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. Sources: Vir Biotechnology, Inc. - Vir Biotechnology Announces ... Vir says hepatitis D drug combination succeeds in first pivotal study Press Release of the Company, dated...
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