EnzymeRx Provides a Clinical Update on Pegsitacase
News Feb 23, 2010
EnzymeRx, LLC has 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).
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.