CONTROL trial is part of Appili’s unique approach to evaluating favipiravir in early-stage disease in the community setting for those most vulnerable to COVID-19, including the elderly, those with significant comorbidities, and frontline workers
Researchers plan to enroll approximately 760 participants in the placebo-controlled study Favipiravir is already approved for emergency treatment of COVID-19 in several countries
October 20, 2020 Read More...
HALIFAX, Nova Scotia--(BUSINESS WIRE)--Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that investigators enrolled and dosed the first cluster of participants in Appili’s CONTROL COVID-19 clinical trial. Appili is sponsoring the Phase 2 cluster-randomized placebo-controlled trial (cluster-RCT) evaluating the effectiveness of favipiravir as a preventative measure against COVID-19 outbreaks in long-term care (LTC) facilities. This Phase 2 trial is an integral part of Appili’s broader clinical program aimed at evaluating early administration of favipiravir to limit the spread and severity of COVID-19 in high-risk patients, including the elderly. Under the trial protocol, once an outbreak is confirmed via a PCR (nasal swab) test in an LTC facility unit, all consenting residents in that unit (cluster) will receive either favipiravir or a placebo. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute (LTRI) in Toronto, is the study’s primary investigator. Researchers plan to conduct the trial at 16 LTC centers throughout the course of the study. The study population will include elderly subjects with co-morbidities and front-line healthcare workers with recent COVID-19 exposure or confirmed infection. Appili expects to report topline data from the study in 2021. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed cases of COVID-19 for at least 24 consecutive days.
“Providing early access for vulnerable patients to antiviral therapy, particularly in a community setting, is a cornerstone of Appili’s COVID-19 clinical strategy. We believe favipiravir’s mechanism of action and oral tablet formulation will best serve patients in these conditions,” said Yoav Golan, MD, Chief Medical Officer at Appili Therapeutics. “Dosing the first cluster of participants in our COVID-19 trial is an important milestone for Appili’s program. Our clinical strategy has a strong potential to show a benefit in this population and truly differentiates Appili’s program from other approaches.”
Favipiravir is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza under the name AVIGAN. 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 patientsiii. Researchers are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in several countries, including the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Favipiravir’s oral tablet form may also provide advantages in the community setting over other approaches to addressing COVID-19, which often require injection or intravenous administration. “Appili was built to solve infectious disease problems, and we believe that favipiravir has the potential to be an important part of the arsenal that ultimately addresses this coronavirus pandemic,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Beginning the rigorous evaluation of favipiravir in patients for COVID-19 indications is an important step for the program, and we are proud to work with our partners, including those at Sinai Health, to continue advancing our COVID-19 clinical program.”