Bayer HealthCare recently announced it will test the efficacy and safety of the drug Riociguat in patients with symptomatic pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP).
The study will take place at more than 50 sites in 11 countries and will include about 120 patients. Designed as signal-generating, the trial intends to improve knowledge about the disease and the drug’s effect on it. The RISE-IIP is a randomized, double-blind, placebo-controlled phase 2b study.
“The RISE-IIP study is of great importance as it evaluates riociguat in a broad range of patients suffering from pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP) – a group of patients where no approved treatment is available,” said Principal Investigator Dr. Steve Nathan, Inova Fairfax Hospital, Virginia, USA.
“We hope that through this study, we will be able to provide the first clinical evidence of an effective treatment option to PH patients with different types of IIPs, for example non-specific interstitial pneumonia and unclassifiable forms of pulmonary fibrosis,” he added.
Riociguat was the first drug approved to treat two pulmonary hypertension indications, which are chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. The medication acts in a novel mechanism and the pharmaceutical company expects it to improve the symptomatic PH associated with IIP by treating mainly the PH component of the disease.
The phase 2a trial, for patients with PH associated with interstitial lung diseases (PH-ILD), revealed that riociguat is safely tolerated by patients.
Pulmonary hypertension is associated with a high rate of mortality, with co-morbidity in 30 to 85% among patients with idiopathic interstitial pneumonia. From the time that it is diagnosed, PH-IIP patients live on average between 2.5 and 3.5 years. Symptoms include dry cough and shortness of breath, which are often mistaken with underlying pulmonary disorders.
The World Health Organization (WHO) includes pulmonary hypertension in the clinical Group 3, which includes pulmonary hypertension with lung diseases and/or hypoxia.