- Trial to be conducted at
University of Washington, led by Dr. Anthony Back -
TORONTO, Canada -- November 30, 2021 -- InvestorsHub
NewsWire -- Cybin
Inc. (NEO:CYBN) (NYSE American:CYBN) ("Cybin"
or the "Company"), a biopharmaceutical company
focused on progressing "Psychedelics to Therapeutics™", today
announced that the U.S. Food and Drug Administration ("FDA") has
authorized an investigator-initiated randomized, placebo-controlled
Phase 2 clinical trial evaluating psychedelic-assisted
psychotherapy with psilocybin for frontline clinicians experiencing
COVID-related distress. The trial will be conducted at the
University of Washington and will aim to treat symptoms of
depression, anxiety, burnout and post-traumatic stress among
frontline doctors, nurses and healthcare professionals. The trial's
Primary Investigator, Dr. Anthony Back, received an investigational
new drug ("IND") approval letter from the FDA, which provides
authority to proceed with the Phase 2 trial.
Further to the authorization from the FDA, the study has also
received Institutional Review Board ("IRB") approval at the
University of Washington. This investigator-initiated trial will be
hosted in Seattle, a city significantly impacted by the COVID-19
pandemic and will be funded by multiple organizations.
"This study offers an important opportunity to assess
psychedelics-assisted therapy as a new modality for clinicians who
have suffered as a result of their frontline work in the pandemic,"
said Dr. Anthony Back.
To support the initiative, Cybin's Chief Clinical Officer, Alex
Belser, PhD and Bill Brennan, PhD (candidate) developed EMBARK, a
six-domain model of psychedelic-assisted psychotherapy. EMBARK was
designed as a transdiagnostic psychotherapy model that can be
adapted to address a range of clinical indications and populations.
In collaboration with Dr. Anthony Back and Ladybird Morgan, RN,
MSW, an adapted version of EMBARK has been co-authored to treat
COVID-related burnout and symptoms of depression among frontline
healthcare workers, and this version includes material that
specifically addresses cultural inclusion anticipating a diverse
population of clinicians. Cybin
launched the EMBARK Psychedelic Facilitator Training
Program for study facilitators in October 2021.
"Throughout the COVID-19 pandemic, nurses, doctors, and
healthcare professionals on the frontlines have worked hard to
provide care under extremely difficult circumstances.
Understandably, under this stress, many frontline healthcare
workers have experienced symptoms of depression and burnout. We
believe psychedelic medicine, when given with a supportive
psychotherapy program like the EMBARK approach, may provide a
promising treatment approach to bolster mental health," said Dr.
Alex Belser, Cybin's Chief Clinical Officer.
"This clinical trial provides an opportunity to better
understand the effectiveness of combining psilocybin and EMBARK.
Learnings from this combination Phase 2 trial will inform the use
of EMBARK in Cybin's upcoming human studies using CYB003, a
proprietary deuterated psilocybin analog that has the potential to
reduce clinic times and dosing levels in half as well as
potentially reduce side effects and adverse events," said Doug
Drysdale, Chief Executive Officer of Cybin.
About the Phase 2 trial
The Phase 2 clinical trial will enroll 30 frontline clinicians
(physicians, nurse practitioners, physician assistants, nurses).
Inclusion criteria include clinically significant symptoms of
depression and anxiety (primary outcome) and existential distress
(secondary outcome) following work exposure during the COVID
pandemic. The trial will employ a randomized parallel design
methodology using an active placebo. The primary outcome will be a
comparison between the two groups in depression and anxiety as
measured by the Montgomery Asberg Depression Rating Scale (MADRS)
total at 4 weeks post dose session. The secondary outcome will be a
comparison between the two groups in symptoms of existential
distress measured by the Demoralization DS-ii at 4 weeks post dose
session. A mediation analysis of self-reported mystical states
(Mystical Experience Questionnaire-30 item (MEQ-30)) and
psychological flexibility (Acceptance and Action Questionnaire II
(AAQII)) on changes in the primary outcome (HADS) will be
analyzed.
Additional assessments include measures of clinician burnout
(Stanford Fulfillment Index), post-traumatic stress (PTSD Checklist
for DSM-5 (PCL-5)) and a semi-structured interview to identify
factors that positively and negatively influence the integration
phase of psychedelic-assisted psychotherapy. The assessment will
also characterize the process of psychological change and effects
on work and home life.
Dr. Anthony Back is a recognized leader in the fields of
palliative care and oncology. He is a board-certified physician at
the University of Washington, Founding Co-director of the
University of Washington Center for Excellence in Palliative Care,
and a University of Washington professor of Oncology and Medicine.
He is triple board certified in Hospice and Palliative Medicine,
Medical Oncology and General Internal Medicine. He was the
principal investigator for the National Cancer Institute-funded
Oncotalk interventions, which enabled the founding of the nonprofit
VitalTalk, co-wrote Mastering Communication with Seriously
Ill Patients, produced the first iPhone app for clinician
communication skills, and is a Contemplative Studies Fellow of the
Mind and Life Institute. His clinical and research interests
include patient-physician communication and quality of life in
palliative care. Dr. Back earned his medical degree at Harvard
Medical School.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working
with a network of world-class partners and internationally
recognized scientists, on a mission to create safe and effective
therapeutics for patients to address a multitude of mental health
issues. Headquartered in Canada and founded in 2019, Cybin is
operational in the USA, UK and Ireland. The Company is focused on
progressing Psychedelics to Therapeutics™ by
engineering proprietary drug discovery platforms, innovative drug
delivery systems, novel formulation approaches and treatment
regimens for mental health disorders.
Cautionary Notes and Forward-Looking
Statements
Certain statements in this press release constitute
forward-looking information. All statements other than statements
of historical fact contained in this press release, including,
without limitation, statements regarding Cybin's future, strategy,
plans, objectives, goals and targets, and any statements preceded
by, followed by or that include the words "believe", "expect",
"aim", "intend", "plan", "continue", "will", "may", "would",
"anticipate", "estimate", "forecast", "predict", "project", "seek",
"should" or similar expressions or the negative thereof, are
forward-looking statements. Forward-looking statements in this news
release include statements regarding the Company's proprietary drug
discovery platforms, innovative drug delivery systems, novel
formulation approaches and treatment regimens to potentially treat
psychiatric disorders.
These forward-looking statements are based on reasonable
assumptions and estimates of management of the Company at the time
such statements were made. Actual future results may differ
materially as forward-looking statements involve known and unknown
risks, uncertainties, and other factors which may cause the actual
results, performance, or achievements of the Company to materially
differ from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Such
factors, among other things, include: implications of the COVID-19
pandemic on the Company's operations; fluctuations in general
macroeconomic conditions; fluctuations in securities markets;
expectations regarding the size of the psychedelics market; the
ability of the Company to successfully achieve its business
objectives; plans for growth; political, social and environmental
uncertainties; employee relations; the presence of laws and
regulations that may impose restrictions in the markets where the
Company operates; and the risk factors set out in the Company's
management's discussion and analysis for the period ended September
30, 2021 and the Company's listing statement dated November 9,
2020, which are available under the Company's profile
on www.sedar.com and with the U.S. Securities
and Exchange Commission on EDGAR at www.sec.gov.
Although the forward-looking statements contained in this news
release are based upon what management of the Company believes, or
believed at the time, to be reasonable assumptions, the Company
cannot assure shareholders that actual results will be consistent
with such forward-looking statements, as there may be other factors
that cause results not to be as anticipated, estimated or intended.
Readers should not place undue reliance on the forward-looking
statements and information contained in this news release. The
Company assumes no obligation to update the forward-looking
statements of beliefs, opinions, projections, or other factors,
should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about
Cybin's proposed products. The U.S. Food and Drug Administration,
Health Canada or other similar regulatory authorities have not
evaluated claims regarding psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds. The efficacy
of such products has not been confirmed by approved research. There
is no assurance that the use of psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds can diagnose,
treat, cure or prevent any disease or condition. Rigorous
scientific research and clinical trials are needed. Cybin has not
conducted clinical trials for the use of its proposed products. Any
references to quality, consistency, efficacy and safety of
potential products do not imply that Cybin verified such in
clinical trials or that Cybin will complete such trials. If Cybin
cannot obtain the approvals or research necessary to commercialize
its business, it may have a material adverse effect on Cybin's
performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC
stock exchange have approved or disapproved the contents of this
news release and are not responsible for the adequacy and accuracy
of the contents herein.
Contacts
Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com
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