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Published on 19 May 2009

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Bayer Schering presents positive results of phase II study with riociguat

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Positive data from a phase II trial with Bayer Schering Pharma’s oral agent riociguat (BAY 63-2521) in chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) were presented today at the American Thoracic Society (ATS) international conference in San Diego, USA.

Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators and is being investigated as a new approach for the treatment of different forms of pulmonary hypertension (PH).

Results from the multicentre, open-label, uncontrolled phase II trial showed that riociguat significantly improved exercise capacity from baseline values in patients with CTEPH and PAH. Riociguat also demonstrated strong and significant effects on pulmonary haemodynamics and symptoms in patients with CTEPH and PAH.

“Bayer Schering Pharma aims to lead the way in advancing cardiopulmonary research to address the significant unmet medical need for innovative treatment options in this field,” said Kemal Malik, MD, head of global development and member of the Executive Committee of Bayer HealthCare. “The data presented at the ATS meeting serve to further reinforce our expectations for riociguat in patients with CTEPH and PAH.”

“Pulmonary hypertension is a severe and life-threatening disease that progresses rapidly and, despite advances in patient care over the last few years, there is a real need for more efficient therapies,” said lead investigator Professor Hossein Ardeschir Ghofrani, head of the Pulmonary Hypertension Division, Department of Internal Medicine, University of Giessen, Germany.

“These findings are a positive step towards improving treatment options for PH patients – the majority of whom are currently still without viable treatment options – and could result in a significant enhancement to the care physicians currently offer their patients.”

The data presentation at ATS follows an earlier presentation of positive topline phase II findings at the Annual Congress of the European Respiratory Society (ERS) in October 2008. Based on these data, randomised placebo-controlled phase III trials in CTEPH (CHEST-1, followed by an open-label extension trial, CHEST-2) and PAH (PATENT-1, followed by an open-label extension trial, PATENT-2) were initiated in December 2008, with first results from the study programme currently expected in 2011.

In addition to the CHEST and PATENT trials, further phase II studies of riociguat in patients suffering from other forms of PH, such as PH secondary to interstitial lung disease (PH-ILD), are ongoing. First results from the PH-ILD study are currently expected in 2009.

Bayer



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