DGAP-News: PAION REPORTS POSITIVE HEADLINE DATA IN U.S. PHASE III TRIAL WITH REMIMAZOLAM FOR PROCEDURAL SEDATION UNDERGOING BRONCHOSCOPY
DGAP-News: PAION AG / Key word(s): Research Update
PAION REPORTS POSITIVE HEADLINE DATA IN U.S. PHASE III TRIAL WITH REMIMAZOLAM FOR PROCEDURAL SEDATION UNDERGOING BRONCHOSCOPY
28.06.2017 / 20:41
The issuer is solely responsible for the content of this announcement.
PAION REPORTS POSITIVE HEADLINE DATA IN U.S. PHASE III TRIAL WITH REMIMAZOLAM FOR PROCEDURAL SEDATION UNDERGOING BRONCHOSCOPY
- Primary efficacy endpoint successfully achieved
- Phase III program successfully completed
- Excellent safety profile of remimazolam confirmed
- Conference call on remimazolam headline data on Thursday, 29 June 2017 at 2:00 p.m. CEST (1:00 p.m. GMT/8:00 a.m. EDT)
Aachen (Germany), 28 June 2017 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that remimazolam, its ultra-short-acting benzodiazepine sedative/anesthetic, met its primary efficacy endpoint in a pivotal U.S. Phase III clinical trial in procedural sedation in patients undergoing bronchoscopy.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "I would like to warmly thank the patients and clinicians who participated in the study. We are very excited about the remimazolam results announced today. With the successful completion of the bronchoscopy trial, we have achieved a significant milestone in PAION's history and on the way to market approval for remimazolam."
This Phase III clinical trial - conducted at 15 sites throughout the U.S. - was a prospective, double-blind, randomized, placebo-controlled study with an open label midazolam arm in 446 patients (of which 431 received study medication) undergoing bronchoscopy for diagnostic or therapeutic reasons. The study was continuously supervised by an independent Data Monitoring Committee (DMC). In this trial 162 patients (37.6%) were ASA III patients (American Society of Anesthesiologists classification; ASA III: patients with severe systemic disease) and the average age of all patients was 62.3 years as compared to 6.6% ASA III patients and an average age of 54.9 years of all patients in the previously reported pivotal Phase III colonoscopy trial. Patients were randomized to receive either remimazolam, midazolam, or placebo in combination with fentanyl for pain control in order to achieve adequate sedation to start and perform the procedure. In order to ensure the performance of the scheduled bronchoscopy, midazolam was available for all patients as rescue medication for non-responders.
The primary outcome measure was a composite endpoint defined as: no need for rescue medication, completion of the procedure and no more than 5 doses within any 15-minute window for remimazolam/placebo and no more than 3 doses within any 12-minute window for midazolam. The primary endpoint was reached in 82.5% of the patients treated in the remimazolam arm and 3.4% in the placebo arm (p-value of <0.0001). Important secondary endpoints included median time from start of medication to start of procedure (5.0 minutes in the remimazolam arm versus 17.0 minutes for placebo) and median time from end of procedure to return to full alertness (remimazolam 6.0 minutes versus placebo 14.0 minutes). Additionally, the patients' subjective impression of time from last dose to "back to normal" was a median of 404 minutes for remimazolam versus 935 minutes for placebo.
In the open label midazolam arm, procedural success was achieved in 34.8% of patients. Midazolam patients showed a median time from start of medication to start of procedure of 16.0 minutes and a median time from end of procedure to return to full alertness of 12.0 minutes. Additionally, time from last dose to "back to normal" as reported by patients on midazolam was a median of 478.5 minutes.
Overview procedural results:
Remimazolam
Placebo
Midazolam
(Open Label)
Procedural Success
82.5%
3.4%
34.8%
Use of Rescue Sedation
16.2%
96.6%
56.5%
Time from First Dose to Start of Procedure
5.0 min
17.0 min
16.0 min
End of Procedure to Fully Alert
6.0 min
14.0 min
12.0 min
Time to "back to normal"
404.0 min
935.0 min
478.5 min
Overall adverse events, treatment-emergent adverse events and, in particular, incidents of hypotension and bradycardia occurred less frequently with remimazolam compared to midazolam. Hypotension was the most frequently reported adverse event occurring in 41.9% of patients treated with remimazolam, 62.7% with placebo and 49.3% with midazolam. Hypoxia occurred in 21.8% of patients given remimazolam, 20.3% in the placebo arm and 18.8% in the midazolam arm. As expected, patients enrolled in this trial were of overall poorer health compared to those enrolled in the pivotal colonoscopy trial. Twenty-one patients across all treatment groups experienced a total of 26 treatment-emergent serious adverse events ("SAE"). Out of these 26 SAEs, only two were considered related to treatment (remimazolam) and occurred in a single patient after administration of fentanyl at twice the dose allowed by the study protocol.
"The study results suggest that remimazolam, the first drug in many years to be tested for use in providing procedural sedation in the bronchoscopy lab has the potential to enhance the options for bronchoscopy patients allowing for a more efficient procedure", Gerard A. Silvestri M.D., M.S, Professor of Medicine, Medical University of South Carolina, Charleston, South Carolina, U.S., commented. "Remimazolam may be an ideal agent for patients who require bronchoscopy because it is safe, ultra-short-acting, has excellent sedative effects, and allows patients to more quickly wake to an alert state. The results of the trial are under further evaluation but already demonstrate that remimazolam is likely to have a place in providing adequate sedation to patients undergoing bronchoscopy."
Conference call:
PAION will hold a conference call (conducted in English) on Thursday, 29 June 2017 at 2:00 p.m. CEST (1:00 p.m. GMT/8:00 a.m. EDT) to present the Phase III headline data.
To access the call, participants may dial from
- Germany +49 (0) 69 7104 45598
- UK +44 (0) 20 3003 2666 and
- U.S. +1 212 999 6659
- other countries: please use the UK number
When prompted, give the password "PAION". The conference call will include a slide presentation which can be accessed during the call at: https://paion-events.webex.com/paion-events/j.php?MTID=m0aee605381a79a61f8d4c03dcb0ba93fAbout remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. 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 1,500 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
Remimazolam is currently in clinical Phase III development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of a Phase II study, development for ICU sedation beyond 24 hours is another attractive indication.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm respectively. For all other markets, remimazolam is available for licensing.
About PAION
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 which is in Phase III clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing 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. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam.
PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom).
PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.
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.
28.06.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de
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
End of News
DGAP News Service
587437 28.06.2017