Bayer Starts Phase II Clinical Trial of Riociguat

Bayer HealthCare has confirmed that they have begun a Phase II clinical trial of riociguat for the treatment of diffuse cutaneous systemic sclerosis (dcSSc).

Systemic sclerosis 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 main forms of SSc and the most fatal rheumatic disease, which mainly affects people in their 40s and 50s.

The randomized, double-blind, placebo-controlled RISE-SSc clinical trial aims to assess the efficacy and safety of riociguat compared to placebo.

The development the drug is part of the Bayer’s strategic collaboration with Merck in the field of soluble guanylate cyclase (sGC) modulation.

Approximately 130 patients at will be enrolled in the clinical trial across over 60 sites in 15 countries, which will evaluate treatment over 52 weeks.

The clinical study will assess riociguat for fibrosis of the skin and the lung, in addition to circulation problems such as digital ulcers.

There is currently no approved treatment to potentially stop or delay the progression of the fibrotic damage in patients with SSc.  Earlier this year, both the European Commission and the US Food and Drug Administration granted orphan drug status for riociguat as an oral investigational drug in SSc.


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