Enanta Pharmaceuticals Reports Antiviral For Respiratory Syncytial Virus Reduces Virus Levels, Symptoms In Study

Enanta Pharmaceuticals Inc. ENTA released on Thursday topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV).

The 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), a 97%-98% reduction in infectious viral load AUC by viral culture, and a 66%-78% reduction of total clinical symptoms score AUC compared to placebo.

EDP-323 lowered viral load AUC by 85% in the high-dose arm and 87% in the low-dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups.

EDP-323 received an FDA Fast Track designation. It is a novel L-protein inhibitor being developed as a once-daily oral treatment for RSV.

EDP-323 demonstrated favorable pharmacokinetics, supporting once-daily dosing. Mean trough plasma concentrations were maintained at 16-fold above the protein-adjusted EC90 with the low dose and 35-fold above the protein-adjusted EC90 with the high dose for both RSV A and B strains.

Overall, EDP-323 demonstrated a favorable safety profile over a five-day dosing period and through 28 days of follow-up. Adverse events were similar between EDP-323 dosing groups and placebo.

Enanta has another RSV treatment under development, zelicapavir, the company’s lead oral N-protein inhibitor.

Zelicapavir is being evaluated in two Phase 2 clinical trials in high-risk pediatric and adult populations.

ENTA Price Action: Enanta Pharmaceuticals stock is down 1.83% at $10.48 at publication Thursday.

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