The first patient has been dosed in the P-III trial (REDWOOD) evaluating fazirsiran (TAK-999/ARO-AAT) in a ratio (1:1) in 160 adult patients with AATD-LD
The 1EPs of the study is a decrease from the baseline of 1 stage of histologic fibrosis METAVIR staging in the centrally read liver biopsy done @106wk. in patients with METAVIR stage F2 and F3 fibrosis
Arrowhead & Takeda collaborated in Oct 2020 to co-develop fazirsiran & will co-commercialized in the US if approved under a 50/50 profit-sharing structure while Takeda will give Arrowhead ~$40M milestones as soon as this crucial study begins. Fazirsiran received BTD from the US FDA in July 2021 & ODD in Feb 2018 for AATD-LD
Ref: Arrowhead | Image: Arrowhead
Related News:- Arrowhead Gains Full Rights to ARO-PNPLA3 for Patients with Non-Alcoholic Steatohepatitis
