Three Ebola Drugs Will Undergo Clinical Trials in West Africa in December
Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders.
The University of Oxford will lead the trial of Durham, N.C.-based Chimerix’s brincidofovir at a site still to be determined. Up to 140 patients in the study will be given two doses of brincidofovir on the first day, followed by one dose on days three, seven, 10 and 14, says Oxford spokesman Jonathan Wood. Fatality rates will be compared with those of patients in the same center prior to the trial’s initiation.
The broad-spectrum antiviral drug shows significant potential to combat Ebola, Wood said. Not only is there good data on the drug’s safety in humans from trials against cytomegalovirus and adenovirus, but it’s also easy to administer and easy to make, should there be a need to scale up production.
Brincidofovir, which prevents viruses from replicating, was first tested against Ebola at the Centers for Disease Control and Prevention. That study returned positive results, and the FDA last month approved the company’s emergency application to begin clinical trials of the drug.
Another trial, led by the French National Institute of Health and Medical Research, will evaluate Fujifilm subsidiary Toyama Chemical Company’s favipiravir on patients in the Guinean city of Guéckédou. The third trial will examine whole blood and plasma transfusions on patients with the disease. It will be led by the Antwerp Institute of Tropical Medicine in the Guinean capital of Conakry.
Inclusion criteria in the three trials are broad, according to Doctors Without Borders, suggesting that investigators might accept patients at different ages and stages of the disease and with a range of different clinical symptoms.
To date, the most developed Ebola treatment is a vaccine developed by the National Institutes of Health and GlaxoSmithKline, which is set to enter Phase II/III testing in Liberia and Sierra Leone by the end of the year. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.