Date: 2013-09-04
Type of information:
phase: 3
Announcement: presentation of data at the European Society for Organ Transplantation in Vienna.
Company: Veloxis Pharmaceuticals (Denmark)
Product: Envarsus® (LCP-Tacro™)
Action mechanism: LCP-Tacro™ is an investigational drug that is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products.
Disease: prevention of graft rejection in kidney transplantation
Therapeutic area: Transplantation
Country: USA, Europe
Trial details: Study 3002 is a randomized, double-blind, multi-centre study that compares once-daily LCP-Tacro against twice-daily Prograf in de novo adult kidney transplant patients. The primary endpoint of the study, a composite endpoint (BPAR (Biopsy Proven Acute Rejection), graft failure, loss to follow up or death), will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf. Secondary endpoints will include safety, tolerability and renal function assessments. The study is being conducted at approximately 90 transplant centres, primarily in the U.S. and Europe. Patients will participate in a 12-month extension period on treatment for follow-up safety assessments.
Latest
news: * On September 4, 2013, Veloxis Pharmaceuticals has announced that data from the 3002, randomized, double-blind, double-dummy, Phase III study in 543 de novo kidney transplant patients will be presented at the European Society for Organ Transplantation as a late-breaker oral presentation at 8:30 a.m. CEST, Sept. 9, in Vienna. Veloxis' once-daily LCP-Tacro™, now with the trade name of Envarsus®, demonstrated comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®). The primary endpoint of the study was a composite endpoint of treatment failure (biopsy-proven acute rejection or BPAR, graft failure, loss to follow up or death) that was evaluated after a 12-month treatment period to demonstrate the non-inferiority of Envarsus® compared to Prograf®. The treatment failure rate for Envarsus® was 18.3% compared to 19.6% for Prograf®, well within the 10% pre-specified non-inferiority margin. A Marketing Authorization Application (MAA) has been already submitted to the EMA and Veloxis Pharmaceuticals is now preparing Envarsus® NDA for submission to the FDA by the end of 2013.* On May 19, 2013, a Veloxis-sponsored abstracts has been presented at the 13th American Transplant Congress. (A Phase 3, Double-Blind, Multi-Center, Non-Inferiority, Randomized Study to Examine the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, twice Daily, in Combination with Mycophenolate Mofetil in De Novo Adult Kidney Transplanation: Baseline Characteristics Rostaing, L., Budde, K. and Bunnapradist, S.) This presentation described the baseline characteristics of patients enrolled and randomized into the 3002 study in de novo kidney transplant patients. (http://www.atcmeetingabstracts.com/abstract/phase-3-double-blind-multi-center-non-inferiority-randomized-study-to-examine-the-efficacy-and-safety-of-lcp-tacro-tablets-once-daily-compared-to-prograf-capsules-twice-daily-in-co/)* On March 29, 2012, Veloxis Pharmaceuticals has announced that enrolment has been completed in its pivotal LCP-Tacro Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002 study is designed to demonstrate non-inferiority versus the gold standard therapy Prograf® and has randomized over 540 patients at approximately 90 clinical sites around the world. Veloxis Pharmaceuticals anticipates the submission of a New Drug Application (NDA) next year.
