Enzymerx completes enrollment for clinical trial of pegsitacase

EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase-PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

The completed trial was a phase 1 safety, pharmacokinetic and pharmacodynamic study of single ascending intravenous doses of pegsitacase (study details available at ClinicalTrials.gov). The study sequentially enrolled five cohorts of four subjects each, with each cohort receiving escalating single doses of pegsitacase administered by intravenous infusion over one hour, without any premedication. Tony Fiorino, MD, PhD, President and Chief Executive Officer of EnzymeRx, remarked: “It is truly gratifying to have completed enrollment in our first clinical study of pegsitacase. The drug was extremely well tolerated in these subjects, with no infusion reactions, and we are very pleased with the potency and duration of uric acid-lowering that we have seen thus far. We plan to present the results from this study at a medical conference later in 2010.”

The recently launched phase 1b trial is studying the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of pegsitacase (study details available at ClinicalTrials.gov to see the study details). In this study, subjects are enrolling into escalating dose cohorts receiving either single doses or three biweekly doses of pegsitacase. Data from this study are expected later this year.

John Bomalaski, MD, Chief Medical Officer of EnzymeRx, noted: “With the completion of the single dose intravenous study, EnzymeRx is now positioned to move pegsitacase forward in tumor lysis syndrome. Similarly, the recently launched multi-dose intramuscular study will, once completed, allow pegsitacase to move into phase 2 development in gout. We have a busy year planned in both indications, and are very excited by the clinical profile exhibited by pegsitacase in the single dose intravenous setting.”

Gout, a painful arthritic caused by the formation of uric acid crystals in the joints, and tumor lysis syndrome, a serious condition that can occur during the treatment of certain tumors, are both associated with elevated levels of uric acid. Pegsitacase metabolizes poorly soluble uric acid into highly soluble allantoin, thus lowering uric acid levels, and its long half-life may provide for an extended duration of uric acid-lowering after with each single dose.