Vir Biotechnology's Tobevibart, Elebsiran Combo Gets FDA Fast Track Status for Chronic Hepatitis Delta

By Chris Wack

Vir Biotechnology said the U.S. Food and Drug Administration has cleared its investigational new drug application and granted Fast Track designation for the combination of tobevibart and elebsiran to treat chronic hepatitis delta infection.

The company said tobevibart and elebsiran are currently being evaluated in its Phase 2 hepatitis delta clinical trial. Complete 24-week treatment data is on track to be reported in the fourth quarter.

The FDA's Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

In June, Vir reported preliminary Phase 2 trial data which suggested treatment with tobevibart alone or in combination with elebsiran was generally well tolerated, and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization.

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(END) Dow Jones Newswires

06-26-24 0851ET