Veloxis Publishes Results of Phase IIIb Study of Envarsus XR in African American Kidney Transplant Recipients
2 April 2018 - - Copenhagen, Denmark-based commercial-stage specialty pharmaceutical company Veloxis Pharmaceuticals A/S (NASDAQ OMX Copenhagen: VELO) has published results of ASERTAA, a randomized prospective crossover pharmacogenetic study of immediate-release versus extended-release tacrolimus in African American kidney transplant recipients in the March 2018 issue of the American Journal of Kidney Diseases, the company said.
ASERTAA was designed to compare the pharmacokinetics of Envarsus XR, a once-daily tacrolimus tablet, to generic twice daily tacrolimus immediate-release capsules in stable African-American renal transplant patients.
In the trial, patients on Envarsus achieved therapeutic drug levels with a 30% lower peak concentration and 20% lower average dose compared to tacrolimus immediate-release regardless of genotype status.
Importantly, patients expressing the CYP3A5*1 genotype on tacrolimus immediate-release reached a peak concentration as high as 26 ng/mL.
Veloxis is committed to improving the lives of transplant patients. The company operates in the US through Veloxis Pharmaceuticals, Inc., a wholly-owned subsidiary headquartered in Cary, North Carolina. Veloxis has successfully developed Envarsus XR (tacrolimus extended-release tablets) based upon the company's unique and patented delivery technology, MeltDose, which is designed to enhance the absorption and bioavailability of select orally administered drugs.