SOURCE: PAION AG

Paion AG

December 01, 2015 08:00 ET

PAION Announces Initiation of U.S. Clinical Safety Trial of Remimazolam in High Risk Patients Undergoing Colonoscopy

MAHWAH, NJ--(Marketwired - December 01, 2015) - PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of a smaller dedicated safety study of Remimazolam in ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing colonoscopy as part of the U.S. Phase III program. This trial will run alongside the two ongoing pivotal U.S. Phase III trials in colonoscopy and bronchoscopy.

The trial is part of the development program, which PAION and the U.S. Food and Drug Administration (FDA) agreed upon for the filing of Remimazolam in the targeted indication 'procedural sedation'.

Dr. Wolfgang Söhngen, Chief Executive Officer of PAION AG, commented: "ASA III/IV patients are outlined by their significant co-morbidities and therefore have a generally poor health status. Hence, they carry a higher risk for complications during or following medical interventions than otherwise healthy patients.

"Despite the use of midazolam, interventions in these patients are predominantly undertaken in hospitals and with the presence of anesthesiologists to account for the significant co-morbidities in this patient population. Although more than 90 % of colonoscopies are carried out in healthier patients (ASA I/II), it is very important for an overall safety characterization of Remimazolam to generate safety data especially in this more severely diseased patient population."

This prospective, double-blind, randomized, placebo- and active controlled, multicenter, parallel group study involves about 75 high-risk patients (i.e. ASA III/IV) undergoing a colonoscopy with Remimazolam compared to midazolam and placebo. Completion of patient recruitment is 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. Confirmatory Phase III programs are now 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 non-cardiac and cardiac surgery, including sedation in 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, and a Pre-NDA meeting is expected to take place in the beginning of 2016.

Development of an indication for ICU sedation beyond 24 hours is planned following successful completion of the currently ongoing 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.

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.

For more information please visit 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.

Contact Information

  • PAION Contact
    Ralf Penner
    Director 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