Trial Initiated to Study Novel Non-Immunogenic Biologic Gout Treatment

Researchers will evaluate the safety, pharmacodynamic profile, and immunogenicity of pegsiticase for the treatment of painful refractory and tophaceous gout.

Selecta Biosciences, Inc, recently announced it has initiated a phase 1 clinical trial to “assess the safety, pharmacodynamic profile, and immunogenicity of pegsiticase, a component of SEL-212,” for the treatment of refractory and tophaceous gout.

According to the company, pegsiticase is “a pegylated urate oxidase or uricase, an enzyme not present in humans that is highly effective in catalyzing the oxidation of uric acid.” Previous phase 1 studies have demonstrated pegsiticase safely and effectively in reduces plasma uric acid levels.

Although uricase enzymes can effectively dissolve tophi and reduce plasma uric acid levels, the formation of anti-drug antibodies quickly diminishes their efficacy. Their clinical utility is also mitigated by the associated risk of allergic reactions.

If it is eventually approved for clinical use, SEL-212 would be the first non-immunogenic version of uricase.

Werner Cautreels, PhD, CEO and President of Selecta, said, “Gout remains an underestimated disease, as persistent elevated uric acid levels can cause joint and kidney damage and are associated with cardiac disease. Once uric acid deposits have built up, only uricase treatment is truly effective at dissolving them.”

In addition to SEL-212, the company is developing other products with “improved therapeutic benefit related to the reduction of unwanted immune responses,” including “a novel Hemophilia A product and novel gene therapy products that enable repeat dosing.”