Isotechnika, a Canada-based biopharmaceutical company, has reported positive 12-month follow-up data from the Phase IIb Promise trial evaluating its lead drug, voclosporin, a next generation calcineurin inhibitor, in de novo kidney transplant patients.
As a dose ranging study, the Phase IIb trial was successful in meeting the primary endpoint demonstrating non-inferiority in biopsy proven acute rejection episodes as compared to tacrolimus control in all three dose groups at six months, the company said. The extended data demonstrates that voclosporin maintained efficacy at 12 months. Voclosporin also demonstrated an improved safety profile versus tacrolimus.
The trial was designed to determine the most appropriate dosing strategy for the Phase III development programs of voclosporin in kidney transplantation. The extension study provides sufficient data to implement a dosing strategy for Phase III designed to provide a better safety profile than tacrolimus while maintaining efficacy at 12 months, the company added.
Isotechnika is in ongoing discussions with regulatory agencies and potential partners with regards to the planning and implementation of a Phase III pivotal trial for voclosporin in kidney transplantation.
Voclosporin in its anticipated therapeutic range demonstrated less new onset diabetes mellitus after transplant and neurological symptoms with equivalent renal function. In addition, the pharmacokinetic and pharmacodynamic analysis confirms a strong concentration-effect relationship for voclosporin, the company noted. Based on these results, the ideal dose for a Phase III trial will encompass the concentration range obtained in the low- to mid-dose treatment groups.
Robert Foster, president and CEO of Isotechnika, said: I’m very pleased that our Promise study further demonstrated that the efficacy of voclosporin is competitive with the market leader tacrolimus, with the bonus of a favorable safety profile. This data combined with the previously announced positive trial results in uveitis from our partner, Lux Biosciences, adds further credibility to the commercial potential of voclosporin. Our next steps are to confirm our Phase III transplant protocol with the FDA.