Dr. Armand Balboni reports
FIRST PATIENT DOSED IN APPILI THERAPEUTICS' PHASE 3 CLINICAL TRIAL OF AVIGAN TABLETS (FAVIPIRAVIR) FOR THE TREATMENT OF COVID-19 IN THE UNITED STATES
Appili Therapeutics Inc.'s 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 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 anti-virals 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 endeavour 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 (postexposure 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 anti-viral therapy is the cornerstone of our clinical strategy. Working with regulatory agencies and our partners, we have chosen to pursue a multipronged 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 anti-viral 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 anti-viral medications for the emergency treatment of COVID-19. 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 Inc.
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 anti-viral 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 anti-fungal, 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 epicentre of the global fight against infection.
We seek Safe Harbor.
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