US releases experimental Ebola drug for DR Congo outbreak trials

The US Department of Health and Human Services confirmed it will provide doses of MBP134, an antibody drug developed by California-based Mapp Biopharmaceutical, for compassionate use in the DRC and to support a clinical trial in the outbreak region.

"The drug is being made available for compassionate use in Congo as well as to advance a clinical trial in the outbreak region," a department spokesperson told Reuters.

Washington had previously said doses of the drug would only be made available to its own citizens considered at high risk after exposure to the virus.

Trial data could help support future regulatory review and possible US approval, the spokesperson added, declining to say how many doses were being provided.

No approved vaccines or treatments exist for the Bundibugyo strain of Ebola, which is responsible for the outbreak.

The DRC has recorded more than 1,000 confirmed cases since the outbreak was confirmed on 15 May. The number of cases has risen faster than in any previous Ebola outbreak on record, the Africa Centre for Strategic Studies warned.

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Drugs on route

Shipments of MBP134 and other treatments intended for trials are already on their way, the WHO said. The agency is working with health partners to prepare trial enrolment at treatment facilities in the affected region.

Trials of the Mapp drug and two antivirals developed by US pharmaceutical company Gilead Sciences are due to begin in the coming weeks, according to information provided by the WHO and scientists involved in the testing.

MBP134 will be tested both on its own and alongside Gilead's remdesivir, also known as Veklury, which was widely used during the Covid-19 pandemic. A second Gilead drug, obeldesivir, will be tested as a possible preventive treatment.

Ethics committees and regulators in the DRC and Uganda are reviewing trial protocols. Earlier studies found the treatments to be safe, but they have not been tested against the Bundibugyo strain.

Experimental drugs and vaccines should still be tested in clinical trials before widespread use, despite the urgency of the outbreak, the WHO has said.

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Trials in a war zone

The Ebola outbreak is concentrated in the northeastern DRC, with more than 97 percent of cases in Ituri, North Kivu and South Kivu provinces. A small number of cases and deaths have also been reported in neighbouring Uganda.

Running trials and delivering care in the eastern DRC will be difficult, global health officials said. Disease testing and contact tracing are challenging, supply chains have been disrupted, mistrust is widespread and health workers have faced attacks.

The outbreak may have circulated for weeks – possibly months – before it was confirmed. Laboratories in the remote region only had tests for more common strains of Ebola, delaying confirmation until blood samples were sent to Kinshasa.

The WHO has since rolled out a decentralised testing network with new devices that can return results within an hour.

(with newswires)