LifeCycle Pharma A/S has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro tablets administered once-daily versus Prograf (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year. These data confirm the previous positive experience with LCP-Tacro in stable kidney and liver transplant patients and support comparability of LCP’s extended release tablet formulation of tacrolimus when compared to twice-daily Prograf capsules. Further, the results indicate that LCP-Tacro tablets may be safely and efficaciously administered once-daily immediately following a liver transplant.
Results from the 14 day pharmacokinetic (PK) portion of this Phase 2 study have previously been reported in August 2009. After the initial 14 day PK period, patients were maintained on either LCP-Tacro or Prograf for one year to assess longer-term safety and efficacy in a comparative setting. While not sized and powered to demonstrate safety and efficacy at a statistically relevant level, once-daily LCP-Tacro appears to be as well tolerated as the currently approved, immediate release, twice-daily product Prograf.
“This study was an important milestone for the company as it provides additional evidence of the comparable safety and efficacy of LCP-TacroTM versus the twice-daily form of tacrolimus,” said Dr. William J. Polvino, President and CEO of LifeCycle Pharma. “It is also very encouraging that the safety and efficacy data compared to twice-daily tacrolimus obtained from this trial are very consistent with results seen in prior studies in kidney transplant patients. We are looking forward to completing our two Phase 3 trials in kidney transplant patients and announcing the data from those studies in 2011 and 2012.”
Date: January 6, 2010
Source: LifeCycle Pharma A/S
Filed Under: Drug Discovery
