The planned trial will evaluate the safety, tolerability and pharmacokinetics of SAN2465 in healthy volunteers. It will also include validated cognitive tests and pharmacodynamic measures such as quantitative EEG, to help establish a suitable dose range for later trials in patients.

SAN2465 is a selective negative allosteric modulator of the GABA-A α5 receptor. The receptor is highly expressed in the hippocampus and related brain regions involved in mood and cognition. In the chronic mild stress model, an established animal model of depression, a single oral dose produced a rapid and lasting reversal of depression-like symptoms, including anhedonia, anxiety and cognitive impairment, with an onset and magnitude comparable to ketamine. Saniona’s aim is a rapid antidepressant effect similar to ketamine and esketamine, but without the dissociative and sedative effects that require those treatments to be given under supervision in a clinical setting.

“The IND application for SAN2465 is an important milestone for Saniona and shows our continued focus on turning strategy into action as we move our prioritized internal programs into clinical development,” says Pierandrea Muglia, Chief Medical Officer at Saniona.