Appili program designed to address the most
urgent aspects of the COVID-19 public health threat
First clinical study to examine the use of
favipiravir for COVID-19 outbreak control; National Institute on
Ageing estimates over 80 per cent of COVID-19 deaths in Canada are
occurring at long-term care facilities
With drug donated by FUJIFILM Toyama Chemical,
Appili will conduct the trial with infectious disease specialists
at Sinai Health in Toronto, the University of Toronto, Sunnybrook
Health Sciences Centre, and Unity Health Toronto
Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or
“Appili”), a biopharmaceutical company focused on anti-infective
drug development, today announced that Health Canada provided
regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM
Toyama Chemical’s (FFTC) favipiravir as a preventative measure
against COVID-19 outbreaks. Dr. Allison McGeer, senior clinician
scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute
in Toronto, Ontario is the study’s primary investigator. Appili
expects trial recruitment to begin imminently. Researchers will
enroll approximately 760 subjects, both residents and staff, at 16
long-term care homes (LTCHs) in Ontario. The National Institute on
Ageing has estimated that as of May 6, 2020, 82 percent of deaths
related to COVID-19 in Canada were associated with long-term care
facilities.i
“Given the severity of COVID-19 amongst the elderly, and the
evidence of ongoing transmission with severe outcomes in LTCHs, it
is critical to develop interventions that minimize the spread of
disease in this setting. As vaccines and treatment for COVID-19
remain unavailable, we must explore all possible solutions,” said
Dr. McGeer. “We look forward to working with Appili on this study,
as the pandemic continues to present devastating consequences for
LTCH residents and their families.”
The Trial
The partially blinded, cluster randomized placebo-controlled
trial (cluster-RCT) will recruit approximately 760 participants
across 16 LTCHs in Ontario. Investigators from the University of
Toronto, Sunnybrook Health Sciences Centre, and Unity Health
Toronto are also participating in the study. The primary objective
of the Phase 2 trial is to evaluate the efficacy of favipiravir or
25 days compared with placebo as a prophylaxis to prevent COVID-19
outbreaks in LTCHs. The primary endpoint will be outbreak control,
defined as no new cases of COVID-19 in residents for 24 consecutive
days up to Day 40 after the start of prophylaxis. Secondary
objectives include measures of safety, rates of infection, disease
progression, and fatality rates.
“With the strikingly high fatality rate from COVID-19 in
long-term care facilities, there is a particularly urgent need to
protect our most vulnerable members of society. Preventing and
controlling COVID-19 outbreaks in long-term care facilities is
therefore of extreme importance,” said Yoav Golan, MD, Chief
Medical Officer at Appili Therapeutics. “Industry and academia are
coming together in unprecedented ways to mitigate this crisis, and
Appili is proud to be part of this unique collaboration. Dr. McGeer
and her team at Mount Sinai, along with our other medical partners
from some of the premier institutions in Toronto, have extensive
experience in working to mitigate respiratory infections in
long-term care settings. Together with the support from FFTC, we
are in a unique position to evaluate the utility of favipiravir as
a COVID-19 prophylaxis to control further outbreaks in these
facilities, which could be a significant advance for Canadian
patients, with implications for global application in similar
high-risk outbreak settings.”
The Company is not making any express or implied claims that its
product has the ability to eliminate, cure or contain the Covid-19
(or SARS-2 Coronavirus) at this time.
Favipiravir
Favipiravir is a broad-spectrum antiviral approved in Japan
under the brand name Avigan. Japanese health authorities provided
approval to FFTC in 2014 to use Avigan as a treatment and stockpile
countermeasure for pandemic influenza outbreak. Recent studies
suggest favipiravir may have potential utility for the treatment of
COVID-19.ii iii Researchers in Wuhan, China, reported in early
February that favipiravir demonstrated anti-viral activity in vitro
against SARS-CoV-2. Small-scale clinical trials conducted in China
have also indicated that favipiravir may provide clinical benefit
in patients with COVID-19.
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 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; 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 (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 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 MacCharles, Tonda. 82% of Canada’s COVID-19 deaths have been
in long-term care, new data reveals. The Star Accessed online May
7, 2020.
ii 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
iii 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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version on businesswire.com: https://www.businesswire.com/news/home/20200521005122/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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