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Biotie Therapies Corp. operates as a drug development company. It focuses on the development of drugs for neurodegenerative and psychiatric disorders, such as Parkinson’s disease, Alzheimer’s disease and other cognitive disorders, alcohol and drug dependence (addiction), and post-traumatic stress disorder; and inflammatory and fibrotic liver diseases. The company has a development portfolio with various small molecule and biological drug candidates at various stages of clinical development. Its advanced product, Selincro (nalmefene) reduces alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. The company’s drug development projects also include Tozadenant (SYN115), an oral, potent, and selective adenosine A2a receptor antagonist in Phase 3 development, which enters the brain and modulates regions associated with motor and non-motor function; SYN120, an oral, potent, and selective antagonist of the 5-HT6 receptor, which has completed single and multiple ascending dose Phase 1 clinical studies and a Phase 1 positron emission tomography imaging study to determine therapeutic dose; and BTT-1023 (VAP-1 antibody) that has completed Phase Ib clinical trials for the treatment of rheumatoid arthritis and psoriasis. In addition, its drug development projects comprise Nepicastat (SYN117), a cocaine dependence enzyme dopamine beta hydroxylase inhibitor focusing on conducting Phase 2 clinical trial; and Ronomilast, an oral phosphodiesterase-4 inhibitor with therapeutic potential in chronic inflammatory disorders. The company has strategic collaboration with UCB Pharma S.A. Biotie Therapies Corp. is based in Turku, Finland.

36 Employees
Last Reported Date: 05/9/14

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biotie therapies oyj (BTH1V) Key Developments

Biotie Announces Positive Phase 2B Study Evaluating Tozadenant, an Adenosine A2a Antagonist, in Parkinson's Disease Patients

Biotie announced that full data from the positive Phase 2b study evaluating tozadenant, an adenosine A2a antagonist, in Parkinson's disease patients experiencing end of dose wearing off have been published in Lancet Neurology. The Phase 2b study was an international, randomised, double blind, placebo-controlled, parallel group, dose finding study in 420 levodopa-treated patients with end of dose wearing off (at least 2.5 hours off time per day). Patients received either 60mg, 120mg, 180mg or 240mg tozadenant or matching placebo twice daily for 12 weeks. The primary outcome was a change from baseline to week 12 in hours per day spent in the off-state, assessed from patient diaries. As previously disclosed, the study demonstrated that tozadenant, when compared to placebo, decreased levodopa related motor fluctuations. Previously released topline results for this study included clinically relevant and highly statistically improvements in 'off' time, 'on' time, UPDRS part III and UPDRS parts I-III. In addition to providing more details on these endpoints, further data published in Lancet Neurology include highly significant improvements in the clinician global impression of severity and clinician global impression of improvement in all tozadenant groups compared with placebo and patient global impression of improvement in the 120 mg BID group. Results of sensitivity analyses of the primary efficacy outcome using multiple methods were consistent with the improvements of the primary analysis. Many patients with Parkinson's disease experience motor fluctuations despite treatment with available drugs. During this "off-state" the symptoms of Parkinson's, including rigidity, tremors and difficulty in movement, come back and can have a significant impact on daily living. There is a great need for new drugs that can maintain robust benefits for patients throughout the day or that can be added to existing treatments to smooth the response without exacerbating dyskinesias that develop with long term therapy with existing treatments.

Biotie Therapies Wins $2 Million Research Contract

Biotie Therapies has signed a USD 2 million research contract with The Michael J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson's disease patients with dementia. SYN120 is a dual antagonist of 5-HT6 and 5-HT2a receptors and these two distinct modes of action could result in a unique therapeutic profile for SYN120 combining pro-cognitive and antipsychotic activities.

Biotie Therapies Corp. Completes Nepicastat Study in Cocaine Dependence

Biotie Therapies Corp. announced that patient enrollment into the Phase 2 study investigating nepicastat for cocaine dependence has been completed ahead of schedule. The 11-week, 179-patient study is being conducted at 10 US clinics under a Collaborative Research and Development Agreement (CRADA) with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health. Top-line results from the study are expected around the end of 2014.


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