TORONTO, Canada -- December 8, 2021 -- InvestorsHub NewsWire
-- Cybin Inc. (NEO:CYBN) (NYSE American:CYBN)
("Cybin" or the "Company"),
a biopharmaceutical company focused on progressing "Psychedelics to
Therapeutics™" is pleased to announce that it has
confirmed a scientific advice meeting with the UK Medical and
Healthcare Products Regulatory Agency ("MHRA") for
the first quarter of calendar year 2022. This program milestone
brings the Company closer toward advancing its lead investigational
candidate CYB003 into clinical development for the treatment of
major depressive disorder ("MDD") and alcohol use
disorder ("AUD").
"Encouraged by positive preclinical findings that demonstrated
the advantages of our novel deuterated psilocybin analog over oral
psilocybin for the treatment of mental health, we are moving
rapidly to progress CYB003 toward clinical development. We are
looking forward to engaging with the MHRA to determine next steps
for our clinical development path evaluating CYB003 for the
treatment of MDD and AUD in the UK," said Doug Drysdale, Chief
Executive Officer of Cybin.
"CYB003 was designed to address the shortcomings of existing
treatments, while retaining the therapeutic benefits of oral
psilocybin. We believe that CYB003 has the potential to achieve
better patient outcomes, including less variability, faster onset
of action, shorter duration of effect, and improved brain
penetration. As a society, we need to prioritize the treatment of
mental health, and Cybin is committed to taking these next
important steps toward progressing psychedelics to therapeutics,"
concluded Drysdale.
On November 8, 2021, the Company reported preclinical data for
CYB003 demonstrating:
- a 50% reduction in variability compared to oral psilocybin;
indicates potential for more accurate dosing in patients with MDD
and AUD;
- a 50% reduction in dose compared to oral psilocybin; indicates
potential to maintain equivalent efficacy while reducing side
effects, such as nausea, in patients with MDD and AUD;
- a 50% shorter time to onset when compared to oral psilocybin;
indicates potential for shorter duration of treatment, lower
inter-subject variability, better therapeutic control and safety,
leading to a better patient experience, with lower cost and
scalability; and
- nearly double brain penetration when compared to oral
psilocybin; indicates potential for a less variable treatment
response, a lower dose therapeutic effect, and reduced patient side
effects.
The Company plans to file a clinical trial application with the
MHRA in the second quarter of calendar year 2022.
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 United States, United Kingdom 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:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com
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