The US Food and Drug Administration (FDA) has accepted Bellerophon Therapeutics’ study design for the Phase IIb clinical trial of INOpulse in patients with Interstitial Lung Disease (ILD) associated pulmonary hypertension (PH).
In June this year, the firm presented its positive findings to the FDA from INOpulse’s Phase IIa trial in idiopathic pulmonary fibrosis (IPF) patients, as well as reviewed clinical plans for Phase IIb iNO-PF trial for pulmonary fibrosing diseases within ILD.
The Phase IIa results showed that the trial met its primary endpoint with a 15.3% average increase in blood vessel volume and demonstrated clinically meaningful 14% decrease in systolic pulmonary arterial pressure (sPAP).
Subsequently, the FDA accepted the study design and also an investigational new drug (IND) application for the evaluation of INOpulse in patients at low and high risk for pulmonary fibrosis-associated PH.
The INOpulse therapy’s dual mode of action featuring vasodilation and ventilation / perfusion matching is expected to aid a wide range of patients.
Bellerophon Therapeutics CEO Fabian Tenenbaum said: “The proprietary targeted delivery and the dual mode of action of INOpulse may allow it to be used in pulmonary fibrosing diseases where systemic vasodilators have proven to be ineffective.
“The lack of approved therapies for pulmonary hypertension associated with interstitial lung diseases represents a unique opportunity to develop a new therapy in this serious and significant unmet medical need.”
Set to commence next year, the Phase IIb trial will involve a total of 40 pulmonary fibrosis patients, 50% of which are at intermediate to high risk of PH.
The trial’s design does not include the right heart catheterisation procedure that is considered strenuous for participating subjects.
Image: HRCT of pulmonary fibrosis. Photo: courtesy of Drriad/Wikipedia.