Bellerophon Presents Positive Trial Results for INOpulse in IPF-associated PH


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INOpulse study results

Bellerophon Therapeutics recently presented promising new data from two Phase 2 clinical trials investigating its product INOpulse in patients with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF), and PH associated with chronic obstructive pulmonary disease (COPD) at the American Thoracic Society 113th International Conference (ATS 2017).

The INOpulse device delivers inhaled nitric oxide (iNO) and is designed to be portable for use by ambulatory patients with PH. The device automatically adjusts to a patient’s breathing pattern to deliver a constant and appropriate dose of pharmaceutical-grade nitric oxide over time independent of a patient’s activity level, ensuring more consistent dosing in the alveoli of the lungs.

Nitric oxide is a molecule naturally produced in the endothelial lining of blood vessels that plays a significant role in the opening of the arteries, including those in the lungs. When given to a patient with PH who has constricted blood vessels in the lungs, it is absorbed by the smooth muscles and help them to relax, causing the blood vessels in the affected area to dilate and open.

“Pulmonary hypertension with IPF or COPD has no approved therapies and has been associated with increased hospitalizations and mortality. The therapies used in other pulmonary hypertension populations, which act systemically, have failed to show a benefit for these patients, creating a critical unmet need for effective and safe long-term treatment options,” W. De Backer, MD, professor and director in the Department of Pulmonary Medicine at University Hospital and the University of Antwerp, said in a press release.

At ATS 2017, Bellerophon presented the first results of its efforts to evaluate the performance of INOpulse in conditions like PH associated with IPF (PH-IPF) and PH associated with COPD (PH-COPD).

In the presentation titled “Unravelling the Mode of Action of Pulsed Inhaled Nitric Oxide in Severe IPF Using Functional Respiratory Imaging (FRI),” researchers showed the benefits of INOpulse use in patients with PH-IPF.

All patients showed a statistically significant increase in blood vessel volume and consistent improvements in hemodynamics, namely in the systolic pulmonary arterial pressure (sPAP; a measure of blood pressure in the arteries supplying blood to the lungs), which was reduced on average by 14 percent.

Patients using the INOpulse device also walked an average of 75 meters (246 feet) more at the end of four weeks of treatment in the six-minute walk test (6MWD; a measure of exercise capacity).

Bellerophon also shared preliminary results from a Phase 2 clinical trial (NCT01728220) in patients with PH-COPD in a presentation titled “Pulsed Inhaled Nitric Oxide Has the Potential to Improve Exercise Tolerance in Severe COPD Subjects with Pulmonary Hypertension.

The company showed that INOpulse offered a consistent improvement in vasodilation and a meaningful reduction in pulmonary artery pressures (17.4 percent on average) within four weeks of treatment. The full study results are expected in the second half of 2017.

“Pulsed iNO has a potentially unique and distinguishing advantage as the data from these trials shows that it can provide selective vasodilation to the well-functioning parts of the lung, allowing for improvement in hemodynamic measures as well as increased exercise capacity without worsening oxygenation,” Backer concluded.

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