Veloxis Pharmaceuticals A/S (OMX: VELO) today announced dosing of the first patient in the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) Phase IIIb study of LCP-Tacro™ in kidney transplant recipients experiencing drug-induced tremors. The STRATO study is designed to explore whether a conversion of patients who have symptomatic tremor from treatment with standard immediate release twice-daily tacrolimus capsules to extended release once-daily LCP-Tacro™ tablets leads to a measurable improvement in tremor.
Drug-induced tremor is a concerning side effect experienced by almost half of transplant patients taking twice-daily tacrolimus, the current standard of care therapy. Evidence suggests that tacrolimus-induced tremor is related to peak concentration levels that usually occur approximately two hours after dosing. LCP-Tacro™, currently in Phase III development for prophylaxis of rejection in kidney transplant recipients, utilizes Veloxis' proprietary extended release formulation based on the MeltDose® technology, which offers once-daily administration and a flatter pharmacokinetic profile. This characteristic is postulated to be potentially beneficial in mitigating peak-related neurotoxic effects of tacrolimus.
"We believe this is the first trial in kidney transplant recipients that will utilize a sophisticated and reproducible measurement of tremor," said Dr. Anthony J. Langone, M.D., Assistant Professor of Medicine at Vanderbilt University Medical Center. "This study will determine if renal transplant patients who currently experience tremors have a measurable reduction in symptoms after conversion to LCP-Tacro™, while maintaining comparable drug exposure. In addition to improving tremor symptoms and quality of life in patients with tremors, LCP-Tacro™ may obviate the need for dose-reductions and address compliance issues that may stem from experiencing neurotoxicity related to tacrolimus."
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