Drugs / EDP-514
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04971512 | Aug → Dec 2021 | chronic hepatitis B virus infection | Enanta Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1 | NCT04783753 | Nov 2020 → Jun 2021 | hepatitis B virus infection | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04470388 | Sep 2020 → Aug 2021 | chronic hepatitis B virus infection | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04008004 | Jun 2019 → Jul 2021 | chronic hepatitis B virus infection | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-06-08 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Data Presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022 enanta.com ↗
EDP-514, a Potent Pangenotypic Class II Hepatitis B Virus Core Inhibitor Demonstrates Significant HBV DNA and HBV RNA Reductions in a Phase 1b Study in Viremic, Chronic Hepatitis B Patients |
| 2021-11-12 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Positive Final Data from its Phase 1b Studies of EDP-514, a Novel Hepatitis B Virus Core Inhibitor enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced final Phase 1b data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, in conjunction with two posters presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD). |
| 2021-06-22 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Positive Data from Phase 1b Study of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic Chronic HBV Patients enanta.com ↗
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. |
| 2021-05-06 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Positive Data from Part 2 of its Phase 1b Study of EDP-514 in Chronic Hepatitis B Virus Patients on Treatment with a Nucleoside Reverse Transcriptase Inhibitor enanta.com ↗
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. |
| 2021-05-06 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET enanta.com ↗
Reported Positive Data from a Phase 1b Study of EDP-514 in NUC-Suppressed Chronic Hepatitis B Virus (HBV) Patients Supporting Once Daily Dosing and Combination Approach |
| 2020-08-28 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents New Data from its Hepatitis B and Non-Alcoholic Steatohepatitis Programs at the Digital International Liver Congress™ 2020 enanta.com ↗
New Pharmacokinetic and Safety Results from Phase 1a Study of HBV Core Inhibitor EDP-514, Highlighting Good Safety and Tolerability, and Pharmacokinetics Suitable for Once Daily Dosing |
| 2020-02-06 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter and Three Months Ended December 31, 2019 enanta.com ↗
We achieved the first of our 2020 milestones with today’s announcement of positive data in healthy subjects with EDP-514, our core inhibitor for HBV. |
All press releases naming this drug 9 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EDP-514 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04783753 ↗ |
| Route | Oral | “orally administered doses of EDP-514” NCT04008004 ↗ |