Biotie has finished Phase 1 positron emission tomography (PET) clinical study of SYN120.
SYN120 was discovered at Roche and is currently being developed by Biotie, under a licensing agreement.
SYN120 is a potent, selective and orally bioavailable 5-HT6 receptor antagonist, which targets regions in the brain associated with memory function.
The imaging study was designed to examine the appropriate dose of SYN120 for Phase 2 trials in cognitive disorders including Alzheimer’s disease and schizophrenia.
The study assessed occupancy of the 5-HT6 receptor in the brain in nine healthy volunteers who were treated with different doses of SYN120.
The results showed that the 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.
Biotie chief executive officer Timo Veromaa said 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," Veromaa said.