Enanta Pharmaceuticals’ EDP-323 Receives the US FDA’s Fast Track Designation for the Treatment of Respiratory Syncytial Virus
- The US FDA has granted FTD for Enanta’s EDP-323 (L-protein inhibitor) for the treatment of the respiratory syncytial virus. EDP-323 is being studied in a P-I study evaluating the safety, tolerability, and PK with expected results in Q2’23
- The company plans to present new preclinical PK data at ECCMID 20323. EDP-323 has good oral bioavailability, good plasma exposures in preclinical species, and PK characteristics that support qd, oral dosing in humans
- In vitro data showed that EDP-323 significantly inhibits RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types
Ref: Businesswire | Image: Enanta Pharmaceuticals
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