COVID-19：富士フイルム､米国でアビガンP3治験：Appili Therapeutics（動画）:
COVID-19:FUJIFILM,Phase3 Avigan clinical trial in the US:with Appili:
COVID-19：Fujifilm，Avigan在美国的3期临床试验：“ Appili Therapeutics”
富士フイルムホールディングス：
カナダの製薬企業Appili Therapeuticsと協力し、米国で新型コロの治療薬「アビガン」の臨床試験（治験）を始めたことが3日わかった。
米国で第3相治験実施：
800人超の患者を対象に、最終段階にあたる第3相の治験を実施する。
治験で有効性を確認し、米国での販売を目指す。
’ Appili Therapeutics’：
富士フイルムは4～11月に米国で第2相治験を実施した。現在データを解析している。
第3相治験を、カナダの製薬企業アピリ・セラピューティクスが実施する。
日本経済新聞
https://www.nikkei.com/article/DGXMZO66964210T01C20A2916M00
First Patient Dosed in Appili Therapeutics’ Phase 3 Clinical Trial of Avigan® Tablets (Favipiravir) for the Treatment of COVID-19 in the United States
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, December 2, 2020
Appili Therapeutics Inc. (“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.
Health Canada Clears Appili Therapeutics for New Phase 3 Clinical Trial to Evaluate Avigan Tablets (Favipiravir) in the Prevention of COVID-19 in Exposed Individuals in the Community
Company signs agreement with CRO and files Phase 3 clinical trial protocol with U.S. FDA in advance of anticipated study initiation in the U.S.
Double-blind, randomized, placebo-controlled study will include approximately 1,156 participants in the U.S. and Canada;
Appili expects enrollment to begin early 2021
The ability to prevent outbreaks in the community setting with an antiviral oral tablet would provide substantial benefits over other approaches currently under study
Business Wire