Selecta Biosciences, Sobi announce DISSOLVE I and II meet primary endpoinr

Selecta Biosciences and Sobi announced topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. DISSOLVE I met its primary endpoint, with 56% of patients receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response. The DISSOLVE II also met its primary endpoint, with 47% receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme. Detailed results from the DISSOLVE I and DISSOLVE II trials are expected to be presented at an upcoming medical meeting. Regulatory submission in the U.S. is anticipated in the first half of 2024. Sobi licensed SEL-212 from Selecta in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. Selecta is responsible for ImmTOR manufacturing. The Phase 3 program for SEL-212 was run by Selecta and funded by Sobi. Under the terms of the agreement with Sobi, Selecta is eligible to receive additional development and regulatory milestone payments totaling $65 million and up to an additional $550M in commercial milestones. Selecta is also eligible to receive tiered double-digit royalties on sales.