FDA批准的Favipiravir口服片剂在美国进行临床试验
TrialSite一直在记录抗病毒药物favipiravir及其抗SARS-CoV-2（COVID-19背后的病毒）的潜在功效。
在俄罗斯至少批准了轻度COVID-19病例，
中国和
印度，
在美国正在进行少数favipiravir试验。现在是生物制药公司Appili Therapeutics Inc.（TSXV：APLI； OTCQX：APLIF）（“公司”或“ Appili”）
专注于抗感染药物的研发，
宣布
在Appili申请广谱抗病毒药物favipiravir的研究用新药（IND）申请后，美国食品药品监督管理局（FDA）批准了公司的批准程序。
Appili正在将其2期临床试验扩展到美国，以评估favipiravir片剂在长期护理（LTC）设施中暴露于COVID-19后控制爆发的安全性和有效性。
Appili的2期临床试验
正利用法维拉韦作为口服片剂的多功能性，适用于包括长期护理在内的各种护理环境。
阿皮利
计划在美国和加拿大招募多达760名参与者参加此2期临床试验。
加拿大卫生部
于2020年5月21日为Appili的第二阶段研究提供了监管许可，该研究评估了FUJIFILM富山化学（FFTC）的favipiravir作为预防COVID-19爆发的措施。
Favipiravir
Favipiravir was originally developed and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza outbreak under the name AVIGAN.
Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.
Researchers
are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries, including
- the United States,
- Japan,
- China, and
- the United Kingdom.
TrialSite has followed the pathway of the research around the world.
Of note, favipiravir was an antiviral
that caught the interest of the U.S. Department of Defense (DOD). Just five years ago, the DOD spent over $200 million on favipiravir clincial trials involving a company called MediVector.
Appili Therapeutics current Chief Executive Officer, Dr. Armand Balboni, was involved with those DOD-based initiatives so he knows a great deal about the drug and its potential.
The Elderly Must be Protected
In a press release today, Dr. Allison McGeer, a senior clinical scientist at the Lunenfield-Tanenbaum Research Institute at Sinai Health, and principal investigator of the trial, reports,
“The elderly are at the highest risk for contracting the disease and the rising rates of COVID-19 infection currently seen in much of the U.S. will likely continue to be a major threat to those living and working in long-term care facilities.”
Dr. McGeer suggests that a randomized controlled trial will help medical professionals better understand if the Japanese antiviral represents a potential option to control outbreaks.
Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics, commented,
The burden of illness in long-term care centers continues to be a significant problem,
and finding ways to offer LTC residents and staff protection against COVID-19 with an oral treatment would be a significant advantage in our fight to control the devastating effects of this pandemic.
Dr. Balboni continued,
The limited response to vaccines often seen in the elderly further supports expanding this trial into the U.S. Favipiravir is an antiviral that can be administered orally as a tablet, without the need to be given intravenously or as injections, and may be an important option to avoid and/or control outbreaks in elderly residents living in LTC facilities.
Of course, the company had to disclose in its press release that it isn’t making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 virus.
FDA Clears Favipiravir for COVID-19 Facility Outbreak Prevention Study
https://www.contagionlive.com/news/fda-clears-favipiravir-covid19-facility-outbreak-prevention-study