Selecta’s lead product candidate, SEL‑212, is a therapeutic enzyme designed to be the first biologic treatment for gout that durably controls uric acid in refractory gout and dissolves and removes the harmful deposits of uric acid in chronic tophaceous gout, each a painful and debilitating disease with unmet medical need. High concentrations of uric acid in the blood also increase the risk for other conditions, including hypertension, diabetes, atherosclerosis and kidney disease. No treatment has been approved to remove uric acid deposits from joints and tissues.
SEL-212 consists of SVP™-Rapamycin co-administered with pegsiticase, our proprietary pegylated uricase, for the treatment of refractory and chronic tophaceous gout. SVP-Rapamycin uses our SVP technology to encapsulate the approved immunomodulator rapamycin in biodegradable nanoparticles. Our preclinical data indicate that SVP-Rapamycin, when co-administered with pegsiticase, induces antigen-specific immune tolerance to pegsiticase and substantially reduces the formation of associated anti-drug antibodies (ADAs). We believe that SEL-212 has the potential to offer a uniquely effective treatment for patients with refractory or chronic tophaceous gout, as well as to demonstrate the clinical effectiveness of our SVP technology.
Approximately 8.3 million patients in the United States and 10 million in Europe suffer from gout, which is caused by elevated levels of serum uric acid. Excessive uric acid levels result in harmful uric acid deposits in joints and tissues, causing joint damage and painful inflammation. Approximately 50,000 patients in the United States have been diagnosed with chronic refractory gout, an orphan indication defined as uric acid levels that cannot be controlled by available oral therapies. In addition, approximately 500,000 patients in the United States suffer from tophaceous gout, in which patients develop nodular masses of uric acid crystals referred to as tophi, typically in the joints of fingers, toes or elbows. Tophi are a source of inflammation and pain, and have been associated with diseases of the heart, vascular system, metabolism, kidney and joints or in the tissues that make up organs such as the kidney and heart. There is no approved drug for chronic tophaceous gout.
The illustration below depicts the association between gout and diseases of the heart, vascular system, metabolic process, kidney and joints.