MSF starts trials of Ebola candidates
pharmafile | November 14, 2014 | News story | Research and Development, Sales and Marketing | Ebola, MSF, Médecins Sans Frontières, avigan, brincidofovir, favipiravir
Three experimental Ebola therapies will be tested at sites operated by Médecins Sans Frontières (MSF) in West Africa, according to the medical charity which hopes to report data by February.
The trials were announced just after the death toll for Ebola passed the 5,100 mark, with more than 14,000 cases recorded centred particularly around Guinea, Liberia and Sierra Leone. Two will take place at centres in Guinea, with the location of the third yet to be decided.
The researchers behind the trials have accelerated their set-up because the only realistic way to test Ebola treatment is during an active outbreak.
MSF’s site in Guéckédou, Guinea, will be used to test Toyama Chemical’s favipiravir, an antiviral drug which is already approved to treat influenza in Japan under the trade name Avigan, with the trial run by the French National Institute of Health and Medical Research (INSERM).
The other Guinean site in Conakry will be used to trial the use of whole blood and plasma therapy from recovering Ebola vaccines as a form of passive immunity for new cases, led by the Antwerp Institute of Tropical Medicine (ITM).
Finally, the third location will be used to test the antiviral drug brincidofovir, originally developed by Chimerix, in a trial funded by the Wellcome Trust and led by the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC).
The World Health Organization is now allowing untested medicines that have skipped some clinical trials to be used on patients, but there is a pressing need to generate hard data on candidate therapies.
Two Ebola vaccines have also started trials, with a candidate developed by GlaxoSmithKline (GSK) under test in Mali and a second – developed by the Public Health Agency of Canada – being studied at the US National Institutes of Health (NIH). Johnson & Johnson meanwhile says its vaccine will start trials in early 2015.
MSF said the three trials’ protocols are in the final stages of development and are being designed with a simple target of 14-day survival and broad inclusion criteria, to allow as many patients as possible to enrol.
The initial aim is to enrol around 400 people across all three studies, with additional patients recruited if early results are promising. There are also procedures in place to allow the trial protocols to be modified to react to early findings, for example by combining the treatments.
“Conducting clinical trials of investigational drugs in the midst of a humanitarian crisis is a new experience for all of us, but we are determined not to fail the people of West Africa,” says Professor Peter Horby, chief investigator of the ISARIC trial.
While clinical trials are underway, MSF is urging the drugs’ developers to scale up production supply straight away so there will be no gap between the end of the trials and the large-scale introduction of products found to be safe and effective.
Phil Taylor
Related Content
FDA approves Regeneron’s antibody Ebola treatment
The FDA has approved Regeneron’s antibody drug inmazeb for treating Ebola. The treatment works through …
Fujifilm to begin clinical trials testing Avigan in COVID-19 patients in Kuwait
Fujifilm will begin clinical trials investigating the effectiveness of Avigan in treating coronavirus patients in …
European Commission announces approval for Janssen’s Ebola vaccine
Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen …
