Vir Biotechnology Secures Breakthrough Designation for Chronic Hepatitis Delta Treatments

### Vir Biotechnology Advances Treatments for Chronic Hepatitis Delta

Vir Biotechnology, Inc. announces a significant milestone in its fight against chronic hepatitis delta (CHD), as the U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy designation to its therapies tobevibart and elebsiran. Concurrently, the European Medicines Agency (EMA) awards these treatments Priority Medicines (PRIME) designation. These recognitions are rooted in promising safety and efficacy data presented from the Phase 2 SOLSTICE trial at the recent AASLD The Liver Meeting® in San Diego. The upcoming Phase 3 ECLIPSE registrational program is set to commence in the first half of 2025, aiming to further evaluate the effectiveness of this therapeutic combination.

CHD is a severe liver condition caused by the hepatitis delta virus, which drastically increases the risk of liver cancer and can lead to cirrhosis and liver failure within five years of infection. Currently, there are no approved therapies available for CHD in the U.S., and treatment options are limited in Europe and globally. Mark Eisner, M.D., M.P.H., Chief Medical Officer at Vir Biotechnology, underlines the urgent need for effective treatment solutions. The SOLSTICE trial data strengthens this need, as it reveals that the combination of tobevibart and elebsiran can reduce the hepatitis delta virus to undetectable levels, potentially offering hope to patients grappling with this life-threatening disease.

The FDA and EMA designations aim to accelerate the development of investigational therapies for serious medical conditions with unmet needs. They facilitate early dialogue between drug developers and regulators to enhance data collection and expedite marketing authorization applications. Earlier in the year, both therapies received FDA Fast Track designation and a positive opinion from the EMA’s Committee for Orphan Medicinal Products, further solidifying their potential to transform the treatment landscape for CHD.

In summary, Vir Biotechnology is poised to make significant strides in addressing the critical need for effective therapies for CHD. With the Phase 3 ECLIPSE trial on the horizon, the company is dedicated to advancing research that could lead to much-needed treatment options for patients suffering from this severe liver disease. The recognition from regulatory bodies underscores the promising nature of their therapies and the potential for these treatments to improve patient outcomes in a currently underserved medical area.