Research & Development
FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at US Long-Term Care Facilities
10 August 2020 - - The US Food and Drug Administration has granted Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX Venture: APLI) (OTCQX: APLIF) clearance to proceed after Appili's filing of an investigational new drug application for broad-spectrum antiviral favipiravir, the company said.

Appili is expanding its Phase 2 clinical trial into the US to evaluate the safety and efficacy of favipiravir tablets in controlling outbreaks following exposure to COVID-19 in long-term care 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 US and in Canada.

Health Canada provided regulatory clearance on May 21, 2020 for Appili's Phase 2 study evaluating FUJIFILM Toyama Chemical's 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.

The company is not making any express or implied claims that it has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programmes that provide solutions to existing challenges 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.


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