Biotie provides update on tozadenant Phase 3 program
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 23 April 2015
at 10.15 a.m.
Biotie provides update on tozadenant Phase 3 program
Biotie has further refined its plans for the design and conduct of Phase 3
trials in Parkinson's disease (PD) patients experiencing levodopa related end-
of-dose 'wearing-off' (motor fluctuations). The phase 3 program will consist of
a double- blind trial with an open-label extension and, providing this
demonstrates safety and efficacy, will be followed by a separate open-label
trial to generate further clinical safety data.
The refinement in the trial design does not impact the expected overall timeline
to submission of a U.S. New Drug Application for tozadenant, but allows top-line
results from the double-blind portion to be available by the end of 2017,
approximately one year earlier than previously planned, while maintaining
adequate statistical power in the study.
In the double-blind portion, 450 participants will be randomized 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 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 and the number of
patients being enrolled into the study, top-line data is expected to be
available by the end of 2017.
Providing the double-blind portion of the trial meets its primary efficacy
endpoint, another open-label trial will be initiated in a separate population of
450 PD patients to establish the requisite number of unique patient exposures
required for approval. The open label trial will evaluate safety over a year and
is also expected to be conducted in North America and selected European
countries. Patients will be dosed with 120 mg of tozadenant twice/day, although
the investigator may adjust the dose to 60 mg twice/day based on individual
response.
Turku, 23 April 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 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 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.
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Source: Biotie Therapies Oyj via GlobeNewswire
[HUG#1913793]
Unternehmensinformation / Kurzprofil:
Datum: 23.04.2015 - 09:15 Uhr
Sprache: Deutsch
News-ID 387974
Anzahl Zeichen: 4939
contact information:
Town:
Turku
Kategorie:
Business News
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