The JLABS @ BE resident company, Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, announced that its lead molecule, SDI‐118, has entered into Phase I clinical development.
The first‐in‐human Phase I study is investigating the safety, tolerability and pharmacokinetics of single ascending doses of SDI‐118 in healthy subjects. The study also includes PET imaging in a group of subjects to directly measure the binding of SDI‐118 to SV2A in the brain and to assess the relationship between SV2A occupancy and plasma exposure.
Jonathan Savidge, CEO of Syndesi, said “We are delighted to announce the entry of SDI‐118 into clinical development following successful completion of pre‐clinical studies during the first year following Syndesi’s incorporation. Conducting PET imaging in parallel with the dose escalation provides us with highly valuable data very early in the development program. This ability to measure the degree of target engagement of our compound in humans greatly facilitates the choice of doses in future trials, de‐risking one of the major challenges in CNS drug development.”