PAION AG Aachen (PA8)

[Leff0815]

REMIMAZOLAM PHASE III COLONOS
COPY DATA TO BE PRESENTED
AT THE AMERICAN COLLEGE OF GASTROENTEROLOGY 2016
MEETING
•
Phase III colonoscopy study data accepted as a late breaker
•
Primary investigator Prof. Douglas Rex will present study data
on Tuesday, 18 October 2016
Aachen, 22 September 2016 – PAION AG, a specialty pharma company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces
today that an oral presentation on the clinical results of remimazolam’s U.S.
Phase III colonoscopy trial has been accepted for the ACG meeting.
Remimazolam is an innovative, ultra-short acting anesthetic/sedative for which
positive headline data from this trial were published in June 2016.
Prof. Douglas Rex, M.D., Indiana University, Indianapolis, U.S., primary
investigator of this Phase III trial, will present the data in the Colon/Stomach
oral session that runs from 2:15 - 3:45 pm PDT (11:15 pm – 0:45 am CEST)
on 18 October 2016 at ACG in Las Vegas. The title of the abstract is:
“
Remimazolam is a safe and effective agent for sedation in outpatient
colonoscopy: Results of a phase 3, multi-center, randomized, placebo
controlled trial.
”
PAION will be available for discussions at Medical Information booth 1322 in
the exhibition hall.
Prof. Douglas Rex, M.D., commented: “ The acceptance of the study results as
a late breaker underscores the landmark status of the remimazolam Phase III
study in patients undergoing colonoscopy. I look forward to discuss these
important data with my fellow gastroenterologists .”

Dr. Wolfgang Söhngen, CEO of PAION AG, commented:
“We are proud that after eight years of work on remimazolam the data of the first Phase III
performed by PAION were accepted as a late breaker. Scientific presentations
of this successful pivotal trial are important activities to prepare the market
together with our U.S. licensing partner Cosmo Pharmaceuticals (Cosmo).
”
In addition to the detailed analysis of the primary endpoint of
the Phase III trial (comparison to placebo) also data comparing remimazolam to the
open label arm with gold standard midazolam will be presented, and relevant safety, efficacy and efficiency parameters will be addressed.

Link:
http://www.paion.com/uploads/tx_news/PAIONP162209en.pdf