AACHEN, Germany --(BUSINESS WIRE)--
PAION AG, a specialty pharma company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces today that an oral presentation on the clinical results of remimazolam's U.S. Phase III colonoscopy trial has been accepted for the ACG meeting. Remimazolam is an innovative, ultra-short acting anesthetic/sedative for which positive headline data from this trial were published in June 2016.
Prof. Douglas Rex, M.D., Indiana University, Indianapolis, U.S., primary investigator of this Phase III trial, will present the data in the Colon/ Stomach oral session that runs from 2:15 - 3:45 pm PDT (11:15 pm - 0:45 am CEST) on 18 October 2016 at ACG in Las Vegas. The title of the abstract is: "Remimazolam is a safe and effective agent for sedation in outpatient colonoscopy: Results of a phase 3, multi-center, randomized, placebo controlled trial."
PAION will be available for discussions at Medical Information booth 1322 in the exhibition hall.
Prof. Douglas Rex, M.D., commented: "The acceptance of the study results as a late breaker underscores the landmark status of the remimazolam Phase III study in patients undergoing colonoscopy. I look forward to discuss these important data with my fellow gastroenterologists."
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "We are proud that after eight years of work on remimazolam the data of the first Phase III performed by PAION were accepted as a late breaker. Scientific presentations of this successful pivotal trial are important activities to prepare the market together with our U.S. licensing partner Cosmo Pharmaceuticals (Cosmo)."
In addition to the detailed analysis of the primary endpoint of the Phase III trial (comparison to placebo) also data comparing remimazolam to the open label arm with gold standard midazolam will be presented, and relevant safety, efficacy and efficiency parameters will be addressed.
About the U.S. Phase III trial in colonoscopy: The Phase III trial enrolled a total of 461 patients at 13 U.S. sites and was designed to evaluate the efficacy and safety of remimazolam compared to placebo (with midazolam rescue) in patients undergoing proceduralist- administered sedation for colonoscopy. The primary outcome measure, success of the procedure, was reached in 91.3% of the patients in the remimazolam arm and 5.0% in the placebo (including midazolam rescue) arm. The safety profile of remimazolam was consistent with that observed in previous studies.
Important secondary endpoints in the remimazolam arm showed a mean time to start of procedure of 5.1 minutes and a mean time from end of procedure to return to full alertness of the patients of 9.25 minutes.
This study also included an open label arm in which midazolam was dosed according to U.S. label. The data resulting from this non-comparative arm may be useful for hypothesis generation for future development and pharmacoeconomic modelling.
Although the study designs are not identical, the Phase III study results were in line with findings from a previous U.S. Phase IIb double-blind randomized comparative study between remimazolam and midazolam in 162 patients undergoing routine colonoscopy, where patients in the remimazolam arm showed significantly enhanced colonoscopy success rates and shorter times to start of procedure, shorter times from end of procedure to return to full alertness and, therefore, shorter overall procedure times than patients in the midazolam arm.
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/ anesthetic, currently in Phase III clinical development for procedural sedation in the U.S. The first of two pivotal Phase III studies was completed successfully and reached its primary endpoint. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.
In clinical studies, remimazolam demonstrated efficacy and safety in over 1,000 patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
A pediatric development plan has been agreed with the FDA and will be implemented by Cosmo following completion of current development of remimazolam for adult patients. A full clinical development program for general anesthesia has been completed in Japan, and a Phase II study in general anesthesia has been completed in the E.U. Based on the positive results of the Phase II study in Japan, development for ICU sedation beyond 24 hours is considered following successful completion of development in procedural sedation and general anesthesia.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all other markets, remimazolam is available for licensing.
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs to be used in 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 drug candidate. Currently, remimazolam is in active Phase III clinical development for use in procedural sedation in the U.S., where PAION is focusing all its business and financial resources on successfully completing its ongoing clinical development program in procedural sedation. Outside the U.S., PAION has so far focused on the development of remimazolam in the indication general anesthesia. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea.
PAION is headquartered in Aachen (Germany) with further sites in Cambridge (United Kingdom) and New Jersey (USA).
PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.
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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