The research conducted at Cedar Clinical
Research in Draper is part of the
first ever phase 3 program of psilocybin therapy, and the largest
of its kind
VANCOUVER,
BC, May 30, 2023 /PRNewswire/ - Numinus
Wellness Inc. (TSX: NUMI) is pleased to announce that Cedar
Clinical Research (CCR) has begun studying COMP360 psilocybin
therapy, an investigational new therapy for treatment-resistant
depression (TRD), as part of the largest-ever international
clinical study of psilocybin therapy. Dr. Paul Thielking, Chief Science Officer at
Numinus, and the team have begun accepting people with TRD who
fulfill certain eligibility criteria to join the study.
The study in Draper,
Utah, is a part of COMPASS Pathway's phase 3 program in TRD.
The international program is composed of two pivotal trials, each
with a long-term follow-up component. It will enroll over 800
participants, with topline data expected in summer 2024 and
mid-2025.
The launch of the phase 3 program follows
positive results from COMPASS Pathways' phase 2b trial, published in the New England Journal
of Medicine, the world's leading peer-reviewed medical journal.
The objective of the randomized, controlled, double-blind phase
2b study was to understand the
efficacy and safety of a single dose of investigational COMP360
psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD.
After a single 25mg dose of COMP360 psilocybin, in combination with
psychological support, 29.1% of participants with TRD were in
remission by week 3.
"COMPASS is helping to lead the way in psilocybin
research and development for treatment-resistant depression," said
Dr. Paul Thielking, Chief Science
Officer at Numinus. "We are very proud of the work we are doing
alongside COMPASS to elevate the industry and contribute to the
growing body of research."
Dr Guy Goodwin,
Chief Medical Officer, COMPASS Pathways, said: "Tens of millions of
people around the world suffer with depression that doesn't respond
to traditional treatments. The results from our phase 2b study of investigational COMP360 psilocybin
therapy were very encouraging, and we hope that the data from our
pivotal phase 3 program will form the basis for our submission to
regulatory bodies. We're grateful to all the people involved in our
phase 3 program around the world. It is a significant milestone in
our journey to make COMP360 psilocybin therapy available to
patients, and towards building a better future for mental health
care."
People who are interested in taking part in
the study should go to
https://compasspathfinderstudies.com/ or
https://numinus.com/clinical-trials/psychedelics/#!/study/28 to
understand if they might be eligible to join.
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 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.
Cedar Clinical Research (CCR) is a wholly-owned
subsidiary of Numinus Wellness Inc.
Learn more at numinus.com and follow us
on LinkedIn, Facebook, Twitter,
and Instagram.
About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental
health care company dedicated to accelerating patient access to
evidence-based innovation in mental health. Our focus is on
improving the lives of those who are suffering with mental health
challenges and who are not helped by current treatments. We are
pioneering the development of a new model of psilocybin therapy, in
which our proprietary formulation of synthetic psilocybin, COMP360,
is administered in conjunction with psychological support. COMP360
has been designated a Breakthrough Therapy by the US Food and Drug
Administration (FDA) and has received Innovative Licensing and
Access Pathway (ILAP) designation in the UK for treatment-resistant
depression (TRD). We have commenced a phase 3 clinical program of
COMP 360 psilocybin therapy in TRD, the largest randomized,
controlled, double-blind psilocybin therapy clinical program ever
conducted. Previously, we completed a phase 2b study with top line data showing a
statistically significant (p<0.001) and clinically relevant
improvement in depressive symptom severity after three weeks for
patients who received a single high dose of COMP360 psilocybin with
psychological support. We are also running phase 2 clinical trials
of COMP360 psilocybin therapy for post-traumatic stress disorder
(PTSD) and anorexia nervosa. COMPASS is headquartered in
London, UK, with offices in
New York and San Francisco in the US. Our vision is a world
of mental wellbeing. www.compasspathways.com
Forward-looking
statements
Statements and other information contained in
this press release about anticipated future events constitute
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. 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, possibility of
adverse events, and the timeline for the availability of the
treatment under investigation; the laws, challenges and risks
involved in 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 (a) Numinus public
disclosures available on SEDAR at www.sedar.com, and (b) COMPASS
public disclosures available on EDGAR at www.sec.gov/edgar.
Forward-looking statements are based on estimates and opinions of
the company's respective management at the date the statements are
made. Neither Compass nor Numinus undertake any obligation to
update forward-looking statements even if circumstances or
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.