PAION Announces Initiation Of Second U.S. Phase 3 Clinical Trial Of Remimazolam For Procedural Sedation During Bronchoscopy

MAHWAH, N.J., June 8, 2015 /PRNewswire/ -- PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of the second pivotal U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy.

The current trial forms the second pivotal study of the Remimazolam Phase 3 program. PAION and the U.S. Food and Drug Administration (FDA) have agreed on the remaining development program (indications, size of studies and design).

Greg Papaz, president and chief executive officer of PAION, Inc., said: "The Phase 3 bronchoscopy study is intended to confirm the efficacy and safety profile of Remimazolam in additional procedural sedation applications with the intention of broadening the target patient population and to achieve a broad label in procedural sedation. Because most patients undergoing bronchoscopy have a pre-existing pulmonary disease, Remimazolam's benign safety profile including its effect on the respiration system is critically important to its success as a sedative for these procedures. During Phase 2 clinical trials in colonoscopy and upper endoscopy, Remimazolam had an excellent safety profile including respiratory stability and was highly effective in providing sedation resulting in successfully completed procedures."

This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing bronchoscopies. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary endpoint is the successful completion of the bronchoscopy procedure with no requirement for an alternative sedative. The completion of patient recruitment is expected in 2016.

About Remimazolam
Remimazolam is an innovative ultra-short-acting general sedative/anesthetic. As a result of its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anesthesia compounds. Remimazolam's rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body. While the key positioning in conscious sedation will be a low impact on respiratory function it will be cardiovascular stability for general anesthesia. Remimazolam has potential in three indications:

• Procedural sedation (Lead indication U.S.)
• General anesthesia (Lead indication EU, Japan)
• ICU sedation (Phase 2 Japan)

Remimazolam is available for licensing outside China, Russia (CIS) Turkey, MENA Region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.

About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in Aachen, Germany with further sites in Cambridge, UK and New Jersey, US. The company has a track record of developing hospital-based treatments for which there is substantial unmet medical need. PAION's strategy is to participate in the commercialization of Remimazolam and extend its business with a focus on anesthesia/critical care products. Remimazolam is the building block for its future marketing activities.

For more information please visit www.paion.com

PAION Corporate Contact
Greg Papaz
President and CEO
PAION, Inc.
201-512-8850
[email protected]

Media Contact
Matt Middleman, M.D.
Russo Partners
212-845-4272
[email protected]

PAION AG Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen – Germany
Phone: +49 241 4453-152
E-mail: [email protected] 
www.paion.com

Investor Relations Support in the US
The Trout Group
Thomas Hoffman
+1 646 378 2931 Direct
[email protected] 
www.troutgroup.com

Disclaimer:

This release contains certain forward-looking statements concerning the future business of PAION, Inc. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION, Inc'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, Inc. has no obligation to periodically update any such forward-looking statements to reflect future events or developments.

SOURCE PAION, Inc.

Related Links

http://www.paion.com