Phase III study of LCP-Tacro (Veloxis Pharma) meets primary endpoint in Kidney Transplant patients

Results from a Phase III clinical trial (Study 3002) of Kidney Transplant recipients show that LCP-Tacro (tacrolimus once daily), from Veloxis Pharmaceuticals, met its primary efficacy and primary safety endpoints. The randomized, double-blind and double-dummy study in 543 patients used Prograf as the comparator. Results demonstrated non-inferiority to Prograf, twice-daily, based on the composite endpoint of treatment failure at one year (LCP-Tacro 18.3%, Prograf 19.6%).

In addition, treatment failure rates through the first three months after transplant were 10.4% for LCP-Tacro and 14.2% for Prograf. There was a similar incidence of adverse events and impact on laboratory results. Regulatory submission to the FDA is on track for second half of 2013.