Veloxis Pharmaceuticals A/S, a specialty pharmaceutical company, has dosed 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.

Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.

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."

Patients experiencing tacrolimus-related neurotoxicity, as demonstrated by moderate-to-severe tremors, on immediate release tacrolimus products, will be enrolled in this Phase IIIb study of kidney transplant recipients. Patients will be converted to once-daily LCP-Tacro and their neurotoxicity symptoms assessed using the Fahn-Tolosa-Marin tremor rating scale, as well as by tremorometer readings. Quality of life assessments will also be undertaken to determine the level of improvement during the study.