Gilead Sciences today announced week 96 results from its pivotal Phase 3 MYR301 clinical trial of the "first-in-class" inhibitor Hepcludex (bulevirtide) for the treatment of chronic hepatitis D virus (HDV) infection in adults. The analysis showed that continued use of Hepcludex showed clinical benefit in patients who initially produced partial or no remission, and that viral load continued to decline as treatment duration increased.
Hepatitis D is one of the most serious types of viral hepatitis, with a 5-year mortality rate of up to 50% for patients who develop cirrhosis! Generally speaking, the hepatitis D virus only infects people with hepatitis B. With both viruses, hepatitis D virus and hepatitis B virus, the liver becomes more rapidly diseased, liver fibrosis, cirrhosis and liver dyscrasia occur more quickly, and the risk of liver cancer and death is higher.
Hepcludex, developed by MYR GmbH, is an innovative hepatitis therapy that binds to NTCP receptors on the surface of liver cells, thereby inhibiting the entry of hepatitis D virus and hepatitis B virus into liver cells and also inhibiting the spread of the virus within the liver. In March 2021, Gilead Sciences announced the completion of the acquisition of MYR GmbH at a cost of approximately €1.45 billion, thereby acquiring the latter's lead product, Hepcludex.
The evaluation of data on the efficacy and safety of Hepcludex at week 96 of the MYR301 clinical phase 3 trial is based on the 48-week data published yesterday in the New England Journal of Medicine. Patients treated with either the 2 mg or 10 mg dose of Hepcludex achieved similar remissions (i.e., alanine aminotransferase normalization and virologic remission) at week 96. Compared to week 48, patients' combined virologic and biochemical remission rates continued to increase through week 96, with remission rates of 55% and 56% for 2 mg and 10 mg Hepcludex, respectively. In a new analysis, 43% and 82% of patients who presented poor virologic remission (no or partial remission) at 24 weeks on Hepcludex monotherapy achieved virologic remission at 96 weeks of continued treatment, respectively.
The safety profile of the drug at week 96 was consistent with that observed at week 48, with no resistance observed and no serious adverse events due to Hepcludex treatment.