New data from a Phase III PATENT-1 pulmonary arterial hypertension (PAH) trial designed to evaluate Bayer HealthCare’s investigational drug ricoiguat in both treatment-naïve patients and in patients pre-treated with an endothelin receptor anatognist or an oral, inhaled, or subcutaneous prostanoid, indicates that the drug has met its primary endpoints and also exhibited patient improvement.
The study’s origins stem from the need for new treatment options for individuals living with PAH, says Pamela Cyrus, MD, Bayer Healthcare Pharmaceuticals, vice president and head, US Medical Affairs. Cyrus adds that the company is committed to addressing the needs of pulmonary hypertension patients by, “developing innovative medicines.”
Researchers note that the study met its endpoints by demonstrating a statistically significant improvement in the 6-minute walk distance (6MWD). Patients treated with riociguat reportedly displayed an improvement of 36 meters 95%-CI after 12 weeks when compared with the placebo.
The results also suggest a statistically significant improvement in 6MWD both in the treatment-naïve patient group, 38 meters after 12 weeks when compared with the placebo (95%-CI, 15 meters to 62 meters) and the pre-treated patient group, 36 meters after 12 weeks when compared with the placebo (95%-CI 15 meters to 56 meters). Researchers add that the most frequently reported adverse events associated with riociguat when compared to the placebo included headache, dyspepsia, peripheral edema, nausea, dizziness, diarrhea, nasopharyngitis, dyspnea, cough, and vomiting.
Hossein Ardeschir Ghofrani, MD, University Hospital and Marburg, Germany, principal investigator of the PATENT study, emphasizes the study’s results and its implication of riociguat as, “a potential treatment option for both patients who have never been treated for PAH as well as for those who have received prior treatment,” Ghofrani says.
The study also exhibits significant improvements in secondary endpoints including pulmonary vascular resistance (PVR), N-terminal prohormone brain natriuertic peptide (NT-pro BNP), WHO functional class, time to clinical worsening (TTCW), and Borg dyspnea score. According to a recent news release, secondary endpoints that were unable to achieve statistical significance included the European quality of life 5-dimensions questionnaire (EQ-5D) and living with pulmonary hypertension questionnaire (LPH).
The study is scheduled to appear an a late-breaking abstract in an oral absract session at the annual meeting of the American College of Chest Physicians (ACCP), CHEST 2012 in Atlanta, Ga.
Source: Bayer HealthCare