Data Monitoring Committees (DMCs), after predefined interim analyses, recommended that Paion should proceed with their phase IIa study, as well as phase Ib of CNS 7065 for anesthetic/sedative.
The phase IIa study is designed to evaluate the safety and success of sedation of CNS 7056, as well as the time to full recovery and discharge, in comparison to the ‘gold-standard’ agent – midazolam.
The company said that the phase Ib study will allow Paion to generate additional data on pharmacodynamics and pharmacokinetics. Both the studies are aimed to determine dose regimes for the further clinical development. As of today, more than 50% of the patients/volunteers, respectively, have been recruited in both the trials.
Wolfgang Söhngen, CEO of Paion, said: “While we have already demonstrated proof of concept in our earlier Phase I first in man study, we are now looking forward to identify the best dose regimes for the next steps of the clinical program for which we are already initiating preparatory work”.