Enanta Pharmaceuticals, Inc. Announces Nomination of Clinical Candidate Edp-235, Its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of Covid-19
August 05, 2021 at 07:00 am EDT
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Enanta Pharmaceuticals, Inc. announced the nomination of EDP-235, its lead oral protease inhibitor specifically designed for the treatment of COVID-19. Enanta plans to advance EDP-235 into the clinic early next year. EDP-235 potently and selectively inhibits SARS-CoV-2 replication in multiple cellular models, including primary human airway epithelial cells, with an EC90 of 33nM. EDP-235 retained activity against protease enzymes from currently circulating SARS-CoV-2 variants. Additionally, EDP-235 has a clean preclinical safety profile and has demonstrated a high barrier to resistance. Importantly, EDP-235 has excellent lung distribution in rats and demonstrates properties supportive of once daily oral dosing, in contrast to other protease inhibitors currently in development. Furthermore, EDP-235 has shown activity against other coronaviruses, providing the opportunity to potentially treat other infections that may emerge in the future. Enanta will apply for Fast Track designation and expects to initiate a Phase 1 single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of EDP-235 in approximately 75 healthy volunteers in early 2022.
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).
Enanta Pharmaceuticals, Inc. Announces Nomination of Clinical Candidate Edp-235, Its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of Covid-19
ENANTA PHARMACEUTICALS, INC. 
