EDP-721 / Enanta Pharma - LARVOL DELTA

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b | N=26 | Terminated | Sponsor: Enanta Pharmaceuticals | N=106 ➔ 26 | Trial completion date: Aug 2023 ➔ Dec 2021 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2023 ➔ Dec 2021; Due to adverse safety signals in Part 1 (HV)

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Enanta Pharmaceuticals Announces Update to its Hepatitis B Virus (HBV) Program (Businesswire) - "Enanta Pharmaceuticals, Inc...announced it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers."

Discontinued • Hepatitis B • Infectious Disease

"$ENTA Discontinuing Clinical Development of EDP-721, an Oral HBV RNA Destabilizer" (@BioStocks)

Clinical

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b; N=106; Recruiting; Sponsor: Enanta Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-721, Its Oral Hepatitis B Virus RNA Destabilizer (Businesswire) - "Enanta Pharmaceuticals, Inc...today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for chronic HBV patients....Data from the first part of the study are expected in the first half of 2022."

P1 data • Trial status • Hepatitis B • Infectious Disease

Enanta Pharmaceuticals Reports Financial Results for Its Fiscal Third Quarter Ended June 30, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET (Businesswire) - "On track to dose the first subject this month in a Phase 1 clinical study of EDP-721, an oral, potent and selective HBV RNA destabilizer being developed for use in combination with other mechanisms, with the goal of developing an all-oral regimen to achieve a functional cure. Data are expected in the first half of 2022."

New P1 trial • P1 data • Hepatitis B • Infectious Disease

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION. (clinicaltrials.gov) - P1a/1b; N=106; Not yet recruiting; Sponsor: Enanta Pharmaceuticals

Clinical • Combination therapy • New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

[VIRTUAL] Discovery and characterization of EDP-721, a novel hepatitis B virus RNA destabilizer (EASL-ILC 2021) - "EDP-721 is a potent and selective HBV RNA destabilizer that leads to robust reductions in viral proteins including, HBsAg, and has the potential to be a key component of a regimen enabling a functional cure for CHB."

Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

ENANTA PHARMACEUTICALS PRESENTS NEW DATA FOR EDP-721, AN ORAL HEPATITIS B VIRUS RNA DESTABILIZER, AT THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL) INTERNATIONAL LIVER CONGRESS (Enanta Press Release) - "Enanta Pharmaceuticals, Inc...today reported new preclinical data for EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for HBV. The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model...Enanta expects to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety and tolerability of EDP-721 in healthy volunteers in mid-2021."

New P1 trial • Preclinical • Hepatitis B • Infectious Disease

Enanta Pharmaceuticals to Present Preclinical Data for EDP-721, its Novel Oral Hepatitis B Virus RNA Destabilizer, at the International Liver Congress 2021 Sponsored by the European Association for the Study of the Liver (Businesswire) - "Enanta Pharmaceuticals, Inc...announced that the company will have a poster presentation showcasing preclinical data for EDP-721, a novel, potent and selective oral HBV RNA destabilizer being developed for use in an all-oral functional cure of hepatitis B virus, at the upcoming European Association for the Study of the Liver’s (EASL) International Liver Congress 2021, being held virtually June 23-26, 2021."

Preclinical • Hepatitis B • Infectious Disease