EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the US 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 tumour lysis syndrome. Tumour lysis syndrome is a serious condition that can occur during the treatment of certain tumours, 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 tumour lysis syndrome. EnzymeRx plans to launch a dose-ranging phase-1 clinical trial of intravenous Uricase-PEG 20 shortly.

Tony Fiorino, 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."

Uricase-PEG 20 is a recombinant uricase derived from Candida utilis, modified by the attachment of multiple 20 kilodalton molecules of polyethylene glycol (PEG). Uricase-PEG 20 has a prolonged half-life and reduced immunogenicity compared with unmodified uricase, and has been well tolerated in preclinical studies and in a prior phase-1 study in gout patients.