Enanta announces data from of EDP-323 study to treat respiratory syncytial virus

Enanta Pharmaceuticals announced positive topline data from a Phase 1 study assessing the safety, tolerability, and pharmacokinetics of orally administered single ascending doses and multiple ascending doses of EDP-323 in healthy adult subjects. EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration, is a novel L-protein inhibitor in development as a once-daily oral treatment for respiratory syncytial virus. Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with good exposure multiples, thereby supporting further clinical advancement of EDP-323. “With the significant unmet need for effective antivirals to treat patients with RSV, we are pleased to report positive Phase 1 results for EDP-323. These data demonstrate that EDP-323 was generally safe and well-tolerated up to 800 mg, with a PK profile supportive of once-daily dosing and strong exposure multiples across both RSV A and B strains” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “EDP-323 is an inhibitor of the L-protein, a distinct mechanism of action from EDP-938, our potent N-protein inhibitor, which allows the potential for each compound to be used alone or in combination therapy. With these positive results, we are advancing EDP-323 into a human challenge study by early fourth quarter of 2023 and we look forward to continuing to build upon our leadership in the RSV field.” …Based on these positive data, Enanta plans to initiate a human challenge study evaluating EDP-323 by early fourth quarter of 2023.