Vir’s hepatitis D drug combination succeeds in first pivotal study

Vir Biotechnology reported that its experimental combination of elebsiran and tobevibart met the primary endpoint in the Phase 3 ECLIPSE 1 trial, its first pivotal study in chronic hepatitis D.

At Week 48, 44% of patients who began the combination immediately had both undetectable hepatitis D virus RNA and normalized ALT, a liver enzyme. No patients in the delayed-treatment group met that combined endpoint at Week 12 (p<0.0001).

A key secondary measure showed 79% of patients on the combination had undetectable virus at Week 48. The trial enrolled 124 patients.

The result is an important step toward a possible filing, but the drugs are still investigational. Vir is also studying the combination in two other pivotal trials and has said it plans to use all three studies in a potential U.S. application.