Vir Biotechnology has concluded subject enrolment for the Phase III Eclipse 1 trial assessing the efficacy and safety of tobevibart and elebsiran combination for chronic hepatitis delta (CHD).
This trial is part of the company’s Eclipse registrational programme, which also includes the ongoing Eclipse 2 and Eclipse 3 studies.
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Eclipse 1 aims to provide safety and efficacy data required for submissions to regulatory agencies globally, and in the US and Europe.
The last Eclipse 1 participant is expected to reach the primary endpoint in the fourth quarter of 2026. Topline data are anticipated in the first quarter of 2027.
Vir Biotechnology CEO Marianne De Backer said: “Reaching full enrolment in our Eclipse 1 Phase III clinical trial marks an essential milestone as we work towards submission of the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta to global regulatory agencies.
“We are dedicated to advancing our registrational programme with utmost urgency to deliver a much-needed new treatment option for people living with hepatitis delta.”
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By GlobalDataVir Biotechnology chief medical officer Mark Eisner said: “The strong interest and participation in Eclipse 1 reflect the urgent need for innovative solutions in chronic hepatitis delta, as well as the encouraging potential of the combination of tobevibart and elebsiran.”
CHD is considered the most severe chronic viral hepatitis and has recently been classified as carcinogenic by the International Agency for Research on Cancer. The disease can rapidly progress to cirrhosis, liver failure and death.
Tobevibart and elebsiran aim to target multiple aspects of the viral lifecycle, with the objective of eliminating the virus.
The US Food and Drug Administration (FDA) awarded breakthrough therapy and fast track designations to this combination. In addition, the European Medicines Agency granted priority medicines (PRIME) and orphan drug designations.
In September 2023, Vir Biotechnology dosed the first patient in the Phase I HVTN 142 clinical trial of the new T cell vaccine VIR-1388 to prevent human immunodeficiency virus (HIV).
