TrialSite has been chronicling the antiviral favipiravir and its potential efficacy against SARS-CoV-2, the virus behind COVID-19. Approved for at least mild COVID-19 cases in Russia, China, and India, a handful of favipiravir trials are ongoing in America. Now Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir. Appili is expanding its Phase 2 clinical trial into the U.S. to evaluate the safety and efficacy of favipiravir tablets in controlling outbreaks following exposure to COVID-19 in long-term care (LTC) facilities. Appili’s Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care. Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across both the U.S. and in Canada. Health Canada provided regulatory clearance on May 21, 2020 for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.
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.
About Appili Therapeutics
Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges that patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit here.
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