High-risk Americans exposed to Ebola in the current outbreak in Central Africa will now receive an antibody treatment that has shown great promise in animal studies but has not yet undergone clinical trials to show whether it works in humans, the Department of Health and Human Services confirmed Thursday.
The antibody treatment, known as MBP-134, is being manufactured by San Diego-based Mapp Biopharmaceuticals with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that supports the development of medical countermeasures against rare and emerging diseases and biological threats.
It is currently unknown how many doses of MBP-134 exist. When STAT contacted the company, it said Mapp Bio could not reveal the numbers because BARDA owns the doses.
An American doctor who contracted Ebola in the outbreak area was flown to Germany for treatment last month. His wife, who is also a doctor, and their four children were also taken to Germany for quarantine. The sick doctor, Peter Stafford, is still receiving treatment, but is reported to be on the mend. Another doctor from the same group of Christian missionaries is considered a high-risk infection and is in isolation in the Czech Republic. he is staying healthy. There are currently no other known exposures among Americans.
An expert panel advising the World Health Organization on potential treatments that could be tested or used in the outbreak, which is occurring in northeastern Democratic Republic of the Congo and neighboring Uganda, has identified MBP-134 as one of the priority products for testing.
“MBP-134…represents a promising option for single-dose treatment,” the technical advisory group said in a statement released last week.
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In an email exchange with STAT on condition that his name not be published, an HHS spokesperson said BARDA is coordinating a shipment of monoclonal antibodies that “may be used in high-risk Americans who have been exposed to the virus.” The treatment would be used under the Food and Drug Administration’s “investigational use mechanism,” which allows emergency use of treatments that have not yet been approved, this person said.
The email from HHS officials did not say where the monoclonal antibodies would be shipped, but the U.S. government is building a quarantine center in Kenya for Americans exposed to Ebola. The 50-bed facility will also include high-containment beds for initial treatment of those who become ill.
If Americans develop Ebola, the government has announced it would evacuate them to Europe for treatment, a plan that has faced widespread criticism from public health officials and Kenyans. The opening of the detention camp, scheduled for May 29, has been blocked by a Kenyan court. Violent protests have broken out across the country against the plan.
Still, the Trump administration appears intent on moving ahead with the containment camp, with Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services, saying earlier this week that officials were hopeful that they could “work something out with Kenya.” The administration maintains that people infected with Ebola or at high risk of infection will not be allowed to enter the United States until they are cured or undergo a 21-day incubation period.
The latter approach was adopted during the 2014-2016 Ebola outbreak in West Africa, and the administration insists it is faster to transport sick people to advanced care in Europe than to fly them back to the United States, even though U.S. taxpayers have spent millions of dollars on a network of advanced containment facilities built specifically for this purpose. All but one of the eight returnees survived.
MappBio was founded in 2003 to develop medical countermeasures for the prevention and treatment of infectious diseases, with a particular focus on unmet needs in global health and biodefense, the company’s website states. The company has been researching Ebola hemorrhagic fever monoclonal antibodies for many years.
MBP-134 is considered a pan-Ebola treatment that can increase the chances of survival for people infected with Ebola who require treatment. This outbreak is caused by the Bundibugyo Ebola virus. This is the third time in recorded history that this version of the virus has caused an outbreak. Trials in primates suggest that MBP-134 is effective not only against Bundibugyo, but also against Ebola viruses in Zaire and Sudan.
However, only clinical trials can determine whether a treatment is effective in people. And a pandemic like this one provides a unique opportunity to conduct a clinical trial of its kind.
The US government has not yet confirmed that it will provide doses of MBP-134 for clinical trials. At a press conference last week, government officials acknowledged there had been a request for supplies of the drug to be used in clinical trials. The official had no attitude. “We are working to assess availability and identify the best ways to distribute and leverage the courses we have,” officials said.
But those planning clinical trials in this outbreak hope that MBP-134 will be among the treatments tested.
“The partners’ protocols are in front of the Congolese regulators,” said Armand Sprester, an emergency physician who works with Médecins Sans Frontières and a veteran of the Ebola outbreak response. “They have completed their ethics review. People from the Institute of Tropical Medicine in Antwerp are walking around Ituri, the epicenter of the outbreak, conducting on-site assessments. All machinery is working.”
