Americans with high-risk exposure to Ebola in the ongoing Central African outbreak will have access to a promising antibody treatment known as MBP-134. While this treatment has shown significant potential in animal studies, it has yet to undergo clinical trials to determine its effectiveness in humans, as confirmed by the Department of Health and Human Services (HHS) on Thursday.
MBP-134 is developed by Mapp Biopharmaceuticals, located in San Diego, with funding from the Biomedical Advanced Research and Development Authority (BARDA). This agency under HHS specializes in developing medical countermeasures for rare and emerging diseases, as well as biological threats.
The current stock of MBP-134 remains undisclosed. Mapp Bio, when questioned by STAT, stated they could not reveal the number of available doses, as ownership lies with BARDA.
Recently, an American doctor who contracted Ebola was transported to Germany for treatment, along with his wife, also a doctor, and their four children, who were placed under quarantine. The infected physician, Peter Stafford, is reportedly recovering. Another doctor from the same Christian missionary group, considered at high-risk of exposure, is under quarantine in the Czech Republic but remains healthy. There are no other known American exposures at this time.
An expert panel advising the World Health Organization has identified MBP-134 as one of the therapies to be prioritized for testing in the current outbreak, which affects northeastern Democratic Republic of the Congo and adjacent Uganda.
“MBP-134 … represents a promising option for treatment at a single dose,” stated the technical advisory group in a recent statement.
A spokesperson from HHS, who requested anonymity, explained to STAT via email that BARDA is organizing a shipment of monoclonal antibodies for potential use in Americans at high risk of exposure. The treatment would be administered under the FDA’s “investigational use mechanisms,” allowing emergency use of unlicensed treatments.
The HHS official did not disclose the destination of the antibodies, but the U.S. is constructing a quarantine facility in Kenya for Americans exposed to Ebola. This 50-bed station will include high-containment beds for initial treatments.
Should any Americans develop Ebola, the administration plans to evacuate them to Europe for medical care, a move that has faced criticism from public health professionals and Kenyan citizens. The opening of the containment camp, scheduled for May 29, was postponed by a Kenyan court amid violent protests against the initiative.
Nonetheless, the Trump administration is determined to continue with the camp’s establishment. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, expressed optimism earlier this week about reaching an agreement with Kenya. The administration maintains that individuals with Ebola or high-risk exposure must be cured or quarantined for a 21-day incubation period before entering the United States.
The administration argues that transporting patients to Europe offers faster access to high-level care than flying them back to the U.S., despite the U.S. having invested millions in high-containment facilities during the 2014-2016 West African Ebola outbreak, where all but one of the eight repatriated individuals survived.
MappBio, founded in 2003, focuses on developing medical countermeasures for infectious diseases, emphasizing unmet global health and biodefense needs. The company has been working on Ebola monoclonal antibodies for several years.
MBP-134 is thought to be a universal Ebola therapy, enhancing survival chances irrespective of the Ebola strain affecting patients. This outbreak, caused by the Bundibugyo ebolavirus, marks only the third recorded instance of this strain triggering an outbreak. Tests in primates indicate MBP-134’s efficacy against Bundibugyo, Zaire, and Sudan ebolaviruses.
Only clinical trials can confirm the therapy’s effectiveness in humans, and such outbreaks provide the sole opportunity for conducting these trials.
The U.S. government has yet to confirm the provision of MBP-134 for clinical trials. An administration official acknowledged a request for the drug’s supply during a recent press conference. The official was non-committal, stating, “We are working to assess the availability and to best identify how to distribute and utilize the courses that we have.”
Those organizing the clinical trials remain hopeful that MBP-134 will be among the treatments tested.
“The partners’ protocol is in front of the Congolese regulatory authorities,” said Armand Sprecher, an emergency physician involved in Ebola outbreak responses with Doctors Without Borders. “They’ve got their ethical review done. The folks from the Institute of Tropical Medicine in Antwerp are poking around in Ituri” — the outbreak’s epicenter — “doing site evaluations. All the machinery is in motion.”
