TURKU, FINLAND--(Marketwire - March 01, 2012) - Biotie today announced the completion of a Phase 1 clinical study using positron emission tomography (PET) imaging for its 5-HT6 receptor antagonist SYN120. The study was designed to establish the appropriate dose of SYN120 for Phase 2 trials in cognitive disorders, including Alzheimer's disease and schizophrenia.
The PET study was conducted at the Johns Hopkins University School of Medicine in the United States. It evaluated occupancy of the 5-HT6 receptor in the brain in nine healthy volunteers who were treated with different doses of SYN120. The results demonstrate that target levels of receptor occupancy expected for efficacy can be achieved with SYN120 doses that are an order of magnitude lower than those that have previously been shown to be safe and well tolerated for up to two weeks in healthy older volunteers.
"We are extremely pleased with the outcome of this study," commented Dr Timo Veromaa, Biotie's Chief Executive Officer. "These data suggest that Phase 2 trials can be conducted at doses that are fully expected to be therapeutic and yet maintain a wide safety margin. We are now in the process of preparing a Phase 2 enabling package to be submitted to Roche for their evaluation."
Turku, 1 March 2012
Biotie Therapies Corp.
President and CEO
NASDAQ OMX Helsinki Ltd
SYN120 is a potent, selective and orally bioavailable 5-HT6 receptor antagonist, exclusively targeting regions in the brain associated with memory function. SYN120 has been shown to enhance cognition in various preclinical models, and has completed single and multiple-ascending dose studies in Phase 1.
The compound was discovered at Roche and is being developed by Biotie under a licensing agreement. Roche retains an opt-in right on the 5-HT6 program which can be exercised on completion of this imaging study. Biotie will provide Roche with an extensive package of preclinical and clinical data to facilitate their decision.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. 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 disease.
The company has a strong and balanced development portfolio with 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. The Marketing Authorization Application for Biotie's most advanced product, Selincro™ (nalmefene) for alcohol dependence was filed in the EU by our partner H. Lundbeck A/S and was accepted for review by the European Medicines Agency in December 2011.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.