Oral Therapy for Respiratory Syncytial Virus Gets Fast Track Designation

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The FDA's Fast Track designation allows for accelerated development and review of the product.

The Food and Drug Administration (FDA) has granted Fast Track designation to EDP-323 for the treatment of respiratory syncytial virus (RSV).

The designation is supported by in vitro data that showed EDP-323, a novel, oral L-protein inhibitor, significantly reduced RSV replication with consistent potency across a range of RSV clinical isolates in various cell types.

The investigational agent is currently being evaluated in a double-blind, placebo-controlled phase 1 study (ClinicalTrials.gov Identifier: NCT05587478) that will assess the safety, tolerability, and pharmacokinetics of EDP-323 in healthy adults. Topline study data is expected in the second quarter of 2023.

“Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window,” said Scott T. Rottinghaus, MD, Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”


Enanta Pharmaceuticals receives FDA Fast Track designation for EDP-323, its oral, L-protein inhibitor in development for the treatment of respiratory syncytial virus. News release. Enanta Pharmaceuticals. Accessed April 6, 2023. https://www.businesswire.com/news/home/20230406005158/en/Enanta-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-EDP-323-its-Oral-L-Protein-Inhibitor-in-Development-for-the-Treatment-of-Respiratory-Syncytial-Virus.