Bellerophon therapeutics, inc. presents new positive data from cohort 1 of ongoing phase 2/3 study of inopulse® for treatment of pulmonary hypertension associated with interstitial lung disease at chest 2019 annual meeting
Bellerophon therapeutics, inc. presented additional new 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) as a late-breaking oral presentation at the american college of chest physicians (chest) 2019 annual meeting in new orleans. the data were presented by steven d. nathan, m.d., f.c.c.p., medical director of the advanced lung disease and lung transplant program at inova fairfax hospital and chair of bellerophon’s steering committee. bellerophon previously presented positive top-line data from cohort 1 of its ongoing ino-pf trial. 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. data highlights 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). the chest presentation included additional responder analysis data, as well as new long-term results for subjects on ole. presentation highlights included: responder analysis: 85% of subjects on placebo declined in mvpa, overall activity and non-sedentary activity; 46% of subjects on inopulse improved in mvpa, 62% in overall activity and 39% in non-sedentary activity (compared to only 15% of subjects on placebo in each category); ole: collectively, subjects (with an average of 27 weeks of ole data) demonstrated maintenance of mvpa, overall activity and non-sedentary activity; subjects randomized to active treatment in the blinded portion of the trial continued to maintain their activity levels when transitioning to ole over 27 weeks of open-label treatment; subjects randomized to placebo in the blinded portion of the trial transitioned from a decline during blinded treatment to stabilization of activity levels (mvpa, overall activity and non-sedentary activity) over 27 weeks of open-label treatment.
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