Syndesi Therapeutics announces successful completion of first-in-human Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment.
Belgium – 5 November 2019 – Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that the first-in -human Phase I study of its lead molecule, SDI-118, has been successfully completed.
The first-in -human Phase I study was a randomized, placebo controlled, single ascending dose study in healthy male subjects designed to investigate the safety, tolerability and pharmacokinetics of oral doses of SDI-118. The study also included PET imaging in a group of subjects to directly measure SV2A target engagement by SDI-118 in the brain.
SDI-118 was safe and well tolerated at all doses administered, with no serious adverse events. All adverse events considered to be related to SDI-118 adminis tration were reported as mild. SDI-118 also showed favorable pharmacokinetic properties suitable for once daily dosing. Data from PET imaging following administration of a range of SDI-118 doses demonstrated a clear relationship between central SV2A occupancy and plasma exposure. Importantly, these results also demonstrated that the plasma exposures reached in the study, shown to be safe and well tolerated, provided essentially complete brain SV2A occupancy.