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Enanta Pharmaceuticals Reports Positive Data from Phase 1b Study of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic Chronic HBV Patients
Positive 28-Day Data from First Two EDP-514 Dose Cohorts: 200 mg and 400 mg EDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\nPositive 28-Day Data from First Two EDP-514 Dose Cohorts: 200 mg and 400 mg\n\nEDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of Once-Daily, Oral Dosing\n\nPatients Dosed with 400 mg EDP-514 Showed a Mean Reduction of 3.3 Logs in HBV DNA\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 announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta’s novel class II oral HBV core inhibitor, was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively.\n\n“We are extremely pleased with these promising clinical results for EDP-514, which are comparable to the best antiviral effects reported for any core inhibitor to date and also extend the compound’s excellent safety and tolerability profile,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “In particular, we are encouraged by the rapid and robust declines in HBV DNA, which position EDP-514 to be a key component of a combination regimen for HBV. We believe EDP-514, in combination with a NUC and other mechanisms, could provide a foundation for an all-oral treatment approach to achieve functional cures in patients with chronic HBV infection. We look forward to progressing EDP-514 in combination with our oral HBV RNA destabilizer, EDP-721, a compound that has demonstrated significant reductions in HBsAg preclinically and which we expect to advance into the clinic mid-year. Ultimately, our all-oral, triple combination approach could provide potent suppression of multiple key steps in HBV replication, including HBV DNA, HBV RNA and HBsAg, to achieve our goal of developing a functional cure for HBV patients.”\n\nThe randomized, double-blind, placebo-controlled Phase 1b study is evaluating the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in viremic patients with chronic HBV...