Veloxis Pharmaceuticals A/S announced that the LCP-Tacro Phase III clinical trial in stable kidney transplant patients, the 3001 study, has been published online in the American Journal of Transplantation. The article reports on the randomized, controlled, multicenter Phase III trial, which demonstrated that LCP-Tacro dosed once-daily was not inferior to the current transplant drug, Prograf®, dosed twice-daily. Non-inferiority was determined by a composite endpoint, measured over a year of follow up that included death, graft failure, biopsy-proven acute rejection or loss to follow-up.

Results of this trial demonstrated that patients can be successfully converted from twice-daily Prograf to once-daily LCP-Tacro, which may increase patient compliance. Non-adherence to drug regimens is a contributor to graft failure. The results also demonstrated that, over the 12 month study, the daily dose of LCP-Tacro could be lowered significantly compared to the baseline Prograf dose, while the target blood levels remained stable and within target range.

This reflected the enhanced bioavailability provided by Veloxis' proprietary MeltDose® formulation. The technology optimizes the formulation and delivery characteristics of the LCP-Tacro product to permit once daily dosing.