Data Show that INOpulse was Associated with Clinically Meaningful Improvements in Hemodynamics and Exercise Capacity in Difficult-to-Treat PH-IPF Patients
Phase 2b Study in PH-IPF Population Planned
This proof of concept study (n=4) was conducted at University Hospital Antwerp led by Prof. W. De Backer MD, Director in the
The study was divided into an acute and a chronic phase. The acute phase was designed to identify the optimum iNO dose and evaluate the impact on hemodynamic measures. In the chronic phase, the impact of iNO on exercise capacity was evaluated using the 6 minute walk test after 4 weeks of treatment.
- Clinically important improvements were seen acutely and at 4 weeks in both hemodynamics and exercise capacity in all patients.
- Hemodynamics, as determined by reduction in systolic pulmonary arterial pressure (sPAP) showed improvement in all patients with an average reduction of 14% compared to baseline.
- Dose titration suggested that the iNO 30 dose can safely provide clinically relevant reduction in sPAP.
- The 6 minute walk distance increased on average 75 meters from baseline after 4 weeks of chronic use of INOpulse therapy.
- Improved oxygenation during the 6 minute walk test provides supportive evidence of targeted vasodilation and improved ventilation and perfusion (V/Q) matching.
- The investigators also evaluated the effect of INOpulse on two composite endpoints which combine oxygen saturation with walk distance: Distance Saturation Product (DSP) and Integral Distance Saturation Product (IDSP). These composite endpoints showed consistent improvement and may prove to be valuable as predictors of disease progression and outcomes.
- Detailed study data, including for the composite endpoints and respiratory imaging, will be presented in the poster at the ATS meeting.
“The results from this study suggest that iNO allows selective vasodilation to the well-functioning parts of the lung to improve hemodynamic measures as well as exercise capacity,” said Prof. W. De Backer MD, Director in the
“Development of pulmonary hypertension co-morbidity in IPF patients greatly impacts quality of life and survival. There are no approved treatments for this condition resulting in a profound unmet clinical need,” said
Details on this Phase 2 proof of concept study will be available at ATS in the following poster presentation.
|Title:||Unraveling the mode of action of pulsed inhaled NO in severe IPF using Functional Respiratory Imaging (FRI)|
|Authors:||B. Hajian1, B. Shivalkar1, F. Ferreira2, C. Van Holsbeke2, W. Vos2, J. De Backer2, D. Quinn3, A. Hufkens1, P.M. Parizel1, J. Clukers1, W. De Backer1|
|1 - University Hospital Antwerp - Antwerp/BE|
|2 - FLUIDDA - Kontich/BE|
|3 - Bellerophon Therapeutics|
|Date:||Sunday, May 21|
|Time:||9:15am - 4:15pm Eastern Time|
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF), both of which are in Phase 2 development. For more information, please visit www.bellerophon.com.
Contacts At Bellerophon:
Fabian Tenenbaum, Chief Executive Officer (908) 574-4767 At LifeSci Advisors: Bob Yedid(646) 597-6989 firstname.lastname@example.org