A first phase-II trial with Bayer Schering Pharma’s oral agent riociguat (BAY 63-2521) in pulmonary hypertension owing to interstitial lung disease (PH-ILD) has successfully been completed. PH-ILD is a form of pulmonary hypertension for which no approved treatment options are currently available. The primary objectives of the study – to investigate safety and tolerability of riociguat in this subgroup of PH-patients – were achieved. The study demonstrated a reduction in pulmonary vascular resistance (PVR), together with a considerable increase in cardiac output and slight improvement of exercise capacity as measured by a six-minute walk test (6-MWT). Riociguat is the first member of a novel class of therapeutics called soluble guanylate cyclase (sGC) stimulators and is being investigated as a new approach to treat different forms of pulmonary hypertension (PH).

“These preliminary results from this initial investigation of riociguat in patients with PH-ILD are very promising in this difficult-to-treat indication where therapies are urgently needed,” said lead investigator professor Marius Hoeper, Hannover Medical School, Hannover, Germany. “The reduction in pulmonary vascular resistance was remarkable and in the same range we have seen in previous studies with riociguat in pulmonary arterial hypertension. These positive results will pave the way for further studies on riociguat in PH-ILD and may offer physicians an opportunity to provide their patients a treatment in the future.”

It is planned to present the data at an international scientific meeting in 2010.

“Based on the encouraging data on riociguat in PH-ILD, Bayer will consider initiating the next step in the clinical PH-ILD program in 2010,” said Frank Misselwitz, vice president of Global Clinical Development and Head of the Cardiovascular and Coagulation Therapeutic Area, Bayer Schering Pharma AG. “We are making good progress in all our study programmes with riociguat. We are well on track in our work on pulmonary hypertension owing to chronic obstructive pulmonary disease, having completed a first phase-II study in this field. Detailed data analyses are ongoing and will be presented in 2010.”

Bayer Schering Pharma is exploring the potential of riociguat as an innovative therapy for patients suffering from pulmonary hypertension, including forms for which there are currently no drug therapies.

Riociguat is an oral agent being investigated in phase-III clinical trials as a potentially new approach to treating in chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH), two life-threatening types of PH.