Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and Business Outlook for 2018 during the 36th Annual J.P. Morgan Healthcare Conference

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 Jay R. Luly, Ph.D., Enanta’s President and Chief Executive Officer, will provide an update on its research and development programs in non-alcoholic steatohepatitis (NASH)/primary biliary cholangitis (PBC), respiratory syncytial virus (RSV), and hepatitis B virus (HBV) and its business outlook for 2018 during Enanta’s presentation at the 36^th Annual J.P. Morgan Healthcare Conference on January 9, 2018 at 4:00 p.m. PT.

“Enanta has executed well on its stated goals and as a result has achieved significant clinical progress,” stated Jay R. Luly, Ph.D. President and CEO Enanta. “We begin the year with two wholly-owned clinical programs ongoing for RSV and PBC, with a third for NASH to initiate soon. In addition, ongoing royalties from our HCV collaboration, along with our strong cash position at the end of our fiscal year of approximately $294 million, provide us a source of non-dilutive funding for these programs.”

The following are details of Enanta’s research and development program updates and expectations for 2018.

Research and Development Update:

EDP-305, FXR agonist for NASH/PBC:

• A Phase 2 dose-ranging clinical study of EDP-305, Enanta’s lead FXR agonist, has been initiated in patients with PBC. The Phase 2 clinical study, “INTREPID”, is a 12-week, randomized, double blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with PBC, with or without an inadequate response to ursodeoxycholic acid. The efficacy of EDP-305 will be assessed by evaluating reductions in levels of alkaline phosphatase versus placebo.
• Enanta plans to initiate a Phase 2 dose-ranging clinical study of EDP-305 in NASH patients in early 2018.
• 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.
• Data is being presented at the 2018 NASH-TAG conference in Park City, Utah, January 4-6, 2018, from Enanta’s Phase 1 study of EDP-305 in healthy subjects and in subjects with presumptive non-alcoholic fatty liver disease (NAFLD). Top line results were first announced on October 23, 2017, and data from this trial studying the safety, pharmacokinetic, and pharmacodynamic properties of EDP-305 support further clinical evaluation of EDP-305 in NASH and PBC patients.

Respiratory Syncytial Virus: