DGAP-News: PAION REPORTS POSITIVE RESULTS OF ITS SHORT ACTING ANAESTHETIC/SEDATIVE REMIMAZOLAM (CNS 7056) IN A PHASE IIB STUDY IN COLONOSCOPY
(firmenpresse) - PAION AG / Key word(s): Research Update
22.11.2010 07:30
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PAION REPORTS POSITIVE RESULTS OF ITS SHORT ACTING ANAESTHETIC/SEDATIVE
REMIMAZOLAM (CNS 7056) IN A PHASE IIB STUDY IN COLONOSCOPY
- Primary endpoint achieved
- Successful short-term sedation in patients undergoing colonoscopy
- Rapid recovery post sedation
- Good tolerability in all dose groups confirms safety profile
Company to host conference call today at 10 AM CET in German language and a
conference call today at 4 PM CET in English language
Aachen (Germany), 22 November 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
publishes positive headline data from the Phase IIb dose finding clinical
trial assessing its ultra short-acting intravenous anaesthetic/sedative
Remimazolam in patients undergoing colonoscopy.
The primary objective of the trial, to assess the success of a colonoscopy
procedure in comparison to midazolam (the gold-standard agent), was met,
and showed success rates of 97.5 % in the lowest, 95.0 % at the middle and
92.5 % at the highest dose regimen with Remimazolam, compared to 75% with
Midazolam. The primary endpoint was a composite consisting of sedation
sufficient to initiate and complete the procedure, no mechanical or manual
ventilation and no rescue sedation.
In addition, the results show that Remimazolam patients recovered faster
from their procedure, being fully alert within 13.3 minutes in the lowest,
11.3 minutes at the middle and 13.6 minutes at the highest dose regimen,
compared to 15.2 minutes with Midazolam after the last dose of study drug.
PAION's current interpretation is that the unexpected relatively short wake
up times of Midazolam are attributable to the fact that 25% of the
midazolam patients did not respond to treatment and therefore received
Propofol as a rescue medication quite early which is known as a short
acting compound. Therefore they did not receive 'a typical' midazolam dose
to allow accumulation resulting in a longer offset times. However Propofol
has other disadvantages.
This is the third clinical trial showing clinically relevant improvements
of Remimazolam over Midazolam.
'Remimazolam has the potential to become the new gold standard in
procedural sedation, both as a fixed single bolus and as a bolus with
top-ups', commented Dr. Wolfgang Söhngen, PAION's CEO. 'From our
discussions with clinicians and potential partners we know that the profile
assessed and shown in all our trials exactly meets market needs. We will
now endeavour to turn Remimazolam into a commercial success.'
Notes to Editor
About the Phase IIb study
The Phase IIb trial was a double-blind, randomized, parallel group study
examining three dose regimens of Remimazolam compared with Midazolam in 160
patients undergoing a colonoscopy. The patients received either one of
three different initial doses of Remimazolam or Midazolam followed by
'top-ups' (i.e. multiple doses) as required to maintain an adequate
sedation level to undergo a standard colonoscopy procedure.
The study - conducted in multiple sites in the U.S. - was designed to
evaluate the safety of Remimazolam and the success of the sedation, the
time to peak sedation as well as the time to full recovery anddischarge,
in comparison to the gold-standard agent, Midazolam. In addition, based on
the results of the successfully concluded Phase Ib and IIa studies, this
study was designed to further refine the optimal dose regimen before moving
into Phase III.
The following data are based on the ITT (intent to treat) analysis:
The patients received one of the following doses of Midazolam or
Remimazolam:
- Midazolam - 2.5 mg with 1.0 mg top-ups (40 patients)
- Remimazolam - 8.0 mg with 3.0 mg top-ups (40 patients)
- Remimazolam - 7.0 mg with 2.0 mg top-ups (40 patients)
- Remimazolam - 5.0 mg with 3.0 mg top-ups (40 patients)
The dose of Midazolam was selected as representing the labeled dose. The
doses of Remimazolam were selected based on the findings of the previous
clinical trials.
The success of the procedure was a composite endpoint consisting of
sedation sufficient to initiate and complete the procedure, no mechanical
or manual ventilation and no rescue sedation. The success rate (ITT) with
Midazolam was 75 %. The success rate with Remimazolam was 97.5 % at the
lowest dose regimen, 95 % at the middle and 92.5 % at the highest dose
regimen. A rapid recovery to fully alert (13.3 minutes in the lowest, 11.3
minutes at the middle and 13.6 minutes at the highest dose regimen compared
to 15.2 minutes with Midazolam after the last dose of study drug) and short
time to 'ready for discharge' (13.5 minutes in the lowest, 14 minutes at
the middle and 16.8 minutes at the highest dose regimen compared to 17.1
minutes with Midazolam after the last dose of study drug) were observed.
The time to fully alert was shorter in the Remimazolam groups when compared
to Midazolam. PAION's current interpretation is that the unexpected
relatively short wake up times of Midazolam are attributable to the fact
that 25% of the midazolam patients did not respond to treatment and
therefore received Propofol as a rescue medication quite early which is
known as a short acting compound. Therefore they did not receive 'a
typical' midazolam dose to allow accumulation resulting in a longer offset
times. However Propofol has other disadvantages.
This is the third clinical trial showing clinically relevant improvements
of Remimazolam over Midazolam.
Overall, the study showed that it is possible to achieve better results
with Remimazolam as compared to the gold standard Midazolam. The safety
profile observed in this trial confirmed the good tolerability also shown
in all previous studies and as anticipated for a benzodiazepine. There were
no unusual findings observed and no patient required manual or mechanical
ventilation. As expected the number of top-ups could be substantially
reduced from an average of 4.6 in the Phase Ib study to an average of 1.9
per patient in the Phase IIb study (Midazolam 2.4). Overall, there was good
cardiovascular and respiratory stability with Remimazolam treatment. As a
consequence of the improved treatment regimen the AESI's (adverse events of
special interest) rate was substantially lower (10 related AESI's in 160
subjects in the Phase IIb study) compared to the Phase Ib study (29 in 45
subjects).
Conference Call
PAION will hold a conference call today, Monday, 22 November 2010 at 10
a.m. CET (9 a.m. GMT, 4 a.m. ET) for media representatives and shareholders
in German. PAION will also be available for analysts and investors in a
further conference call in English at 4 p.m. CET.
PAION will host the conference calls to present details on the headline
data of the Phase IIb study with Remimazolam.
To access the call, please dial:
Germany +49 (0) 69 710445598
UK +44 (0) 20 3003 2666
US + 1 866 966 5335
(other countries: please choose from D/UK/US numbers).
The participant pass code is 'PAION'.
To allow for smooth processing we suggest that you dial in ten minutes
before the beginning of the call.
The conference call will be supplemented by a webcast presentation which
can be accessed during the call under the following link:
www.meetingzone.com/presenter/
For the call at 10 a.m. CET, please use the PIN1961272.
For the call at 4 p.m. CET, please use the PIN 4349347.
The dial-in details for the conference call and the webcast link are also
available on PAION's website http://www.paion.com
The conference call will be recorded. Details on how to access the replay
will be posted on the same web page after the call.
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About Remimazolam (CNS 7056)
Remimazolam is an innovative short-acting general anaesthetic/sedative.
Sedatives are used, for example, in endoscopic procedures such as
colonoscopies. After intravenous administration Remimazolam rapidly induces
the desired sedation. Importantly, this sedative effect quickly disappears.
This rapid offset of the effect of the substance is due to its metabolism
by tissue esterase enzymes that are widely distributed throughout the body.
Remimazolam is being developed as a sedative agent for day case procedures
(procedural sedation) as well as for the induction and maintenance of
anaesthesia. It could also be used as a sedative for patients in the
Intensive Care Unit (ICU).
PAION is exploring partnering opportunities for the territories outside
Japan, where the compound is partnered with Ono Pharmaceuticals in order to
be able to initiate the development of Remimazolam in other indications as
early as possible.
As recently published, the INN (International Nonproprietary Name) for CNS
7056 recommended by the World Health Organization is Remimazolam.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search&Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
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(at)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.
22.11.2010 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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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
Deutschland
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Hamburg, München, Berlin, Düsseldorf, Stuttgart
End of Announcement DGAP News-Service
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Datum: 22.11.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 32685
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