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RNA Flu Therapy Clinical Trials Complete Enrollment

Influenza ultrastructure illustration (Dan Higgins, CDC)

Influenza ultrastructure illustration (Dan Higgins, CDC)

19 February 2015. Two late-stage clinical trials testing an influenza treatment that disrupts a virus’s genetic replication ability finished recruiting more than 2,000 participants worldwide. The trials are being conducted by MediVector Inc., a drug development company in Boston, for Joint Project Manager Medical Countermeasure Systems, an office in the U.S. Department of Defense developing treatments and preventions for chemical and biological warfare agents.

The drug tested in the trials, favipiravir, is an anti-viral compound first developed by Toyama Chemical Co., a unit of Fujifilm in Japan. Favipiravir is taken orally for five days and works by blocking the ability of ribonucleic acid or RNA in the virus to replicate. RNA is genetic material similar to DNA, containing instructions reflecting the DNA code sent to the body’s cells. The compound is designed by Toyama to act against a variety of viruses that replicate through their RNA, and because it targets the virus’s basic replication mechanism, can avoid being neutralized by resistance from mutations.

The two clinical trials test favipiravir against a placebo, among patients with uncomplicated influenza. In each trial, the main objectives are to reduce the amount of time patients experience fever and other symptoms such as cough, sore throat, and headache. The trials are also looking at the drug’s safety, actions of the drugs in the body, and changes in viral load. One trial recruited patients in the U.S., Canada, Mexico, and six countries in Central and South American. The other trial has patients from the U.S., Australia, New Zealand, Russia, South Africa and nine countries in Europe.

Favipiravir was tested in a intermediate stage clinical trial with 530 patients in the U.S. MediVector says the trial shows the drug reduces the time patients suffer flu symptoms compared to a placebo. In addition, says the company, patients taking favipiravir cleared the virus faster than patients receiving the placebo. The drug was also well tolerated with no adverse effects reported during the study.

MediVector is a drug development enterprise making extensive use of software and data-driven decision-support systems that the company says speeds up the process of developing new drugs and taking them to market.

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