DGAP-Adhoc

PAION REPORTS POSITIVE HEADLINE DATA IN U.S. PHASE III TRIAL WITH REMIMAZOLAM FOR PROCEDURAL SEDATION UNDERGOING BRONCHOSCOPY

DGAP-Ad-hoc: 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-Jun-2017 / 20:15 CET/CEST Disclosure of an inside information acc. to Article 17 MAR, transmitted by DGAP - a service of EQS Group AG. 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.

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.

End of inside information

Contact

Ralf Penner

Vice President Investor Relations/Public Relations

PAION AG

Martinstrasse 10-12

52062 Aachen - Germany

Phone [phone]

E-mail [e-mail]

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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28-Jun-2017 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language:	English
Company:	PAION AG
	Martinstr. 10-12
	52062 Aachen
	Germany
Phone:	[phone]
Fax:	[phone]
E-mail:	[e-mail]
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 Announcement	DGAP News Service

587429  28-Jun-2017 CET/CEST