Bayer Trial Will Evaluate Riociguat in New Indication



Bayer HealthCare announced the start of a randomized, double-blind, placebo-controlled Phase 2b study. The RISE-IIP study (Riociguat in Patients with Symptomatic Pulmonary HypErtension associated with Idiopathic Interstitial Pneumonias) is designed to investigate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP).
Pulmonary hypertension is a co-morbidity seen in 30 to 85% of patients with idiopathic interstitial pneumonia (IIP) and is associated with increased mortality. Once diagnosed, the median survival time in PH-IIP patients is estimated to be 2.5 to 3.5 years. Initially, patients may present with non-specific symptoms like dry cough and shortness of breath, so that the diagnosis of PH is often delayed. The clinical symptoms and signs of PH usually appear late in the course of IIP, so that they are often masked by this underlying pulmonary disorder. 
“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.”
Within the World Health Organization’s (WHO) clinical classification system for pulmonary hypertension (Dana Point 2008), PH-IIP belongs to Group 3, representing pulmonary hypertension owing to lung diseases and/or hypoxia. Riociguat is the first drug to be approved in two pulmonary hypertension indications, namely chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) and pulmonary arterial hypertension (PAH, WHO Group 1). It is the objective of the RISE-IIP study to better understand the effects of riociguat in patients belonging to WHO Group 3. Due to its novel mode of action, riociguat may benefit patients with symptomatic PH associated with IIP by primarily treating the PH component of the disease, as PH is linked to an increased mortality in this patient population. In a Phase 2a proof of concept study in patients with PH associated with interstitial lung diseases (PH-ILD), riociguat was well tolerated with a good safety profile. 
The RISE-IIP trial will be carried out at more than 50 sites in 11 countries and will enroll approximately 120 patients. The study is designed as a ‘signal-generating’ study which may help to better understand the disease and the effect of riociguat on it. Based on the results, further steps will be decided.


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