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2015-03-31

Biotie Therapies Oyj: Biotie announces start of patient enrolment into Phase 2a clinical study with BTT1023 in primary sclerosing cholangitis

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 (B
TT1023, a human monoclonal antibody targeting vascu
lar adhesion prot
ein (VAP-1), in the tre
atment of patients with primary sclerosing cho
langitis) 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@biotie.com

DISTRIBUTION
NASDAQ OMX Helsinki Ltd
Main Media
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

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