Mapp Biopharmaceutical's promising treatment for Ebola virus fell short of hitting its goals in a clinical trial, improving survival rates but failing to hit the threshold for statistical significance.
The National Institutes of Health tested Mapp's drug, called ZMapp, in West Africa, planning to enroll 200 patients but managing to recruit just 72 as the area's Ebola outbreak waned.
In the end, 22% of patients treated with ZMapp and standard of care died after 28 days, compared with 39% of Ebola-infected subjects treated with standard of care alone, a difference that was not significant. Mapp's treatment, administered through three injections, improved survival rates for patients regardless of their viral levels, NIH said, but didn't reach statistical significance in any single patient population.
Despite missing its main goal, ZMapp "showed promise" for treating Ebola infection, NIH said, and Mapp is planning to press forward in hopes of securing approval for the antibody therapy.
The FDA added ZMapp to its fast-track program last year, as Mapp's treatment stood out as the most promising among a cadre of novel therapies for Ebola, and the company said it intends to work with regulators to push the development process forward.
"The outcome of this truncated study is supportive of ZMapp's antiviral activity in humans," Mapp President Larry Zeitlin said in a statement. "While this trial is not definitive, its results are consistent with the favorable results observed in animal efficacy testing in nonhuman primates."
- read the NIH statement
- here's Mapp's release