Business
Enanta Pharmaceuticals Provides Update on NASH FXR Agonist Programs
– EDP-305 1.0 mg Selected as Optimal Dose Following ARGON-2 Interim Analysis – – EDP-297 Not Substantially Differentiated from EDP-305 Based on Recent Phase
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n– EDP-305 1.0 mg Selected as Optimal Dose Following ARGON-2 Interim Analysis –\n\n– EDP-297 Not Substantially Differentiated from EDP-305 Based on Recent Phase 1 Results –\n\n– Company to Discontinue ARGON-2 Trial Evaluating EDP-305 as a Monotherapy and Prioritize Combination Approaches for FXR Agonists Through Out-Licensing Strategy –\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today provides an update on its two clinical stage farnesoid X receptor (FXR) agonists, EDP-305 and EDP-297, for the treatment of non-alcoholic steatohepatitis (NASH). A pre-planned interim analysis of a subset of patients through week 12 in the Phase 2b ARGON-2 study of EDP-305 as a monotherapy and data from its Phase 1 clinical study of EDP-297 provided meaningful information on dose selection and characterization for these compounds. Enanta has made a business decision to prioritize combination approaches through an out-licensing strategy for further development of these two programs and does not plan to continue further development internally.\n\n“Looking at a broad range of doses in NASH patients, our interim analysis of EDP-305 in ARGON-2, in comparison to clinical data from ARGON-1, indicates that the 1.0 mg dose of EDP-305 provides the best balance of efficacy and tolerability,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We believe that the multiple mechanisms in development for NASH today, which reflect the complex pathophysiology of this disease, make it likely that a combination approach with FXR agonists will ultimately provide the optimal treatment regimen for patients. Given this evolving landscape, we have decided to discontinue the 72-week ARGON-2 study early in favor of pursuing a combination regimen. Based on the significant data generated to date, we believe EDP-305, our lead, late-stage candidate, which has been administered in almost 600 patients for up to 12 weeks, and EDP-297, our follow-on candidate, are well-positioned to be an important component of a combination therapy to bring a much-needed treatment to patients with NASH. Going forward, we are eager to concentrate our resources on developing oral drug candidates ...