The top-line results from PHPF-002 demonstrated that acute treatment with INOpulse provided statistically and clinically significant improvements in hemodynamic parameters, including:
- Pulmonary vascular resistance reduced by 21%, with increased benefit (p<0.01) on dose escalation from iNO30 (30 mcg/kg IBW/hr) to iNO45 (45 mcg/kg IBW/hr).
- Mean pulmonary arterial pressure reduced by 12%.
- iNO was well-tolerated with no safety concerns across the doses.
The acute hemodynamic improvements observed on iNO, along with the increased benefit demonstrated on iNO45 versus iNO30, correlate with the chronic benefit of iNO recently reported in Phase 2 of the Company’s ongoing Phase 2/3 iNO-PF study.
In Phase 2 of iNO-PF, subjects on iNO30 and iNO45 maintained their level of moderate to vigorous physical activity (MVPA), defined as walking, climbing stairs, yard work, and similar activities, while subjects on placebo deteriorated. The improvements in MVPA were supported by benefits in other key parameters, with subjects on iNO45 demonstrating placebo corrected improvements in:
- MVPA: Improved by 14 minutes per day, representing 20% (p=0.02).
- St. George Respiratory Questionnaire (SGRQ): Clinically meaningful benefit of 5 points (Activity domain), 6 points (Impacts domain), and 3 points (Total Score).
University of California, San Diego Shortness of Breath Questionnaire: Clinically meaningful benefit of 5 points.
“The benefits demonstrated in our multiple Phase 2 studies support INOpulse’s potential to become a transformative therapy for PH-PF patients,” said
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Contacts | |
At Bellerophon: | At LifeSci Advisors: |
Fabian Tenenbaum, Chief Executive Officer | Brian Ritchie |
(908) 574-4767 | (212) 915-2578 |
britchie@lifesciadvisors.com |
Source: Bellerophon Therapeutics, Inc.