Vir Biotech Gets FDA Breakthrough and EMA PRIME for Tobevibart and Elebsiran in Chronic Hepatitis Delta

Vir Biotechnology, Inc. has announced significant progress in its efforts to combat chronic hepatitis delta (CHD), a severe and progressive liver disease caused by the hepatitis delta virus. The company's investigational therapies, tobevibart and elebsiran, have received both Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). These designations highlight the potential of these therapies to offer new hope for individuals suffering from this challenging condition.

The Phase 2 SOLSTICE trial provided the compelling data that supported these designations. This trial demonstrated the safety and efficacy of tobevibart and elebsiran in reducing hepatitis delta virus (HDV) levels to undetectable amounts. The study's results were recently shared at The Liver Meeting® organized by the American Association for the Study of Liver Diseases (AASLD) in San Diego. Following these encouraging findings, Vir Biotechnology plans to advance its Phase 3 ECLIPSE registrational program for tobevibart and elebsiran, aiming to start in the first half of 2025.

Chronic hepatitis delta is a particularly severe form of viral hepatitis, often leading to liver cancer, cirrhosis, and liver failure within five years of infection. Currently, there is no approved treatment for CHD in the United States, and treatment options are limited in Europe and worldwide. This highlights the urgent need for effective therapeutic solutions for individuals affected by this debilitating disease.

Dr. Mark Eisner, Executive Vice President and Chief Medical Officer at Vir Biotechnology, emphasized the devastating impact of chronic hepatitis delta on patients' lives and the importance of developing highly effective treatment options. He expressed optimism that the FDA Breakthrough Therapy and EMA PRIME designations will expedite the development and availability of tobevibart and elebsiran for those in need.

The FDA's Breakthrough Therapy designation is intended to accelerate the development and review process for therapies that have shown promising preliminary clinical evidence in addressing serious conditions. Similarly, the EMA's PRIME designation is granted to investigational medicines with the potential to offer significant benefits over existing treatments. Both designations aim to facilitate the timely introduction of innovative therapies to patients.

The Phase 2 SOLSTICE trial was a multi-center, open-label, and randomized study designed to evaluate the safety, tolerability, and efficacy of tobevibart, either alone or in combination with elebsiran, in patients with CHD. The trial's primary endpoints included assessing the proportion of participants with undetectable HDV RNA levels, normalization of alanine aminotransferase (ALT), and monitoring treatment-emergent adverse events. Secondary endpoints focused on evaluating HDV RNA levels at various timepoints over the study duration.

Tobevibart is a broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen, designed to prevent the entry of hepatitis B and delta viruses into liver cells and reduce circulating viral particles. Elebsiran is a small interfering ribonucleic acid (siRNA) therapy aimed at degrading hepatitis B virus RNA transcripts, thereby limiting the production of the hepatitis B surface antigen. Both tobevibart and elebsiran are administered subcutaneously and are in clinical development for treating chronic hepatitis B and delta infections.

Vir Biotechnology is a clinical-stage biopharmaceutical company dedicated to using the immune system to develop treatments for serious infectious diseases and cancer. The company is engaged in various clinical and preclinical programs targeting infectious diseases and oncologic malignancies. Through its innovative research, Vir Biotechnology aims to bring new therapeutic solutions to patients with unmet medical needs.