The company is developing INOpulse for patients with pulmonary arterial hypertension (PAH), PH associated with chronic obstructive pulmonary disease (COPD), and PH linked to interstitial lung disease (ILD).
“I am pleased to report continued progress in our clinical development programs evaluating INOpulse to treat pulmonary hypertension in a wide range of unmet chronic diseases,” Fabian Tenenbaum, the CEO of Bellerophon, said in a press release.
INOpulse helps relax blood vessels in the lungs. It is administrated with a portable device about the size of a paperback book that automatically adjusts nitric oxide pulses to a patient’s breathing pattern. The delivery system reduces the risk of side effects while widening blood vessels.
This was a milestone because it triggered an interim analysis of INOpulse’s safety and effectiveness by an independent trial Data Monitoring Committee. The findings of the interim analysis are expected by mid-2018. They will decide whether the trial should continue or be stopped, or if the number of participants should be increased.
Bellerophon anticipates announcing key results of the INOvation-1 trial by the end of the year.
Supported by positive results from another trial (NCT02267655) in patients with PH associated with pulmonary fibrosis, the company has started a randomized Phase 2b study (NCT03267108) in patients with PH-ILD.
The trial showed that INOpulse improved blood pressure in the main artery supplying blood to the lungs, as well as patients’ exercise capacity.
The new Phase 2b trial will evaluate the safety and efficacy of inhaled nitric oxide in comparison with a placebo in about 40 patients with pulmonary fibrosis. Similar to previous trials, the investigators will determine inhaled nitric oxide’s ability to improve patients’ blood flow and exercise capacity. Top-line results of this study are expected by the end of 2018.
INOpulse is also being evaluated in PH-COPD, with a Phase 2 trial (NCT02267655) showing positive results. The study included 10 patients with COPD who received 30 mcg/kg IBW/hr of inhaled nitric oxide.
INOpulse led to statistically significant improvements in patients’ blood-flow and exercise capacity after four weeks of treatment. Based on the results, Bellerophon is planning the next clinical trial with an eye toward regulatory approval of INOpulse as a treatment for PH-COPD.
Tenenbaum said 2018 “has the potential to be transformative for Bellerophon, with data expected in our PAH and PH-ILD programs, as well as anticipated further progress in our PH-COPD clinical development program. We are excited about these opportunities and remain focused on developing first-in-class therapies for patients suffering from serious chronic orphan pulmonary diseases.”