Site screening is required in advance of
potential outbreaks in Ontario long-term care centers
Only trial in the world investigating use of
favipiravir as preventative measure against COVID-19 outbreaks
Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on
anti-infective drug development, today announced that the Company
has initiated site screening of long term care (LTC) facilities in
Ontario for its Phase 2 study evaluating favipiravir as a
post-exposure outbreak control measure against COVID-19. Residents
at screened sites will be eligible for enrollment and randomization
into the trial upon confirmation of a COVID-19 outbreak. The trial
is expected to ultimately enroll approximately 760 participants at
16 LTC facilities. Appili may increase the number of LTC facilities
screened depending on the trajectory of the COVID-19 pandemic.
“As expected, as physical distancing restrictions are eased,
COVID-19 cases are increasing in Ontario and across Canada” said
Primary Investigator Dr. Allison McGeer, senior clinician scientist
at the Lunenfeld-Tanenbaum Research Institute at Sinai Health. “We
have made significant progress in screening potential trial sites,
which is a necessary precursor to dosing trial participants. When
COVID-19 inevitably is introduced into these facilities, our team
will be ready to treat participants and gather the necessary data
to understand the utility of favipiravir for outbreak control.”
Favipiravir is a broad-spectrum antiviral available in oral
tablet form. Appili is conducting this partially blinded,
placebo-controlled cluster-randomized trial (RCT) to evaluate the
safety and efficacy of favipiravir in controlling outbreaks of
COVID-19 in long term care facilities. Residents of long-term care
comprise the vast majority of Canadian COVID-19 deaths.
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.i ii
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.
“We believe that we will ultimately need a multi-faceted
approach to defeat the COVID-19 global pandemic, and that
favipiravir will be an important part of the arsenal that helps
defeats the biggest public health threat of our lifetime,” said
Armand Balboni, MD, Chief Executive Officer at Appili Therapeutics.
“In addition to the growing body of scientific data indicating
antiviral activity against this corona virus, favipiravir has the
added benefit of being an oral treatment, not an intravenous drug,
which is of particular utility in the LTC setting. Furthermore, it
may provide an additional avenue of prophylaxis for this highly
vulnerable patient population, as vaccines are less likely to work
in elderly or immunocompromised patients.”
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 and the
likelihood that the clinical trial will be consummated on the terms
and timeline provided herein or at all; and the potential use of
favipiravir as a prophylactic agent for the treatment of COVID-19.
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; site availability and patient enrolment; and other
expectations and assumptions concerning the proposed clinical trial
(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 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.
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.
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/20200730005470/en/
Media Relations Contacts: 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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