Idorsia announces positive results of the two Japanese registration studies with clazosentan - Seite 2

The studies confirmed the well documented safety profile of clazosentan which has now been administered to over 2000 patients around the globe. In these registration studies in Japanese patients post-aSAH there were no unexpected safety findings. Treatment emergent adverse events occurring >5% in the clazosentan group with a difference of >2% compared to placebo were vomiting and signs of hemodilution or fluid retention (i.e. hyponatremia, hypoalbuminemia, anemia, pleural effusion, brain and pulmonary edema).

Satoshi Tanaka, Dr Med Sci. and President of Idorsia Pharmaceuticals Japan, commented:

“I want to start by thanking the investigators and their highly skilled staff for the excellent conduct of the study. I also thank the Idorsia Japan team, many of whom have worked on clazosentan for many years and never doubted the benefit that it could bring to the patients, I’m very proud of the whole team. Most of all I want to thank the patients who have taken part in this study and their families, they can all be very proud of being part of this very important advancement for Japanese patients whose lives are so impacted by this devastating consequence of aSAH. My team will now rapidly analyze the study in full detail with the objective to file the NDA with the PMDA in the first half of 2021 and make the full results available through scientific publication.”

Teiji Tominaga, M.D., Ph.D., Professor & Chairman, Department of Neurosurgery, Tohoku University Graduate School of Medicine commented:
“The clinical consequences of the vasospasm that can follow aSAH can be far reaching, ranging from neurological to other physical problems that can be very severe in nature. aSAH is a significant problem in Japan with an incidence around twice as high as in other countries around the world. This makes the medical need particularly high in Japan and the discovery of a new therapeutic option that can help Japanese patients to overcome the consequences of this devastating condition is important. I have worked with the team to develop clazosentan since the first studies, it is very rewarding to see the years of research come to fruition with these great results.”