The results of the trial suggested that once-daily LCP-Tacro is non-inferior in efficacy compared to twice-daily standard tacrolimus tablets (Prograf).
The Phase 3 trial was a randomized, multicenter, prospective and an open-label trial which involved around 324 kidney transplant recipients 3-60 months post-transplant taking oral Prograf.
Veloxis CEO William Polvino said the positive data from this trial suggest that LCP-Tacro may provide efficacy matching twice-daily tacrolimus but at a lower dose and using a once-daily dosing regimen.
"Our second Phase 3 trial in de novo kidney transplant patients is ongoing and we expect to report results from that trial by the first quarter of 2013," Polvino said.