Bellerophon is developing INOpulse — inhaled nitric oxide delivered with the help of a portable device — for patients with pulmonary arterial hypertension (PAH), pulmonary hypertension (PH)-associated with chronic obstructive pulmonary disease (COPD), and PH linked to interstitial lung disease (ILD).
The company underscored that if INOpulse proves effective and is approved, it would be the first treatment for PH in patients with other lung diseases.
“We continue to achieve important progress in all three of our INOpulse clinical development programs,” Fabian Tenenbaum, Bellerophon’s CEO, said in the financial report.
INOpulse is in the most advanced development stage for PAH, where a global Phase 3 trial (INOvation-1; NCT02725372) is ongoing, and still recruiting a planned 188 patients. While the full data of the trial will be analyzed when all participants have completed 16 weeks of treatment with either INOpulse or a placebo, the company plans to conduct an interim analysis when data is available for 75 participants.
“In our INOvation-1 Phase 3 trial for PAH, we now have over 100 sites activated in 17 countries and patient enrollment is progressing as planned. We expect to review both an interim analysis and top-line results from this trial in 2018,” said Tenenbaum. Enrollment information is available here.
Bellerophon earlier announced that it had received a green light from the U.S. Food and Drug Administration (FDA) to shorten its Phase 3 program in PAH. Instead of a second randomized Phase 3 trial, the company plans to launch a randomized withdrawal study, exploring how patients fare after stopping the treatment.
The study, which will include about 40 patients recruited directly from the INOvation-1 trial, is expected to start in the second half of 2018.
The development of INOpulse in patients with PH-COPD is also moving forward, with a new Phase 2b study in the planning stage.
“We are especially encouraged with the recently announced positive topline Phase 2 data in patients with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease,” Tenenbaum said.
Among patients with PH-ILD, the company has to date gathered data in those with PH and idiopathic pulmonary fibrosis (IPF). In May, data from a proof-of concept Phase 2a trial including only four patients indicated that the treatment may be effective in these patients, both in terms of lung blood pressure and exercise capacity.
Now, the company plans a larger Phase 2b study in patients with IPF and PH, as well as another study with other types of PH-ILD. Both are expected to launch in early 2018, with results available by the end of that year.
The PH-ILD study, called iNO-PF, will recruit about 40 patients with pulmonary fibrosis who are either at high or low risk of PH.
“These results further support the potentially unique role that INOpulse’s targeted vasodilation could have in becoming the first therapy approved for patients suffering from pulmonary hypertension associated with lung diseases, such as PH-COPD and PH-ILD,” Tenenbaum concluded.