Bayer HealthCare, a subsidiary of German conglomerate Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), announced the start of a randomized, double-blind, placebo-controlled Phase IIb study. The RISE-IIP study or 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 or PH associated with idiopathic interstitial pneumonia or IIP.
According to the company, 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.
Pulmonary hypertension or PH is a severe, progressive, life-changing and life-threatening disorder of the heart and lungs in which the blood pressure in the pulmonary arteries is above normal, and which can lead to heart failure and death.
Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonia (PH-IIP) is a rare disease in which patients suffer both from pulmonary hypertension and idiopathic interstitial pneumonia or IIP.
Riociguat is a soluble guanylate cyclase or sGC stimulator, the first member of a novel class of compounds, discovered and developed by Bayer as an oral treatment to target a key molecular mechanism underlying PH. Riociguat is being investigated as a new and specific approach to treat different types of PH. sGC is an enzyme found in the cardiopulmonary system and the receptor for nitric oxide (NO). When NO binds to sGC, the enzyme enhances synthesis of the signaling molecule cyclic guanosine monophosphate or cGMP. cGMP plays an important role in regulating vascular tone, proliferation, fibrosis, and inflammation.
by RTT Staff Writer
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