Bellerophon to present additional data from Cohort 1 of INO-PF study
Bellerophon announced that it would present a late-breaking abstract with additional data from Cohort 1 of its ongoing Phase 2/3 randomized, double-blind, placebo-controlled clinical study iNO-PF of INOpulse for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease, or PH-ILD, as an oral presentation at the American Thoracic Society, or ATS. The company will also provide a corporate overview and an update on its PH-ILD development program during the session at the Respiratory Innovation Summit, or RIS. Based on results from Cohort 1 of its ongoing iNO-PF trial, Bellerophon reached an agreement with the FDA on the use of MVPA as the primary endpoint in the pivotal Phase 3 study. In addition, the FDA agreed with the company's proposal that the ongoing Phase 2b study be amended to a seamless Phase 2/3 trial, allowing Bellerophon to continue directly into the final third cohort required for approval. Bellerophon is actively recruiting patients in Cohort 2 of its INO-PF trial, which will assess a higher dose as well as a longer duration of treatment to 16 weeks. The company continues to see strong recruitment activity and support from clinical sites and top-line data from Cohort 2 are anticipated in the second half of 2019. Bellerophon also expects to initiate Cohort 3 in the second half.