Date: 2014-06-03
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: Bayer HealthCare (Germany)
Product: riociguat
Action
mechanism: soluble guanylate cyclase (sGC) stimulator. Riociguat (BAY 63-2521) is a member of a novel class of compounds, the stimulators of enzyme found in the cardiopulmonary system, soluble guanylate cyclase (sGC). When nitric oxide (NO) binds to sGC, the enzyme catalyzes synthesis of the signaling molecule cyclic guanosine monophosphate (cGMP), which plays an important role in regulating vascular tone, proliferation, fibrosis, and inflammation. The ability of riociguat to directly stimulate sGC independent of NO while also increasing the sensitivity of sGC to NO is potentially important in PAH. Endothelial dysfunction associated with PAH can be related to low levels of NO.
Disease: symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias
Therapeutic area: Rare diseases - Cardiovascular diseases - Respiratory diseases
Country:
Trial
details: The RISE-IIP trial will be carried out at more than 50 sites in 11 countries and will enrol 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.
Latest
news: * On June 3, 2014, Bayer HealthCare announced the start of a randomized, double-blind, placebo-controlled Phase IIb 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). The RISE-IIP trial will be carried out at more than 50 sites in 11 countries and will enrol 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.
