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.
"There is an urgent need to find safe and effective treatments for Parkinson's patients suffering from impaired cognition," said Timo Veromaa, Chief Executive Officer at Biotie. "We look forward to collaborating with The Michael J. Fox Foundation (MJFF) and the Parkinson Study Group to advance SYN120 into a Phase 2 trial later this year. This grant provides a great opportunity to further characterize the potential of this drug candidate".
MJFF will fund an 80 patient, Phase 2a, randomized, double-blind, placebo-controlled trial of 16 weeks duration in patients with Parkinson's disease dementia. In addition to assessing safety and tolerability, the main focus of the trial will be to establish efficacy of SYN120 on cognition using the Cognitive Drug Research (CDR) Computerized Cognition Battery as the primary efficacy endpoint. This trial, which is expected to begin in H2 2014, will be conducted by the Parkinson Study Group (PSG) at approximately 10 US sites specializing in cognitive dysfunction in Parkinson's disease. Biotie and the PSG will share responsibility to design and execute this study.
"A substantial number of Parkinson patients will develop dementia. While patients and doctors may not openly discuss dementia during clinic visits, its presence may be the single most important factor limiting the use of standard pharmacotherapy for the motor impairments in Parkinson's disease," says Hubert H. Fernandez, MD, the Co-Chair of the Parkinson Study Group Executive Committee and the study's Principal Investigator.
Further details, including study design and goals, can be found below.