VANCOUVER, BC, April 17,
2024 /PRNewswire/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSX: NUMI) (OTCQX:
NUMIF), a mental health care company advancing traditional and
innovative behavioral health treatments with a focus on safe,
evidence-based novel therapies, is proud to announce that its
research site, Cedar Clinical Research ("CCR"), has been chosen as
one of multiple sites for Cybin's Phase 3 pivotal, multinational
clinical trial of CYB003 for the adjunctive treatment of Major
Depressive Disorder ("MDD").
In its recently completed Phase 2 trial in participants with
moderate to severe major depressive disorder, Cybin reported that
at four months after dosing, 75% of patients receiving two 16mg
doses of CYB003 achieved remission from depression symptoms. With
the Phase 2 trial data, the U.S. Food and Drug Administration
("FDA") granted CYB003 breakthrough therapy designation,
potentially shortening the drug development timeline.
The Phase 3 trial for CYB003 is planned to commence enrollment
mid-2024 and focus on its safety and efficacy. CCR's Murray, Utah, location will be one of the 15
U.S. sites. Dr. Paul Thielking,
Chief Science Officer of Numinus, will be the Principal
Investigator.
"The Phase 2 results from the CYB003 trials were impressive and
demonstrated the potential for treating a serious condition that
affects over 20 million Americans," said Dr. Thielking. "We look
forward to working with Cybin on the Phase 3 trials to add to the
knowledge of CYB003's efficacy and address an important unmet need
in patient care."
"With many drug candidates advancing to later stages of clinical
trials, 2024 is turning out to be a critical year for
psychedelic-assisted therapy," added Payton
Nyquvest, Numinus Founder and CEO. "We are proud of our role
in working with drug developers to facilitate the important
research that will help move these candidates to FDA approval and,
ultimately, patient care."
To learn more about enrolling in the CYB003 Phase 3 Trial,
please visit this link.
About Numinus
Numinus Wellness Inc. (TSX: 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 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, and Instagram.
Forward-looking
statements
Statements and other information contained in this press
release about anticipated future events constitute forward-looking
statements. Forward-looking statements are often, but not always,
identified by the use of words such as "seek", "anticipate",
"believe", "plan", "estimate", "expect" and "intend" and statements
that an event "may", "will", "should", "could" or "might" occur or
other similar expressions. Forward-looking statements are subject
to risks and uncertainties and other factors that could cause
actual results to differ materially from those contained in the
forward-looking statements, including challenges and uncertainties
inherent in product and/or treatment development and in the
psychedelics industry generally, availably of suitable subjects,
the uncertainties of clinical success, the possibility of adverse
events, and the timeline for the availability of the treatment
under investigation; the laws, challenges and risks involved in the
production of a psychedelics drug; and the uncertainty of the level
of demand, uptake and/or insurance coverage for treatment other
risks that are set forth in and other risks that are set forth in
our annual information form dated November
29, 2023 and available on SEDAR at
www.sedarplus.ca. Forward-looking statements are based on
estimates and opinions of management at the date the statements are
made. Numinus does not undertake any obligation to update
forward-looking statements even if circumstances or management's
estimates or opinions should change except as required by
applicable laws. Investors should not place undue reliance on
forward-looking statements.
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SOURCE Numinus Wellness Inc.