Biotie Therapies Corp. ("Biotie") announces the start of the phase 2a clinical study of SYN120, a 5-HT6/5-HT2A antagonist, in patients with Parkinson's disease dementia (PDD). The study is being funded by The Michael J. Fox Foundation (MJFF).

The SYNAPSE study is an 80 patient, phase 2a, randomised, double-blind, multi-centre, placebo-controlled trial in patients with Parkinson's disease dementia. Patients will be randomised 1:1 to placebo or SYN120 dosed once daily over a 16 week treatment period. In addition to assessing safety and tolerability, the main focus of the study is to establish efficacy of SYN120 on cognition using the Cognitive Drug Research (CDR) Computerised Cognition Battery as the primary efficacy endpoint. The study will be conducted by the Parkinson Study Group (PSG) at approximately 12 sites in the United States specialising in cognitive dysfunction in Parkinson's disease. Biotie and the PSG will share responsibility for the design and execution of the study, and top-line results of the study are expected in the second half of 2016. Biotie retains the rights to SYN120 and will be able to use data from the MJFF-funded study for any future regulatory submission.

Final preparations are ongoing for an investigator-sponsored phase 2 study of Biotie's monoclonal anti-VAP-1 antibody BTT1023 in primary sclerosing cholangitis. The BUTEO study, previously expected to commence by the end of 2014, is now expected to start in Q1 2015.

Data are currently being analyzed from the NIDA-sponsored phase 2 study investigating Biotie's DBH inhibitor nepicastat in cocaine dependence. Top-line results from the study are expected to be available during Q1 2015.