Revive Provides Update on its Clinical Development Plan for Cannabidiol in the Treatment of Autoimmune Hepatitis
February 18 2020 - 8:41AM
Revive Therapeutics Ltd. (“Revive” or the “Company”), a company
focused on the research, development and commercialization of novel
cannabinoid-based and life sciences products, is pleased to provide
an update on the Company’s clinical development plan for
Cannabidiol (“CBD”) in the treatment of Autoimmune Hepatitis (AIH).
Revive is currently in the process of preparing
its Investigational New Drug (“IND”) application for submission to
the U.S. Food and Drug Administration (“FDA”) for CBD in the
treatment of AIH. The Company plans to submit the IND within
ninety days with the objective to proceed with a proposed Phase
1/2a clinical study to determine the recommended dose of CBD for
future clinical studies of AIH, to assess its safety, efficacy and
clinical benefit, as well as to support a New Drug Application
(“NDA”) for FDA approval. The Company aims to initiate a
clinical study by the end of Q2 or early Q3-2020.
“Revive is focused on advancing its
cannabinoid-based product pipeline towards human clinical studies
with our lead program being CBD in the treatment of AIH, a rare
liver disease that represents a large market opportunity globally,”
said Michael Frank, Chief Executive Officer of Revive. “Our
objective in proceeding with a first-in-kind human clinical trial
under a U.S. IND will further support our cannabinoid
pharmaceutical initiatives by expanding into other rare diseases
that Revive is pursuing such as the use of CBD in the prevention of
ischemia and reperfusion injury (“IRI”) resulting from solid organ
transplantation, which includes liver, kidney, heart and
lung. The Company has received FDA orphan drug designation
for CBD in both AIH and IRI.”
Revive’s program is to meet a clear unmet
medical need in patients with AIH. AIH is a rare inflammatory
condition of the liver that can affect all ages and gender across
the world. If not treated properly, may cause liver fibrosis
or cirrhosis, liver failure requiring a liver transplant, and even
death. The prevalence of AIH is estimated at 75,000 patients
in the U.S. The current standard of care for AIH is the use
of steroids alone or steroids combined with azathioprine. It
has been noted in medical literature that the current standard of
care when used in a certain period of time has caused severe
treatment-related side effects in 13%, treatment failure in 9%,
incomplete response in 13%, and relapse after drug withdrawal up to
86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb
28; 16(8): 934–947). Therefore, given the unwanted outcomes
associated with a steroid-based therapy, an alternative
steroid-free treatment option such as CBD, with its known safety
profile, may provide a potential solution for an improved treatment
strategy for those patients unresponsive to, intolerant of, or
non-adherent with a steroid-based therapy for AIH.
Revive has an exclusive license from South
Carolina Research Foundation for its intellectual property for the
use of CBD, either in synthetic or natural form, in the treatment
of autoimmune hepatitis (U.S. patent No. 8242178). Also, the
FDA has granted to Revive orphan drug designation for CBD in the
treatment of AIH, which provides valuable incentives that could
accelerate the approval process, including seven-year market
exclusivity, tax credits on U.S. clinical trials, fast-tracking of
regulatory proceedings, and exemption from certain fees, such as
waiver of filing fees under the Prescription Drug User Fee Act
(PDUFA), and orphan drug grants.
About Revive Therapeutics Ltd.
Revive is a company focused on the research,
development and commercialization of novel cannabinoid-based and
life sciences products. Revive’s cannabinoid delivery technology is
being advanced to fill the medical needs for diseases and disorders
such as pain, inflammation, and wound care. Revive’s cannabinoid
pharmaceutical portfolio focuses on rare inflammatory areas such as
liver disease. The company has been granted FDA orphan drug status
designation for the use of CBD to treat auto-immune hepatitis
(liver disease) and FDA orphan drug status designation for the use
of CBD 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: 905.605.5535 Email:
mfrank@revivethera.com Website:
www.revivethera.com
Neither the Canadian Securities Exchange nor its
Regulation Services Provider have reviewed or accept 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 IND submission to the FDA, including plans to submit the IND
within sixty to ninety days, a proposed Phase 1/2a clinical
study, and the aim to initiate a clinical study by the end of
Q2-2020. 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.
Factors that may cause actual results to differ materially from
those anticipated by these forward looking statements include: the
risk that the Company may not be able to submit the IND to the FDA;
the Company many not obtain approval to proceed with a human
clinical study; the inability of the Company to satisfy all
conditions to proceed with a human clinical study and the risk of
unforeseen delays in the submission of the IND. Reference is also
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,
2019, which has been filed on SEDAR and is available under the
Company’s profile at www.sedar.com.
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