Revive
Therapeutics Files
For FDA Orphan Drug Designation for Psilocybin in
Traumatic
Brain Injury
TORONTO,
April
27,
2021 -- InvestorsHub NewsWire -- Revive Therapeutics Ltd.
("Revive" or the "Company") (CSE: RVV, USA: RVVTF), a specialty life sciences company
focused on the research and development of therapeutics for medical
needs and rare disorders, is pleased
to announce
it has
filed an application with the U.S. Food and Drug Administration
("FDA") to receive Orphan Drug Designation ("ODD") for
Psilocybin to treat moderate
to severe traumatic brain injury ("TBI").
There
are no FDA approved treatments for cognitive impairments due to
TBI. Moderate to severe
TBI is a subset of TBI and can lead to a
physical, cognitive, emotional, and behavioral changes over the
course of a person's life. These changes may affect a person's
ability to function in their everyday life. Approximately
50% of
people with severe
TBI
will experience further decline in their daily lives or die
within 9
years
of their injury. People
with
TBI are fifty times more likely to die from seizures
and six
times more likely
to die
from pneumonia.[1]
Psilocybin
offers
a
potential solution to manage
moderate to severe cases of TBI. Psilocybin has the
potential with its neuroreparative
effect
to improve loss of cognitive function after TBI lessening
disability.
The
clinical effect of psilocybin appears to be related to its
attenuation of traumatically-induced glutamate excitotoxicity
during the early post-injury period. In preclinical
studies conducted at the National Health Research
Institutes, which was part of
the research program acquired
from PharmaTher
Holdings Ltd. (CSE:
PHRM) (OTCQB: PHRRF),
characterized the
potential neuroreparative
effect
of psilocybin compared to being treated with a vehicle (saline)
using a TBI mouse model. Adult mice were randomly assigned to 4
groups: (1) control, (2) TBI+vehicle,
(3) TBI+low
dose
psilocybin, and (4) high dose psilocybin. Cognitive function was
examined by the Morris water maze test after the injury. It was
found that psilocybin, given after injury, improved cognitive
function in TBI mice. Also, there were no adverse effects observed
with psilocybin.
Michael
Frank, CEO of Revive commented: "The
FDA orphan drug application for psilocybin to treat moderate to
severe TBI is an important
milestone for Revive as we focus on building a robust product
pipeline focused on novel uses and
delivery forms of psilocybin to
treat significant unmet
medical needs. We are currently
seeking to evaluate psilocybin in a clinical trial for moderate to
severe TBI and advancing our
development of a proprietary oral thin film psilocybin
product for the potential
treatment of certain
neurological
disorders, such as brain
damage caused by all forms of
TBI and
stroke, and other related mental health and
substance abuse disorders."
The
Orphan Drug Act grants special status to a drug or biological
product to treat a rare disease or condition upon request of a
sponsor. This status is referred to as orphan designation (or
sometimes "orphan status").
The FDA grants ODD status to products that treat rare diseases,
providing incentives to sponsors developing drugs or biologics. The
FDA defines rare diseases as those affecting fewer than 200,000
people in the United States at any given time. ODD would qualify
psilocybin for certain benefits and incentives, including seven
years of marketing exclusivity if regulatory approval is ultimately
received for the designated indication, potential tax credits for
certain clinical drug testing costs, activities, eligibility for
orphan drug grants, and the waiver of the FDA New Drug Application
filing fee of approximately USD $2,400,000.
About
Revive Therapeutics Ltd.
Revive
is a life sciences company focused on the research and development
of therapeutics for infectious diseases and rare disorders, and it
is prioritizing drug development efforts to take advantage
of several regulatory incentives awarded by the FDA such as Orphan
Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease
designations. Currently, the Company is exploring the use of
Bucillamine for the potential treatment of infectious diseases,
with an initial focus on severe influenza and COVID-19. With its
recent acquisition of Psilocin Pharma Corp., Revive is advancing
the development of Psilocybin-based therapeutics in various
diseases and disorders. Revive's cannabinoid pharmaceutical
portfolio focuses on rare inflammatory diseases and the company was
granted FDA orphan drug status designation for the use of
Cannabidiol
(CBD)
to treat autoimmune hepatitis (liver disease) and to treat ischemia
and reperfusion injury from organ transplantation. For more
information, visit
www.ReviveThera.com.
For
more information, please contact:
Michael
Frank
Chief
Executive Officer
Revive
Therapeutics Ltd.
Tel: 1
888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation
Services Provider has reviewed or accepts responsibility for the
adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within
the meaning of applicable Canadian securities legislation. These
statements relate to future events or future performance. The use
of any of the words "could", "intend", "expect", "believe", "will",
"projected", "estimated" and similar expressions and statements
relating to matters that are not historical facts are intended to
identify forward-looking information and are based on Revive's
current belief or assumptions as to the outcome and timing of such
future events. Forward looking information in this press release
includes information with respect to the
the
Company's cannabinoids, psychedelics and infectious diseases
programs.
Forward-looking information is based on reasonable assumptions that
have been made by Revive at the date of the information
and is subject to known and unknown risks, uncertainties, and other
factors that may cause actual results or events to differ
materially from those anticipated in the forward-looking
information. Given these risks, uncertainties and assumptions, you
should not unduly rely on these forward-looking statements. The
forward-looking information contained in this press release is made
as of the date hereof, and Revive is not obligated to update or
revise any forward-looking information, whether as a result of new
information, future events or otherwise, except as required by
applicable securities laws. The foregoing statements expressly
qualify any forward-looking information contained herein. Reference
is made to the risk factors disclosed under the heading "Risk
Factors" in the Company's annual MD&A for the fiscal year ended
June 30, 2020, which has been filed on SEDAR and is available under
the Company's profile at www.sedar.com.
Source:
-
https://www.cdc.gov/traumaticbraininjury/pdf/moderate_to_severe_tbi_lifelong-a.pdf