Appili Also Provides Additional Trial
Updates
Appili Therapeutics Inc. (TSX: APLI) (OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, has added several clinical
research sites in Mexico and Brazil to its Phase 3 clinical trial
evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral
therapy for patients with mild-to-moderate COVID-19. The expansion
into Mexico and Brazil will ensure a timely completion of this
pivotal trial and reaffirm favipiravir as one of the most advanced
oral COVID-19 antiviral candidates in development with top-line
data expected in Q3 2021.
Appili’s PRESECO (PREventing
SEvere COVID-19) study is evaluating the safety and
efficacy of Avigan/Reeqonus, an oral antiviral that selectively
inhibits viral RNA-dependent RNA polymerase (RdRP), as a potential
home-based treatment for patients with mild-to-moderate COVID-19.
The primary goal of the study is to demonstrate a significant
shortening of the time to sustained recovery for study patients
receiving the experimental medicine compared to a placebo.
There are more than 730 U.S. patients currently enrolled in the
PRESECO study. Site activation is underway in Mexico and the first
sites are active and enrolling patients. Site activation in Brazil
is expected to start in the coming weeks. With the addition of the
new sites, Appili expects to complete enrollment and report
top-line results by the end of September.
“While the situation is improving in the U.S., COVID-19 remains
an international crisis. Here and abroad, physicians and government
leaders have been calling for effective oral antiviral medicines to
treat these patients. With cases decreasing in the U.S. our
clinical expansion into Brazil and Mexico will help us meet our
enrollment goal. With this expansion of our trial, we will be able
to move quicker towards our goal of determining whether
Avigan/Reeqonus is effective in helping people who suffer from
mild-to-moderate COVID-19 to recover faster and avoid
hospitalization and death,” said Yoav Golan, M.D., Chief Medical
Officer, Appili Therapeutics.
Recently, an independent Data and Safety Monitoring Board (DSMB)
recommended continuation of PRESECO without modification. This
expansion is a key component of continuing the trial
completion.
As part of the expansion and prioritization of the PRESECO
treatment study, Appili has ended its CONTROL trial. CONTROL was a
Phase 2 trial designed to determine whether Avigan/Reeqonus could
prevent an outbreak of COVID-19 in long-term care settings and
originally developed in collaboration with researchers at Sinai
Health as part of the early response to the COVID-19 pandemic.
Appili has also planned a Phase 3 study PEPCO (Post Exposure
Prophylaxis for COVID-19), designed to evaluate Avigan/Reeqonus
for the prevention of COVID-19 when given to asymptomatic
individuals who have had direct exposure (within 72 hours) to an
infected person. Appili expects to initiate enrollment in the
second half of 2021 following successful completion of the PRESECO
study.
“We are prioritizing and expanding PRESECO to meet the acute
need for effective oral COVID-19 therapies and are looking forward
to our top-line data readout next quarter,” said Armand Balboni,
Chief Executive Officer, Appili Therapeutics. “However, we also
recognize that the value of oral antivirals goes beyond treatment
and expect our post-exposure prophylaxis study PEPCO to rapidly
follow our PRESECO readout. This Phase 3 study, already filed with
the FDA, has the potential to significantly expand the value of
Avigan/Reeqonus and protect vulnerable patients.”
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 outpatient setting 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. Participants are
expected to be outpatients who do not require hospitalization and
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 them 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 the 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 24,
2020 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/20210617005237/en/
Media Contacts Mackenzie
Mittleman/APCO Worldwide T: (760) 578-5079 Email: Mmittleman@apcoworldwide.com Investor Relations Contacts Kimberly Stephens,
CFO Appili Therapeutics E: Info@AppiliTherapeutics.com Laura Kiernan, IRC,
CPA High Touch Investor Relations T: 914-598-7733 E: AppiliTherapeutics@htir.net
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