Trial of Bundibugyo Ebola drugs starts in DRC

Patients are being recruited into a clinical trial of two potential therapies for the Bundibugyo species of Ebola in the Democratic Republic of the Congo (DRC), according to the World Health Organization (WHO).

The PARTNERS trial is testing two out of three drugs previously identified by the WHO as "priority" candidates for Bundibugyo – Mapp Biopharmaceutical's MBP134 and Gilead's remdesivir – to see if they can improve survival among people diagnosed with the virus, either alone or in combination. The first patient was enrolled yesterday.

The third priority drug, Regeneron's maftivimab, is part of the company's three-antibody Ebola cocktail Inmazeb. Because the WHO wants to test it as a monotherapy, work is ongoing to generate and validate stocks of the maftivimab component on its own for testing, and PARTNERS' adaptive trial design means it can be included at a later date.

On 1st July, DRC said it had recorded 1,406 confirmed cases of Ebola, with 438 deaths and 609 patients hospitalised, while Uganda said it had 20 confirmed cases and two deaths. There has also been one case in France and another in a US citizen medically evacuated to Germany that are believed to be imported from areas affected by the ongoing outbreak.

"Even without approved therapeutics, people are recovering from this disease, but, of course, we could save many more lives with safe and effective therapeutics in our toolkit," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

"The PARTNERS trial, established with national authorities and scientific partners in record time, offers real hope that we can deliver concrete results for – and with – the communities at the heart of the outbreak."

MBP134 is an antibody billed as a 'pan-Ebola' candidate that is designed to target the four species that are known to infect humans. Remdesivir, an antiviral, was an important part of the response to the COVID-19 pandemic.

PARTNERS is expected to include more than 1,000 patients, and sufficient stocks of MBP134 and remdesivir are already in place to complete the study, according to the WHO.

"One of the key lessons from recent outbreaks is that research needs to happen alongside the response, not after it,” commented Prof Amanda Rojek, operations lead for the PARTNERS trial, who is associate professor of health emergencies, at the University of Oxford's Pandemic Sciences Institute in the UK.

"The PARTNERS trial gives us an opportunity to evaluate potential treatments during the outbreak itself, so that the evidence generated can help inform patient care when it is needed most – in months, rather than years," she added.

The study is sponsored by the WHO and is being coordinated by the Institut National de Recherche Biomédicale (INRB) in DRC, the Institute of Tropical Medicine in Belgium, and the University of Oxford.