DGAP-Adhoc

PAION REPORTS POSITIVE HEADLINE DATA IN U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN HIGH-RISK PATIENTS UNDERGOING COLONOSCOPY - Seite 2

The primary objective was to assess the safety of multiple doses (initial dose and additional top-up doses) of remimazolam compared to placebo and midazolam, following administration of a standard dose of fentanyl. The fentanyl, remimazolam and midazolam doses were reduced compared to the pivotal U.S. Phase III trials as indicated in the label for midazolam which PAION is targeting for remimazolam.

In PAION's view, this safety trial confirms remimazolam's safety profile and tolerability shown in all previous studies in a more vulnerable patient population. Overall, remimazolam demonstrated good respiratory and cardiovascular stability as compared to placebo with midazolam rescue. No adverse events of concern were observed in either group.

There were several additional outcome measures included to assess efficacy: One such outcome was a composite endpoint, composed of success of the procedure, no need for rescue medication, and completion of the procedure with no more than 5 doses given within any 15-minute interval. This endpoint was achieved in 84.4% of the patients in the remimazolam arm and 0% in the placebo arm. Further relevant endpoints for remimazolam showed a median time from start of medication to start of procedure of 5.0 minutes (placebo 18.5 minutes) and a median time from end of procedure to return to full alertness of 3.0 minutes (placebo 5.0 minutes).

This study also included an open label arm in which midazolam was dosed according to U.S. label. Success of the procedure was achieved in 12.9% of the midazolam patients. Midazolam patients showed a median time from start of medication to start of procedure of 19.0 minutes and a median time from end of procedure to return to full alertness of 7.0 minutes.

End of inside information

 

PAION Contact

Ralf Penner

Director Investor Relations / Public Relations

PAION AG

Martinstrasse 10-12

52062 Aachen - Germany

Phone: [phone]

E-mail: [e-mail]
www.paion.com

Disclaimer:

This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.