Researchers from Assembly Biosciences Inc. presented the discovery and preclinical characterization of novel small-molecule hepatitis B (HBV) and D virus (HDV) entry inhibitors.
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
New data confirming that Gilead Sciences Inc.’s Hepcludex (bulevirtide) effectively cures hepatitis delta virus (hepatitis D), one of the most severe viral infections of the liver, and favorable phase III results from Madrigal Pharmaceuticals Inc.’s nonalcoholic steatohepatitis (NASH) contender were among the highest-profile scientific announcements at the International Liver Congress (ILC) 2022.
Gilead Sciences Inc.’s move to grab Myr GmbH for about €1.15 billion (US$1.39 billion) in cash up front, with €300 million if the latter’s Hepcludex (bulevirtide) wins FDA clearance, put chronic hepatitis delta virus (HDV) in the headlines and benefited the stock of another player in the space: Eiger Biopharmaceuticals Inc. (NASDAQ:EIGR), which closed at $10.27, up $1.51, or 17%.
Although Eiger Biopharmaceuticals Inc. sees more would-be opportunities with ultra-rare disease-targeting Zokinvy (lonafarnib), the company’s vice president of clinical and development operations, Colin Hislop, said that “at the moment, we’re very clearly focused on the population identified in the label, because it fits most closely with the mechanism of action.”
