Regeneron says Ebola trial ended early after treatment shows superiority to SoC
Regeneron Pharmaceuticals announced that the company was informed by study investigators that a randomized, controlled trial evaluating four investigational therapies for Ebola virus infection was stopped early because REGN-EB3 was superior to ZMapp in preventing death. ZMapp served as the control arm of the trial because it was considered the standard-of-care based on the previous PREVAIL II clinical trial, the company noted. The protocol specified that the PALM trial would only be stopped early for a highly statistically significant result. The independent data safety monitoring board decided to stop the trial after reviewing interim mortality data from 499 patients. The trial was conducted in the Democratic Republic of Congo, where the current outbreak is ongoing. Neil Stahl, Executive Vice President of Research and Development at Regeneron, said, "We are moved to know our therapy is helping save the lives of people facing this deadly infectious disease. We look forward to reviewing the trial data and are working with governments and other collaborators, including BARDA, to make REGN-EB3 available for the current outbreak and future use."