Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

ENTA reports_positive_phase-1b_data_for EDP-514 in_viremic_HBV patients:

https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Phase-1b-Study-of-EDP-514-a-Hepatitis-B-Virus-HBV-Core-Inhibitor-in-Viremic-Chronic-HBV-Patients/default.aspx

Enanta Pharmaceuticals…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.

“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 [i.e. EDP-721, ENTA’s small-molecule RNA destabilizer (#msg-164178077)], could provide a foundation for an all-oral treatment approach to achieve functional cures in patients with chronic HBV infection.

The third dosing cohort from this phase-1b EDP-514 trial (800mg; n=6) is still in progress.

Please see the bottom of #msg-163654846 for related info.