Clinical study with Biotie's BTT1023 in primary sclerosing cholangitis awarded external grant funding

Biotie Therapies Corp.          Stock Exchange Release    24 July 2014 at 3.15 p.m.

Clinical study with Biotie's BTT1023 in primary sclerosing cholangitis awarded external grant funding

Biotie Therapies Corp. will be working in partnership with the University of Birmingham, UK, who have been awarded funding of up to approximately EUR 1.0 million for an investigator-sponsored, Phase 2, proof of concept study with its vascular adhesion protein-1 (VAP-1) antibody, BTT1023, in primary sclerosing cholangitis (PSC). PSC is a chronic and progressive orphan fibrotic disease for which there are currently no approved therapeutic treatments. The study will be conducted in the UK and is expected to start recruiting patients by the end of 2014.

The grant holder and Chief Investigator for the study, 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, said "We have demonstrated that PSC is driven by aberrant lymphocyte homing and were the first to report a role for VAP-1 in mediating liver inflammation and fibrosis. We are delighted to have been awarded this peer-reviewed grant which will allow us to investigate whether blocking VAP-1 with BTT1023 can offer the first effective therapeutic option for this life-changing disease."

The investigator-sponsored study will be an open label, single arm, multi-centre study enrolling 41 patients which will examine the efficacy, safety and pharmacokinetic properties of BTT1023 in patients with primary sclerosing choloangitis. The duration of drug treatment in the study is 11 weeks and the primary efficacy endpoint will be reduction of elevated levels of alkaline phosphatase, a blood biomarker of bile duct inflammation.

This project was awarded by the NIHR Efficacy and Mechanism Evaluation (EME) Programme* and is funded and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. Biotie retains full rights to BTT1023.

Turku, 24 July 2014

Biotie Therapies Corp.

Timo Veromaa
President and CEO

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) and prevents inflammation. Biotie has previously demonstrated encouraging efficacy and safety for BTT1023 in early clinical studies in rheumatoid arthritis and psoriasis patients and in a range of preclinical models of inflammatory diseases, including COPD. More recently, Biotie has generated data indicating that VAP-1, in addition to its role in inflammatory diseases, has an important role in fibrotic diseases. These data, generated in collaboration with National Institute for Health Research Liver Biomedical Research Unit at the University of Birmingham, UK, reveal significant potential for BTT1023 in fibrotic diseases of the liver.