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news.Bayer Schering Pharma has presented top-line findings from a Phase II study in patients with chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Based on positive Phase II trial findings, the company will move into Phase III trials with its oral agent riociguat.
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Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008.
In addition to significantly increased exercise capacity, patients improved as well in terms of hemodynamic parameters such as pulmonary vascular resistance, cardiac output and pulmonary arterial pressure in comparison to baseline values, the company said. The study also showed that riociguat was well tolerated and had a favorable safety profile.
Kemal Malik, head of global development and member of the executive committee of Bayer HealthCare, said: “Riociguat has the potential to overcome limitations of current standards of care in pulmonary hypertension (PH). We are expanding into areas of high unmet medical need and riociguat is an example of the kind of novel approach to treating cardiovascular disease to which Bayer is committed.”
In addition to the completed Phase II study and the two Phase III trials in CTEPH and PAH about to begin, further Phase II studies of riociguat are underway in patients suffering from other forms of PH such as PH in patients with interstitial lung disease or PH in patients with chronic obstructive pulmonary disease. First results from these studies are currently expected for 2011 and 2009, respectively.