Boston, February 17, 2015 -More than 2,000 patients enrolled in the Americas, Europe, Australia, New Zealand and South Africa-
MediVector, Inc. today announced it has successfully completed enrollment in two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza (often called the “flu”). The two studies enrolled 2,021 patients in participating clinics and practices in the Americas, Europe, Australia, New Zealand and South Africa. Favipiravir is an orally administered novel anti-viral compound with a unique mechanism of action that is active against a wide range of RNA-based viruses in laboratory tests.
“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.”
The randomized, double-blind, placebo-controlled, multi-centered Phase 3 FAVOR studies are evaluating the time to alleviation of all primary influenza symptoms consistent with uncomplicated influenza, after treatment with favipiravir. Primary symptoms include cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Additional outcome measures include reduction in virus and safety. Favipiravir is orally administered for five days, with a higher dosage level on day one. The first study includes patients (1161) from the Americas and the second study includes patients (860) from the United States, Europe, Australia, New Zealand and South Africa. Data review is ongoing and study reports will be provided to FDA once complete.
Favipiravir is being developed by the Department of Defense’s BioDefense Therapeutics (BDTX), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office.
“We are pleased with the rapid enrollment of these clinical trials, and are hopeful the results will reinforce the promise seen in earlier studies,” said Lieutenant Colonel Eric G. Midboe, US Army, Joint Project Manager for BDTx. “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.”
Favipiravir (originally known as T-705) is a broad-spectrum antiviral candidate discovered in Japan by Toyama Chemical Co, a unit of Fujifilm Holdings. It is a novel anti-viral compound that works by a different mechanism than approved antiviral agents used to treat people who have become ill with influenza. Favipiravir inhibits synthesis of viral RNA genomes and messenger RNAs that produce the proteins that will form new viruses. Laboratory studies indicate that favipiravir may also be effective against a variety of other RNA viruses.
In a 530 patient Phase 2 multi-center, double-blind, placebo-controlled study in the United States, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of the six influenza symptoms. In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir was well tolerated with no serious adverse events reported during this study.
Influenza is a contagious respiratory illness that can cause mild to severe illness and in some cases can result in hospitalization or death. Older people, young children and people with serious health conditions are at the highest risk of complications from influenza. Currently three anti-viral drugs are approved by the FDA for treating influenza, oral Tamiflu® (oseltamivir), inhaled Relenza® (zanamivir) and intravenously-administered Rapivab® (peramivir). Drug resistance is a growing problem and there is a need for new classes of drugs with novel mechanisms of action.
About MediVector, Inc.
MediVector, Inc. is a Boston-based drug development company specializing in decreasing the time and cost of bringing drugs to market. The company complements its team’s clinical development, regulatory and science expertise with proprietary processes and software based decision support systems and data management tools. MediVector’s management team has a track record of successfully transforming innovative therapeutics with highly challenging clinical and regulatory hurdles into blockbuster drugs that address unmet medical needs and improve public health. For more information please visit www.medivector.com.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
The U.S. Department of Defense’s JPM-MCS is one of seven JPMs within the Joint Program Executive Office for Chemical and Biological Defense. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation’s biodefense response capability. MCS-BDTX—a component of JPM-MCS—develops Food and Drug Administration-approved therapeutics that provide prophylaxis and treatment for traditional, emerging and engineered viral, bacterial and toxin biological warfare agents.