PsyBio Therapeutics Advances Proprietary
Patent Pending Manufacturing Towards Fully Developed GMP Production
Methodology
OXFORD,
Ohio and DENVER,
June 2,
2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB)
(OTCQB: PSYBF) ("PsyBio" or the "Company"), a fully
integrated and intellectual property driven biotechnology company
developing novel, bespoke psychoactive medicinal candidates
targeting the potential treatment of mental health challenges,
neurological disorders and other human health conditions, today
reported that it has initiated formal process development for
commercially scalable, patent pending manufacturing technology
expected to enable Good Manufacturing Practice ("GMP") production.
PsyBio's manufacturing process utilizes state of the art bioreactor
manufacturing technology to facilitate expansion of PsyBio's
portfolio of compounds. This process methodology is another
necessary component for the Chemistry, Manufacturing and Controls
section ("CMC") for its therapeutic candidate portfolio
Investigational New Drug ("IND") applications with the United
States Food and Drug Administration ("FDA").
"This latest manufacturing milestone demonstrates PsyBio's
continued progress, maintaining our role as one of the only
biotechnology companies in the psychoactive therapeutic sector
developing their own compounds," stated Evan Levine, PsyBio's Chief Executive Officer.
"PsyBio remains committed to developing effective and scalable
techniques designed to enhance our ability to produce an
ever-growing number of psycho-targeted therapeutic candidates in a
rapid and highly cost-efficient approach."
PsyBio retains the global, exclusive, and perpetual right to
license a platform technology enabling rapid generation of
tryptamines and related compounds through a biosynthetic process
using genetically modified bacteria and has demonstrated the
ability to manufacture one of its first promising therapeutic
candidates at commercial scale. Commercial purification process
development furthers the ability to manufacture compounds with
predictable and reproducible purity.
"The mark of successful product development is the ability to
transfer technology from the bench to full scale GMP production.
PsyBio has been working throughout the COVID-19 pandemic to develop
commercial methodology for the manufacture of pipeline compounds
using biotechnology. The initiation of GMP process development is
an important step leading to clinical trial initiation," stated
Michael Spigarelli, MD, PhD, MBA,
PsyBio's Chief Medical Officer. "This is expected to allow us to
reliably produce predictably pure drug product for clinical
evaluation in order to determine its ability to potentially improve
mental and neurological health."
About PsyBio Therapeutics
Corp.
PsyBio is an intellectual property driven biotechnology company
developing new, bespoke, fully approved, 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, specifically because they
are already known to have an effect within the brain.
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: the impact of this manufacturing
process achievement on the CMC section of PsyBio's IND application
with the FDA; the impact of this manufacturing process achievement
on GMP production; PsyBio's ability to develop compounds more
readily and rapidly than competitive methods; PsyBio's plans for
filing IND applications with the FDA; PsyBio's ability to develop
novel formulations to potentially treat neurologic and psychologic
conditions and other disorders; PsyBio's plans to move towards
clinical trials for psycho-targeted therapeutics intended to
potentially improve mental and neurological health; PsyBio's
ability to launch clinical trials; PsyBio's ability to build
its intellectual property portfolio of novel drug candidates;
PsyBio's ability to achieve cost competitive synthesis with reduced
environmental impact over current production methods; and PsyBio's
ability 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: this manufacturing process will enable GMP production and
will help facilitate expansion of PsyBio's portfolio of compounds;
this manufacturing process will have a positive impact on progress
toward the filing of IND applications with the FDA; PsyBio will
receive approval from the FDA to launch clinical trials; PsyBio
will be successful in protecting its intellectual property; PsyBio
will be successful in discovering new valuable target molecules;
PsyBio will be successful in submitting IND applications and will
be able to obtain all necessary approvals for 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; and 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.