FDA Grants Fast Track Designation to Enanta Pharmaceuticals, Inc.’s FXR Agonist Candidate, EDP-305, for Treatment of NASH with Liver Fibrosis
January 04, 2017 at 06:00 pm IST
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Enanta Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Enanta’s drug candidate EDP-305, an FXR agonist, Fast Track designation for the treatment of patients with non-alcoholic steatohepatitis (NASH) with liver fibrosis. Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is also eligible for more frequent meetings and communications with the FDA to discuss the drug's development plan. EDP-305 is currently in Phase 1 clinical development. Enanta’s double-blind, placebo-controlled Phase 1a/b study is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-305 in healthy adults, and in adults with presumptive non-alcoholic fatty liver disease (NAFLD) (obese, with or without pre-diabetes or type 2 diabetes). The study will enroll approximately 90 subjects and is planned to evaluate up to 5 dose cohorts, with EDP-305 administered orally, once daily. The current study includes subjects with presumptive NAFLD in order to obtain initial safety data and additional data regarding the relationship between EDP-305 plasma concentration levels and certain pharmacological effects in the context of fatty liver disease. This relationship will be explored by using biomarkers that are relevant to the disease and to the activity of EDP-305, such as evaluation of lipids, glucose, insulin resistance and specific markers of FXR activity.
Enanta Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to creating small molecule drugs with an emphasis on indications in virology and immunology. The Company's research and development programs are focused on respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU). The Company discovered glecaprevir, the second of two protease inhibitors discovered and developed through its collaboration with AbbVie for the treatment of chronic infection with hepatitis C virus (HCV). Glecaprevir is co-formulated as part of AbbVie's direct-acting antiviral (DAA) combination treatment for HCV, which is marketed under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.) (glecaprevir/pibrentasvir). Its research and development programs are in virology, namely RSV, SARS-CoV-2 and hepatitis B virus. The Company has a research program targeting development of single agents with broader spectrum antiviral activity against both RSV and human metapneumovirus (hMPV).