Featured Event
May 16, 2012
Presentation of the Interim Report for the 1st Quarter

Clinical trials and results

LCP-Tacro™ is being developed as a once-daily dosage version of tacrolimus for the treatment of kidney and liver transplant patients. For kidney transplant patients, LCP-Tacro™ has successfully completed one phase 3 study, and one phase 3 study is ongoing. Positive clinical phase 2 top-line results have been announced for de novo liver transplant patients.

Compared with Prograf® and Advagraf®, Veloxis expects that LCP-Tacro™ may offer the following potential key differences:

  • Improved systemic absorption and reduced variability
  • Improved bioavailability and thus a lower dose of tacrolimus required
  • Limited variability in the concentration of tacrolimus in the blood ("peak-to-trough" fluctuation)
  • Once-daily dosing
Top-line results from the final phase 3 study are expected by early 2013. Following completion, Veloxis estimates that it will require approximately 3 to 4 months to consolidate and analyze the study results for submission of an NDA and a MAA to regulatory agencies in the US and the European Union, respectively (submissions are anticipated for the first half of 2013).