EnzymeRx has launched its first clinical study for Uricase-PEG20. The company said that subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG20. The company said that its investigational new drug application for intravenous Uricase-PEG20 had become effective to develop it as an agent for the management of elevated uric acid associated with tumor lysis syndrome, and as an intramuscular agent for the treatment of refractory gout.
Uricase-PEG20 metabolizes poorly soluble uric acid into highly soluble allantoin, and in a prior phase 1 clinical trial, it was shown to lower uric acid levels in gout patients. Because its long half-life may provide for an extended duration of uric acid-lowering after just a single dose, Uricase-PEG20 may offer a convenient alternative to existing therapies for tumor lysis syndrome.
Tony Fiorino, president and chief executive officer of EnzymeRx, said: “Our team has worked very diligently with the study sites and with Kendle to launch this clinical trial after receiving FDA clearance. Sites are screening potential enrollees, and several subjects have already received Uricase-PEG20.”
John Bomalaski, chief medical officer of EnzymeRx, said: “It is gratifying to see Uricase-PEG20 back in the clinic. This study will provide important information on the safety, tolerability, pharmacokinetics and uric acid lowering capacity of Uricase-PEG20 administered intravenously, and will allow us to proceed to future development in tumor lysis syndrome.”