DGAP-Adhoc: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

2020. november 19., csütörtök, 22:44





DGAP-Ad-hoc: PAION AG / Key word(s): Research Update


PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA


19-Nov-2020 / 22:44 CET/CEST


Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.


The issuer is solely responsible for the content of this announcement.




PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

- Primary endpoint met: remimazolam demonstrated non-inferiority to propofol for anesthetic effect



- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol



- EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia



Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia. In the trial with 424 patients, remimazolam met both the primary and key secondary endpoints.



The randomized, single-blind, propofol-controlled, confirmatory Phase III trial enrolled 424 ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing planned surgery at more than 20 European sites.



The primary objective of the trial was to demonstrate non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery. The primary efficacy endpoint was defined as the anesthetic effect of remimazolam and propofol assessed as a percentage of time of a Narcotrend (NCT) index below 60 (depth of anesthesia) during the maintenance phase of general anesthesia. In the final analysis, non-inferiority was demonstrated with an NCT index below 60 with 95.7% (n=235) of the time with remimazolam and 99.1% (n=92) with propofol at a significance level of p=0.0001.



The key secondary objective was to show improved hemodynamic stability compared to propofol. Hemodynamic stability is measured by avoidance of intraoperative drop in mean arterial blood pressure (MAP) between start of anesthesia and 15 minutes after the first skin incision, as well as usage of vasopressors. Although adjustments in the statistical testing were required based on the nature of the obtained data, a statistically significant superior hemodynamic stability of remimazolam compared to propofol could be shown with a number of hemodynamic events per patient of 62.62 ± 39.46 (n=270) with remimazolam and 71.03 ± 41.12 (n=95) with propofol at a significance level of p=0.0151.



End of inside information






Information and Explanation of the Issuer to this News:

About PAION

PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for 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. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam was approved in the U.S. and China for procedural sedation in July 2020 and in Japan for general anesthesia in January 2020. In South Korea, a market application for remimazolam in general anesthesia was filed in December 2019.



In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019.



PAION"s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.



PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).



Contact

Ralf Penner

Vice President 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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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
EQS News ID: 1149475





 
End of Announcement DGAP News Service




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