Investigational New Drug application for Uricase-PEG 20 approved

EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become effective.

EnzymeRx filed this IND for intravenous Uricase-PEG 20 in the management of elevated uric acid levels associated with tumor lysis syndrome. Tumor lysis syndrome is a serious condition that can occur during the treatment of certain tumors, and can result in sharply elevated uric acid levels. Uricase-PEG 20 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-PEG 20 may offer a convenient alternative to existing therapies for tumor lysis syndrome. EnzymeRx plans to launch a dose-ranging phase 1 clinical trial of intravenous Uricase-PEG 20 shortly.

Tony Fiorino, MD, PhD, President and Chief Executive Officer of EnzymeRx, remarked: “We are pleased with the FDA’s review of the IND, which allows us begin the clinical development of intravenous Uricase-PEG 20. Our near-term plans include not only launching the intravenous phase 1 study, but also resuming the clinical development of intramuscular Uricase-PEG 20 in gout. The EnzymeRx team is looking forward to a busy fourth quarter.”