Bayer begins Phase II trial of riociguat to treat patients with dcSSc

SSc is a rare multisystem, autoimmune disease that results in the overproduction and abnormal growth of collagen, which causes fibrosis of the skin and internal organs.

dcSSc is one of the two major forms of SSc and the most fatal rheumatic disease, which mostly affects people aged in their 40s and 50s.

The randomized, double-blind, placebo-controlled RISE-SSc trial will evaluate the efficacy and safety of riociguat against placebo in these patients.

The development of riociguat to treat dcSSc is part of the company’s worldwide strategic collaboration with Merck in the field of soluble guanylate cyclase (sGC) modulation.

Around 130 patients at more than 60 sites in 15 countries will be enrolled in the Phase II RISE-SSc trial, which will evaluate whether 52 weeks of treatment with riociguat in dcSSc is superior to placebo.

The trial will evaluate the effect of riociguat on fibrosis of the skin and the lung, as well as on circulation problems such as digital ulcers.

There are no approved drugs currently available to potentially stop or delay the progression of the fibrotic damage in patients with SSc.

Both the European Commission and the US Food and Drug Administration (FDA) have granted orphan drug status in July 2014 for riociguat as an oral investigational drug in SSc.

Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.