Veloxis Announces Scientific Publication of Phase II Study Demonstrating Conversion from Twice-Daily Tacrolimus to Once-Daily Envarsus® in Liver Transplant Patients

- Study published online in Liver Transplantation -

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Apr 28, 2014, 11:00 ET

HORSHOLM, Denmark, April 28, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of a Phase II study demonstrating conversion from twice-daily tacrolimus to once-daily Envarsus^® in stable liver transplant patients in Liver Transplantation.

Key points:

Envarsus^® is an extended release formulation of tacrolimus designed for once-daily dosing, flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus or Prograf^®
Adult liver transplant patients stable on twice-daily tacrolimus were converted to and maintained on Envarsus^® for up to six months to evaluate pharmacokinetics (PK) and a 52-week safety evaluation
57 patients completed Envarsus^® dosing in the core study (days 8-21) and 43 patients completed the extension phase
Similar to what was observed in kidney transplant clinical trials, the mean Envarsus^® dose was approximately 30% less than that of the twice-daily tacrolimus dose
Envarsus^® demonstrated significantly lower peak blood levels and less peak-to-trough fluctuation
The pharmacokinetics of Envarsus^® after 6 months of therapy are comparable to those after 14 days of therapy
Envarsus^® was well tolerated with no new safety concerns.

The article can be found at: http://onlinelibrary.wiley.com/doi/10.1002/lt.23844/abstract.

The top-line study results were reported by Veloxis on July 8, 2008 and now are published as a peer-reviewed scientific manuscript.

Quotes:
John Weinberg, chief operating officer of Veloxis said, "As in kidney transplant clinical trials with Envarsus^®, results from this study demonstrated that stable liver transplant patients may benefit from the same properties of Envarsus^® that emerged from clinical studies in kidney transplant patients. These include a required dose of Envarsus^® approximately 30% less than the total daily dose of Prograf^® and a flatter PK profile that was stable for up to six months in this study."

For more information, please contact:
Veloxis Pharmaceuticals A/S
John Weinberg, M.D.
EVP & Chief Operating Officer
Phone: +1 732 321 3208
Email: [email protected]

About Envarsus^® (formerly LCP-Tacro™) and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus® 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.

About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is Envarsus^® for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose^®, can improve absorption and bioavailability at low scale up costs. Veloxis has a lipid lowering product, Fenoglide^®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.

For further information, please visit www.veloxis.com.

SOURCE Veloxis Pharmaceuticals