Enanta Pharma reports topline results from Phase 2a RSV trial
Enanta Pharmaceuticals (NASDAQ:ENTA) reported that, compared with placebo, EDP-938 significantly reduced viral load and resolved clinical symptoms in healthy adults infected with respiratory syncytial virus (RSV).
In the Phase 2a human challenge study of EDP-938, an N-protein inhibitor, 115 subjects were inoculated with RSV. Once infection was confirmed, participants were randomized to receive either 600 mg of EDP-938 once-daily, a 500 mg loading dose followed by a 300 mg twice-daily dose of EDP-938, or placebo, for five days.
EDP-938 administration resulted in a statistically significant reduction in viral load compared with placebo. There was no statistically significant difference between the two EDP-938 dosing groups.
“RSV is a serious unmet medical need with no therapeutic treatment currently available,” Jay Luly, Enanta’s president and CEO, said in a statement.
“Based on today’s positive data for EDP-938, the only N-inhibitor in clinical development, our goal is to initiate our first Phase 2b study by the end of calendar 2019 in adult outpatients with confirmed RSV infections,” he added.