PAION AG / Key word(s): Research Update
28.05.2014 18:45
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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PAION REPORTS POSITIVE PHASE II RESULTS OF ITS SHORT ACTING ANAESTHETIC
REMIMAZOLAM IN MAJOR CARDIAC SURGERY
- Excellent cardiovascular stability confirmed in major cardiac surgery
- Primary Endpoint met
- Outstanding safety profile of Remimazolam confirmed
Aachen (Germany), 28 May 2014 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange Prime Standard: PA8), a specialty pharma company, today
announced positive headline data from the Phase II clinical trial in
Germany with the short-acting anaesthetic/sedative Remimazolam in the EU
lead indication "general anaesthesia" in patients undergoing major cardiac
surgery with extracorporeal circulation.
The primary efficacy endpoint of effectiveness as a general anaesthetic
(defined as successful anaesthesia not requiring rescue therapy) was
achieved in 98% of patients in the two Remimazolam dose groups and 96% in
the Propofol/Sevoflurane group. Therefore, an excellent efficacy rate
across all treatment groups was shown. As expected, the onset and offset of
action profile was comparable between all treatment groups, showing that
Remimazolam indeed shares the fast-acting sedative profile of Propofol.
The safety profile was generally very good in all treatment groups.
One of the key targets of this trial was to assess the cardiostability
during cardiac surgery with Remimazolam when compared to
Propofol/Sevoflurane, both of which are known to cause cardiac depression.
The study evaluated a substantial number of parameters to analyse these
effects. Remimazolam already had shown excellent cardiostability in the ONO
Phase III study. During cardiac surgery norepinephrine is routinely used to
maintain blood pressure in the normal range and counteract pronounced blood
pressure decreases. Norepinephrine and other adrenergic substances however
are known to impair the microcirculation in vital organs and thus have a
negative effect on short, mid and long-term outcomes. Therefore lowering
the norepinephrine dose is of high medical relevance. The amount of
norepinephrine required to counteract the cardio-depressive effects (e.g.,
drop in blood pressure) is a direct measure of the cardio-depressive
effects in each group: a higher amount of norepinephrine would be used to
counteract higher cardio-depressive effects. The use of norepinephrine was
36.7% lower in Remimazolam treated patients when compared to the
Propofol/Sevoflurane group which can be regarded as a clinically meaningful
differentiation.
Notes to Editor
About the Phase II study
The Phase II study was a randomized, Propofol and Sevoflurane (standard
treatment) controlled Phase II study to evaluate the efficacy, tolerability
and pharmacokinetics of Remimazolam during general anaesthesia in patients
undergoing cardiac surgery using a heart-lung machine. After surgery, a
follow-up sedation in the recovery room or in the intensive care unit (ICU)
could be continued for up to 24 h. A total of 90 patients have been
treated.
The study was carried out at the Heart Centre Leipzig - University Hospital
and was designed to provide detailed information about the cardiovascular
safety profile of Remimazolam as an anaesthetic during general anaesthesia
for cardiac surgery. Moreover, it is expected to deliver further insights
on titration of sedation in the postoperative phase.
Two doses of Remimazolam (6 mg/kg/h and 12 mg/kg/h) have been evaluated
head to head and against Propofol during induction of general anaesthesia.
In the maintenance phase of anaesthesia, Remimazolam was tested against the
standard combination of Propofol and Sevoflurane. Furthermore, data in the
postoperative sedation phase in the postoperative care unit or ICU against
Propofol were obtained and can be used for further exploration of the ICU
sedation indication. The study was designed such that the data can
complement the anaesthesia study results conducted by Ono in Japan and
could then be used together with the Japanese studies for filing for
regulatory approval.
###
About Remimazolam
Remimazolam is an innovative short-acting general anaesthetic/sedative. Due
to its short duration of action and good controllability, it has a
preferable efficacy and safety profile relative to other currently marketed
anaesthesia compounds. The rapid offset of Remimazolam's effect is due to
its metabolism by tissue esterase enzymes that are widely distributed
throughout the body.
Remimazolam has potential in three indications:
- Procedural sedation
- General anaesthesia
- ICU sedation
Remimazolam is available for licensing outside Japan, China, Russia (CIS)
and Turkey, as well as South Korea, where the compound is partnered with
Ono Pharmaceutical, Yichang Humanwell, R-Pharm and Hana Pharm.
About PAION
PAION AG is a publicly-listed specialty pharma company headquartered in
Aachen, Germany with a second site in Cambridge, UK. The company has a
track record in developing hospital-based treatments for which there is
substantial unmet medical need. PAION AG is transforming its business model
from a pure development company to a specialty pharmaceutical company with
a focus on anaesthesia products to take advantage of the unique profile of
its main compound, Remimazolam.
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 PAION AG'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.
28.05.2014 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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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: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, München, Stuttgart
End of Announcement DGAP News-Service
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DGAP-Adhoc: PAION REPORTS POSITIVE PHASE II RESULTS OF ITS SHORT ACTING ANAESTHETIC REMIMAZOLAM IN MAJOR CARDIAC SURGERY
| Source: EQS Group AG