Selecta Biosciences Announces Presentation of Data from Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout During Late-Breaking Session at the EULAR 2023 European Congress of Rheumatology
- Phase 3 DISSOLVE I and DISSOLVE II studies both met their primary efficacy endpoints, with SEL-212-treated patients demonstrating statistically significant higher response rates compared to placebo -
- SEL-212 was observed to have a favorable safety profile and was well-tolerated across both doses of ImmTOR -
- BLA filing expected in 1H 2024 -
WATERTOWN, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced the presentation of positive data from the Phase 3 DISSOLVE I and DISSOLVE II double-blind, placebo-controlled studies of SEL-212 in patients with chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase). The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.
“Marked by chronic pain and significant functional impairment, chronic refractory gout carries a large disease burden, with currently available therapies falling short and patients experiencing an impaired and poor quality of life,” stated the study’s lead author and Principal Investigator of the DISSOLVE Program, Herbert S.B. Baraf, M.D., FACP, MACR, founding Medical Director of The Center for Rheumatology and Bone Research, and Clinical Professor of Medicine at George Washington University in Washington, DC. “We believe SEL-212 has demonstrated strong potential to serve as a safe and effective uricase-based intervention for patients suffering from this debilitating disease without the need for separate oral traditional immunosuppressants and with the convenience of once-monthly dosing.”
“The efficacy and safety profile observed across the Phase 3 DISSOLVE program underscores our belief that the ImmTOR platform, which, to our knowledge, represents the only immune tolerance platform with positive Phase 3 data, has the potential to deliver meaningful tolerogenic therapies. We look forward to continuing to work with our partner, Sobi®, to file a Biologic License Application (BLA) for SEL-212 in the first half of next year,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta.
DISSOLVE I & II Results
DISSOLVE I (US Study) & DISSOLVE II (Global Study) were Phase 3, double-blind, placebo-controlled studies of SEL-212 evaluated at two doses of ImmTOR™ (0.1 mg/kg and 0.15 mg/kg) and one dose of pegadricase (0.2 mg/kg). In March 2023, the Company announced topline data from both studies. Data featured at EULAR 2023 Congress are summarized below.
About the DISSOLVE Clinical Program
About Selecta Biosciences, Inc.
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