Xoma has reported that its fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate has met the primary endpoint in the Phase III perindopril amlodipine for the treatment of hypertension (PATH) trial.
The FDC of perindopril arginine and amlodipine besylate was statistically significantly superior in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment in the trial involving 837 patients.
XOMA CEO John Varian said the positive study results, along with existing clinical data for the FDC, will support an NDA submission.
"We are extremely proud of our team for completing this trial ahead of schedule and now will be working to identify appropriate potential ways to move this FDC forward to the US market," Varian said.
"XOMA does not intend to directly market this FDC, but rather intends to sublicense this product to a third-party organisation that is dedicated to commercialising products for the cardiovascular marketplace."
The FDC was well-tolerated in the trial, which reported no unexpected serious adverse events.
Mild to moderate edema, cough and headache, which are recognised side effects of the individual components of the FDC, were the most common adverse events reported during the study.
Perindopril, an angiotensin converting enzyme inhibitor (ACE inhibitor), has demonstrated beneficial effect in treating essential hypertension and stable coronary artery disease while Amlodipine, a calcium channel blocker (CCB), is a commonly used antihypertensive in the US.
ACE inhibitors and CCBs are frequently used by the physicians in combination to treat hypertensive patients.