The U.S. government is deploying stockpiled doses of Mapp Biopharmaceutical’s experimental antibody drug, MBP134, to support clinical trials for the Bundibugyo strain of Ebola in the Democratic Republic of Congo and Uganda. According to the U.S. Department of Health and Human Services, this shift in policy moves the drug from a restricted supply reserved for Americans to an active treatment and research tool in the outbreak region. The World Health Organization (WHO) confirmed that trials involving this antibody and Gilead Sciences’ antivirals are slated to begin in the coming weeks to address an outbreak that has already caused over 1,000 cases and 250 deaths.
Why is the U.S. changing its distribution strategy?
The U.S. government previously limited access to its experimental Ebola stockpiles to American citizens at high risk of exposure. A spokesperson for the Department of Health and Human Services stated that the current policy shift aims to facilitate compassionate use in the Democratic Republic of Congo while simultaneously generating clinical trial data. This data is expected to inform future U.S. regulatory reviews and potential drug approvals. The pivot follows criticism regarding the scale of the U.S. response, as the Centers for Disease Control and Prevention warned this could become the most severe Ebola outbreak on record if left uncontained.
Unlike the Ebola Zaire strain, which has established vaccines and treatments, the Bundibugyo strain currently lacks any approved medical countermeasures. This gap in the medical arsenal makes the upcoming clinical trials for MBP134 and Gilead’s antivirals particularly critical for regional health stability.
How will the clinical trials be conducted?
Trials will be led by the University of Oxford in collaboration with the governments of Congo and Uganda, according to the WHO. The research program features two primary testing tracks for the drugs:
- Treatment: The Mapp Biopharmaceutical drug MBP134 will be tested both as a standalone therapy and in combination with Gilead’s remdesivir, a drug previously deployed during the COVID-19 pandemic.
- Prevention: Gilead’s antiviral obeldesivir is being evaluated as a preventative measure, with potential trials beginning as early as this month under the guidance of the Africa Centres for Disease Control and Prevention.
Conducting these trials remains logistically challenging. Global health officials cited ongoing conflict, disrupted supply chains, and significant public mistrust of health workers as primary obstacles to patient enrollment and contact tracing efforts.
When will vaccines become available?
Vaccine development is currently trailing behind therapeutic treatments. WHO Director-General Tedros Adhanom Ghebreyesus noted that while therapeutics are ready for immediate testing, vaccines require additional manufacturing and safety verification. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), stated that Phase 1 vaccine trials could commence in July, likely in the United Kingdom or Uganda. CEPI is currently backing four candidates, including those developed by Oxford with the Serum Institute of India and a separate mRNA-based candidate from Moderna.
Monitor updates from the Africa Centres for Disease Control and Prevention for the most accurate information on regional trial sites. Enrollment criteria for clinical trials in conflict-hit zones are frequently updated to reflect real-time security conditions on the ground.
Frequently Asked Questions
Are the treatments being tested safe?
According to the WHO and Mapp Biopharmaceutical, these treatments have demonstrated safety in earlier trials. However, they have not yet been rigorously tested for efficacy against the specific Bundibugyo strain of Ebola.
Who is sponsoring these trials?
The trials are a multi-agency effort involving the WHO, the University of Oxford, the Congolese and Ugandan governments, the Africa CDC, and France’s ANRS Emerging Infectious Diseases agency.
Can patients access these drugs outside of a trial?
The Department of Health and Human Services indicated that the drug is being made available for compassionate use in Congo, providing a pathway for access while formal clinical trials are underway.
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