DGAP-News: PAION AG / Key word(s): Conference
PAION AG: REMIMAZOLAM PHASE III COLONOSCOPY DATA TO BE PRESENTED AT THE
AMERICAN COLLEGE OF GASTROENTEROLOGY 2016 MEETING
22.09.2016 / 14:00
The issuer is solely responsible for the content of this announcement.
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REMIMAZOLAM PHASE III COLONOSCOPY 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.
About the U.S. Phase III trial in colonoscopy:
The Phase III trial enrolled a total of 461 patients at 13 U.S. sites and
was designed to evaluate the efficacy and safety of remimazolam compared to
placebo (with midazolam rescue) in patients undergoing proceduralist-
administered sedation for colonoscopy. The primary outcome measure, success
of the procedure, was reached in 91.3% of the patients in the remimazolam
arm and 5.0% in the placebo (including midazolam rescue) arm. The safety
profile of remimazolam was consistent with that observed in previous
studies.
Important secondary endpoints in the remimazolam arm showed a mean time to
start of procedure of 5.1 minutes and a mean time from end of procedure to
return to full alertness of the patients of 9.25 minutes.
This study also included an open label arm in which midazolam was dosed
according to U.S. label. The data resulting from this non-comparative arm
may be useful for hypothesis generation for future development and
pharmacoeconomic modelling.
Although the study designs are not identical, the Phase III study results
were in line with findings from a previous U.S. Phase IIb double-blind
randomized comparative study between remimazolam and midazolam in 162
patients undergoing routine colonoscopy, where patients in the remimazolam
arm showed significantly enhanced colonoscopy success rates and shorter
times to start of procedure, shorter times from end of procedure to return
to full alertness and, therefore, shorter overall procedure times than
patients in the midazolam arm.
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About Remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/
anesthetic, currently in Phase III clinical development for procedural
sedation in the U.S. The first of two pivotal Phase III studies was
completed successfully and reached its primary endpoint. In the human body,
remimazolam is rapidly metabolized to an inactive metabolite by tissue
esterases and not metabolized by cytochrome-dependent hepatic pathways.
Like other benzodiazepines, remimazolam can be reversed with flumazenil to
rapidly terminate sedation and anesthesia if necessary.
In clinical studies, remimazolam demonstrated efficacy and safety in over
1,000 patients. Data so far indicate that remimazolam has a rapid onset and
offset of action combined with a favorable cardio-respiratory safety
profile.
A pediatric development plan has been agreed with the FDA and will be
implemented by Cosmo following completion of current development of
remimazolam for adult patients. A full clinical development program for
general anesthesia has been completed in Japan, and a Phase II study in
general anesthesia has been completed in the E.U. Based on the positive
results of the Phase II study in Japan, development for ICU sedation beyond
24 hours is
considered following successful completion of development in procedural
sedation and general anesthesia.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm),
Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all
other markets, remimazolam is available for licensing.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing
and aiming to commercialize innovative drugs to be used in out-patient and
hospital-based sedation, anesthesia and critical care services. PAION’s
lead compound is remimazolam, an intravenous, ultra-short-acting and
controllable benzodiazepine sedative/anesthetic drug candidate. Currently,
remimazolam is in active Phase III clinical development for use in
procedural sedation in the U.S., where PAION is focusing all its business
and financial resources on successfully completing its ongoing clinical
development program in procedural sedation. Outside the U.S., PAION has so
far focused on the development of remimazolam in the indication general
anesthesia. Development of remimazolam in the indication intensive care
unit (ICU) sedation is also part of the longer term life-cycle plan for
remimazolam.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea.
PAION is headquartered in Aachen (Germany) with further sites in Cambridge
(United Kingdom) and New Jersey (USA).
PAION’s vision is to become an acknowledged “PAIONeer” in sedation and
anesthesia.
PAION Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen – Germany
Phone: +49 241 4453-152
E-mail: r.penner@paion.com
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.
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22.09.2016 Dissemination of a Corporate News, transmitted by DGAP – a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
End of News DGAP News Service
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504393 22.09.2016
