- Enanta Pharmaceuticals (NASDAQ:ENTA) will provide an update on its R&D programs and its 2018 outlook 2018 at the 36th Annual J.P. Morgan Healthcare Conference on January 9 at 4:00 p.m. PT.
- The following are details of Enanta’s R&D program updates and expectations for 2018.
- EDP-305, FXR agonist for NASH/PBC: A Phase 2 dose-ranging INTREPID clinical study of EDP-305 has been initiated in patients with primary biliary cholangitis (PBC). The efficacy will be assessed by evaluating reductions in levels of alkaline phosphatase versus placebo.
- Phase 2 dose-ranging clinical study of EDP-305 in non-alcoholic steatohepatitis (NASH) patients will begin early this year.
- FDA has has granted EDP-305 Fast Track designation for the treatment of NASH and PBC patients.
- Respiratory Syncytial Virus: A Phase 1 clinical study of EDP-938, a potent non-fusion inhibitor of both RSV-A and RSV-B activity, has been initiated. The objective is to evaluate the safety, tolerability and pharmacokinetics of single ascending dose and multiple ascending dose levels of EDP-938 in healthy volunteers.
- Upon successful completion of this study, a Phase 2 proof-of-concept challenge study is expected to begin later in 2018.
- Glecaprevir, Enanta’s second protease inhibitor developed through its collaboration with AbbVie, is now being marketed as MAVYRET (U.S.) or MAVIRET (ex-U.S.).
- Total cash received from AbbVie under the collaboration through December 31, 2017 totaled ~$526M.
- #JPM18
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