Clinical-stage biotherapeutics company, Bellerophon Therapeutics, Inc., recently announced that its proprietary program device, a new version of the INOpulse drug-device delivery system, has received EC certification with CE marking, meaning that it has met the European Union’s regulatory health, safety, and environmental requirements for a new medical device and can be marketed in Europe.
The certification covers the design, development, and manufacture of inhaled pulsatile nitric oxide drug delivery systems, including Bellerophon’s tri-lumen cannula and application software.
Bellerophon is now developing three inhaled nitric oxide therapy devices under its INOpulse program for patients with pulmonary hypertension. INOpulse is a portable device for ambulatory patients, programmed to deliver a personalized and constant dose of inhaled nitric oxide over time, based on a patient’s breathing patterns.
Nitric oxide is a therapeutic agent for patients with respiratory distress syndrome and persistent pulmonary hypertension. It is a potent vasodilator that acts by reducing pulmonary artery pressure and vasodilating the blood vessels in the ventilated regions.
Currently, Bellerophon Therapeutics is focusing on the lead indication, pulmonary arterial hypertension (PAH), for which a Phase 3 program is being developed under an agreement between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This program will include two trials involving 450 patients, with its primary endpoint being improvement in the six-minute walk distance (6MWD) test, and with time to clinical worsening (TTCW) as the trials’ secondary endpoint.
The company previously presented promising data regarding the system’s effectiveness as a pulmonary hypertension treatment at the European Respiratory Society (ERS) International Congress 2015. Bellerophon also plans to continue Phase 2 testing of the INOpulse program for other indications, namely pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), and PH associated with idiopathic pulmonary fibrosis (PH-IPF).
“We are pleased to announce EC Certification for the new INOpulse drug-delivery system. This marks an important regulatory milestone in support of Bellerophon’s PAH Phase 3 program. The new device is significantly smaller and lighter than its predecessor, and includes an improved user interface and breath detection system. As such, it will offer greater convenience and usability to PAH patients receiving INOpulse therapy,” Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, said in a press release.