HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within 5 years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). At least 12 million people worldwide are likely currently co-infected with HDV and HBV. HDV co-infection leads to more serious liver disease than HBV alone and is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the United States and Europe, there are collectively more than 230,000 people living with HDV, which remains underdiagnosed globally.
"HDV is a devastating disease with high unmet medical need. With Hepcludex we have the opportunity to address that need with a first-in-class therapy,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to working with the team at MYR to realize the full potential of Hepcludex for patients with HDV worldwide. This will build on the work that Gilead has been doing for almost two decades to innovate and improve therapies for viral hepatitis.”
“We are proud of our achievement in bringing Hepcludex from preclinical stage to patients in need within such a short timeframe,” said Dmitry Popov, Chief Executive Officer, MYR GmbH. “We are excited to join Gilead, whose experience in the hepatitis field and global infrastructure will realize the full potential of Hepcludex and provide access to as many patients as possible around the world with this debilitating disease.”
Hepcludex (bulevirtide) is an entry inhibitor that binds to NTCP, an essential HBV and HDV receptor on hepatocytes, blocking the ability of HDV to enter hepatocytes. Bulevirtide has been tested in more than 500 patients in completed and ongoing clinical studies. The benefit of bulevirtide has been demonstrated by an effective reduction of HDV RNA levels and improvement of liver inflammation. In the MYR202 study, which was a controlled, open-label Phase 2 study, 54 of 90 patients treated with bulevirtide plus tenofovir disoproxil fumarate (TDF) had at least a 2 log10 HDV RNA decline or undetectable HDV RNA at week 24 versus 1 of 28 patients given TDF alone. Almost half of patients treated with bulevirtide and TDF also showed a normalization in the blood levels of the liver enzyme ALT, indicating an improvement of liver disease, as compared to 7% of patients who received TDF alone.In the Phase 2 MYR203 study evaluating a 48-week treatment course of bulevirtide, a further 15 patients were treated with Hepcludex 2mg daily monotherapy for 48 weeks. In this limited dataset, the safety and efficacy profiles were similar to patients treated for 24 weeks in combination with TDF in the MYR202 study. Interim 24-week data from the ongoing Phase 3 study MYR301 of bulevirtide is anticipated in the first half of 2021 and is expected to serve as the basis for filing in the United States.