Bayer Announces New Riociguat Trial
Bayer announced the launch of a new Phase IIB trial to evaluate its FDA-approved pulmonary hypertension drug riociguat (brand name Adempas) in a new indication.
The placebo controlled, double blind, randomized RISE-IIP study (Riociguat in Patients with Symptomatic Pulmonary HypErtension associated with Idiopathic Interstitial Pneumonias) will investigate efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP).
Principal Investigator Dr. Steve Nathan of Inova Fairfax Hospital in Virginia said, “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. 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.”
Pulmonary hypertension occurs as co-morbidity in 30 to 85 patients with idiopathic interstitial pneumonia. Patients with PH-IIP have a median survival time of 2.5 to 3.5 years. The symptoms of PH typically manifest late and are masked by underlying IIP.
Riociguat is a soluble guanylate cyclase (sGC) stimulator belonging to a novel class of compounds. The drug is an oral treatment designed to target a key molecular mechanism underlying PH, which may benefit patients with symptomatic PH associated with IIP. Riociguat has demonstrated favorable safety profile in a previous Phase IIa proof of concept study in patients with PH associated with interstitial lung diseases (PH-ILD). The company submitted an application seeking approval for riociguat for the treatment of pulmonary arterial hypertension in Japan last April.
The new trial will enroll around 120 patients and will be carried out at over 50 sites across 11 countries. The RISE-IIP trial will serve as a ‘signal-generating’ study and will form the basis of possible future clinical developments and regulatory applications.