Date: 2014-11-13
Type of information: Initiation of the trial
phase: 2
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: diffuse cutaneous systemic sclerosis
Therapeutic area: Autoimmune diseases - Rare diseases
Country:
Trial details:
Latest
news: * On November 13, 2014, Bayer HealthCare announced the initiation of a randomized, double-blind, placebo-controlled Phase II study to investigate the efficacy and safety of riociguat against placebo in patients with diffuse cutaneous systemic sclerosis (dcSSc), the most severe form of systemic sclerosis (SSc). The development of riociguat in dcSSc is part of the recently announced worldwide strategic collaboration with Merck&Co in the field of soluble guanylate cyclase (sGC) modulation.
The RISE-SSc study (Riociguat Safety and Efficacy in patients with diffuse cutaneous Systemic Sclerosis [dcSSc]) will include 130 patients at more than 60 sites in 15 countries and will evaluate whether 52 weeks of treatment with riociguat in dcSSc is superior to placebo. The effect of riociguat on fibrosis of the skin and the lung, as well as on circulation problems such as digital ulcers will be evaluated.
Currently, there are no approved drugs available to potentially stop or delay the progression of the fibrotic damage in patients with SSc. In July 2014, both the European Commission and the FDA granted orphan drug status for riociguat as an oral investigational drug in SSc.
