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Enanta Pharmaceuticals Announces Positive Data From a Phase 1 Clinical Study of EDP-323, an Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus
- Generally Safe and Well-Tolerated up to 800 mg for Seven Days with Pharmacokinetics Supportive of Once-Daily Dosing - All Doses Resulted in Strong Exposure
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Generally Safe and Well-Tolerated up to 800 mg for Seven Days with Pharmacokinetics Supportive of Once-Daily Dosing\n\n\n- All Doses Resulted in Strong Exposure Multiples Against Both RSV A and B Strains\n\n\n- Human Challenge Study to be Initiated by Early Fourth Quarter 2023\n\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections, today announced positive topline data from a Phase 1 study assessing the safety, tolerability, and pharmacokinetics (PK) of orally administered single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-323 in healthy adult subjects. EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel L-protein inhibitor in development as a once-daily oral treatment for respiratory syncytial virus (RSV). 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.\n\n\n“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.”\n\n\nThis first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study enrolled healthy volunteers to evaluate the safety, tolerability, and PK of oral EDP-323 for seven days. The study evaluated a range of single and multiple doses in fasted and fed states. The SAD phase enrolled a total of six dose cohorts (doses ranging from 50 to 800 mg)...