Enanta receives FDA fast track designation for L-protein inhibitor for RSV treatment

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Enanta Pharmaceuticals, Inc., a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections, has received Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV) from the the U.S. Food and Drug Administration (FDA).

"Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, MD, senior vice president and chief medical officer of Enanta Pharmaceuticals. “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. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”Scott T. Rottinghaus, MDScott T. Rottinghaus, MD

The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met.

EDP-323 is being evaluated in a phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April and expects to report topline data from the phase 1 study this quarter.

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