Randomized, double-blind, placebo-controlled study expected to enroll more than 800 outpatients with confirmed mild-to-moderate COVID-19 infections
Appili’s broad COVID-19 clinical program focuses on the use of oral antivirals as an early intervention against the coronavirus in the outpatient setting
HALIFAX, Nova Scotia–(BUSINESS WIRE)–#Appili–Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that investigators have dosed the first participant in its Phase 3 trial (referred to as the “PRESECO” clinical trial) evaluating oral Avigan® tablets (favipiravir) for the treatment of COVID-19. Appili has engaged PRA Health Sciences as a clinical research organization (CRO) to administer the trial at 47 outpatient sites. The randomized, double-blind, placebo-controlled study will enroll approximately 826 participants. This study is the second Appili-sponsored COVID-19 clinical trial that has initiated dosing this quarter. Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand the program to other areas of the world affected by COVID-19.
“Dosing the first participants in our first Phase 3 trial is a significant milestone as we work to stem the tide of this coronavirus,” said Dr. Yoav Golan, Chief Medical Officer, Appili Therapeutics. “Early intervention with patients before they develop severe COVID-19 and require hospitalization remains a significant unmet need in the COVID-19 treatment landscape. As is the case with influenza, we believe that even with effective vaccines, oral antivirals will play a critical role in treating COVID-19 and preventing its progression. Avigan’s pill format and shelf-life stability make it particularly well-suited for this endeavor and we look forward to gathering the necessary data to determine Avigan’s utility for these patients.”
Appili’s COVID-19 Clinical Program
Appili is sponsoring three randomized, double-blind, placebo-controlled clinical studies to determine the safety and effectiveness of Avigan tablets in outpatients in multiple COVID-19 indications:
- The Phase 3 PRESECO (Preventing Severe COVID Disease) study aims to determine the efficacy of Avigan as a treatment for COVID-19 in patients with a positive COVID-19 test and mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions;
- The Phase 3 PEPCO (Post Exposure Prophylaxis for COVID-19) study is evaluating Avigan in preventing the development of COVID-19 when given to asymptomatic individuals who have had direct exposure (within 72 hours) to an infected person; and
- The Phase 2 CONTROL study is evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities, where the burden of severe disease and death is unusually high.
“We are fully committed to obtaining robust clinical data that demonstrates how Avigan may best fit into the full spectrum of a global pandemic response by addressing significant unmet needs,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Providing early access to antiviral therapy is the cornerstone of our clinical strategy. Working with regulatory agencies and our partners, we have chosen to pursue a multi-pronged clinical trial approach, with triggers for treatment that include either a positive COVID diagnosis or known recent exposure to a COVID-19 case. Our target patient population includes those in the outpatient setting most vulnerable to the devastating effects of advanced COVID-19 infections, including those over 50, with significant co-morbidities, and front-line workers.”
About Avigan (Favipiravir)
Avigan is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.i ii FFTC recently announced positive Phase 3 data in the use of Avigan in hospitalized COVID-19 patients.
Unlike most other interventions that researchers are evaluating in COVID-19, Avigan 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’s 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 Labs, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) This consortium is designed to ensure that Avigan is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide 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® (favipiravir) 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 and parameters of the proposed Avigan® (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the anticipated timing for the release of study data; the potential use of Avigan® (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 Avigan® (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: 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 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 Avigan® (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 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.
Contacts
Media Contacts
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Investor Relations Contact
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSX: APLI
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