The U.S. has begun supplying doses of an experimental antibody treatment developed by Mapp Biopharmaceutical for clinical trials aimed at addressing the escalating Ebola outbreak in the Democratic Republic of Congo, according to a statement from a spokesperson in the Health Department. This marks a change from their earlier stance, which limited access to the drug solely for Americans.
After significantly cutting back U.S. aid to the region and dismantling the U.S. Agency for International Development, the U.S. is now making modest contributions to assist with what the Centers for Disease Control and Prevention has warned could be one of the most severe Ebola outbreaks yet, especially without an effective response.
The Health Department spokesperson chose not to provide specifics on the quantity of doses, stating via email that the antibody treatment is being made accessible for compassionate use in Congo, alongside efforts to advance a clinical trial in the affected area.
The results from these trials might offer valuable insights for regulatory reviews and potential approval in the U.S., the spokesperson noted.
No approved vaccines or treatments currently exist for the Bundibugyo strain of Ebola, which has already claimed more than 1,000 cases and over 250 lives in Congo. There have also been a few cases and fatalities reported in Uganda.
Doses of the Mapp drug, along with other treatments for trials, are currently being transported, as confirmed by the World Health Organization, which is collaborating with health partners to set up trial enrollment.
This situation represents the first instance where the U.S. has shown intentions to support clinical trials of the Mapp antibody treatment known as MBP134 by providing stored doses. Previously, the U.S. had stated that the doses would be reserved for Americans at high risk after virus exposure.
To date, the U.S. has committed hundreds of millions to combat the Ebola crisis and is involved in constructing a quarantine center in Kenya for American citizens, reflecting a focus on preventing the virus from entering the U.S.
Upcoming Trials
The Mapp drug is anticipated to be one of the initial treatments tested in this outbreak, declared a public health emergency by the WHO just over a month ago, marking it as the third-largest Ebola outbreak recorded.
Even with the pressing need, the WHO believes that experimental treatments and vaccines should undergo testing in clinical trials prior to broader implementation.
Trials for the Mapp drug and two antivirals from Gilead Sciences are set to commence in the coming weeks, per statements from the WHO and scientists engaged in the research.
However, vaccines will likely require more time before they can be considered, although a key official from a global vaccine organization suggested that preliminary trials may begin next month—though probably not in Congo.
Conducting clinical trials in a conflict-affected region, where testing and contact tracing are challenging, and health worker safety is a concern, poses difficulties, according to global health officials. Addressing these challenges will be crucial to ensure that patients can access any safe and effective drugs post-trial.
Testing Drugs
The Mapp MBP134 will be tested independently for Bundibugyo, as well as in conjunction with Gilead’s antiviral remdesivir, also known as Veklury, which gained attention during the COVID-19 pandemic.
The trial is backed by the WHO and is being led by the University of Oxford, along with the Congolese and Ugandan governments.
Another Gilead antiviral, obeldesivir, is expected to be evaluated as a preventative measure, likely starting this month, with the trial conducted in collaboration with Congo, Uganda, and the Africa Centers for Disease Control and Prevention.
Gilead has not disclosed details about shipments to Congo, but has indicated readiness to support requests for both drugs.
Ethics committees and regulatory bodies in both Congo and Uganda are reviewing trial specifics, with earlier trials showing the treatments are safe, though their effectiveness against Bundibugyo has not been established yet.
Vaccine Development
Vaccine trials are a bit further down the road, as WHO Director-General Tedros Adhanom Ghebreyesus mentioned recently. Vaccines need to be produced and assessed for safety and possible side effects before being deployed in outbreak areas in Congo.
Phase 1 trials could potentially kick off in July, likely in the U.K. or Uganda, according to Richard Hatchett of the Coalition for Epidemic Preparedness Innovations.
CEPI currently supports four vaccine candidates, with the first to potentially be tested being one developed by Oxford and the Serum Institute of India, alongside an mRNA-based candidate from Moderna.
“We have the resources, and how the trials will be established and conducted, and where the Phase 1s will happen,” Hatchett mentioned. “Anything beyond that is still being worked through.”
