U.S. expansion of antiviral outbreak control
trial in long-term care facilities
Favipiravir already approved in India and
Russia for emergency use against COVID-19 and as a pandemic
influenza antiviral medication in Japan
First oral antiviral that may provide
protection for elderly and vulnerable populations without need for
intravenous administration or injections
Over 40% of deaths in the United States involve
nursing home residents and staff i
Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on
anti-infective drug development, today announced that the U.S. Food
and Drug Administration (FDA) has granted the Company clearance to
proceed after Appili’s filing of an investigational new drug (IND)
application for broad-spectrum antiviral favipiravir. Appili is
expanding its Phase 2 clinical trial into the U.S. to evaluate the
safety and efficacy of favipiravir tablets in controlling outbreaks
following exposure to COVID-19 in long-term care (LTC) facilities.
Appili’s Phase 2 clinical trial is leveraging the versatility of
favipiravir as an oral tablet suitable for administration across a
wide variety of care settings, including long-term care. Appili
intends to enroll up to 760 participants in this Phase 2 clinical
trial across both the U.S. and in Canada. Health Canada provided
regulatory clearance on May 21, 2020 for Appili’s Phase 2 study
evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a
preventative measure against COVID-19 outbreaks.
“The burden of illness in long-term care centers continues to be
a significant problem, and finding ways to offer LTC residents and
staff protection against COVID-19 with an oral treatment would be a
significant advance in our fight to control the devastating effects
of this pandemic,” said Dr. Armand Balboni, Chief Executive Officer
at Appili Therapeutics. “The limited response to vaccines often
seen in the elderly further supports expanding this trial into the
U.S. Favipiravir is an antiviral that can be administered orally as
a tablet, without the need to be given intravenously or as
injections, and may be an important option to avoid and/or control
outbreaks in elderly residents living in LTC facilities.”
“The elderly are at the highest risk for contracting the disease
and the rising rates of COVID-19 infection currently seen in much
of the U.S. will likely continue to be a major threat to those
living and working in long-term care facilities,” said Primary
Investigator Dr. Allison McGeer, senior clinician scientist at the
Lunenfeld-Tanenbaum Research Institute at Sinai Health. “Through
the means of a randomized control clinical trial, our team is
looking forward to working with clinical partners in the U.S. to
understand if favipiravir could be an option for outbreak control
in this setting.”
Favipiravir was originally developed and approved in Japan as a
treatment and stockpile countermeasure for pandemic influenza
outbreak under the name AVIGAN. Following promising clinical
studies, Russia and India recently approved favipiravir-based
antiviral medications for the emergency treatment of COVID-19.ii
iii Researchers are conducting additional trials evaluating
favipiravir as a treatment for COVID-19 in countries including the
United States, Japan, China, and the United Kingdom.
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.
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 Canada
and 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 a method of outbreak control in long-term care
facilities). 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 Canada and the U.S.; finalizing a
mutually acceptable clinical trial agreement and related agreements
with the applicable clinical research organizations relating to
this clinical trial; patient enrolment; and other expectations and
assumptions concerning the proposed clinical trial in Canada and
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 Canada, 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.
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 The New York Times: More Than 40% of U.S.
Coronavirus Deaths Are Linked to Nursing Homes ii RDIF and ChemRar
announce first interim results of clinical trials of Favipiravir
drug’s effectiveness in coronavirus therapy iii 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/20200810005098/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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