The multi-centre, randomised, open-label single, subcutaneous dose Phase II trial was designed assess safety, pharmacodynamics and pharmacokinetics in chronic kidney disease patients not on dialysis.
The study, which was conducted by the Serum Institute of India, enrolled 30 subjects who were grouped into three cohorts of 10 subjects each.
The subjects were randomised to receive subcutaneous doses of either 0.5µg/kg, 1µg/kg or 2 µg/kg of polysialylated erythropoietin in the anterior femoral skin.
The study results revealed that the rise in reticulocyte count was maintained for up to 28 days after a single injection.
The drug was well-tolerated and safe at all dose levels, and no adverse events were observed in the study.
ErepoXen, which is being developed for the treatment of anaemia in renal disease patients, uses Lipoxen’s PolyXen drug delivery technology which improves the efficacy, stability and half life of protein drugs and reduces toxicity risk, the company said.