- Company expects to initiate Phase 3 pivotal
trial in late summer 2024 -
- Phase 3 pivotal study to include 30 clinical
sites across the United States and Europe with deep expertise in
depression studies -
- Pivotal trial designs incorporate elements to
address functional unblinding -
- Company to report 12-month Phase 2 efficacy
data for CYB003 in Major Depressive Disorder (“MDD”) in Q4 2024
-
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin”
or the “Company”), a clinical-stage breakthrough
neuropsychiatry company committed to revolutionizing mental
healthcare by developing new and innovative next-generation
treatment options, today announced that it held a Type B Initial
Breakthrough Therapy Meeting with the U.S. Food and Drug
Administration (“FDA”) late last week in Washington, D.C. The
Company plans to initiate its Phase 3 pivotal trial of CYB003 for
the adjunctive treatment of MDD in late summer of 2024.
“Following our productive Type B meeting, we continue to expect
to commence our Phase 3 pivotal program in late summer,” said Doug
Drysdale, Chief Executive Officer of Cybin. “Having selected 30
clinical sites across the United States and Europe, we are eager to
initiate this next phase of clinical development and to build on
the positive impact of CYB003 to date. In our Phase 2 study, CYB003
showed a robust and sustained effect, with 75% of patients in
remission from depression four months after two 16mg doses. We
expect to report 12-month efficacy data from the Phase 2 study in
the fourth quarter of this year. We look forward to ongoing
engagement with the FDA as we advance our path to bringing new,
improved treatment options to patients and providers.”
Further to recent industry discussions around the subject of
functional unblinding, the Company plans to implement multiple
measures to attempt to mitigate the risk of functional unblinding
in its pivotal study program, as follows:
- The pivotal study program will include one study with a
three-arm design with a high dose, mid-dose, and placebo arm.
Patients will not know if they received the therapeutic high dose
or the sub therapeutic mid-dose, mitigating the unblinding to an
extent and addressing potential expectancy bias;
- The study will utilize remote, independent, blinded raters who
will not have any information on the dose received or the
participant’s dosing experience;
- The reporting of effects during the dosing session will be
firewalled to ensure that the study team stays blinded;
- The studies will recruit participants who are largely
psychedelic naïve to reduce the impact of expectancy bias;
- The studies will assess long-term efficacy data points up to
one year, to outlast any potential expectancy effects.
In addition, the study will include manual and real time
artificial intelligence screening of monitoring sessions to ensure
monitor fidelity and patient safety.
The Company also today announced the realignment of the
composition of its Governance and Nominating Committee, and
Compensation Committee which will now be comprised solely of
existing independent Directors Eric Hoskins (Chair), Mark Lawson,
and Theresa Firestone; and Grant Froese (Chair), Mark Lawson and
Theresa Firestone, respectively.
About Cybin
Cybin is a clinical-stage breakthrough neuropsychiatry company
on a mission to create safe and effective next-generation
therapeutics to address the large unmet need for new and innovative
treatment options for people who suffer from mental health
conditions.
Cybin’s goal of revolutionizing mental healthcare is supported
by a network of world-class partners and internationally recognized
scientists aimed at progressing proprietary drug discovery
platforms, innovative drug delivery systems, novel formulation
approaches and treatment regimens. Cybin is currently developing
CYB003, a proprietary deuterated psilocybin analog program for the
treatment of major depressive disorder and CYB004, a proprietary
dDMT molecule for generalized anxiety disorder and has a research
pipeline of investigational psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is
operational in Canada, the United States, the United Kingdom, the
Netherlands and Ireland. For Company updates and to learn more
about Cybin, visit www.cybin.com or follow the Company on X,
LinkedIn, YouTube and Instagram.
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company
are forward-looking statements and are prospective in nature.
Forward-looking statements are not based on historical facts, but
rather on current expectations and projections about future events
and are therefore subject to risks and uncertainties which could
cause actual results to differ materially from the future results
expressed or implied by the forward-looking statements. These
statements generally can be identified by the use of
forward-looking words such as “may”, “should”, “could”, “intend”,
“estimate”, “plan”, “anticipate”, “expect”, “believe” or
“continue”, or the negative thereof or similar variations.
Forward-looking statements in this news release include statements
regarding the Company’s plans to progress to a Phase 3 trial of
CYB003 in late summer 2024; the release of 12-month durability data
from Phase 2 study of CYB003 in Q4 2024; commencing enrollment at
30 clinical sites across the U.S. and Europe; and the Company’s
plans to engineer proprietary drug discovery platforms, innovative
drug delivery systems, novel formulation approaches and treatment
regimens for mental health conditions.
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: 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; implications of disease outbreaks on the
Company's operations; and the risk factors set out in each of the
Company's management's discussion and analysis for the three months
ended June 30, 2024 and the Company’s annual information form for
the year ended March 31, 2024, which are available under the
Company's profile on www.sedarplus.ca 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. 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 Cboe Canada, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240813535574/en/
Investor & Media Contact: Gabriel Fahel Chief Legal
Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or –
media@cybin.com