- Enanta Pharmaceuticals Inc ENTA has announced data from the first two dose cohorts of Part 2 of its Phase 1b study evaluating EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC).
- The data demonstrated that EDP-514, the Company's novel class II oral HBV core inhibitor, was safe and well-tolerated, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in a mean reduction in HBV RNA of 1 log.
- A mean reduction in HBV RNA of 1 log (10 times) was observed in patients dosed with EDP-514 compared to 0.3 log (2 times) in the placebo group after 28 days of treatment, similar to reported results for other HBV core inhibitors.
- A maximum reduction of 2.3 log (HBeAg-negative) and 2.8 log (HBeAg-positive) was observed in patients receiving EDP-514 compared with a maximum 1.2 log reduction in those receiving placebo.
- The HBV DNA assessment did not show any change from baseline as these patients already had suppressed HBV DNA levels from NUC therapy. Additionally, no virologic failure or breakthrough was observed, and as expected, there were no changes in HBsAg, HBeAg, or HBcrAg levels.
- EDP-514 was safe and well-tolerated, and pharmacokinetics were supportive of once-daily dosing.
- EDP-514 exposure increased linearly with dose, achieving trough concentrations up to 18-fold the protein-adjusted EC50.
- No liver enzyme elevations or other laboratory abnormalities were reported, and no serious adverse events occurred during the treatment period and the 4-week follow-up.
- Price Action: ENTA shares are trading lower by 2.98% at $49.47 on the last check Friday.
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