Veloxis Pharmaceuticals A/S, a specialty pharmaceutical company, announced results of a preliminary analysis from the first 16 patients in its Switching Study of Kidney Transplant Patients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro.

Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP Tacro is an investigational drug that 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, tremor, diabetes, high blood pressure, 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.

"Tremor is a common side effect of tacrolimus administration and it can significantly affect quality of life for transplant patients," said Anthony Langone, M.D., Associate Professor at Vanderbilt University and Medical Director of Renal Transplantation, Nashville Veteran Affairs Hospital.  "It would be a significant help for patients to have options for managing this troublesome side effect and potentially LCP-Tacro may be of benefit."

William Polvino, chief executive officer of Veloxis said, "We are encouraged by these promising results from our preliminary analysis. These early findings suggest that key measures of tremor may be improved in stable kidney transplant patients converted from standard twice-daily tacrolimus to once-daily LCP-Tacro.  We are now looking forward to completing enrollment of the full cohort in 2013."

In the open-label STRATO trial, kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of tremor were switched to once-daily LCP-Tacro. Tremor was evaluated by independent neurologists, pre and post conversion to LCP-Tacro, using the Fahn-Tolosa-Marin tremor rating scale (FTM-TRS), the Tremorometer™, an accelerometry instrument that measures frequency and amplitude of tremor and by PGI (Patient Global Impression of Change), a validated 7-point scale to assess change in amount of tremor reported by patients.

The primary endpoint of the trial is the mean change from baseline in the FTM tremor rating scale for overall tremor score 7 days after LCP-Tacro conversion. The preliminary analysis of available data on 16 subjects showed improvement in FTM rating scales, reduction in tremor amplitude by tremorometer recordings and PGI rating improvements.

The study continues to enroll and final data is expected in first half of 2013.  The interim study results will be submitted for presentation at upcoming scientific meetings.