-Positive Phase III 3001 Study Results in Hand -
-LCP-Tacro MAA Submission to Occur Mid-2012-
Report is Available for Download at: www.lifesciadvisors.com/clients/veloxis
Last Wednesday morning, Veloxis Pharmaceuticals (OMX: VELO) published the Company’s annual report and announced year-end results. During 2011, Veloxis received positive results for the first Phase III study (3001) of LCP-Tacro in stable kidney transplant patients and initiated a new Phase IIIb STRATO study. The Phase III study 3002 is ongoing in de novo patients and results are expected in a year.
Over the previous year, Veloxis has made significant progress towards the development of the Company’s lead product candidate, LCP-Tacro. LCP-Tacro is an optimized, branded version of the #1 transplant drug, Prograf, and has a Best-in-Class profile.
All Endpoints Met in Phase III LCP-Tacro Study (3001) in Stable Kidney Transplant Patients. Importantly, the Company achieved positive results from the first Phase III Study (3001) of LCP-Tacro in stable kidney transplant patients. The study met all primary efficacy and safety endpoints and most importantly, LCP-Tacro demonstrated non-inferiority to the market leader, Prograf. We expect LCP-Tacro to have a commercial advantage due to the once-daily dosing and a possible efficacy advantage as Study 3001 demonstrated a numerical trend towards lower rejection rates as determined by central blinded pathology readings (LCP-Tacro BPAR rate 0.6%, n=1; Prograf 3.1%, n=5; p=0.214). Furthermore, Prograf patients that switched to LCP-Tacro required an average of 20% less drug during treatment (p<0.0001). We anxiously await the results of the second Phase III study (3002) in de novo patients within a year and enrollment (n=540) should be complete by the end of next quarter.