Company is committed to evaluating use of the
broad-spectrum antiviral in the early treatment setting of COVID-19
to shorten the time to clinical recovery in adult patients with
mild to moderate symptoms
Investigators plan to recruit 826 participants
in the randomized, placebo-controlled trial
Study subset will focus on favipiravir’s
potential to reduce viral shedding, diminishing the period of
infectiousness
Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on
anti-infective drug development, today announced that it has
submitted a new protocol to its open investigational new drug
application (IND) with the U.S. Food and Drug Administration (FDA)
to conduct a Phase 3 clinical study evaluating favipiravir in the
early treatment outpatient setting for adult COVID-19 infections.
Favipiravir is a broad-spectrum antiviral administered in oral
tablet form. Investigators will seek to determine if favipiravir is
a safe and effective treatment for mild-to-moderate COVID-19
infections and, if administered early, may shorten the time to
clinical recovery and keep the infection from progressing into the
severe or life-threatening form of the illness.
“As the global incidence of COVID-19 cases continues to rise at
alarming rates, and we learn more about the virus and patient
demographics, it is clear that we will need multiple approaches to
effectively quell this pandemic,” said Dr. Armand Balboni, Chief
Executive Officer at Appili Therapeutics. “As part of this global
effort, Appili has focused on the outpatient setting with the first
orally available antiviral for the potential treatment of COVID-19
in adults with mild to moderate disease. We look forward to working
with clinical teams to rigorously study the utility of favipiravir,
helping to determine if it can help reduce the spread and inhibit
COVID-19 disease progression.”
Appili’s study is designed to be a randomized, double-blind
placebo-controlled, multi-center Phase 3 trial investigating the
safety and efficacy of favipiravir in the early treatment
outpatient setting for adult COVID-19 infections with mild to
moderate symptoms. Appili plans to recruit 826 eligible
participants, who are recently diagnosed as COVID-19 positive with
mild to moderate symptoms, across multiple clinical trial sites in
the U.S. Participants are expected to be outpatients who do not
require hospitalization and who have had a positive COVID-19 test.
Participants will self-administer the drug regimen in their homes,
with clinical investigators monitoring them remotely. Appili
expects to initiate trial recruitment in the Fall of 2020.
In a sub study, researchers intend to further examine 136 trial
participants to evaluate favipiravir’s effect on viral shedding.
This occurs when the virus is contagious, replicating inside the
body, and is released into the environment. In this portion of the
study, investigators are seeking to determine if treatment with
favipiravir can shorten the period of viral shedding, thus
diminishing the period of infectivity and decreasing the spread of
the virus.
“Helping to reduce the time to clinical recovery and infection
severity could reduce the need for invasive and costly measures
such as hospitalizations,” said Yoav Golan, MD, Chief Medical
Officer, Appili Therapeutics. “Reducing the duration in which a
patient is contagious could help reduce secondary cases and
infection spread. Our goal is to generate robust clinical data that
can help determine if favipiravir can safely and effectively
support these outcomes. Favipiravir’s preliminary clinical data,
broad spectrum antiviral activity, and oral formulation make this
an exciting candidate for early intervention and treatment against
COVID-19.”
Favipiravir is a broad-spectrum antiviral in oral tablet form
originally developed by FUJIFILM Toyama Chemical Inc. and approved
in Japan as a treatment and stockpile countermeasure for pandemic
influenza under the name AVIGAN. Following promising clinical
studies, Russia and India recently approved favipiravir-based
antiviral medications for the emergency treatment of COVID-19.i ii
Clinicians are conducting additional trials evaluating favipiravir
as a treatment for COVID-19 in countries including Japan, China,
and the United Kingdom.
About Appili Therapeutics
Appili Therapeutics Inc. was founded to advance the global fight
against infectious disease by matching clearly defined patient
needs with drug development programs that provide solutions to
existing challenges patients, doctors, and society face in this
critical disease space. Appili has built a pipeline of assets
designed to address a broad range of significant unmet medical
needs in the infectious disease landscape. This diverse pipeline
aims to address some of the most urgent threats in global public
health, including ATI-2307, a novel, broad spectrum, clinical-stage
antifungal candidate in development for severe and
difficult-to-treat invasive fungal infections; ATI-1701, a vaccine
candidate for tularemia, a very serious biological weapons threat;
ATI-1503, a drug discovery program aimed at generating a novel
class of antibiotics with broad-spectrum activity against
Gram-negative superbugs; and ATI-1501, which employs Appili’s
proprietary, taste-masked, oral-suspension technology with
metronidazole for the growing number of patients with difficulty
swallowing. In addition, the Company is also testing FUJIFILM
Toyama Chemical Inc.’s drug favipiravir for the prevention of
COVID-19 as a potential prophylaxis treatment. Headquartered in
Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is
pursuing worldwide opportunities in collaboration with scientific
and industry commercial partners, governments and government
agencies. For more information, visit www.AppiliTherapeutics.com.
Forward looking statements
This news release contains “forward-looking statements,” which
reflect the current expectations of the Company’s management for
future growth, results of operations, performance and business
prospects and opportunities, including statements with respect to:
the scope and parameters of the proposed clinical trial in the U.S.
and the likelihood that such clinical trial will be consummated on
the terms and timeline provided herein or at all; and the potential
use of favipiravir for the treatment of COVID-19 (including as an
early treatment of COVID-19 to control disease progression and
limit virus spread). Wherever possible, words such as “may,”
“would,” “could, “ “should,” “will,” “anticipate,” “believe,”
“plan,” “expect,” “intend,” “estimate,” “potential for” and similar
expressions have been used to identify these forward-looking
statements. Forward looking statements contained in this press
release are provided in reliance on certain assumptions, including
with respect to: securing all requisite required approvals and
funding for the clinical trial in the U.S.; finalizing mutually
acceptable clinical trial agreement and related agreements with the
applicable clinical research organizations relating to this
clinical trial; site and patient enrolment; and other expectations
and assumptions concerning the proposed clinical trial in the U.S.
(including with respect to potential outcomes and benefits).
Although the Company believes that the expectations reflected in
these forward-looking statements are reasonable, the Company cannot
give assurance that these expectations will prove to have been
correct.
Forward-looking statements involve significant known and unknown
risks, uncertainties and assumptions, including, without
limitation, economic, competitive, political and social
uncertainties; known and unknown risks and liabilities relating to
the ongoing COVID-19 pandemic; risks relating to the inability of
Appili to secure any requisite rights to manufacture and
commercialize favipiravir in the U.S and other jurisdictions on
favourable terms or at all; unforeseen events, developments, or
factors causing any of the aforesaid expectations and assumptions
not to be correct; and the other risk factors listed in the annual
information form of the Company dated June 24, 2020 and the other
filings made by the Company with the Canadian securities’
regulatory authorities (which may be viewed at www.sedar.com).
Should one or more of these risks or uncertainties materialize or
should assumptions underlying the forward-looking statements prove
incorrect, actual results, performance or achievements may vary
materially from those expressed or implied by the forward-looking
statements contained in this news release. These factors should be
considered carefully, and prospective investors should not place
undue reliance on the forward-looking statements. The Company
disclaims any intention or obligation to revise forward-looking
statements whether as a result of new information, future
developments or otherwise, except as required by law.
The Company is not making any express or implied claims that it
has the ability to eliminate, cure or contain the Covid-19 (or
SARS-2 Coronavirus) at this time
Neither the TSX Venture Exchange, nor its regulation services
provider (as that term is defined in the policies of the exchange),
accepts responsibility for the adequacy or accuracy of this
release.
i RDIF and ChemRar announce first interim results of clinical
trials of Favipiravir drug’s effectiveness in coronavirus therapy
ii Glenmark Becomes the First Pharmaceutical Company in India to
Receive Regulatory Approval for Oral Antiviral Favipiravir, for the
Treatment of Mild to Moderate COVID-19
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200911005196/en/
Media Relations Contact: Canadian Media: Chantal Allan Sam Brown
Inc. T: 613-319-4384 (CAN) T: 805-242-3080 (U.S.) E:
chantalallan@sambrown.com US/Trade Media: Andrea Cohen Sam Brown
Inc. T: 917-209-7163 E: andreacohen@sambrown.com Investor Relations
Contact: Kimberly Stephens, CFO Appili Therapeutics Inc. TSXV: APLI
E: Info@AppiliTherapeutics.com
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