Enanta’s EDP-323 meets Phase 2a endpoints in respiratory syncytial virus

Enanta Pharmaceuticals announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus – RSV -. These data demonstrated that EDP-323 was generally safe and well-tolerated and achieved an 85-87% reduction in viral load area under the curve – AUC – by qRT-PCR, a 97-98% reduction in infectious viral load AUC by viral culture, and a 66-78% reduction of total clinical symptoms score AUC vs. placebo. EDP-323, which received Fast Track designation from the FDA, is a novel L-protein inhibitor in development as a once-daily oral treatment for RSV. EDP-323 demonstrated a rapid and sustained antiviral effect. EDP-323 demonstrated favorable pharmacokinetics, supportive of once-daily dosing. Overall, EDP-323 demonstrated a favorable safety profile over a 5-day dosing period and through 28 days of follow-up. Adverse events were similar between EDP-323 dosing groups and placebo. There were no serious adverse events, no severe adverse events, and no adverse events leading to treatment discontinuation or study withdrawal.