infectious disease · africa
DRC Bundibugyo Ebola Trial to Begin, Two Candidate Therapies Move Into Field Testing During Outbreak
As cases accumulate rapidly and no specific drugs or vaccines have yet been approved, WHO is moving Mapp’s MBP134 and Gilead’s remdesivir into clinical testing; this is not a declaration of victory, but the most urgent and difficult generation of evidence during an outbreak.
In an Ebola outbreak, treatment options are often not a matter of calmly ranking choices in a laboratory, but a matter of time at the bedside. The World Health Organization said preparations for a Bundibugyo virus disease trial in the Democratic Republic of the Congo have been completed, with launch expected next week, to assess whether two candidate therapies can reduce mortality among confirmed patients.
The trial will include Mapp Biopharmaceutical’s monoclonal antibody combination MBP134 and Gilead Sciences’ antiviral drug remdesivir, and will test their effects when used alone or in combination. WHO Director-General Tedros Adhanom Ghebreyesus said at a June 24 media briefing that the United States and Gilead will donate the trial drugs; the implementing consortium includes the DRC’s National Institute for Biomedical Research, the medical humanitarian organization ALIMA, the University of Oxford, and WHO.
Bundibugyo virus is one of the pathogens related to Ebola virus, but there are currently no drugs or vaccines specifically approved to prevent or treat Bundibugyo virus disease. This gives the clinical trial a dual pressure: on one hand, patients and medical teams urgently need more effective tools; on the other, candidate products must still be used within a rigorous and interpretable research framework in order to determine their true safety and efficacy.
WHO convened a therapeutics prioritization expert meeting in late May to review existing evidence for antivirals and monoclonal antibodies, including clinical safety, pharmacokinetics, animal model data, and experience from past filovirus outbreaks. The group listed MBP-134, maftivimab, and remdesivir as priority candidates for Bundibugyo virus disease treatment trials, and also recommended evaluating combination therapy with remdesivir and monoclonal antibodies. The DRC trial now set to begin effectively brings two of those priority options into the outbreak setting.
The outbreak context makes the study more urgent. WHO reported that, as of the June 24 briefing, the DRC had 1,094 confirmed cases and 277 deaths; cases had also reached Uganda, and health workers had been infected. WHO also said treatment beds and testing capacity had expanded within weeks, but the outbreak was still moving ahead of the response, with contact tracing, isolation care, infection control, safe burials, and humanitarian access all still under pressure.
The trial results should not be interpreted prematurely. The selection of MBP134 and remdesivir means they have a basis in the existing evidence for moving into clinical validation, not that they have been proven to treat Bundibugyo virus disease; whether combination therapy adds benefit or brings different safety issues also needs to be answered by data. For communities affected by the outbreak, what truly matters is that two things hold at the same time: the research must be fast enough not to miss the window for saving lives, and it must be rigorous enough not to mistake hope for an answer.