WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that data from Enanta’s wholly-owned development programs, including EP-027367, one of Enanta’s novel core inhibitors in preclinical testing for hepatitis B virus (HBV), and EDP-305, an FXR agonist in development for non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC), have been accepted for presentation at The International Liver Congress™ (ILC) 2018, April 11-15, in Paris, France.
EP-027367, one of several core inhibitors Enanta is evaluating, has been selected for an oral presentation. There will also be three posters on EDP-305, which is currently in a Phase 2 study for NASH and a Phase 2 study for PBC. The U.S. Food and Drug Administration has granted EDP-305 Fast Track designation for the treatment of NASH patients with liver fibrosis and Fast Track designation for the treatment of patients with PBC.
In addition, several abstracts from AbbVie will be presented on their HCV regimens containing glecaprevir/pibrentasvir and marketed under the tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.). Glecaprevir is Enanta’s second protease inhibitor discovered and commercialized through its protease inhibitor collaboration with AbbVie.
The full ILC 2018 scientific program as well as the abstracts can be found at http://ilc-congress.eu/. Further details will be available at the time of these presentations.
Thursday, April 12, 17:45 - 18:00 CET
PS-032 - “Discovery of a novel HBV core inhibitor EP-027367 with potent antiviral activity both in vitro and in a humanized mouse model” (M.Vaine, S.Clugston, J.Kass, X. Gao, H. Cao, W. Li, X. Peng, L.J. Jiang, K. Daniels, Y. Qiu, Y.S. Or, K. Lin)
Thursday, April 12, 09:00 - 17:00 CET
- THU-469 - “EDP-305 modulates lipoprotein metabolism via distinct chromatin and microRNA regulatory mechanisms” (M. Roqueta-Rivera, M.D. Chau, K. Garlick, Y. Li, G. Wang, Y.S. Or, and L.J. Jiang)
Friday, April 13, 09:00 - 17:00 CET
- FRI-084 - “EDP-305, a highly selective and potent farnesoid X receptor agonist, favorably regulates the expression of key fibrogenic genes in vitro and in vivo” (Y. Li, J.Y. Shang, M.D. Chau, M. Roqueta-Rivera, K. Garlick, P. An, K. Vaid, G. Wang, Y. Popov, Y. S. Or, and L. J. Jiang)
- FRI-489 - “Pharmacokinetics, pharmacodynamics, and safety of EDP-305, in healthy and presumptive NAFLD subjects” (A. Ahmad, K. Sanderson, D. Dickerson, N. Adda)
Enanta Pharmaceuticals has used its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery of small molecule drugs for the treatment of viral infections and liver diseases. Two protease inhibitors, glecaprevir and paritaprevir, discovered and developed through Enanta’s collaboration with AbbVie, have now been approved in jurisdictions around the world as part of AbbVie’s direct-acting antiviral (DAA) regimens for the treatment of hepatitis C virus (HCV) infection, including the regimens marketed as MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir) and VIEKIRA PAK® (paritaprevir/ritonavir/ombitasvir/dasabuvir) (U.S.) and VIEKIRAX® (paritaprevir/ritonavir/ombitasvir) (ex-U.S.).
Royalties from the AbbVie collaboration are helping to fund Enanta’s research and development efforts, which are currently focused on the following disease targets: non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B virus (HBV). Please visit www.enanta.com for more information.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for continuing royalties from the AbbVie collaboration and the prospects for Enanta’s further development of EDP-305 and EP-027367. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the marketing and commercialization efforts of others with respect to treatment regimens for HCV that are competitive with MAVYRET/MAVIRET; regulatory and reimbursement actions affecting MAVYRET/MAVIRET, any competitive regimen, or both; the development risks of Enanta’s early stage discovery efforts in NASH, PBC, RSV and HBV; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key scientific personnel; the need to obtain and maintain patent protection for glecaprevir and Enanta’s other product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-Q for the fiscal quarter ended December 31, 2017 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.