Swedish biopharma company Calliditas Therapeutics AB (STO:CALTX) on Friday reported positive topline data from its Phase 2b TRANSFORM trial evaluating setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness.

The trial met its primary endpoint, demonstrating statistically significant improvement in ALP (Alkaline Phosphatase) for both setanaxib doses versus placebo and positive trends on liver stiffness assessed by FibroScan at 24 weeks. Over 40% of patients were on dual or triple therapy, indicating setanaxib's potential incremental benefit beyond standard care.

Setanaxib treatment was generally well tolerated.

Calliditas is continuing clinical development with setanaxib, anticipating topline data in IPF (idiopathic pulmonary fibrosis) in Q4 2024/Q1 2025 and in Alport syndrome in 2025.