US provides Ebola treatment for outbreak in Congo, bringing trials closer

The United States has provided doses of an experimental antibody treatment developed by Mapp Biopharmaceutical for use in clinical trials targeting a growing Ebola outbreak in the Democratic Republic of Congo, a U.S. Health and Human Services spokesperson said.

The department declined to disclose the number of doses being supplied, stating that the drug is being made available under compassionate use in Congo and to support ongoing clinical trials in the outbreak region.

Officials said the data gathered from the trials could help guide future regulatory evaluation and potential approval in the United States.

There are currently no approved vaccines or treatments for the Bundibugyo strain of Ebola, which has resulted in more than 1,000 reported cases in Congo, including over 250 deaths. Additional cases and fatalities have also been confirmed in neighboring Uganda.

The World Health Organization (WHO) said doses of the Mapp treatment and other investigational therapies are now being shipped for use in trials. World Health Organization is coordinating with health partners to prepare clinical trial enrollment at treatment facilities in affected areas.

This marks the first time the U.S. government has indicated direct support for clinical trials of Mapp’s antibody therapy, known as MBP134, through the provision of stockpiled doses. Previously, U.S. policy had limited distribution to individuals considered high-risk following exposure.

The U.S. has already committed hundreds of millions of dollars to support Ebola response efforts and has also supported containment measures abroad, including quarantine planning for potential cases involving American citizens.

Clinical Trials to Begin in Coming Weeks

The MBP134 antibody treatment is expected to be among the first therapies tested during the current outbreak, which was declared a public health emergency by the WHO just over a month ago and is now the third-largest Ebola outbreak on record.

Despite urgent needs, the WHO has emphasized that experimental treatments and vaccines must still undergo formal clinical trials before wider use.

In addition to MBP134, antiviral drugs from Gilead Sciences, including remdesivir (Veklury), are also expected to be tested in upcoming trials. These studies are expected to begin in the coming weeks, according to WHO officials and researchers involved.

The MBP134 trial is being sponsored by the WHO and led by the University of Oxford in partnership with health authorities in Congo and Uganda.

Another antiviral candidate from Gilead, obeldesivir, will also be evaluated as a preventive option, with trials potentially starting this month. That study will be led by Congolese and Ugandan health agencies, the Africa Centres for Disease Control and Prevention, and international research partners.

Challenges in Outbreak Regions

Global health officials warned that conducting trials in conflict-affected regions presents major challenges, including limited access to testing, disrupted supply chains, mistrust of health systems, and risks to health workers.

The WHO said addressing these issues is a priority, along with ensuring that any successful treatments remain accessible in affected countries after trials conclude.

Ethics committees and regulators in both Congo and Uganda are currently reviewing trial protocols. While the drugs have been deemed safe in earlier studies, they have not yet been tested for effectiveness against the Bundibugyo strain.

Vaccine Development Still in Early Stages

Ebola vaccine trials remain further behind, according to WHO Director-General Tedros Adhanom Ghebreyesus. Manufacturing and safety testing must be completed before large-scale deployment in outbreak regions.

Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, said early-stage vaccine trials could begin as soon as July, likely in the United Kingdom and potentially in Uganda.

CEPI is currently supporting four vaccine candidates, including one developed by Oxford in partnership with the Serum Institute of India, as well as an mRNA-based candidate from U.S. drugmaker Moderna.

“We have the resources and are working through how the trials will be implemented and where Phase 1 studies will take place,” Hatchett said. “Beyond that, planning is still ongoing.”

-Reporting by Mariam Sunny and Siddhi Mahatole in Bengaluru and Jennifer Rigby in London; Editing by Caroline Humer and Bill Berkrot/Reuters