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Phase 3 trials of treatment combo for hepatitis D expected in 2025

On the heels of positive Phase 2 clinical trial data, Vir Biotechnology is planning for the 2025 launch of a Phase 3 program, dubbed ECLIPSE, to test its treatment combination of tobevibart and elebsiran in adults with chronic hepatitis D.

If positive, the results from the program’s two Phase 3 trials are expected to support regulatory applications for approval of the treatment duo, the company stated in a press release announcing the Phase 2 study data.

Findings from the ongoing Phase 2 SOLSTICE study (NCT05461170) show the treatment combo suppressed the hepatitis delta virus — known as HDV, or hepatitis D — and normalized a liver damage marker in hepatitis D patients.

“People living with hepatitis delta in the U.S. have no approved treatment options, and therapies are limited globally,” said Marianne De Backer, PhD, CEO of Vir. “We are confident that our regimen has the potential to deliver transformative benefits for patients, and we will build on our strong SOLSTICE data to start our Phase 3 registrational ECLIPSE program as soon as possible in 2025.”

Vir presented SOLSTICE data at a session of The Liver Meeting, hosted by the American Association for the Study of Liver Diseases on Nov. 16 in San Diego.

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