Biotie announces start of patient enrolment into Phase 2a clinical study with BTT1023 in primary sclerosing cholangitis
(Thomson Reuters ONE) -
Biotie Therapies Corp. Stock Exchange Release 31 March 2015 at 9.00
am
Biotie announces start of patient enrolment into Phase 2a clinical study with
BTT1023 in primary sclerosing cholangitis
Biotie Therapies Corp ("Biotie") announces 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). PSC is a progressive immune mediated biliary disease
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 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 grant holder and Co-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 excited to be working with Biotie to
investigate whether blocking VAP-1 with BTT1023 can offer the first effective
therapeutic option for this life-changing disease."
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.
Clinicaltrials.gov identifier: NCT02239211.
Turku, 31 March 2015
Biotie Therapies Corp.
Timo Veromaa
President and CEO
For further information, please contact:
Virve Nurmi, Biotie Therapies Corp.
tel. +358 2 274 8900
e-mail: virve.nurmi(at)biotie.com
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www.biotie.com
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.
ABOUT BIOTIE
Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. Biotie's development has delivered
Selincro (nalmefene) for alcohol dependence, which received European marketing
authorization in 2013 and is currently being rolled out across Europe by partner
Lundbeck. The current development products include tozadenant for Parkinson's
disease, which is transitioning into Phase 3 development, and two additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, and primary sclerosing cholangitis (PSC), a rare
fibrotic disease of the liver.
ABOUT EME
*The project is managed by the Efficacy and Mechanism Evaluation Programme, a
Medical Research Council and NIHR partnership in the UK, that supports later-
phase "science-driven" clinical trials and evaluative studies, which seek to
determine whether a health intervention (e.g. a drug, diagnostic technique or
device) works and in some cases how or why it works. The programme is funded by
the MRC and NIHR (www.nihr.ac.uk), with contributions from the CSO in Scotland,
NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern
Ireland. www.nets.nihr.ac.uk/programmes/eme
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Source: Biotie Therapies Oyj via GlobeNewswire
[HUG#1907746]
Unternehmensinformation / Kurzprofil:
Datum: 31.03.2015 - 08:03 Uhr
Sprache: Deutsch
News-ID 382258
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