-
Low recruitment of cardiac surgery patients
-
No drug-related serious adverse events have been observed
-
New EU Phase III trial subject to further funding
-
Focus on U.S. Phase III program
AACHEN, Germany I February 9, 2016 I PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), announces today’s decision to discontinue the European Remimazolam Phase III trial in cardiac surgery.
The European Phase III Remimazolam clinical trial in cardiac surgery faced recruitment challenges due to the complex study design. Despite intensive efforts to enhance study recruitment, the trial proved to be difficult to implement in practice. PAION decided to discontinue the trial in order to avoid a long and expensive study with the existing design.
No drug-related serious adverse events have been observed. Accordingly, PAION will work together with recognized experts on setting up an alternative design in general surgery patients.
The EU decision will have no impact on the U.S. program. The company will now focus on the ongoing U.S. development program in procedural sedation with highest priority. The Phase III colonoscopy trial is on track and completion of patient recruitment is still expected in the first quarter 2016. Patient recruitment in the Phase III bronchoscopy trial remains moderate which could possibly extend the completion into 2017. Conditional on successful implementation of ongoing counter measures, PAION expects filing for approval in 2017.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: “Following intensive discussion and consultations, we decided to discontinue the trial. Together with our business partners around the world, we continue to see great value in the General Anesthesia indication. We will develop a clinical plan in Europe that builds on the insights we gained from the cardiac surgery trial, once funding is available.
In the meantime we will be allocating additional resources to the U.S., our biggest market opportunity. ”
About the EU Phase III trial in cardiac surgery
The Phase III study is a multi-national, multicenter, randomized, single-blind, propofol-controlled, confirmatory study in patients undergoing major cardiac surgery. A total of 530 patients were planned to be treated in several European study centers. Results of the study were expected in 2016.
About Remimazolam
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. 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 in order to rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in more than 1,000 patients. A confirmatory Phase III program is currently in progress. Data so far indicate that Remimazolam has the expected rapid onset and offset of action combined with a favorable hemodynamic stability profile.
In the U.S., Remimazolam is initially being developed for procedural sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being developed for general anesthesia in patients undergoing general and cardiac surgery, including post-operative sedation in post anesthesia care or intensive care units (ICUs) for up to 24 hours after the operation.
In Japan, a clinical Phase III program in anesthesia has been successfully completed.
Development of an indication for ICU sedation beyond 24 hours is planned following successful completion of the above-mentioned Phase III programs. A pediatric development plan has been agreed with the FDA and will be implemented following approval of Remimazolam for adult patients. A similar approach is planned for EU.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm. In the U.S. and EU, PAION focuses on the attractive opportunity of an own commercialization or co-commercialization.
About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company headquartered in Aachen (Germany) with operations in Cambridge (United Kingdom) and New Jersey (USA). PAION’s lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic that is currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION’s vision to become an acknowledged “PAIONeer” in sedation and anesthesia.
SOURCE: Paion
Post Views: 68
-
Low recruitment of cardiac surgery patients
-
No drug-related serious adverse events have been observed
-
New EU Phase III trial subject to further funding
-
Focus on U.S. Phase III program
AACHEN, Germany I February 9, 2016 I PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), announces today’s decision to discontinue the European Remimazolam Phase III trial in cardiac surgery.
The European Phase III Remimazolam clinical trial in cardiac surgery faced recruitment challenges due to the complex study design. Despite intensive efforts to enhance study recruitment, the trial proved to be difficult to implement in practice. PAION decided to discontinue the trial in order to avoid a long and expensive study with the existing design.
No drug-related serious adverse events have been observed. Accordingly, PAION will work together with recognized experts on setting up an alternative design in general surgery patients.
The EU decision will have no impact on the U.S. program. The company will now focus on the ongoing U.S. development program in procedural sedation with highest priority. The Phase III colonoscopy trial is on track and completion of patient recruitment is still expected in the first quarter 2016. Patient recruitment in the Phase III bronchoscopy trial remains moderate which could possibly extend the completion into 2017. Conditional on successful implementation of ongoing counter measures, PAION expects filing for approval in 2017.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: “Following intensive discussion and consultations, we decided to discontinue the trial. Together with our business partners around the world, we continue to see great value in the General Anesthesia indication. We will develop a clinical plan in Europe that builds on the insights we gained from the cardiac surgery trial, once funding is available.
In the meantime we will be allocating additional resources to the U.S., our biggest market opportunity. ”
About the EU Phase III trial in cardiac surgery
The Phase III study is a multi-national, multicenter, randomized, single-blind, propofol-controlled, confirmatory study in patients undergoing major cardiac surgery. A total of 530 patients were planned to be treated in several European study centers. Results of the study were expected in 2016.
About Remimazolam
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. 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 in order to rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in more than 1,000 patients. A confirmatory Phase III program is currently in progress. Data so far indicate that Remimazolam has the expected rapid onset and offset of action combined with a favorable hemodynamic stability profile.
In the U.S., Remimazolam is initially being developed for procedural sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being developed for general anesthesia in patients undergoing general and cardiac surgery, including post-operative sedation in post anesthesia care or intensive care units (ICUs) for up to 24 hours after the operation.
In Japan, a clinical Phase III program in anesthesia has been successfully completed.
Development of an indication for ICU sedation beyond 24 hours is planned following successful completion of the above-mentioned Phase III programs. A pediatric development plan has been agreed with the FDA and will be implemented following approval of Remimazolam for adult patients. A similar approach is planned for EU.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm. In the U.S. and EU, PAION focuses on the attractive opportunity of an own commercialization or co-commercialization.
About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company headquartered in Aachen (Germany) with operations in Cambridge (United Kingdom) and New Jersey (USA). PAION’s lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic that is currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION’s vision to become an acknowledged “PAIONeer” in sedation and anesthesia.
SOURCE: Paion
Post Views: 68
