First patient treated in Takeda’s phase 3 trial for alpha-1 antitrypsin deficiency
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Arrowhead Pharmaceuticals announced that the first patient has been treated in Takeda Pharmaceuticals’ phase 3 clinical trial of fazirsiran for the treatment of alpha-1 antitrypsin deficiency associated liver disease.
Fazirsiran, an investigational RNA interference therapy intended to reduce the production of the mutant alpha-1 antitrypsin protein, was co-developed by both Takeda and Arrowhead. The drug was first granted FDA orphan drug status for the treatment of alpha-1 antitrypsin deficiency in 2018 and later gained breakthrough therapy designation in 2021.
The phase 3 REDWOOD clinical trial is a randomized, double-blind, placebo-controlled study to assess safety and efficacy of fazirsiran among patients with alpha-1 antitrypsin deficiency associated liver disease. Adult patients with METAVIR stage F2 to F4 fibrosis (n=160) will be randomized 1:1 to receive either fazirsiran or placebo.
The primary endpoint of this study will be a reduction from baseline of at least 1 stage of histologic fibrosis METAVIR staging in the centrally read liver biopsy completed at week 106.
Arrowhead stated that the REDWOOD study is now actively recruiting across several sites in the U.S.
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