Biotie announces start of patient enrolment into Phase 2a clinical study with BTT1023 in primary sclerosing cholangitis - Seite 2

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For further information, please contact:

Virve Nurmi, Biotie Therapies Corp.
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ABOUT BTT1023

BTT1023 is a fully human monoclonal antibody that specifically binds to vascular adhesion protein-1 (VAP-1). BTT1023 has demonstrated encouraging efficacy and safety in early clinical studies in rheumatoid arthritis and psoriasis patients and in a range of preclinical models of inflammatory diseases, including COPD. More recently, an important role for VAP-1 has also been demonstrated in fibrotic diseases.

BTT1023 is in Phase 2 clinical development for the treatment of primary sclerosing cholangitis (PSC), a chronic and progressive fibrotic liver disease for which there are currently no effective therapeutic treatments. BTT1023 has received Orphan Drug Designation in the EU for the treatment of PSC. Biotie retains full rights to BTT1023.

About the Investigators

The grant holder and Co-Investigator for the study is Professor David Adams, Director of the National Institute for Health Research (NIHR) Biomedical Research Unit in Liver Disease and Centre for Liver Research at the University of Birmingham, UK.

The University of Birmingham delivers excellence in liver research and has access to a large, well-defined, cohort of patients with PSC. Professor Adams at Birmingham developed the concept of PSC as a disease driven by aberrant lymphocyte homing and first reported a role for VAP-1 in the liver in mediating liver inflammation and fibrosis. Together with Chief Investigator Dr Gideon Hirschfield he runs the PSC translational programme in Birmingham from where patients will be recruited for the trial.

About Primary sclerosing cholangitis

PSC is an orphan disease featuring chronic and progressive inflammation of the liver and is characterised by bile duct fibrosis and progression to cirrhosis. It most commonly affects men of working age and more than 50% of patients require liver transplantation within 10-15 years of symptomatic presentation. In the later stages of the disease patients feel severely unwell, with abdominal pain, itching, jaundice, poor appetite, deep fatigue and signs of malnourishment and eventually liver failure and death. There are currently no effective treatments to treat PSC and there is a high unmet medical need for new treatment options.