Biotie: BTT1023 receives positive opinion for Orphan Drug Designation from COMP
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 17 February
2015 at 10.30 a.m.
Biotie: BTT1023 receives positive opinion for Orphan Drug Designation from COMP
The Committee for Orphan Medicinal Products (COMP) of the European Medicines
Agency (EMA) has in its February meeting issued a positive opinion recommending
orphan drug designation for Biotie's BTT1023 drug candidate for the treatment of
primary sclerosing cholangitis (PSC). PSC is a chronic and progressive fibrotic
liver disease for which there are currently no effective therapeutic treatments.
BTT1023 is a fully human monoclonal antibody targeting Vascular Adhesion Protein
-1 (VAP-1) and is currently advancing into Phase 2 clinical development. The
BUTEO study will be an open label, single arm, multi-centre investigator-
sponsored study that will be conducted in partnership with the University of
Birmingham, UK and supported through external grant funding. The study is
expected to enroll 41 patients and will examine the efficacy, safety and
pharmacokinetic properties of BTT1023 in PSC patients. The duration of drug
treatment in the study is 11 weeks and the primary efficacy endpoint is
reduction of elevated levels of alkaline phosphatase, a blood biomarker of bile
duct inflammation. The BUTEO study will be conducted in the UK and is expected
to start recruiting patients in Q1/2015.
Turku, 17 February 2015
Biotie Therapies Corp.
Timo Veromaa
President and CEO
Further information:
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi(at)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 transitioning into Phase 2 clinical development in primary sclerosing
cholangitis (PSC), a chronic and progressive fibrotic liver disease for which
there are currently no effective therapeutic treatments. BTT1023 has received a
positive opinion from the Committee for Orphan Medicinal Products (COMP) of the
European Medicines Agency (EMA), recommending Orphan Drug Designation for
BTT1023 for the treatment of PSC.
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 three additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, cocaine dependence, and primary sclerosing
cholangitis (PSC), a rare fibrotic disease of the liver.
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Source: Biotie Therapies Oyj via GlobeNewswire
[HUG#1894989]
Unternehmensinformation / Kurzprofil:
Datum: 17.02.2015 - 09:30 Uhr
Sprache: Deutsch
News-ID 371888
Anzahl Zeichen: 4210
contact information:
Town:
Turku
Kategorie:
Business News
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