LifeCycle Pharma announced results from its Phase 3 trial, Study 3001, of LCP-Tacro for patients undergoing kidney transplants. Study 3001 was an open-label, conversion (switch) study with 326 stable kidney transplant recipients. The primary efficacy endpoint for the study was a comparison between once-daily sustained-release LCP-Tacro and twice-daily immediate-release tacrolimus (Prograf; Astellas Pharma), which LCP-Tacro successfully demonstrated non-inferiority. As measured by the central blinded pathologist, the rates of Biopsy-Proven Acute Rejection (BPAR) were 0.6% for LCP-Tacro and 3.1% for Prograf (P=0.214). Similar safety and tolerability profiles were demonstrated across both groups and these results were achieved with a daily dose of LCP-Tacro 20% lower than patients receiving Prograf.
LCP-Tacro is an immunosuppressant being developed for kidney and liver transplants.
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