Bayer HealthCare has initiated 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., Inc. in the field of soluble guanylate cyclase (sGC) modulation.

Bayer HealthCare and Merck & Co. announced the SGC pact with Bayer’s $14.2-billion acquisition of Merck & Co.’s consumer healthcare business under which the companies will develop and commercialize sGC modulators. This sGC collaboration includes Bayer's Adempas (riociguat), the first in a novel class of compounds and the only treatment approved for both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), as well as the investigational compound vericiguat that is currently in Phase II development. The collaboration also includes opt-in rights for other early-stage sGC compounds in development by both companies. As part of the deal, Merck was to make an upfront payment of $1 billion in connection with the sGC collaboration. 

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 US Food and Drug Administration granted orphan drug status for riociguat as an oral investigational drug in SSc.

Source: Bayer HealthCare