More than 1,200 patients enrolled in the
United States, Mexico, and Brazil
Study expected to include patients with top
priority 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 enrollment in its global Phase 3 PRESECO (PREventing SEvere
COVID-19) trial evaluating oral
Avigan®/Reeqonus™ (favipiravir) as a potential COVID-19 treatment.
Appili expects to report top-line data from this trial in
approximately 60 days.
Appili launched the PRESECO clinical trial in November 2020 to
evaluate oral Avigan/Reeqonus as a potential at-home therapy for
patients with mild-to-moderate COVID-19. Enrollment targets were
subsequently increased to maximize the number of patients and
COVID-19 variant cases, including Delta, in the trial. With today’s
announcement, the double-blind, placebo-controlled, randomized,
global, multi-center trial has enrolled 1,231 patients from 38
study sites across the United States, Mexico, and Brazil.
“Completing enrollment in this large Phase 3 pivotal trial in
just ten months is a tremendous accomplishment for Appili. With
this major milestone now achieved, we have a clear path to
completing the PRESECO data analysis in the coming weeks and
determining if Avigan/Reeqonus has the potential to meet the urgent
global clinical need for a safe and effective oral treatment for
this deadly disease,” said Armand Balboni, M.D., Ph.D., Chief
Executive Officer, Appili Therapeutics.
The primary goal of PRESECO is to evaluate the impact of oral
Avigan/Reeqonus on time to COVID-19 symptom resolution. The study
also aims to evaluate the effect of oral treatment on progression
to more severe COVID-19 disease. Finally, this Phase 3 clinical
trial includes a viral shedding sub-study, which is evaluating
impact of the treatment on time to viral clearance. Viral isolates
will also be sequenced for identification of COVID-19 variants.
“As we have seen over the past 18 months, this virus continues
to mutate, enhancing its ability to infect and cause significant
symptoms, especially in those who have not been vaccinated. My hope
is that Avigan/Reeqonus will emerge as a standard of care treatment
for mild to moderate COVID-19 patients, resolve patient’s symptoms
more rapidly, and limit progression to more severe disease,” said
Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics.
About the PRESECO Clinical Trial
The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study
is a double-blind, placebo-controlled, randomized, multi-center,
global superiority trial investigating the safety and efficacy of
oral Avigan/Reeqonus in the early treatment for adults infected
with COVID-19 and showing mild-to-moderate symptoms. Participants
were enrolled 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 ongoing Avigan® /Reeqonus (generic name: favipiravir) clinical
trial and the likelihood that such clinical trial 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 clinical trial;; other
expectations and assumptions concerning the clinical trial
(including with respect to 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/20210923005533/en/
Media Contact Mackenzie Mittleman APCO Worldwide T:
1-760-578-5079 E: mmittleman@apcoworldwide.com
Investor Relations Contact Stéphane Paquette; Senior
Director, Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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