TORONTO, Canada -- June 16, 2021 -- InvestorsHub NewsWire
-- Cybin Inc. (NEO:CYBN)
(OTCQB:CLXPF)
("Cybin" or the "Company"), a
biotechnology company focused on progressing psychedelic
therapeutics, today announced that it has selected social anxiety
disorder ("SAD") and generalized anxiety disorder ("GAD") as the
initial target indications for its proprietary psychedelic molecule
CYB004.
"People struggle with many different mental health challenges,
but anxiety affects more people than any other," said Dr. Alex
Belser, Chief Clinical Officer. "With the advent of the COVID-19
pandemic, rates of anxiety have increased 3-fold, leaving many
folks in a debilitating state. We think that treatment with
psychedelic medicine may help. Our team's previous research on
anxiety at New York University and the trials conducted at UCLA and
Johns Hopkins showed large magnitude decreases in anxiety after
treatment with psychedelic-assisted psychotherapy. This is a
promising approach to treat anxiety with a clear pathway."
SAD, sometimes called social phobia, describes the persistent
and irrational fear of embarrassment and humiliation in social
situations. SAD typically begins in childhood or adolescence and,
untreated, can be associated with the subsequent development of
major depression, substance abuse, and other mental health
problems. The disorder can be associated with extensive functional
impairment and reduced quality of life.
SAD is a prevalent condition, estimated to affect between 3% and
7% of the United States adult population.
SAD Market Size: Based on estimates
derived from currently available FDA approved treatments, the
current US market is estimated at US$165M with global estimates at
US$1.15B as of 2021. The market is currently made up of multiple
approved drugs still under patent protection, generics and off
label use drugs.
GAD is marked by excessive anxiety and worry (apprehensive
expectation) about a range of everyday topics/events and is one of
the most common mental disorders in both community and clinical
settings and is associated with increased use of health care
services.
GAD is a prevalent condition, estimated to affect between 3% and
6% of the United States adult population.
GAD Market Size: Current global estimates
are approximately US$2.99B and projected to grow to US$4.5B by
2027. The market is currently made up of multiple approved drugs
still under patent protection, generics and off label use drugs,
including benzodiazepines which carry a risk of addiction, misuse
and dependence.
According to The World Health Organization (WHO), 1 in 13 adults
globally suffers from anxiety. Current FDA-approved medications for
anxiety disorders include SSRIs and SNRIs, which have slow onset of
action and side-effects including weight gain, nausea, vomiting and
sexual dysfunction. Many patients also do not respond to SSRI or
SNRI treatments for the anxiety disorders.
Various studies reviewing the improvements in anxiety with
psychedelic treatments showed a significant response to therapy and
were relatively well-tolerated. In these studies, patients
benefited from a faster onset of action with less addictive
effects.
"The decision to pursue anxiety disorders indications for CYB004
follows months of thoughtful, in-depth work by the Cybin
development team. Careful consideration of many factors drives
these decisions, including the prevalence of anxiety disorders, the
measurable clinical endpoints, a realistic pre-clinical and
clinical plan, along with an understanding of the effects of the
molecule itself. For the Cybin team, this decision represents a
further opportunity to help millions of sufferers of these
all-too-prevalent disorders," stated Doug Drysdale, Chief Executive
Officer.
References
Anxiety & Depression Association of America.
Belser, A. B., Agin-Liebes, G., Swift, T. C., Terrana, S.,
Devenot, N., Friedman, H. L., ... & Ross, S. (2017). Patient
experiences of psilocybin-assisted psychotherapy: an interpretative
phenomenological analysis. Journal of Humanistic
Psychology, 57(4), 354-388.
Danforth, A. L., Struble, C. M., Yazar-Klosinski, B., &
Grob, C. S. (2016). MDMA-assisted therapy: a new treatment model
for social anxiety in autistic adults. Progress in
Neuro-Psychopharmacology and Biological
Psychiatry, 64, 237-249.
Dos Santos, R. (2018). Efficacy, tolerability, and safety of
serotonergic psychedelics for the management of mood, anxiety, and
substance-use disorders: a systematic review of systematic
reviews. Expert review of Clinical Pharmacology, Vol.
11, No. 9, 889–902.
GlobalData Pharma Intelligence Center. (2021). Epidemiology
Market Size Data. [Data File]. Retrieved from
pharma.globaldata.com
GlobalData Pharma Intelligence Center. (2021). Annual Sales and
Forecast. [Data File]. Retrieved from pharma.globaldata.com
Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A.,
Richards, W. A., Richards, B. D., ... & Klinedinst, M. A.
(2016). Psilocybin produces substantial and sustained decreases in
depression and anxiety in patients with life-threatening cancer: A
randomized double-blind trial. Journal of
psychopharmacology, 30(12), 1181-1197.
Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay,
C. R., Halberstadt, A. L., & Greer, G. R. (2011). Pilot study
of psilocybin treatment for anxiety in patients with advanced-stage
cancer. Archives of general
psychiatry, 68(1), 71-78.
Harvard Medical School, 2007. National Comorbidity Survey (NCS).
(2017, August 21) .
Kessler, R. C. (2005). Lifetime Prevalence and Age-of-Onset
Distributions of DSM-IV Disorders in the National Comorbidity
Survey Replication. Arch Gen Psychiatry, 62(6)
593-602.
Kessler, R. C., Berglund, P., Demler, O., Jin, R., Merikangas,
K. R., & Walters, E. E. (2005). Lifetime prevalence and
age-of-onset distributions of DSM-IV disorders in the National
Comorbidity Survey Replication. Archives of general
psychiatry, 62(6), 593-602.
Muttonia, S. (2019). Classical psychedelics for the treatment of
depression and anxiety: A systematic review. Journal of
Affective Disorders, 258:11–24.
Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T.,
Cohen, B., Mennenga, S. Belser, A., Kalliontzi, K., Babb, J., Su,
Z., Corby, P. & Schmidt, B. L. (2016). Rapid and sustained
symptom reduction following psilocybin treatment for anxiety and
depression in patients with life-threatening cancer: a randomized
controlled trial. Journal of
psychopharmacology, 30(12), 1165-1180.
Ruscio, A. M. (2008). Psychological Medicine,
38(1):15-28.
Santabárbara, J., Lasheras, I., Lipnicki, D. M., Bueno-Notivol,
J., Pérez-Moreno, M., López-Antón, R., ... & Gracia-García, P.
(2021). Prevalence of anxiety in the COVID-19 pandemic: An updated
meta-analysis of community-based studies. Progress in
Neuro-Psychopharmacology and Biological
Psychiatry, 109, 110207.
Siegel, A. N. (2021). Registered clinical studies investigating
psychedelic drugs for psychiatric disorders. Journal of
Psychiatric Research, 139: 71–81.
Weston, N. M. (2020). Historic psychedelic drug trials and the
treatment of anxiety disorders. Depression Anxiety,
37:1261–1279.
About Cybin
Cybin is a leading biotechnology company focused on progressing
psychedelic therapeutics by utilizing proprietary drug discovery
platforms, innovative drug delivery systems, novel formulation
approaches and treatment regimens for psychiatric disorders.
Cautionary Notes and Forward-Looking
Statements
Certain statements in this news release related 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 may include
statements regarding enhanced liquidity, the value of additional
capital markets exposure, access to institutional and retail
investors, the Company's new strategic brand messaging campaign,
and psychedelic drug development programs to potentially treat
mental health disorders. There are numerous risks and uncertainties
that could cause actual results and Cybin's plans and objectives to
differ materially from those expressed in the forward-looking
information. Actual results and future events could differ
materially from those anticipated in such information. These and
all subsequent written and oral forward-looking information are
based on estimates and opinions of management on the dates they are
made and are expressly qualified in their entirety by this notice.
Except as required by law, the Company does not intend to update
these forward-looking statements.
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 or
nutraceutical products. 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 or nutraceuticals can diagnose, treat,
cure or prevent any disease or condition. Vigorous 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.
The NEO Exchange has neither approved nor disapproved the
contents of this news release and is not responsible for the
adequacy and accuracy of the contents herein.
Contacts
Investor Contacts:
Tim Regan/Scott Eckstein
KCSA Strategic Communications
Cybin@kcsa.com
Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com
Media Contacts:
John Kanakis
Cybin Inc.
John@cybin.com
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