Bellerophon therapeutics, inc. presents new data from cohort 1 of ongoing phase 2/3 study of inopulse for treatment of pulmonary hypertension associated with interstitial lung disease at pulmonary fibrosis foundation summit 2019
Bellerophon therapeutics, inc. announced that it is presenting 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 (ph-ild) at the pulmonary fibrosis foundation (pff) summit 2019, being held november 7-9, 2019, in san antonio, tx. cohort 1, the first of 3 cohorts, included 41 subjects randomized 1:1 to either ino 30 (30 mcg/kg ibw/hr) or placebo, for a period of 8 weeks of blinded treatment. highlights from the newly presented subgroup analysis included: placebo corrected benefit of 33% in mvpa for intermediate/high probability of ph; placebo corrected benefit of 28% in mvpa for low probability of ph; placebo corrected benefit of 40% in mvpa for subjects with baseline 6mwd =300 meters as well as 33 meters in 6mwd and 39 meter% in distance saturation product (6mwd × spo2 nadir); the company previously presented positive data from cohort 1 that included: mvpa (walking, stairs, yardwork, etc.) improved by 34% (8% increase on ino vs. 26% decrease on placebo; p=0.04); 23% of subjects on inopulse had a clinically significant improvement in mvpa, compared to 0% of subjects on placebo (placebo corrected difference of 23%); 39% of subjects on inopulse had a clinically significant decline in mvpa, compared to 71% of subjects on placebo (placebo corrected difference of 32%); proportion of awake time spent in mvpa improved by 38% (16% increase on inopulse vs. 22% decrease on placebo; p=0.04); overall activity improved by 12% (stable on inopulse vs. 12% decrease on placebo; p=0.05).
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