Phase III study of LCP-Tacro (Veloxis Pharmaceuticals) shows drug is non-inferior to current treatment in Kidney Transplant patients

New data on the 3001 Study of LCP-Tacro, from Veloxis Pharmaceuticals, in stable Kidney Transplant patients has been published. This randomized, controlled, multicenter Phase III trial demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf, dosed twice-daily. Results 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 (Prog. Transplant, 19:277-284, 2009).

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. Data were published in the American Journal of Transplantation. See: "Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial" S. Bunnapradist et al. American Journal of Transplantation, 21 DEC 2012 DOI: 10.1111/ajt.12035