XOMA said the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate, licensed by the company from Les Laboratoires Servier, proved in a Phase III trial to be statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.
In results of the 837-patient PATH trial (perindopril amlodipine for the treatment of hypertension) disclosed by XOMA, the company said the perindopril/amlodipine FDC appeared to be well tolerated in the trial, and there were no unexpected serious adverse events reported.
The most common adverse events included mild to moderate edema, cough, and headache, which are known side effects of the individual components of the FDC.
“We believe that based upon our previous conversations with FDA, the positive PATH results combined with the body of existing clinical data for this FDC will support an NDA submission," XOMA CEO John Varian said in a statement. “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 U.S. market.”
He said XOMA does not intend to directly market the perindopril/amlodipine FDC, but to sublicense it to a third-party organization dedicated to commercializing cardiovascular products.
XOMA acquired U.S. rights to the perindopril/amlodipine FDC and the rest of the perindopril franchise in January 2012 from Servier, XOMA's partner for its lead antibody product candidate, gevokizumab (formerly XOMA 052). Servier markets the fixed-dose combination product under the name COVERAM® in 91 countries outside the U.S.
The perindopril/amlodipine FDC is the first product candidate XOMA elected to develop from a portfolio of three fixed-dose combination product candidates where perindopril is combined with other active ingredient(s). The perindopril in each of the combination product candidates is patent-protected until 2023.
"We expect a partnership at some point in 2013, approval in 2014 and royalties to XOMA starting soon thereafter and going until 2023," Cowen & Co. analysts Simos Simeonidis, Ph.D., and Yatin Suneja said in a note to investors this morning.
While positive data, licensing, and eventual approval could translate into royalty stream for XOMA, the analysts said investors are more closely watching two Phase II and three Phase III gevokizumab trials under way, with data to be released between now and the first half of 2014. Data from the Phase II proof-of-concept trials in acne and erosive osteoarthritis of the hand are expected by year's end and mid-2013, respectively, while the three Phase III uveitis trials are expected to read out between the end of 2013 and mid-2014.
Perindopril, an angiotensin converting enzyme (ACE) inhibitor, has been studied in seven landmark clinical trials involving more than 54,000 patients assessing its impact in treating essential hypertension and stable coronary artery disease.