Bellerophon Therapeutics announced positive topline results from cohort 2 of an ongoing phase 2/3 iNO-PF study of INOpulse (pulsed, inhaled nitric oxide) delivery system for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The INOpulse delivery system is designed to deliver inhaled nitric oxide via a proprietary triple-lumen nasal cannula directly to the well-ventilated parts of the lung matching ventilation to perfusion (V/Q matching) and improving oxygenation. The Company believes INOpulse will allow inhaled nitric oxide, which is inactivated shortly after contact with blood, to be locally administered to blood vessels with minimal systemic effects.
iNO-PF is a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of INOpulse in adults with PH-ILD. Patients (N=80) were divided into 3 cohorts. In particular, cohort 2 included 44 patients randomized 2:1 to receive either iNO45 (45mcg/kg IBW/hr) or placebo for 4 months followed by an open-label extension period. Results demonstrated that patients treated with iNO45 in cohort 2 showed a statistically significant improvement in moderate to vigorous physical activity (MVPA), defined as walking, climbing stairs, yard work, and similar activities, compared with placebo. Additionally, the following topline parameters showed improvements for patients treated with iNO45 compared with placebo:
- MVPA improved by 14 minutes/day, representing a 20% improvement (P =.02)
- Overall activity improved by 100 counts/min, representing a 7% improvement
- St. George Respiratory Questionnaire (SGRQ) Total score improved by 3 points
- SGRQ Activity score improved by 5 points
- SGRQ Impacts score improved by 6 points
- University of California, San Diego Shortness of Breath Questionnaire improved by 5 points
INOpulse was well-tolerated with no safety concerns.
“The top-line results from Cohort 2 in the iNO-PF study are exciting and highlight the potential therapeutic benefit of INOpulse,” said Steven D. Nathan, MD, FCCP, Medical Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital and Chair of Bellerophon’s Steering Committee. “It is validating and reassuring to see the results from Cohort 2. The statistically significant benefit shown by INOpulse in MVPA, as well as the consistent benefit in overall activity over a four month period, are especially encouraging considering that this patient population has a median life expectancy of approximately 18 months.”
The Company plans to initiate the pivotal cohort 3 of iNO-PF as well as initiating a phase 3 clinical trial for INOpulse in the first quarter of 2020.
more information visit bellerophon.com.