HALIFAX, NS, May 17, 2021 /PRNewswire/ -- Appili
Therapeutics Inc. (TSX: APLI, OTCQX: APLIF) (the "Company" or
"Appili"), a biopharmaceutical company focused on drug development
for infectious diseases, today announced that an independent Data
and Safety Monitoring Board (DSMB) has recommended continuation
without modification of Appili's ongoing Phase 3 PRESECO
(PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™
(favipiravir) as a potential oral therapy for patients with
mild-to-moderate COVID-19.
"Even with effective vaccines available, COVID-19 is here to
stay for the foreseeable future. A safe and effective oral
anti-viral medicine is what government leaders and physicians
around the world have been asking for since the start of the
pandemic. We remain hopeful that once PRESECO is completed,
Avigan/Reeqonus will emerge as the first prescription oral medicine
for newly diagnosed patients with COVID-19," said Dr. Armand Balboni, Chief Executive Officer, Appili
Therapeutics.
The PRESECO 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 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. The DSMB reported no safety issues
that would have required the study to be terminated. It also did
not recommend stopping the study for futility. As a result, Appili
will continue the study without modification.
The interim analysis is based on data from approximately 600
subjects. Appili Therapeutics will continue recruiting patients at
the 27 study sites across the United
States and expects to report top-line results in Q3 2021,
which will inform subsequent interactions with regulators,
including the possibility Appili will pursue an Emergency Use
Authorization from the U.S. Food and Drug Administration.
"COVID-19 is surging again in various parts of the world,
including Asia and South America. As a practicing infectious
diseases physician, I understand the importance of discovering and
delivering new medicines to treat COVID-19 here and around the
world," said Yoav Golan, Chief
Medical Officer, Appili.
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.
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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SOURCE Appili Therapeutics
