PsyBio is committed to innovate, develop, and
optimize technology related to its ever growing
psycho-targeted portfolio through formal regulatory
pathways
Based on feedback received, PsyBio intends to
request its initial compound-specific pre-IND meeting
OXFORD, Ohio and COCONUT CREEK, Fla., Dec. 7, 2021 /CNW/ - PsyBio Therapeutics Corp.
(TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the
"Company"), an intellectual property driven biotechnology
company focused upon discovery and development of new, bespoke,
psycho-targeted therapeutics to potentially improve mental
and neurological health, today announced the successful
completion of its initial pre-Investigational New Drug
("IND") application meeting with the United States Food and
Drug Administration ("FDA") as part of the regulatory
submission process.
"PsyBio was created to develop novel therapeutic candidates with
the goal to help improve human health," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief
Medical Officer. "To achieve this goal, regulatory approval for any
potential therapeutic candidate is absolutely necessary to bring
that product to the patients who may benefit. As such, it is
critically important to have open discussions, such as this
meeting, with regulatory officials to most efficiently and
effectively follow all requirements and guidance to facilitate
future approvals."
The focus of this pre-IND meeting was to discuss potential
indications, manufacturing strategy, and obtain regulatory guidance
as PsyBio guides its technology forward towards regulatory
approval. The responses received from the FDA to these initial set
of questions were constructive and no changes were proposed with
respect to PsyBio's approach. Based upon this initial
discussion, PsyBio intends to submit compound specific pre-IND
meeting requests to define manufacturing and clinical trial
parameters.
"This initial pre-IND meeting marks our formal entry into the
regulatory process, which is paramount and of foremost importance
to PsyBio as part of our commitment to being a leader in developing
psycho-targeted therapeutic candidates," stated Evan Levine, PsyBio's Chief Executive Officer.
"The FDA has provided invaluable guidance which the Company plans
to heed and implement during the development period. We look
forward to collaborating with the FDA and other regulatory agencies
to demonstrate our potential therapeutic candidates are safe and
effective for their proposed indications."
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company
focusing on discovering and developing new, bespoke,
psycho-targeted therapeutics to potentially improve mental and
neurological health. The team has extensive experience in drug
discovery based on synthetic biology and metabolic engineering as
well as clinical and regulatory expertise progressing drugs through
human studies and regulatory protocols. Research and development is
currently ongoing for naturally occurring psychoactive tryptamines
originally discovered in different varieties of hallucinogenic
mushrooms, other tryptamines and phenethylamines and combinations
thereof. The Company utilizes a bio-medicinal chemistry approach to
therapeutic development, in which psychoactive compounds can be
utilized as a template upon which to develop precursors and
analogs, both naturally and non-naturally occurring.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute
"forward-looking information" ("forward-looking
information") within the meaning of applicable Canadian
securities legislation. All statements, other than statements of
historical fact, are forward-looking information and are based on
expectations, estimates and projections as at the date of this news
release. Any statement that discusses predictions, expectations,
beliefs, plans, projections, objectives, assumptions, future events
or performance (often but not always using phrases such as
"expects", or "does not expect", "is expected", "anticipates" or
"does not anticipate", "plans", "budget", "scheduled", "forecasts",
"estimates", "believes" or "intends" or variations of such words
and phrases or stating that certain actions, events or results
"may" or "could", "would", "might" or "will" be taken to occur or
be achieved) are not statements of historical fact and may be
forward-looking information. Forward looking-statements in this
press release include statements regarding: PsyBio's plans to
submit compound specific pre-IND meeting requests to the FDA to
define manufacturing and clinical trial parameters; the ability of
PsyBio to develop novel formulations to potentially treat
neurologic and psychologic conditions and other disorders; the
ability of PsyBio to launch clinical trials; the ability of PsyBio
to build and protect its intellectual property portfolio of novel
drug candidates; the ability to achieve cost competitive synthesis
with reduced environmental impact over current production methods;
and the ability of PsyBio to move target candidates into scaled
commercial manufacturing and regulatory application.
In disclosing the forward-looking information contained in this
press release, the Company has made certain assumptions, including
that: PsyBio will be successful in protecting its intellectual
property; PsyBio will be successful in discovering new valuable
target molecules; PsyBio will file one or more IND Applications
with the FDA; PsyBio will be successful in obtaining all necessary
approvals for clinical trials; PsyBio will be successful in
launching clinical trials; the results of preclinical safety and
efficacy testing will be favourable; PsyBio's technology will be
safe and effective; a confirmed signal will be identified in
PsyBio's selected indications; and that drug development involves
long lead times, is very expensive and involves many variables of
uncertainty. Although the Company believes that the expectations
reflected in such forward-looking information are reasonable, it
can give no assurance that the expectations of any forward-looking
information will prove to be correct. Known and unknown risks,
uncertainties, and other factors which may cause the actual results
and future events to differ materially from those expressed or
implied by such forward-looking information. Such factors include,
but are not limited to: compliance with extensive government
regulations; domestic and foreign laws and regulations adversely
affecting PsyBio's business and results of operations; decreases in
the prevailing process for psilocybin and nutraceutical products in
the markets in which PsyBio operates; the impact of COVID-19; and
general business, economic, competitive, political and social
uncertainties. Accordingly, readers should not place undue reliance
on the forward-looking information contained in this press release.
Except as required by law, the Company disclaims any intention and
assumes no obligation to update or revise any forward-looking
information to reflect actual results, whether as a result of new
information, future events, changes in assumptions, changes in
factors affecting such forward-looking information or
otherwise.
PsyBio makes no medical, treatment or health benefit claims
about PsyBio's proposed products. The FDA or other similar
regulatory authorities have not evaluated claims regarding
psilocybin and other next generation psychoactive compounds. The
efficacy of such products has not been confirmed by FDA-approved
research. There is no assurance that the use of psilocybin and
other psychoactive compounds can diagnose, treat, cure, or prevent
any disease or condition. Vigorous scientific research and clinical
trials are needed. PsyBio has not conducted clinical trials for the
use of its intellectual property. Any references to quality,
consistency, efficacy and safety of potential products do not imply
that PsyBio verified such in clinical trials or that PsyBio will
complete such trials. If PsyBio cannot obtain the approvals or
research necessary to commercialize its business, it may have a
material adverse effect on the PsyBio's performance and
operations.
The TSX Venture Exchange (the "TSXV")
has neither approved nor disapproved the contents of this news
release. Neither the TSXV nor its Regulation Services Provider (as
that term is defined in the policies of the TSXV) accepts
responsibility for the adequacy or accuracy of this
release.
SOURCE PsyBio Therapeutics Corp.