The U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced Friday that a clinical trial will be carried out in the United States and Liberia to test the efficacy and safety of experimental drug ZMapp as Ebola treatment.
Developed by Mapp Pharmaceuticals Inc., ZMapp makes use of three proteins known as monoclonal antibodies, preventing the disease from progressing by targeting the Ebola virus' main surface protein. The monoclonal antibodies are derived from tobacco plants and have shown to be effective as antivirals in studies involving nonhuman primates. Though not yet approved at the time for use on humans, ZMapp was given to nine infected patients under emergency use in the U.S., Western Europe and Africa.
"Although ZMapp has been used to treat several Ebola-infected patients in recent months, we cannot determine if the drug actually benefited those patients because it was not administered within the context of a clinical trial," said Anthony S. Fauci, M.D., NIAID director.
The clinical trial will help researchers in determining if the drug, as well as other forms of treatment, will be effective and safe to use in controlling the current outbreak and those that may happen in the future.
A randomized controlled study, the clinical trial will involve both children and adults that may have been admitted in Liberia's treatment units, infected with the virus in West Africa or may have acquired an infection through secondary transmission in the United States. It will be co-led by Moses Massaquoi, M.D., Ebola Incident Management System's National Chair for Case Management in Monrovia and Richard Davey, Jr., M.D., Division of Intramural Research deputy clinical director for the NIAID.
ZMapp will be compared to other treatment options using a study protocol involving a setup for two-arm comparisons. Should a treatment option prove to be ineffective in participants in a given arm, researchers will move on to the next treatment option available for testing. Other treatments that may come head-to-head with ZMapp include Tekmira siRNA, Favipiravir, post-immunization plasma from recent Ebola survivors, Sarepta's AVI-7537 and BioCryst's BCX4430.
Production of the drug is being funded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority. The ZMapp trial is expected to end in December 2016. Researchers will exercise flexibility to accommodate changing conditions in the outbreak. Experts from the Walter Reed National Military Medical Center, the Uniformed Services University of the Helth Sciences, the Food and Drug Administration, the Centers for Disease Control and Prevention, the University of Nebraska Medical Center, Emory University Hospital, Leidos Biomedical Research Inc. and the University of Minnesota will be conducting the trial.
