Vir Biotechnology hepatitis delta combo meets primary goal in phase 3 trial

what happened

Vir Biotechnology said on Sunday that its experimental combination of elebsiran and tobevibart met the primary goal of the phase 3 Eclipse 1 trial in chronic hepatitis delta, according to Seeking Alpha.

After 48 weeks, 44% of patients on the combination had undetectable hepatitis delta virus and normalized liver enzymes, while none in the delayed-treatment control group reached that point. The study enrolled 124 people, including some with advanced liver disease. Separately, updated phase 2 Solstice data showed that all 28 patients who completed 96 weeks of treatment had no detectable virus, and some who stopped therapy stayed virus-free for as long as 48 weeks.

The company plans to seek FDA approval in mid-2027. Further phase 3 results from the Eclipse 2 and Eclipse 3 studies are expected in the first quarter of 2027.

why it matters

For Vir, this is a potentially important milestone because treatment options for hepatitis delta are limited, and approval would open a new commercial opportunity. However, the phase 2 sample is small and follow-up is short, so a lasting cure has not been established. Breakthrough therapy and fast track designations may speed development but do not guarantee approval.

market impact

Vir Biotechnology shares: positive phase 3 data supports investor interest and approval prospects.

• ▲Vir Biotechnology shares pressure up — positive phase 3 data raises the odds of regulatory approval

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