Date: 2014-12-23
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Biotie Therapies (Finland)
Product: SYN120
Action
mechanism: 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 5-HT6 receptors are located exclusively in the brain and blocking them results in increased concentrations of acetylcholine and glutamate, two known pro-cognitive neurotransmitters.
Disease: Parkinson’s disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: This study is a Phase IIa, multicenter, randomized, double-blind, placebo-controlled, two-arm, 16-week study in Parkinson’s disease dementia patients taking a cholinesterase inhibitor. This includes a screening period of up to six weeks, a 16?week treatment period and a two-week safety follow-up period. Eligible volunteers will be randomized to receive placebo or SYN120. Participants will return for evaluation at the study site at weeks four, eight and 16.
Latest
news: * On December 23, 2014, Biotie Therapies announced 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, randomized, double-blind, multi-center, placebo-controlled trial in patients with Parkinson's disease dementia. Patients will be randomized 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) Computerized 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 specializing 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. * On July 8, 2014, Biotie Therapies announced that the company has signed a $ 2 million research contract with The Michael J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson\'s disease patients with dementia. 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. Assuming this pilot study is positive, the next step will be to conduct a six-month dose-finding study (Phase IIb) comparing three to four doses of SYN120 to placebo in order to identify the optimal dose(s). At least one six-month, Phase III study comparing the optimal SYN120 dose to placebo would then be needed in order to request approval from the FDA.
