Date: 2015-03-31
Type of information: Initiation of patient enrollment
phase: 2a
Announcement: initiation of patient enrollment
Company: Biotie Therapies (Finland)
Product: BTT1023 - recombinant human monoclonal antibody binding to vascular adhesion protein-1
Action
mechanism: monoclonal antibody. BTT1023 is a fully human monoclonal antibody targeting VAP-1 (vascular adhesion protein-1). 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 and certain neurological conditions. More recently, Biotie has generated new data indicating that VAP-1, in addition to its clinically demonstrated role in inflammatory diseases, has an important role in fibrotic diseases. These data, generated in part in collaboration with National Institute for Health Research Liver Biomedical Research Unit at the University of Birmingham, UK, reveal significant potential for BTT1023 in certain niche liver inflammatory fibrotic diseases. The first data were published in December 2014 in the Journal of Clinical Investigation (Weston CJ, Shepherd EL, Claridge LC, et al. Vascular adhesion protein-1 promotes liver inflammation and drives hepatic fibrosis ( J Clin Invest 2014; published online Dec 22. doi: 10.1172/JCI73722). The European Commission has granted BTT1023 orphan drug designation in the EU for the treatment of primary sclerosing cholangitis.
Disease: primary sclerosing cholangitis
Therapeutic area: Rare diseases - Inflammatory diseases - Hepatic diseases - Liver diseases
Country: UK
Trial
details: This phase II study is investigating the safety and preliminary efficacy of a human monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use in the treatment of patients with primary sclerosing cholangitis (PSC). (NCT02239211)
Latest
news: * On March 31, 2015, Biotie Therapies announced the start of patient enrolment into the Phase 2a clinical study evaluating BTT1023, Biotie\'s fully human monoclonal antibody targeting Vascular Adhesion Protein-1, in primary sclerosing cholangitis (PSC). This progressive immune mediated biliary disease is characterised by bile duct inflammation and fibrosis, and accompanying hepatic fibrosis, that frequently results in the need for liver transplantation. The study is being funded through the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. 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 BUTEO study (BTT1023, a human monoclonal antibody targeting vascular adhesion protein (VAP-1), in the treatment of patients with primary sclerosing cholangitis) is an investigator-sponsored open label, single arm, multi-centre study that will evaluate efficacy, safety and pharmacokinetic properties of BTT1023 in 41 patients with PSC. Patients 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. The two-stage study design includes a pre-planned futility analysis. Based on current estimates, it is expected that the requisite number of patients will have been treated by the end of 2016 to enable the futility analysis to be completed.
