(1888PressRelease)
May 19, 2009 - Results from the multicenter, 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 hemodynamics and symptoms in patients with CTEPH and PAH.
“Bayer Schering Pharma aims to lead the way in advancing cardio-pulmonary research to address the significant unmet medical need for innovative treatment options in this field.” said Kemal Malik, M.D., 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 Prof. 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, randomized 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 program 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.
About Riociguat
Riociguat (BAY 63-2521) is an oral agent being investigated in phase III clinical trials as a potentially new approach to treating CTEPH and PAH, two life-threatening types of PH. Riociguat is the first member of a novel class of therapeutics called soluble guanylate cyclase (sGC) stimulators. Riociguat works through the same signaling pathway as the body’s own vasodilating substance, nitric oxide (NO). NO relaxes the musculature in the blood-vessel walls, lowers the pulmonary blood pressure and relieves the heart by modulating the activity of the sGC enzyme. Riociguat has a dual mode of action:
it sensitizes sGC to the body’s own NO while also directly stimulating sGC independently of NO. This could be important because the NO levels in the pulmonary circulation are decreased in patients with PH. With its novel mode of action, riociguat has the potential to overcome a number of limitations of other therapies currently used to treat PH.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
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