Enanta Pharmaceuticals Achieves Breakthrough in RSV Treatment with EDP-323, Demonstrating Significant Reductions in Viral Load and Symptoms

EDP-323 Efficacy:
EDP-323, a novel L-protein inhibitor, showed highly statistically significant reductions in viral load and clinical symptoms in a Phase 2a human challenge study involving healthy adults infected with RSV.

Viral Load Reduction:
The study revealed an 85-87% decrease in viral load AUC and a 97-98% decrease in infectious viral load AUC compared to placebo, with no significant difference between the high and low dose groups.

Symptom Alleviation:
EDP-323 demonstrated a 66-78% reduction in clinical symptoms AUC compared to placebo, highlighting its potential as a safe and effective direct-acting antiviral for RSV treatment.

Safety Profile:
The drug exhibited a favorable safety profile with no serious adverse events, severe adverse events, or adverse events leading to treatment discontinuation or study withdrawal.

Fast Track Designation:
EDP-323 has received Fast Track designation from the FDA, underscoring its potential to address the significant unmet need for safe and effective oral treatments for RSV infections.

Enanta's Portfolio:
Enanta Pharmaceuticals has a leading portfolio of potent RSV replication inhibitors, including EDP-323 and zelicapavir, both in Phase 2 development, offering distinct mechanisms that could be developed as standalone treatments or in combination for specific patient populations.