– Top-line statistical results expected mid-2020 –

– Company to meet with FDA in January 2020 regarding Phase 3 clinical development plan –

WATERTOWN, Mass., Dec. 19, 2019 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR™, today announced the completion of patient enrollment in the six-month, head-to-head, Phase 2 COMPARE clinical trial. The trial enrolled 150 patients across 49 sites trial and is evaluating the superiority of a once-monthly dose of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), versus a bi-weekly dose of pegloticase, the current FDA-approved uricase therapy for adult patients with chronic refractory gout. The primary endpoint is maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months. Enrollment in the COMPARE trial commenced in May 2019. Selecta expects to report top-line statistical superiority results by mid-2020.

“There is a demonstrated need for a next-generation treatment for chronic refractory gout, and this trial may reveal important clinical insights that could help physicians best treat patients suffering from this painful, debilitating disease,” said Robert T. Keenan, MD, MBA, MPH, board certified rheumatologist at Duke University School of Medicine and Principal Investigator of the COMPARE trial. “We believe that the speed at which this trial was able to enroll speaks to the significance of the unmet medical need, as well as the need for clinically relevant comparative data to best assess future treatment options for chronic refractory gout patients.”

“Achievement of this enrollment milestone is a testament to the commitment of our clinical investigators and entire team to advancing SEL-212 to address the critical needs of patients with chronic refractory gout, and we are grateful to all of the patients participating in this trial,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. “We are confident that the COMPARE trial will build on the already robust body of SEL-212 data which showed its ability to achieve SUA levels below 6mg/dL, and further the clinical development program for this important therapeutic.”

About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company’s current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company’s lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.

About SEL-212
SEL-212 is a novel combination product candidate designed to sustain control of serum uric acid (SUA) levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, Selecta’s proprietary pegylated uricase, co-administered with ImmTOR, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, rendering these therapies less potent, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.

About Chronic Refractory Gout
Gout is the most common form of inflammatory arthritis with more than 8.3 million patients in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues, and can result in flares that cause intense pain. Approximately 160,000 patients in the United States suffer from chronic refractory gout, a painful and debilitating condition in which patients are not able to get their SUA levels below 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi. Elevated SUA levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.