- Biotie (OTC:BIOZF) commences patient enrollment in a Phase 2a study evaluating its human monoclonal antibody, BTT1023, for the treatment of primary sclerosing cholangitis (PSC), a disease of the bile ducts where inflammation causes scars (fibrosis) which make the ducts hard and narrow and gradually causes serious damage to the liver. The only known cure is a liver transplant.
- The trial will evaluate BTT1023 in 41 patients with PSC. Each patient will receive BTT1023 via intravenous infusion every two weeks over an 11-week treatment period. The primary efficacy endpoint is a reduction of elevated levels of alkaline phosphatase, a blood biomarker of bile duct inflammation. Secondary endpoints include various measures of liver injury and fibrosis. Treatment of all patients should be completed by the end of 2016.