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Product › Details

remimazolam (CNS 7056)

Products Next higher product group analgesic_o
Period Status 2016-04-01 development p3 existent
Organisations Organisation Paion AG
  Group Paion (Group)
  Organisation 2 CeNeS Pharmaceuticals plc (LSE: CEN)
  Today Paion UK Ltd.
  Group Paion (Group)
     

Paion AG. (11/22/10). "Press Release: Paion Reports Positive Results of Its Short Acting Anaesthetic/Sedative Remimazolam (CNS 7056) in a Phase IIb Study in Colonoscopy". Aachen.

· 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


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 “topups” (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 and discharge, 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 PIN 1961272.
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.

###

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@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.

   
Record changed: 2019-06-09

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