Biotie provides portfolio update on tozadenant
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 20 February
2015 at 9.00 a.m.
Biotie provides portfolio update on tozadenant
Biotie announces further detail on its clinical development plan for tozadenant,
an adenosine A2a antagonist in development for Parkinson's disease (PD).
Biotie plans to conduct one Phase 3 study in 882 PD patients experiencing
levodopa related end-of-dose 'wearing-off' (motor fluctuations) in which
participants will be randomized in a double-blind manner to receive twice daily
doses of 60mg or 120mg of tozadenant or placebo in addition to their standard
anti-PD medications, for 24 weeks. The primary endpoint will be time spent in
the "off" state in patients taking tozadenant as compared to placebo between
baseline and week 24. Secondary endpoints will include "on" time without
troublesome dyskinesia, the Unified Parkinson's Disease Rating Scale, Clinical
Global Impression of Change and Patient Global Impression of Change. The
placebo-controlled period will be followed by a 52 week open label treatment
period to collect additional clinical safety data. The planned Phase 3 study is
expected to start recruiting patients in the United States, Canada and selected
European countries in the middle of 2015. Based on current estimates, top-line
data is expected to be available by the end of 2018.
Biotie has previously reported positive data from a 420-patient Phase 2b study
evaluating tozadenant in PD patients experiencing levodopa related end-of-dose
'wearing-off'. Full data from this trial was published in Lancet Neurology in
2014(1). The trial met its primary endpoint of a highly significant decrease in
"off" time vs. placebo, as well as demonstrating efficacy across multiple
secondary endpoints. The Phase 3 protocol will largely replicate that of the
Phase 2b study. Biotie expects that the published Phase 2b study will be
considered the first of two pivotal studies required for registration for
tozadenant in PD patients with end-of-dose 'wearing-off'.
Biotie is considering financing options which may involve a capital raise to
fully fund the tozadenant Phase 3 program to approval.
Turku, 20 February 2015
Biotie Therapies Corp.
Timo Veromaa
President and CEO
For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone), email: stephen.bandak(at)biotie.com
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi(at)biotie.com
www.biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main Media
About tozadenant (SYN115)
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist
being developed for the treatment of Parkinson's disease. Tozadenant has
displayed clinically relevant and statistically highly significant effects in
Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420
patient Phase 2b study completed in December 2012, and it is currently
transitioning into Phase 3 development.
About Parkinson's disease
Parkinson's disease is the second most common neurodegenerative disorder, after
Alzheimer's disease. It affects about one percent of people ages 65-69, rising
to up to three percent of people who are 80 years and older. The symptoms of
Parkinson's disease result from decreased dopamine production in regions of the
brain controlling movement.
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.
(1) Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients
with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b,
double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi:
10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biotie Therapies Oyj via GlobeNewswire
[HUG#1895893]
Unternehmensinformation / Kurzprofil:
Datum: 20.02.2015 - 08:01 Uhr
Sprache: Deutsch
News-ID 373060
Anzahl Zeichen: 5469
contact information:
Town:
Turku
Kategorie:
Business News
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