Bellerophon announces positive initial data from acute hemodynamic dose escalation study of inopulse® for treatment of pulmonary hypertension associated with interstitial lung disease

Bellerophon therapeutics, inc. announced positive initial data from an acute, dose escalation, clinical study (phpf-002) of inopulse® for the treatment of pulmonary hypertension associated with interstitial lung disease (ph-ild). phpf-002 is an ancillary study to the company’s ongoing double-blind, placebo-controlled, randomized, phase 2/3 ino-pf study of inopulse for the treatment of ph-ild, for which the company expects to report top line results for cohort 2 by the end of the year. the results to date from phpf-002 have demonstrated clinically meaningful improvements in multiple pre-specified pulmonary hemodynamic parameters, starting with the lowest dose of 30 mcg/kg ibw/hr (ino30). dose escalation showed: pulmonary vascular resistance (pvr) improved by 29% (baseline pvr was 584 dynes × sec × cm-5); cardiac output (co) improved by 16% (baseline co was 3.5 l/min); mean pulmonary arterial pressure (mpap) improved by 10% across doses (baseline mpap was 34.3 mmhg); oxygen saturation remained stable across doses; and ino was well-tolerated with no safety concerns across doses. phpf-002 is designed to assess the acute hemodynamic benefit of escalating ino doses in ph-ild. the first four phpf-002 study subjects were each treated sequentially, beginning with a dose of ino30, followed by dose escalation to ino45 and ino75. pulmonary hemodynamics were measured via right heart catheterization and collected at baseline, as well as following each sequential ino dose. the company intends to enroll up to four additional ph-ild subjects in this study.
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