WARREN, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced clearance of its Investigational New Drug (IND) 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 (fILD) in China. The study will utilize 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 Chief Executive Officer. “INOpulse has the potential to become the first therapy to treat an fILD 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 fILD, 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.”
“We are excited to continue strengthening our partnership with Baylor BioSciences,” said Naseem Amin, Chairman of Bellerophon Therapeutics. “INOpulse has significant potential in treating various diseases associated with pulmonary hypertension and the clearance of this IND brings us one step closer to a new treatment option for the underserved fILD patient community in Greater China.”
About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.