MONDAY, SEPTEMBER 26, 2016

MediVector finishes enrolling subjects in two Phase 3 favipiravir studies

MediVector finishes enrolling subjects in two Phase 3 favipiravir studies | Courtesy of cdc.gov

MediVector, Inc. recently announced that it has finished enrolling subjects in its two FAVOR favipiravir Phase 3 studies for influenza treatments.

Favipiravir, also called T-705, is an orally administered antiviral candidate with a broad-spectrum of treatments. The treatment inhibits RNA messengers and genomes from producing the proteins that are essential to forming new viruses.

Phase 3 is a randomized, double-blind, placebo-controlled, multi-centered study of the favipiravir treatment. The goal of the study is to determine the treatment's ability to safely and effectively relieve patients of influenza symptoms, such as sore throat, cough, nasal congestion, headache, fatigue, aching and bodily pains.

Subjects will receive favipiravir doses for five days, with the highest dose scheduled for the first day. Over 2,000 adult subjects are enrolled in the two studies.

"Completion of enrollment within a year of initiating these clinical trials is a significant accomplishment, and the resulting data from the carefully designed studies will lay the groundwork for filing an application for approval to market favipiravir in the U.S.," Dr. Carol Epstein, executive vice president and chief medical officer of MediVector, Inc., said. "Resistance to currently available influenza treatments is a growing problem, and there is an urgent need for a new broad-spectrum therapeutic with a different mechanism of action that is active against multiple strains of influenza viruses.” 

Clinics participating in the studies are located in Australia, the Americas, Europe, South Africa and New Zealand. The first study consists of 1,161 subjects from the Americas. The second study has 860 participants from Europe, the United States, New Zealand, Australia and South Africa.

“We are pleased with the rapid enrollment of these clinical trials, and are hopeful the results will reinforce the promise seen in earlier studies,” Lt. Col. Eric G. Midboe, U.S. Army, joint project manager for BDTx, said. “Favipiravir may represent an important new therapeutic to protect our military and nation when a vaccine fails to protect against an emerging influenza strain, a drug resistant influenza, and other RNA-virus threats.”