Safety threat forces Enanta to scrap HBV trials — sending discovery team back to drawing board

2021-11-19

A Massachusetts biotech will discontinue the development of its oral drug intended to treat patients suffering from chronic hepatitis B infections, the company said Thursday. Enanta Pharmaceuticals will no longer develop EDP-721. The news comes after safety signals were seen in healthy participants in a Phase I trial after they were administered the drug, and despite a clean safety profile demonstrated in preclinical trials. “Patient safety is our top priority, and we have therefore decided to discontinue further development of this compound,” said CEO Jay Luly. “We are committed to developing a functional cure for chronic hepatitis B patients, and remain confident in EDP-514, our HBV core inhibitor, which has demonstrated safe and robust antiviral activity in Phase 1b studies of viremic and NUC-suppressed patients with chronic HBV infection.” Enanta will advance its HBV program after further discovery efforts, Luly said. Hepatitis B is a viral infection that can attack the liver and cause both acute and chronic disease. It is most typically transmitted from mother to child in birth and delivery, as well as through other bodily fluids. An estimated 290 million people around the world have chronic HBV infections. Enanta is currently developing candidates to target respiratory syncytial virus, HBV and Covid-19. Its R&D efforts are funded through royalties from its hepatitis C virus products developed alongside AbbVie. Early last month, the company offloaded in-house development of its two FXR agonist NASH drugs, EDP-305 and follow-up candidate EDP-297, and said it would move to an out-licensing strategy after the early data showed little chance of solo success for either drug. Baird analyst Brian Skorney called the decision “incrementally positive,” remarking that Enanta could focus its work on efforts in Covid-19, RSV and HBV, while avoiding the long, winding road that comes along with NASH. But the latest setback will send the company back to the drawing board again. “We believe that the multiple mechanisms in development for NASH today, which reflect the complex pathophysiology of this disease, make it likely that a combination approach with FXR agonists will ultimately provide the optimal treatment regimen for patients,” Luly said in a statement. Enanta did announce positive data from its Phase Ib study of EDP-514 to treat NUC-suppressed chronic HBV patients. The trial showed that it was safe and well-tolerated, and the data support a once-daily oral dosing regimen.

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