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PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY

DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY

08.06.2015 / 14:00

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PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY

Aachen, 08 June 2015 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced
the initiation of the second pivotal U.S. Phase III clinical trial of
Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural
sedation in patients undergoing bronchoscopy.

The current trial forms the second pivotal study of the Remimazolam Phase
III program. PAION and the U.S. Food and Drug Administration (FDA) have
agreed on the remaining development program (indications, size of studies
and design).

Wolfgang Söhngen, M.D., Ph.D., chief executive officer of PAION AG, said:
"The Phase III bronchoscopy study is intended to confirm the efficacy and
safety profile of Remimazolam in additional procedural sedation
applications with the intention of broadening the target patient population
and to achieve a broad label in procedural sedation. Because most patients
undergoing bronchoscopy have a pre-existing pulmonary disease,
Remimazolam's benign safety profile including its effect on the respiration
system is critically important to its success as a sedative for these
procedures. During Phase II clinical trials in colonoscopy and upper
endoscopy, Remimazolam had an excellent safety profile including
respiratory stability and was highly effective in providing sedation
resulting in successfully completed procedures."

This Phase III clinical trial is a prospective, double-blind, randomized,
placebo- and midazolam-controlled, U.S. multicenter study in 460 patients
undergoing bronchoscopies. Patients will be randomized to receive
Remimazolam, midazolam or placebo in addition to fentanyl to achieve
moderate sedation. The primary endpoint is the successful completion of the
bronchoscopy procedure with no requirement for an alternative sedative. The
completion of patient recruitment is expected in 2016.

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