Shots:

• The P-IIb/III study involves assessing the effect of setanaxib (1200 mg/day &1600 mg/day) vs PBO on ALP reduction in ~318 patients with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA) across 150 investigational centers
• The company will conduct an interim analysis once the 99th randomized patient has completed the week 24 visit, which is expected H1’23
• Calliditas is expecting the top data readouts in H2’24/H1’25. In Aug 2021, the company received the US FDA’s FTD for setanaxib in PBC

 Ref: PR Newswire | Image: Calliditas