SOURCE: PAION AG

PAION AG

October 01, 2014 08:00 ET

Two Scientific Remimazolam Presentations Are Accepted for ASA and ACG Meeting in October 2014

AACHEN, GERMANY--(Marketwired - October 01, 2014) -

  • Presentation of the Phase II trial results in anaesthesia at „The Anesthesiology 2014 Annual Meeting" (ASA) on 13th October 2014 in New Orleans, USA
  • Presentation of the Phase IIb trial results in procedural sedation at „American College of Gastroenterology Annual Scientific Meeting" (ACG), 21th October 2014 in Philadelphia, USA

PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3) (FRANKFURT: PA8) announces today that scientific abstracts about clinical data of Remimazolam were accepted for presentation at two major US congresses. The lead investigators will present the clinical results and PAION the hypothetical product profile of its innovative, short acting anaesthetic/sedative to professionals; consisting of gastroenterologists, anaesthetists, surgeons and intensive care professionals. The booth in the commercial exhibition is part of the planned pre-marketing activities.

The presentation by lead investigator Dr Stefan Probst at ASA will be during the session "Drug Disposition, Metabolism and Elimination" at ASA on 13th October 2014 from 3 pm to 4:30 pm. The title of the abstract is: "Phase II Study of an Ultra-Short Acting Benzodiazepine (Remimazolam) Versus a Standard Regime of Propofol/Sevoflurane in Patients Undergoing Cardio-Surgery." The presentation will be available for download on the company's website www.paion.com. The Phase II study in anaesthesia was conducted at the Heart Center Leipzig/Germany from September 2013 to February 2014.

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) for up to 24 h was part of the protocol. A total of 90 patients have been treated.

The primary efficacy endpoint as a general anaesthetic (defined as successful anaesthesia not requiring sedative 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. 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. During cardiac surgery norepinephrine is routinely used to maintain blood pressure in the normal range and counteract pronounced blood pressure decreases.

In this study the total norepinephrine dose used was 36.7 % lower in Remimazolam treated patients when compared to the Propofol/Sevoflurane group which can be regarded as a clinically significant differentiation.

The ASA meeting is the largest international anaesthesia congress. Remimazolam's lead indication in Europe is to be presented also to U.S. Anaesthesiologists because after successful approval in Europe the NDA (New Drug Application) for the indication "General anesthesia" will be also applied for in the U.S.

PAION will be available for discussions at booth 343 in the exhibition hall.

During the ACG meeting Dr Daniel J. Pambianco, the lead investigator of the Phase IIb trial, will present the results of the colonoscopy study during the session "Endoscopy/Colorectal Cancer Prevention on 21 October 2014 between 8.30 am to 10 am. The title of the abstract is: "A Phase IIb Study Comparing the Safety and Efficacy of Remimazolam and Midazolam in Colonoscopy Patients." The presentation will be available for download on the company's website www.paion.com. In connection with ASA a kick off meeting with potential investigators for the Phase III program will also be held.

PAION will be available for discussions at booth 751 in the exhibition hall.

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 success of the sedation under Remimazolam and the time to peak sedation as well as the time to full recovery and discharge, and safety, in comparison to the gold-standard agent, Midazolam. In addition, based on the results of the successfully conducted Phase Ib and IIa studies, this study was designed to further refine the optimal dose regimen before moving into Phase III.

The primary objective of the trial, to assess the success of a colonoscopy procedure in comparison to Midazolam, was met, and showed success rates ranging from 92.5% to 97.5% with the 3 Remimazolam dose groups, compared to 75 % with Midazolam. Thus Remimazolam was clinically superior compared to the current gold standard Midazolam. The primary endpoint was a composite consisting of the following: "sedation sufficient to initiate and complete the procedure, no mechanical or manual ventilation and no rescue sedation."

25% of the patients in the Midazolam group received Propofol as sedative rescue medication compared to 5 % in the combined Remimazolam groups who received either Propofol or Midazolam. This study from 2010 was the third showing a clinically relevant improvement in the course of sedation in comparison to Midazolam.

"We are proud that distinguished scientific organizations like ASA and ACG accepted scientific Remimazolam presentations. This shows that the current product profile attracts increasing attention and underscores the medical need both in conscious sedation and general anesthesia. The presentation of Remimazolam during scientific conferences and congresses is part of the international scientific dialogue about Remimazolam. Furthermore this will initiate our pre-marketing activities that we conduct to accompany the Phase III program both in the US and Europe," comments Dr. Wolfgang Söhngen, CEO at PAION.

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) Turkey, South Korea and Canada, where the compound is partnered with, Ono Pharmaceutical, Yichang Humanwell, R-Pharm, Hana Pharm and Pendopharm.

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's strategy is to extend its business model from a pure development company to a specialty pharmaceutical company with a focus on anaesthesia products. Remimazolam is intended to be the basis for its future marketing activities.

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.

Contact Information

  • 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