Appili Therapeutics Provides Update on Phase 3 PRESECO Clinical Trial Evaluating Avigan®/Reeqonus™
November 12 2021 - 6:19AM
Business Wire
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, today announced that the Phase
3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating
oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of
mild-to-moderate COVID-19 did not achieve statistical significance
on the primary endpoint of time to sustained clinical recovery.
Additional analyses of the trial data are ongoing. The clinical
trial enrolled 1,231 patients with mild-to-moderate COVID-19 from
38 study sites across the United States, Mexico, and Brazil.
“While we are disappointed by the topline results of the PRESECO
trial, we remain steadfast in our belief that safe and effective
oral antivirals are urgently needed for patients who are still
struggling to overcome COVID-19. We wish to thank all the patients
who participated, and hope that information obtained from our trial
can help guide research and development around more potential
treatment options for COVID-19,” said Dr. Armand Balboni, Chief
Executive Officer, Appili Therapeutics. “Appili remains committed
to addressing the challenges posed by infectious diseases and we
will continue developing our pipeline to improve patient lives
around the world.”
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 were outpatients with
mild-to-moderate symptoms who have had a recent positive COVID-19
test (within 72 hours of enrollment). Participants
self-administered 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.
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. 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 involve significant known and unknown
risks, uncertainties and assumptions, including those 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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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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