Appili Therapeutics Submits CTA with Health Canada to Sponsor Prophylactic Phase 2 Clinical Trial Evaluating FUJIFILM Toyama ...
11 Mai 2020 - 1:17PM
Business Wire
First clinical program in the world designed to
assess the use of favipiravir for COVID-19 as prophylaxis for
outbreak control; antiviral drug has shown early efficacy against
COVID-19
Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or
“Appili”), a biopharmaceutical company focused on anti-infective
drug development, today announced that it will sponsor the first
clinical trial evaluating FUJIFILM Toyama Chemical’s (FFTC) drug
favipiravir for the prevention of COVID-19, a respiratory infection
caused by the novel SARS-CoV-2 coronavirus. Favipiravir is approved
in Japan as the anti-influenza drug Avigan. With FFTC providing
support through donated drug product, the phase 2 study will be
conducted at long-term care facilities in Ontario. Appili has filed
the clinical trial application (CTA) with Health Canada and expects
to initiate the trial as soon as possible following receipt of
regulatory clearance.
“As the world races to address the COVID-19 pandemic, Appili is
proud to support this endeavour that is looking at this problem
specifically in Canada’s most vulnerable patients, establishing a
world-class clinical program and significant contribution to the
global dataset that is needed to help address this crisis,” said
Armand Balboni, MD, PhD, Chief Executive Officer, Appili
Therapeutics. “Appili was built to tackle the most urgent needs in
infectious diseases in innovative ways that no other organization
could or would be willing to take on. This program illustrates our
commitment to leverage our relationships and expertise to do the
right thing for patients and public health.”
Favipiravir is a broad-spectrum antiviral developed by FFTC and
approved in Japan under the brand name Avigan. Japanese health
authorities provided approval to FFTC in 2014 to use Avigan as a
treatment in a pandemic influenza outbreak. Favipiravir was also
used in a clinical trial to address the Ebola outbreak in Guinea.
FFTC is actively supporting several controlled clinical trials for
favipiravir to investigate its use against COVID-19. Recent studies
suggest favipiravir may have potential utility for the treatment of
COVID-19.i ii Researchers in Wuhan, China, reported in early
February that favipiravir demonstrated anti-viral activity in vitro
against SARS-CoV-2. Small-scale trials conducted in China have also
indicated that favipiravir may provide clinical benefit in patients
with COVID-19.
“We have an ongoing relationship with Appili and are pleased to
support the company in its efforts to assess favipiravir for the
potential benefit of Canadian patients,” said Junji Okada,
President of FFTC. “We are well-aligned with Appili in our
commitment to innovative R&D work that may address public
health crises by mitigating the threat of deadly infections.”
The cluster randomized placebo-controlled trial (cluster-RCT)
will recruit patients at multiple long-term care facilities
throughout Ontario. The primary endpoint will be the safety and
efficacy of favipiravir in the prevention of further outbreak in
long-term care facilities. Secondary endpoints will assess
favipiravir’s potential to inhibit disease progression in this
subject population. As of May 2020, the majority of deaths in
Canada resulting from COVID-19 have occurred in long-term care
facilities, making this population especially vulnerable to the
pandemic.
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. 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, parameters and particulars 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.
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 regulatory approvals (including Health Canada approval)
and funding for the clinical trial; finalizing a mutually
acceptable clinical trial agreement and related agreements with the
applicable clinical research organizations relating to this
clinical trial; the state of the current market conditions and
their anticipated impact on the Company’s business; and other
expectations and assumptions concerning the proposed clinical
trial. 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 July 3, 2019 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 Cai et al (2020) Experimental Treatment with Favipiravir for
COVID-19: An Open-Label Control Study. Engineering.
https://doi.org/10.1016/j.eng.2020.03.007
ii Chen et al (2020) Favipiravir versus arbidol for COVID-19: A
Randomized Clinical Trial. medRxiv preprint doi:
https://doi.org/10.1101/2020.03.17.20037432
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Media Relations Contact: Canadian Media: Chantal Adams Sam Brown
Inc. T: 805-242-3080 E: chantalallan@sambrown.com
American/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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