Bayer announces data from riociguat Phase III pulmonary arterial hypertension trial

Bayer HealthCareOct 22 2012

Bayer HealthCare today announced data from the Phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid. The study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance (6MWD) with patients treated with riociguat showing an improvement of 36 meters 95%-CI [20-52 meters] (p<0.0001) after 12 weeks compared with placebo.  The results will be presented as a late-breaking abstract in an oral abstract session at CHEST 2012, the annual meeting of the American College of Chest Physicians (ACCP) in Atlanta, Georgia (Abstract No. 1462799).

In addition to meeting its primary endpoint, trial results also showed a statistically significant improvement in 6MWD both in the treatment-naive patient group (38 meters after 12 weeks compared with placebo [95%-CI 15-62 meters]) and the pre-treated patient group (36 meters after 12 weeks compared with placebo [95%-CI 15-56 meters]).

Pulmonary arterial hypertension (PAH), one of the five types of PH, is a rare and lifethreatening disease characterized by elevated pressure in the pulmonary arteries.

"The six-minute walk distance test is a well-validated clinical measure in patients with PAH, and therefore, the results of the PATENT-1 trial are encouraging," said Professor Hossein Ardeschir Ghofrani of University Hospital Giessen and Marburg, Germany and principal investigator of the PATENT study.  "These data from the PATENT study suggest that riociguat may be a potential treatment option both for patients who have never been treated for PAH as well as for those who have received prior treatment."

The ten most frequently reported treatment emergent adverse events with riociguat vs. placebo were: headache (27% vs. 20%), dyspepsia (19% vs. 8%), peripheral edema (17% vs. 11%), nausea (16% vs. 13%), dizziness (16% vs. 12%), diarrhea (14% vs. 10%), nasopharyngitis (10% vs. 11%), dyspnea (6% vs. 11%), cough (5% vs. 10%) and vomiting (10% vs. 9%).

Statistically significant improvements were also observed across secondary endpoints including pulmonary vascular resistance (PVR) (p<0.0001), N-terminal prohormone brain natriuretic peptide (NT-pro BNP) (p<0.0001), WHO functional class (FC) (p=0.0033), time to clinical worsening (TTCW) (p=0.0046) and Borg dyspnea score (p=0.0022). Secondary endpoints that did not achieve statistical significance include the European quality of life 5-dimensions questionnaire (EQ-5D) (p=0.0660) and living with pulmonary hypertension questionnaire (LPH) (p=0.0019).

"New treatment options are needed for people living with PAH," Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "Bayer HealthCare is committed to addressing the unmet needs of pulmonary hypertension patients by developing innovative medicines."