What's Happening?
Vir Biotechnology has announced promising results from its Phase 2 SOLSTICE trial, which evaluated the combination of tobevibart and elebsiran for treating chronic hepatitis delta (CHD). The trial demonstrated
that 66% of participants achieved undetectable levels of hepatitis delta virus (HDV) RNA after 48 weeks of treatment. The combination therapy also showed reductions in alanine aminotransferase (ALT) levels and was well-tolerated, with no severe treatment-related adverse events. These findings were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting and published in the New England Journal of Medicine. The ECLIPSE registrational program, which includes three trials, is underway to further evaluate this combination therapy, with results expected in early 2027.
Why It's Important?
The development of an effective treatment for chronic hepatitis delta is significant due to the severe nature of the disease, which can lead to cirrhosis, liver failure, and death. Currently, there are no approved treatments for CHD in the U.S., and options are limited globally. The combination of tobevibart and elebsiran offers a potential breakthrough by targeting the virus through multiple mechanisms. The U.S. FDA has recognized the potential of this treatment with Breakthrough Therapy and Fast Track designations, highlighting its importance in addressing a critical unmet medical need. Successful development could provide a much-needed therapeutic option for patients and potentially reduce the disease burden.
What's Next?
Vir Biotechnology is advancing its ECLIPSE registrational program, which includes three randomized, controlled trials to evaluate the safety and efficacy of the tobevibart and elebsiran combination. The program aims to provide the necessary data for regulatory submissions. Topline results from these trials are anticipated in the first quarter of 2027. If successful, this could lead to the first approved treatment for CHD in the U.S., offering hope to patients and potentially setting a new standard of care for this challenging condition.
