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Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":" WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-235, its coronavirus 3CL protease inhibitor (also known as the main coronavirus protease, or Mpro) specifically designed as a once-daily, oral treatment for COVID-19.\n\n\"Despite the broad availability of vaccines, there remains a need for highly potent, oral treatments specifically designed to target SARS-CoV-2, a virus that continues to persist and mutate globally. Receiving Fast Track designation from the FDA underscores EDP-235’s potential as a once-daily, oral therapeutic for the treatment and prevention of SARS-CoV-2 infection and as another option in the global fight against the ongoing pandemic,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We believe that the profile of EDP-235 positions it as a potential best-in-class antiviral therapeutic and we remain on track to report data from our ongoing Phase 1 study of EDP-235 next quarter. We look forward to working with the FDA to continue to advance EDP-235 as expeditiously as possible.\"\n\nThe Fast Track program is designed to accelerate the development and review of products such as EDP-235, 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.\n\nCurrently, EDP-235 is in a first-in-human Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of oral EDP-235 in single ascending doses (SAD), including a two-part food effect cohort, and multiple ascending doses (MAD), compared to placebo in healthy volunteers.\n\nPreclinical data show that EDP-235 potently blocks the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells where an EC90 of 33 nanomolar was observed, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection. Preclinical studies demonstrate that EDP-235 has good oral bioava...