The United States has begun providing doses of an experimental antibody drug, MBP134, developed by Mapp Biopharmaceutical, for use in clinical trials to combat the ongoing Ebola outbreak in the Democratic Republic of Congo. This decision represents a change from the U.S. stance of previously limiting the drug’s availability to Americans at high risk following exposure.
A spokesperson for the Department of Health and Human Services confirmed the availability of the drug for compassionate use and to advance clinical trial efforts in the affected region. While the exact number of doses was not disclosed, the U.S. Centers for Disease Control and Prevention has indicated that this outbreak could potentially be the most severe yet without a robust response.
Trials to Begin Amidst Challenges
The experimental treatments, including Mapp’s drug and two antivirals from Gilead Sciences, are being shipped to the region, according to the World Health Organization (WHO). Trials are expected to commence in the coming weeks. The data gathered from these trials could be crucial for informing future regulatory reviews and potential U.S. approval of the treatments.
The current outbreak involves the Bundibugyo strain of Ebola, which has resulted in over 1,000 cases and more than 250 deaths in Congo. Neighboring Uganda has also reported a small number of cases and fatalities. There are currently no approved vaccines or treatments specifically for this strain.
Running clinical trials in a conflict-affected area with disrupted supply chains, widespread mistrust, and attacks on health workers presents significant challenges. Health officials emphasize that addressing these issues is a priority, alongside ensuring access to effective treatments for patients in affected countries after trials conclude.
Multiple Treatments Under Investigation
Mapp’s MBP134 will be tested both as a standalone treatment and in combination with Gilead’s antiviral remdesivir (Veklury). The Mapp drug trial is being sponsored by the WHO and led by the University of Oxford in collaboration with the Congolese and Ugandan governments. Ethics committees and regulators in both Congo and Uganda are currently reviewing the trial protocols.
Additionally, another Gilead antiviral, obeldesivir, will be evaluated as a potential preventive option. This trial, likely starting this month, will be led by Congo, Uganda, the Africa Centers for Disease Control and Prevention, and co-sponsored by Congo’s National Institute for Biomedical Research and France’s ANRS Emerging Infectious Diseases agency.
Vaccine Development Further Out
While experimental treatments are moving toward clinical trials, the development of vaccines is a longer process. WHO Director-General Tedros Adhanom Ghebreyesus stated that phase 1 vaccine trials could begin as early as July, potentially in the U.K. or Uganda. These early-stage trials are supported by the Coalition for Epidemic Preparedness Innovations (CEPI), which is backing several vaccine candidates. The first candidates to reach testing are likely those developed by Oxford and the Serum Institute of India, and by Moderna.
Steve Lopez is the Editorial Page Editor for News Raise. He covers Health. He has won more than a dozen national journalism awards for his reporting and column writing at seven newspapers and four news magazines.
