Bellerophon Therapeutics to conduct phase 3 clinical trial in China for INOpulse in fibrotic interstitial lung disease

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Bellerophon Therapeutics, Inc., a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, announced clearance of its Investigational New Drug application from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) to conduct a phase 3 clinical trial to support the registration of INOpulse for the treatment of fibrotic interstitial lung disease in China. The study will use Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon’s regional partner, Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products for Greater China.

“We are delighted to expand our clinical program with the aim of bringing INOpulse to patients in need in Greater China,” said Peter Fernandes, Bellerophon’s CEO. “INOpulse has the potential to become the first therapy to treat a fibrotic interstitial lung disease population that includes patients at low-, intermediate- and high-risk of pulmonary hypertension. This IND clearance further underscores the potential of INOpulse to improve activities of daily living and quality of life in patients with fibrotic interstitial lung disease, and supports the use of our novel primary endpoint, MVPA, which we are also utilizing in our ongoing phase 3 REBUILD study in the U.S.”


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