PAION AG: Phase Ib and IIa Studies of the Anesthetic/Sedative CNS 7056 on Track

16-Jul-2009 - Germany

The biopharmaceutical company PAION AG announces that the respective Data Monitoring Committees (DMCs), after predefined interim analyses, recommended that the Company should proceed as planned with their Phase IIa study as well as Phase Ib of CNS 7065, a new short-acting intravenous anesthetic/sedative.

Following the successful proof of concept study reported in January 2009, a Phase IIa study (single dose) in patients undergoing endoscopy of the upper gastrointestinal tract and a Phase Ib study (multiple dose) in volunteers undergoing a colonoscopy, were started.

The Phase IIa study is designed to evaluate the safety and the 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 Phase Ib study will allow PAION to generate additional data on pharmacodynamics and pharmacokinetics. Both 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 trials.

On 11 May 2009 positive results of the first part of the Phase Ib trial were reported. The effect of CNS 7056 can be reversed by an established antagonist, flumazenil; no re-sedation of the volunteers was observed.

”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” commented Dr. Wolfgang Söhngen, PAION’s CEO.

The studies are being performed in the US and PAION expects to report results before the end of 2009.

https://www.bionity.com/en/news/103391/paion-ag-phase-ib-and-iia-studies-of-the-anesthetic-sedative-cns-7056-on-track.html