Bellerophon Therapeutics, Inc., a clinical-stage biotherapeutics company specializing in the development of drugs and devices for cardiopulmonary conditions, recently announced that the European Patent Office has issued a Notice of Intention to Grant a European Patent to protect the company’s INOpulse clinical program.
The patent, titled “System of Administering a Pharmaceutical Gas to a Patient,” covers the ability of the INOpulse system to deliver a precise amount of nitric oxide gas (a potent vasodilator) to patients, regardless of their respiration rates or volumes.
The company’s INOpulse clinical program aims to further develop a nitric oxide therapy for patients suffering from lung diseases. The technology is primarily indicated for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by narrowed arteries from the heart to the lungs, resulting in a blood pressure above normal levels.
Based on the positive results from a Phase 2 PAH clinical trial, showing the benefit of INOpulse for patients on long-term oxygen therapy who do not respond well to existing PAH therapies, the device will now be tested in two Phase 3 clinical trials involving 450 patients. Each trial has two main endpoints: improved six-minute walk distance (6MWD) and time to clinical worsening (TTCW).
In addition, INOpulse was recently tested in Phase 2 clinical trials on patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and PH associated with idiopathic pulmonary fibrosis (PH-IPF). The results are expected by the end of 2016.
The patent describing administration of a pharmaceutical gas is currently published in several countries, including the United States, Australia, China, Hong Kong, Japan, and Mexico, and is pending in other countries, like Brazil and Canada.
Other patents aimed at protecting the INOpulse program, in particular the tri-lumen cannula and the indexed valve for the drug cartridge, have been issued in the United States and are pending elsewhere, including in the European Union.
“We are pleased to announce the Intention to Grant for the System of Administration patent. This further supports the innovative technology of the INOpulse delivery system and marks another important milestone in our continued efforts to develop and bring the INOpulse therapy to the European market,” said Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, in a press release.
Upon approval, the patent could officially be issued in up to 38 European countries.