Investor service announcement no. 5/2015
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 21 September 2015
Veloxis Announces Publication of Phase III-b STRATO Study of Envarsus® XR Demonstrating Reduction in Hand Tremors Compared to Twice-Daily Tacrolimus in Kidney Transplant Patients
- Study published in Clinical Transplantation -
Veloxis Pharmaceuticals A/S (OMX: VELO) is announcing the publication of the Phase IIIb Switching STudy of Kidney TRansplant PAtients to LCP-TacrO (STRATO) in the journal Clinical Transplantation. The STRATO study was an open-label, multicenter study demonstrating that kidney transplant patients treated with once-daily Envarsus® XR (formerly known as LCP-Tacro) experienced a reduction in hand tremors following conversion from twice-daily tacrolimus, while maintaining comparable tacrolimus exposure. The results of this study have been presented previously at the 13th American Transplant Congress.
“Kidney transplant patients typically face many immunosuppressant medication side effects that diminish their quality of life,” said Anthony Langone, M.D., associate professor and medical director of the Medical Specialties Clinic at Vanderbilt University. “The data from STRATO indicate that Envarsus XR, the Meltdose formulation of tacrolimus, may meaningfully reduce tremors without compromising drug efficacy. This should provide an additional option to potentially improve the quality of life for transplant patients.”
Tremor is a common side effect of tacrolimus correlated with peak-dose drug concentration and is associated with a decrease in the quality of life (QOL). Envarsus® XR is a once-daily dose formulation of tacrolimus demonstrating flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus or Prograf®.
The STRATO study was a 2-sequence, open-label, prospective Phase IIIb, multi-center, clinical study. Kidney transplant patients who were stable on twice-daily tacrolimus and complained of hand tremor were switched to once-daily Envarsus® XR. Tremor was evaluated by independent, blinded neurologists applying the validated Fahn-Tolosa-Marin (FTM) tremor rating scale. In addition, tremor severity was also evaluated by an objective instrument (TremorometerTM), a quality of life questionnaire (QUEST) and a patient assessment of benefit (the Patient Global Impression of Change). Switch from twice-daily tacrolimus to Envarsus® XR resulted in improvement in FTM total score, tremor amplitude as measured by Tremorometer and quality of life [p-values < 0.05]. Both the patient- and physician-reported global assessments demonstrated significant overall improvement following the switch to Envarsus® XR (p<0.0001).
“The STRATO study demonstrated early evidence of the potential for reduction in tremors in transplant patients and helps to highlight the potential benefits of our novel drug delivery system and differentiates the profile of Envarsus XR compared to immediate release tacrolimus products,” said William Polvino, M.D., president and chief executive officer of Veloxis. “As we prepare to launch Envarsus® XR in the U.S. in late 2015, we look forward to being able to offer a new therapeutic alternative for transplant physicians and recipients.”
The article can be found at: http://onlinelibrary.wiley.com/doi/10.1111/ctr.12581/abstract?39A07000AEE4CB6D3383EB341F627B9.f02t01
