Viral shedding sub-study to assess efficacy
against recent COVID-19 variants, including Delta
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, today announced it has
completed patient enrollment in the viral shedding sub-study
portion of its Phase 3 PRESECO (PREventing SEvere
COVID-19) trial evaluating
Avigan®/Reeqonus™ (favipiravir) as a potential oral antiviral
COVID-19 treatment in the United States.
The viral shedding sub-study is designed to identify COVID-19
variants in study patients and evaluate the direct antiviral effect
of favipiravir against the SARS-CoV-2 virus, including recent and
emerging variants. Saliva samples are being collected daily from
sub-study participants for viral load assessments and whole genome
sequencing. Antiviral efficacy endpoints in study participants with
detectable SARS-CoV-2 virus in saliva (defined as >100 RNA
copies, using an RT-PCR assay) will be assessed from study day 3
onward and include time (number of days) to negative conversion
(defined as <100 RNA copies) to study day 10.
PRESECO and sub-study enrollment targets were recently increased
to maximize the number of cases included in the analysis and to
ensure that there is an adequate representation of variants,
including Delta, which is now dominant worldwide. The sub-study is
now fully enrolled with over 550 patients and full enrollment for
the overall study is imminent.
“The need for an oral, safe and effective antiviral that can be
taken at home early in the course of COVID-19, such as
Avigan/Reeqonus, has never been greater and will continue to grow
as this virus evolves and mutates in response to a changing
environment,” said Yoav Golan, M.D., Chief Medical Officer, Appili
Therapeutics. “This sub-study, which includes patients recently
enrolled from regions with high COVID-19 variant case loads, will
provide critical data to assess Avigan/Reeqonus’ antiviral efficacy
against today’s most relevant variants.”
Viral shedding sub-study results are expected concurrently with
PRESECO top-line results.
About the PRESECO Clinical Trial
The Phase 3 PRESECO (PREventing
SEvere COVID-19 Disease) study is a double-blind,
placebo-controlled, randomized, multi-center superiority trial
investigating the safety and efficacy of Avigan/Reeqonus in the
early treatment for adults infected with COVID-19 and showing
mild-to-moderate symptoms. Investigators are enrolling participants
at multiple clinical trial sites in the United States, Brazil and
Mexico. Participants are outpatients with mild-to-moderate symptoms
who have had a recent positive COVID-19 test (within 72 hours of
enrollment). Participants self-administer the drug regimen in their
homes, with clinical investigators monitoring patients
remotely.
About Avigan/Reeqonus
Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet
form. It is a selective inhibitor of viral RNA-dependent RNA
polymerase (RdRP) with potent antiviral activity against
single-stranded RNA viruses, including coronaviruses. Developed by
FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as
a treatment and stockpile countermeasure for pandemic influenza.
Unlike most other interventions that researchers are evaluating in
COVID-19, Avigan/Reeqonus has already been thoroughly studied in
human trials and has a well-known safety profile, with over 3,000
subjects receiving at least one dose of the drug. Avigan/Reeqonus’
oral tablet form is shelf-stable and has an established commercial
manufacturing process, which may provide advantages over other
COVID-19 interventions, which often require temperature-controlled
storage and/or injection or intravenous administration.
Appili has joined a consortium of companies, including Dr.
Reddy’s Laboratories, Global Response Aid, and FFTC, for the
worldwide development and distribution of Avigan/Reeqonus tablets
for the potential treatment and prevention of COVID-19 (excluding
Japan, China and Russia). This consortium is designed to ensure
that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical
studies and, if it receives the proper regulatory approvals, has
the infrastructure in place to support worldwide manufacturing and
distribution.
About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical
company that is purposefully built, portfolio-driven and
people-focused to fulfill its mission of solving life-threatening
infections. By systematically identifying urgent infections with
unmet needs, Appili’s goal is to strategically develop a pipeline
of novel therapies to prevent deaths and improve lives. As part of
a global consortium, Appili is sponsoring late-stage clinical
trials evaluating the antiviral Avigan/Reeqonus for the worldwide
treatment and prevention of COVID-19. The Company is also advancing
a diverse range of anti-infectives, including a broad-spectrum
antifungal, a vaccine candidate to eliminate a serious biological
weapon threat, and two novel antibiotic programs. Led by a proven
management team, Appili is at the epicenter of the global fight
against infection. 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 design, scope, parameters and location of the proposed Avigan®
/Reeqonus (generic name: favipiravir) clinical trials and the
likelihood that such clinical trials will be consummated on the
terms and timeline provided herein or at all; the anticipated
timing for completion of each study and the release of study data;
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); and the development,
manufacturing and commercialization plans of the parties with
respect to favipiravir. 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: timing of clinical results; securing all requisite
required approvals and funding for the applicable clinical trials;
finalizing mutually acceptable clinical trial agreement and related
agreements with the applicable clinical research organizations
relating to the applicable clinical trials; site and patient
enrolment; other expectations and assumptions concerning the
proposed clinical trials (including with respect to the
continuation and/or expansion of the clinical trials, the timely
completion of such trials and their potential outcomes and
benefits); and the ability of the parties to successfully develop,
manufacture and commercialize favipiravir for the treatment of
COVID-19 following successful completion of the requisite clinical
trials and receipt of all requisite regulatory and other approvals.
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 initiate or complete all requisite clinical trials
(including risks relating to the outcome thereof) and to secure all
required funding and approvals relating thereto; risks relating to
the development, manufacturing and commercialization of favipiravir
in Canada, the U.S and other jurisdictions; 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 23,
2021 and the other filings made by the Company with the Canadian
securities’ regulatory authorities (which may be viewed under the
Company’s profile on SEDAR 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210917005099/en/
Media Contacts Danielle Raabe/APCO Worldwide T:
1-646-717-9915 Email: DRaabe@apcoworldwide.com
Investor Relations Contacts Stéphane Paquette; Senior
Director, Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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