New Funds Will Help Expedite Completion of
Recently Expanded Pivotal Phase 3 Study on Oral Antiviral
Medicine
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, today announced it entered
into an agreement with FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”),
that will provide funding support for its Phase 3 PRESECO
(PREventing SEvere COVID-19)
clinical trial. The new funding of $1,000,000 USD was secured from
FFTC, one of the Company’s partners in a global consortium focused
on the worldwide development, commercialization, and distribution
of Avigan®/Reeqonus™ (favipiravir) tablets for the potential
treatment and prevention of COVID-19.
The new funding will support various components of the recently
expanded PRESECO trial, including study close-out activities as the
Company prepares for database lock and top-line results. Enrollment
targets for PRESECO and the viral shedding sub-study were recently
increased to enable additional enrollment of COVID-19 variant cases
and maximize the number of patients in the final analysis. As part
of the agreement, FFTC will receive direct access to PRESECO data
in support of local regulatory submissions in Japan. PRESECO is
investigating the safety and efficacy of Avigan/Reeqonus in the
early treatment outpatient setting for adults infected with
COVID-19.
“FFTC recognizes the unmet need of this pandemic, which is the
lack of safe, effective oral antiviral medicines to treat
mild-to-moderate COVID-19 patients. With FFTC’s support, we are one
step closer to determining if Avigan/Reeqonus will meet this need,”
said Dr. Armand Balboni, Chief Executive Officer, Appili
Therapeutics.
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
FFTC and originally approved in Japan as a treatment for pandemic
influenza, this product is one of the few oral antiviral candidates
in Phase 3 clinical development to treat newly diagnosed COVID-19
patients.
“We share the sense of urgency that so many physicians and
nurses have expressed globally for the need of new treatments
developed that will help bring this pandemic to an end. We remain
confident Avigan/Reeqonus will play an important role in North
America, Japan, and around the world in the treatment of COVID-19
now, and in the near future,” said Junji Okada, President, FUJIFILM
Toyama Co., Ltd.
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.
About FUJIFILM Toyama Chemical Co., Ltd. (FFTC)
FFTC is an operating company of FUJIFILM Holdings Corporation,
Tokyo, Japan. FUJIFILM Holdings Corporation brings cutting edge
solutions to a broad range of global industries by leveraging its
depth of knowledge and fundamental technologies developed in its
relentless pursuit of innovation. Its proprietary core technologies
contribute to the various fields including healthcare, highly
functional materials, document solutions and imaging products.
These products and services are based on its extensive portfolio of
chemical, mechanical, optical, electronic and imaging technologies.
For the year ended March 31, 2021, the company had global revenues
of $21 billion, at an exchange rate of 106 yen to the dollar.
Fujifilm is committed to responsible environmental stewardship and
good corporate citizenship. For more information, please visit:
www.fujifilmholdings.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/20210920005499/en/
Media Contact Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com
Investor Relations Contact Stéphane Paquette; Senior
Director, Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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