Vir Biotechnology's Tobevibart and Elebsiran Receive FDA and EMA Designations for Chronic Hepatitis Delta Treatment

Vir Biotechnology (VIR) has recently announced significant advancements in the treatment of chronic hepatitis delta (CHD), with its drugs tobevibart and elebsiran receiving U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation. These designations are a testament to the promising safety and efficacy data emerging from the Phase 2 SOLSTICE trial, which was recently presented at the AASLD The Liver Meeting in San Diego, U.S.

CHD is recognized as the most severe form of chronic viral hepatitis, caused by the hepatitis delta virus. It significantly increases the risk of liver cancer and accelerates the progression to cirrhosis and liver failure, often within five years of infection. Currently, there is no approved treatment for CHD in the U.S., and options are scarce in the European Union and globally.

Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer at Vir Biotechnology, emphasized the urgent need for effective therapeutic options for CHD, stating, "Chronic hepatitis delta has devastating effects on liver and overall health, yet people living with this condition are still waiting for highly effective therapeutic options." He further highlighted that the Phase 2 SOLSTICE trial data suggest tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels.

The Phase 3 ECLIPSE registrational program, which will evaluate tobevibart and elebsiran in CHD, is scheduled to commence in the first half of 2025. This program represents a critical step forward in addressing the unmet medical needs of individuals suffering from CHD, offering hope for a transformative treatment option.