Biotie Therapies Corp., a development stage company focused on diseases of the central nervous system, announced the start of a phase II b 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 II b 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 II b 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 SA a license for exclusive, worldwide rights to SYN115. UCB will be responsible for phase III development and commercialization.
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.
Parkinson's disease is the second most common neuro-degenerative 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 neuro-degenerative 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).