapy. This groundbreaking trial was notably diverse, including a
significant representation from the Hispanic/Latino community
(26.9%) and individuals identifying as other than White (33.7%),
presenting a comprehensive insight into the therapy's effectiveness
across a broad spectrum of individuals.
Moreover, the participants undergoing MDMA-AT
displayed a marked improvement in functionality, as measured by the
Sheehan Disability Scale (SDS) functional impairment score, with a
mean change of -3.3 compared to -2.1 in the placebo group, also
showcasing statistical significance with P=0.03 and a moderate
effect size (d=0.4).
An encouraging aspect of the trial outcomes is
the general tolerability of the treatment. While seven participants
experienced a severe treatment emergent adverse event (TEAE), there
were no deaths or serious TEAEs reported, emphasizing the general
safety of the MDMA-AT approach.
"We are truly heartened by the indications from
the trial that MDMA-AT stands as a beacon of hope, potentially
serving as a transformative tool in alleviating the distress and
impairment witnessed in individuals battling moderate to severe
PTSD," said Optimi CEO Bill Ciprick. "It could open new doors and
foster hope where it is much needed."
Optimi gratefully acknowledges the participants,
clinicians, and all involved who have played a crucial role in
bringing this pioneering study to fruition. For further details on
the study, please refer to the ClinicalTrials.gov identifier:
NCT04077437.
www.optimihealth.ca
For further information or to request an
interview, please contact:
Michael KyddInvestor RelationsEmail: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF)
(FRA: 8BN)
Optimi Health Corp. is an end-to-end
Canadian-based drug researcher and formulator licensed by Health
Canada to produce and supply psychedelic substances such as
3,4-Methylenedioxymethamphetamine (“MDMA”) and natural, GMP-grade
psilocybin, as well as functional mushrooms that focus on the
health and wellness markets. Built with the purpose of producing
scalable psychedelic formulations for transformational human
experiences, the Company’s goal is to be the number one trusted,
compassionate supplier of safe drug products throughout the world.
Optimi’s products are grown at its two facilities comprising a
total of 20,000 square feet in Princeton, British Columbia, making
it the largest psilocybin and MDMA producer in North America.
FORWARD-LOOKING STATEMENTS
This news release contains forward‐looking
statements and forward‐looking information within the meaning of
Canadian securities legislation (collectively, “forward‐looking
statements”) that relate to Optimi’s current expectations and views
of future events. Any statements that express, or involve
discussions as to, expectations, beliefs, plans, objectives,
assumptions or future events or performance (often, but not always,
through the use of words or phrases such as “will likely result,”
“are expected to,” “expects,” “will continue,” “is anticipated,”
“anticipates,” “believes,” “estimated,” “intends,” “plans,”
“forecast,” “projection,” “strategy,” “objective,” and “outlook”)
are not historical facts and may be forward‐looking statements and
may involve estimates, assumptions and uncertainties which could
cause actual results or outcomes to differ materially from those
expressed in such forward‐looking statements. No assurance can be
given that these expectations will prove to be correct and such
forward‐looking statements included in this news release should not
be unduly relied upon. These statements speak only as of the date
of this news release.
Forward‐looking statements are based on a number
of assumptions and are subject to a number of risks and
uncertainties, many of which are beyond Optimi’s control, which
could cause actual results and events to differ materially from
those that are disclosed in or implied by such forward‐looking
statements. Such risks and uncertainties include, but are not
limited to, the impact and progression of the COVID‐19 pandemic and
other factors set forth under “Forward‐Looking Statements” and
“Risk Factors” in the Company’s Annual information Form dated
January 9, 2023, and other continuous disclosure filings available
under Optimi’s profile at www.sedarplus.ca. Optimi undertakes no
obligation to update or revise any forward‐looking statements,
whether as a result of new information, future events or otherwise,
except as may be required by law. New factors emerge from time to
time, and it is not possible for Optimi to predict all of them or
assess the impact of each such factor or the extent to which any
factor, or combination of factors, may cause results to differ
materially from those contained in any forward‐looking
statement.
Any forward‐looking statements contained in this
news release are expressly qualified in their entirety by this
cautionary statement.
Optimi Health (TG:8BN)
Historical Stock Chart
From Jan 2025 to Feb 2025
Optimi Health (TG:8BN)
Historical Stock Chart
From Feb 2024 to Feb 2025