The randomised, placebo-controlled Phase I trial has been designed for evaluating the pharmacokinetics, tolerability, pharmacodynamics, and safety of HZN-457, a development-stage medicine, for gout treatment.
A small interfering RNA (siRNA) candidate, HZN-457 has been designed for the treatment of gout by silencing liver xanthine dehydrogenase.
The company stated that the HZN-457 development is part of a global collaboration and license deal, which it signed with Arrowhead Pharmaceuticals last year.
Horizon Therapeutics research and development executive vice-president Elizabeth Thompson said: “As a clinical and commercial leader in gout, Horizon understands the critical need to develop innovative approaches and advance novel treatments to reach more patients who live with this disease.
“The HZN-457 Phase I clinical trial marks an important milestone for Horizon to advance our research and development in this space, fostered by our partnership with Arrowhead.”
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The clinical trial is anticipated to enrol up to 56 healthy volunteers sequentially into the ascending dose cohorts. They will be given HZN-457 subcutaneously as a single dose.
Safety and tolerability comprise the primary endpoint of the trial.
Changes from baseline in uric acid levels and evaluation of plasma and urine pharmacokinetic parameters are the trial’s secondary endpoints.
In March last year, the company enrolled the first patient in a clinical trial of Krystexxa (pegloticase injection) and methotrexate to treat chronic gout refractory to conventional therapy, also known as uncontrolled gout.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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