NIAID is advancing research on several investigational Ebola treatments in different stages of development.
ZMapp
ZMapp, an investigational Ebola treatment developed by Mapp Biopharmaceutical Inc., is a “cocktail” of three different proteins, called monoclonal antibodies. The antibodies are produced in tobacco plants specifically bioengineered to produce large quantities of the proteins. When tested in nonhuman primates, ZMapp demonstrated strong antiviral activity and protected the animals from death as late as five days after infection with Zaire Ebola virus. The NIAID Division of Microbiology and Infectious Diseases supported the earlier development and preclinical testing of ZMapp. BARDA is supporting accelerated development and manufacturing activities.
ZMapp was administered under emergency use authorization to Ebola-infected patients in Africa, the United States, and Western Europe. The NIH-led PREVAIL II clinical trial examining the safety and efficacy of ZMapp launched in March 2015 in the United States, Liberia, Sierra Leone, and Guinea. Investigators originally aimed to enroll 200 participants but closed enrollment at the end of January 2016 with 72 participants total as the West Africa Ebola outbreak ended. Results presented in February 2016 indicate the antibody cocktail was well-tolerated and showed promise, but there was insufficient data to determine definitively whether it is a better treatment for Ebola virus disease than supportive care alone.
Additionally, through the NIAID Centers of Excellence for Translational Research program, Erica Ollmann Saphire, Ph.D., of Scripps Research Institute, leads a consortium to study immunotherapeutics against viral hemorrhagic fevers, which identified ZMapp’s structure and how it binds to Ebola virus. Dr. Saphire is using this knowledge to test next-generation antibodies for better binding and efficacy.
BCX4430
BCX4430, developed by BioCryst Pharmaceuticals with support from NIAID, is an investigational small molecule drug with broad spectrum antiviral activity, including against Ebola. BCX4430 has protected animals against infection with Ebola and Marburg viruses. BioCryst and NIAID launched a Phase 1 clinical study in healthy volunteers in December 2014 to examine the product’s safety and determine a treatment dosage.