Simtuzumab Is Ineffective for Treatment of Primary Sclerosing Cholangitis

Currently there is no effective treatment for primary sclerosing cholangitis (PSC). Because lysyl oxidase like-2 (LOXL2) might be a catalyst in fibrogenesis and elevated concentrations appear in serum and liver of patients with PSC, simtuzumab — a monoclonal antibody against LOXL2 — is under investigation for treating PSC.

In a phase IIb, industry-funded study, researchers evaluated the safety and efficacy of simtuzumab in the treatment of patients with well-compensated PSC. Two hundred and thirty-five patients were randomized in a 1:1:1 ratio to receive subcutaneous simtuzumab (75 or 125 mg) or placebo weekly for 96 weeks. The primary endpoint was mean change in morphometrically assessed hepatic collagen on liver biopsy. Other endpoints inc…