The FINANCIAL — Based on the positive findings from the clinical development phase II trial, Bayer Schering Pharma has begun a phase III program with its oral agent riociguat.
According to Bayer, two phase III trials will investigate the application in patients with both chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). Riociguat is the first member of a new class of therapeutics stimulating the enzyme soluble guanylate cyclase (sGC). Riociguat showed promising phase II results by significantly improving exercise capacity and hemodynamic parameters, such as pulmonary vascular resistance, cardiac output and pulmonary arterial pressure, compared to baseline values.
“Chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension are life-threatening diseases. The currently available treatments are approved only for pulmonary arterial hypertension, and the median survival time for treated patients is still very limited,” said Prof. Hossein Ardeschir Ghofrani, Head of the Pulmonary Hypertension Division, Department of Internal Medicine, University Hospital Giessen and Marburg, Germany. “We are very encouraged by the positive phase II findings with riociguat which, if replicated in phase III trials, will be an exciting breakthrough for patients with pulmonary hypertension and the physicians who treat them.”
The two studies – CHEST-1 (Chronic Thromboembolic Pulmonary Hypertension sGC Stimulator Trial) and PATENT-1 (Pulmonary Arterial Hypertension sGC Stimulator Trial) – will investigate the efficacy and safety of riociguat in patients with CTEPH or PAH. Over 700 patients will be recruited for the two studies.
The first data from the clinical phase II trial were presented at the Annual Congress of the European Respiratory Society (ERS) in Berlin, Germany, on October 6, 2008.
Further data from the phase II study are to be presented at the American Thoracic Society (ATS) International Conference in May 2009, in San Diego, California, USA.
“Cardiology forms one of the focus areas for Bayer’s drug discovery activities. Riociguat is one of the most promising product candidates we are developing in this field,” said Dr. Frank Misselwitz, Head of Global Clinical Development for cardiovascular diseases at Bayer Schering Pharma. “Riociguat has the potential to overcome the disadvantages of current standard therapies. With the two trials – CHEST-1 and PATENT-1 – we are stepping up our commitment, particularly in indications where a high unmet medical need still exists.”
Pulmonary hypertension affects more than 2.5 million people worldwide – and there are limited treatment options available for the majority of them.