SOURCE: Biotie Therapies Corp.
April 07, 2011 02:45 ET
Biotie Announces Start of Phase 2b Trial of SYN115 in Parkinson's Disease
TURKU, FINLAND--(Marketwire - April 7, 2011) - Biotie Therapies Corp., a development stage company focused on diseases of the central nervous system, today announced the start of a Phase 2b trial evaluating SYN115 in Parkinson's Disease (PD). Results from the study are expected in the first half of 2013.
SYN115 is an orally bioavailable potent and selective adenosine A2a receptor antagonist. Adenosine A2a inhibition has been shown in preclinical studies to reverse motor deficits and enhance the effect of current PD therapies, e.g. levodopa and dopamine agonists, without inducing troublesome dyskinesia (involuntary movements). In addition, SYN115 also displays activity in preclinical models on non-motor symptoms of PD including depression, cognition and anxiety.
The Phase 2b trial is a randomized, double-blind, placebo-controlled study that will evaluate four doses of SYN115 versus placebo as adjunctive therapy in 400 levodopa-treated PD patients with end of dose wearing off. In these patients, treatment with levodopa is insufficient to control PD symptoms until their next dose, resulting in an 'off' period when symptoms reappear. The aim of the Phase 2b study is to determine the efficacy and safety of SYN115 in reducing the mean time spent in the 'off' state over a 12 week treatment period. The trial will also assess the impact of SYN115 on various measures of motor symptom severity, dyskinesia and non-motor symptoms.
"SYN115 is the lead product coming from our recent acquisition of Synosia and we are very pleased to advance this promising candidate into late-stage clinical development," said Timo Veromaa, President and Chief Executive Officer of Biotie. "Despite the availability of treatments for Parkinson's Disease, there remains a significant unmet medical need for therapies with an alternative mechanism of action and SYN115 could be the first drug with a novel mechanism of action in PD for a generation."
Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to SYN115. UCB will be responsible for Phase 3 development and commercialization.
In Turku, 7 April 2011
Biotie Therapies Corp.
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SYN115 is an orally bioavailable, potent and selective adenosine A2a receptor antagonist, which enters the brain and modulates regions associated with motor and non-motor function. Biotie obtained development and commercialization rights to SYN115 from Roche in 2007 for selected diseases of the central nervous system and has an option to rights for development in all indications.
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.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (Parkinson's disease, Alzheimer's disease and other cognitive disorders, bipolar disorder, and alcohol and drug dependence) and inflammatory diseases (rheumatoid arthritis, psoriasis, chronic obstructive pulmonary disease and others). It has several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Partnerships with top/tier pharmaceutical partners are in place for several programs as well as a strategic collaboration with UCB Pharma S.A. Biotie's most advanced product, nalmefene for alcohol dependence, is currently in Phase 3 clinical development by licensing partner H. Lundbeck A/S.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.