Veloxis' LCP-Tacro non-inferior to Prograf in preventing organ rejection

Veloxis Pharmaceuticals A/S (CSE:VELO) said once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus from Astellas Pharma Inc. (Tokyo:4503) in the Phase III Study 3002 to prevent organ transplant rejection in de novo kidney transplant recipients. LCP-Tacro was non-inferior to Prograf on a composite of biopsy-proven acute rejection, graft failure, death or loss to follow-up at 12 months (18.3% vs. 19.6%). Veloxis said the pre-specified non-inferiority margin was 10%. The company has an SPA from FDA for the double-blind, double-dummy trial, which enrolled 543 de novo kidney transplant recipients.

Next half, Veloxis plans to submit an NDA to FDA for LCP-Tacro to prevent kidney transplant rejection. In May, EMA accepted for review an MAA for the product, which comprises tacrolimus delivered using the company's MeltDose technology, to prevent organ rejection in kidney transplant patients. The company said it expects a decision on the application next year. ...