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ZMapp shows promise in treating Ebola, says LeafBio trial
SAN DIEGO—LeafBio Inc., the commercial arm of Mapp Biopharmaceutical Inc., has announced results from the Prevail II clinical trial of its ZMapp therapy for treatment of Ebola virus disease. The trial, conducted in Liberia, Sierra Leone, Guinea and the United States over the course of nearly a year, was initiated to evaluate the efficacy of ZMapp in treating Ebola, and concluded on Jan. 29, 2016. While the trial did not ultimately enroll enough patients to produce definitive results, researchers said the drug was well tolerated and showed promise. As a result, the U.S. Food and Drug Administration has encouraged Mapp Biopharmaceutical to continue to make ZMapp available to patients under an expanded access treatment protocol during the product’s ongoing development.
“We are encouraged by these results,” said Dr. Larry Zeitlin, president of Mapp Bio. “The outcome of this truncated study is supportive of ZMapp’s antiviral activity in humans. While this trial is not definitive, its results are consistent with the favorable results observed in animal efficacy testing in nonhuman primates.”
The study closed short of its enrollment goals due to the waning of the Ebola epidemic in West Africa. Liberia, Sierra Leone and Guinea, the three countries hardest hit by the epidemic, had been declared Ebola-free by the World Health Organization at various points through the end of 2015, and there are presently no confirmed cases in the region. At trial closure, 72 participants had been enrolled, 36 percent of the planned enrollment of 200.
The trial compared an optimized standard of care, which consisted of hemodynamic monitoring, fluid and electrolyte replacement and general medical support, to a regimen of optimized standard of care plus ZMapp, which is a cocktail of three monoclonal antibodies directed against the Zaire strain of Ebola virus responsible for the recent epidemic.