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Jun 21, 2011

Phase III Study Shows Noninferiority of LifeCycle’s Sustained-Release Tacrolimus Compared with Prograf

  • LifeCycle Pharma reported positive data from a Phase III trial comparing its sustained-release tacrolimus candidate LCP-Tacro™ with immediate-release tacrolimus (Astellas Pharma’s Prograf®) in terms of preventing organ rejection in stable kidney transplant patients. The data confirmed the non-inferiority of once-daily LCP-Tacro immunosuppression compared with twice-daily Prograf in 326 patients. Additional results from study 3001 suggested that patients on average required a 20% lower dose of LCP-Tacro than Prograf. LifeCycle says this reflects the improved absorption profile engendered by its MeltDose® formulation.

    A separate Phase III study (trial 3002) is evaluating LCP-Tacro in de novo kidney transplant patients, with results expected by the end of 2012. LifeCycle projects filing regulatory submissions in the U.S. and EU during the first quarter of 2013.

    Danish specialty pharmaceuticals firm LifeCycle is focused on the development of treatments in the immunosuppression and cardiovascular fields. The firm is exploiting its MeltDose technology to develop new versions of existing marketed drugs by enhancing the bioavailability of compounds with low water solubility and allowing for a controlled or modified-release plasma profile.

    MeltDose has already been validated in numerous clinical studies and successfully used in development of the FDA-approved dyslipidemia drug  Fenoglide® (LCP-FenoChol), LifeCycle notes. The firm is also looking for partners for continuing the development of two additional cardiovascular drugs: LCP-AtorFen, a fixed dose combination tablet of fenofibrate and atorvastatin, and LCP-Feno, a generic 145 mg fenofibrate tablet.

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