DGAP-News

PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY

DGAP-News: PAION AG / Key word(s): Research Update PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY 28.03.2017 / 07:30 The issuer is solely responsible for the content of this announcement. PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN U.S. PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY

- Headline data expected mid 2017

Aachen (Germany), 28 March 2017 - The specialty pharma company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces the successful completion of patient recruitment in the second pivotal U.S. Phase III clinical trial of remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy.

The trial is the second pivotal study of the remimazolam Phase III program which was agreed upon between PAION and the U.S. Food and Drug Administration (FDA) for the filing of remimazolam for market approval in the targeted indication procedural sedation.

This Phase III clinical trial - conducted at multiple sites throughout the U.S. - is a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 446 patients undergoing bronchoscopy for diagnostic or therapeutic reasons. Patients were randomized to receive either remimazolam, midazolam, or placebo in addition to fentanyl, in order to achieve adequate sedation to start and perform the procedure. The primary efficacy endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. In order to ensure the performance of the scheduled bronchoscopy for all patients regardless of their randomized treatment assignment, non-responders in all treatment arms received midazolam doses according to the physician's discretion.