COVID-19：Fujifilm，Avigan在美国的3期临床试验：“ Appili Therapeutics”
富士胶卷控股：
在与加拿大制药公司Appili Therapeutics的合作中，三日透露，该公司已在美国启动了一种新的冠脉药物“ Abigan”的临床试验（临床试验）。
美国的3期临床试验：
最后的3期临床试验将在800多名患者中进行。
确认临床试验的有效性，并打算在美国销售。
“ Appili Therapeutics”：
富士胶片于4月至11月在美国进行了2期临床试验。 我们目前正在分析数据。
加拿大制药公司Apiri Therapeutics将进行3期临床试验。
日本经济新闻
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