Gilead Sciences Sees Positive Results From Trial for Hepatitis Treatment
June 24 2021 - 9:52AM
Dow Jones News
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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