Vir Biotechnology, Inc. has announced that its investigational therapies, tobevibart and elebsiran, have been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of chronic hepatitis delta (CHD). These designations are intended to accelerate the development and review of therapies that show promise in treating serious conditions with unmet medical needs.
The FDA and EMA's decisions are supported by data from the Phase 2 SOLSTICE trial, which demonstrated compelling safety and efficacy results. New data from this trial were recently presented at AASLD The Liver Meeting in San Diego. The SOLSTICE trial data indicated that the combination of tobevibart and elebsiran can effectively suppress the hepatitis delta virus, often driving it to undetectable levels.
Clinical Significance of Breakthrough Therapy Designation
The Breakthrough Therapy designation from the FDA is reserved for investigational therapies that demonstrate promising preliminary clinical evidence suggesting a potential improvement over existing treatments for serious conditions. Similarly, the EMA's PRIME designation is granted to medicines targeting conditions with unmet medical needs, where no treatment option exists or where the investigational medicine offers a significant therapeutic advantage over existing options.
"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," said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. "The Phase 2 SOLSTICE trial data suggests that tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels. Receiving FDA Breakthrough Therapy and European PRIME designations recognizes this combination's potential to transform the lives of people living with CHD. We look forward to advancing the Phase 3 ECLIPSE program as quickly as possible."
Upcoming Phase 3 ECLIPSE Program
Vir Biotechnology plans to initiate the Phase 3 ECLIPSE registrational program in the first half of 2025. This program will further evaluate the safety and efficacy of tobevibart and elebsiran in patients with chronic hepatitis delta. The ECLIPSE program is designed to support potential regulatory submissions for the combination therapy.
