Selecta Biosciences, Inc., a clinical-stage biopharmaceutical company developing a novel class of targeted antigen-specific immune therapies, today announced the dosing of the first patient in the Company’s Phase 1b clinical trial to assess the safety, pharmacodynamic profile and efficacy of SEL-212, Selecta’s proprietary biologic treatment for refractory and tophaceous gout. Patients suffering from these severe gout indications accumulate uric acid deposits in joints and tissues, which can cause debilitating pain and damage to joints and organs. SEL-212, the lead immunotherapeutic product candidate from Selecta’s proprietary Synthetic Vaccine Particle (SVP) platform, is designed to be the first non-immunogenic version of uricase, an enzyme that metabolizes uric acid. While uricase therapeutics have demonstrated the ability to significantly reduce uric acid levels and dissolve uric acid deposits that cause refractory or tophaceous gout, their utility is limited by undesired immune responses such as anti-drug antibodies (ADAs), which compromise both efficacy and safety. Results from this Phase 1b clinical trial, which follows the successful completion of the Phase 1a clinical trial in the SEL-212 clinical program, are expected in the first half of 2016.
“In gout, tissue deposits of the sodium salt of uric acid cause excruciatingly painful and incapacitating attacks of gouty arthritis and ultimately can lead to impaired health related quality of life, hospital admissions, high medical care costs and joint damage. Furthermore, our options to treat gout and high body uric acid burden, in particular, are currently limited, and especially so in those with the most severe forms of the disease” said Dr. Robert A Terkeltaub, MD, Professor of Medicine at the University of California San Diego, and scientific advisor to Selecta. “We know that uricase has unique, and remarkably rapid efficacy in removing tissue deposits of crystalline uric acid. However, uricase is a foreign protein to humans, and undesired immune responses frequently occur and this has greatly limited our ability to effectively employ uricase treatment use in clinical practice for gout. SEL-212 could be a significant addition to our treatment options for gout.”