By Chris Wack

 

Gilead Sciences Inc. said it saw positive interim results from the Phase 2b and Phase 3 clinical trials evaluating the first-in-class entry inhibitor Hepcludex bulevirtide for the treatment of chronic hepatitis delta virus.

The company said findings from the Phase 3 study support the safety and efficacy profile of bulevirtide 2 mg once daily.

Results from the Phase 2b trial show that treatment with bulevirtide alone or in combination with peginterferon alfa-2a, is associated with a significant HDV RNA decline and improvements in biochemical disease activity at week 24.

Gilead said the Phase 3 data will be included in the filing of bulevirtide to the U.S. Food and Drug Administration later this year. Bulevirtide has been granted Breakthrough Therapy Designation and Orphan Drug status by the FDA.

Treatment with bulevirtide, both as monotherapy or in combination with peginterferon alfa-2a, was well-tolerated, with mostly mild or moderate adverse effects and no reported serious adverse effects or adverse effects leading to discontinuation of bulevirtide. The European Commission granted Hepcludex 2 mg Conditional Marketing Authorization; all other dosing and combinations are investigational.

Bulevirtide is an investigational agent in the U.S. and outside of the European Economic Area; in these regions, health authorities haven't established the safety and efficacy of bulevirtide.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

June 24, 2021 09:44 ET (13:44 GMT)

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