Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company developing a novel class of targeted antigen-specific immune therapies, today announced that it has dosed the first patient in its Phase 2 clinical trial of SEL-212, the company’s lead proprietary immunotherapeutic product candidate for the treatment of chronic gout in patients refractory to conventional therapy. This trial will assess the safety, tolerability and clinical activity of SEL-212, a combination product candidate consisting of pegsiticase (pegylated uricase) and SVP-Rapamycin. SEL-212 is designed to be the first non-immunogenic enzyme therapy for gout. Initial results from this trial are expected in the first half of 2017.
“SEL-212 has the potential to address the large unmet need of severe gout patients, who are currently lacking effective treatment options. By lowering serum uric acid levels and total body uric acid burden with multiple doses of SEL-212 covering up to 6 months of treatment, SEL-212 is designed to eliminate inflammatory deposits that cause debilitating pain and often serious damage to joints and organs,” said Earl Sands, M.D., Selecta’s Chief Medical Officer. “The initiation of this trial marks an important advancement for our Synthetic Vaccine Particles (SVP) immunotherapeutic platform, which has the potential to enable and enhance a large number of biologic therapies including enzyme therapies, gene therapies and biologic cancer treatments by antigen-specific mitigation of undesired immune responses such as neutralizing antibodies.”
This Phase 2 clinical trial of SEL-212 is being conducted at 15 centers in the United States and is expected to enroll more than 36 symptomatic gout patients with elevated uric acid levels. The primary and secondary endpoints of the trial include safety and tolerability of multiple doses of SEL-212, reduction of serum uric acid levels and mitigation of anti-drug antibodies (ADAs). Exploratory endpoints include measurement of uric acid deposits by Dual Energy Computed Tomography (DECT) imaging. Multiple dose treatment with SEL-212 has the potential to significantly lower total uric acid crystal burden in joints and tissues, which cannot be effectively or rapidly achieved by oral gout therapy. The removal of the uric acid crystal deposits is expected to reduce overall inflammation and the frequency of debilitating gout flares.