Sobi, Selecta: Phase 3 DISSOLVE Program Of SEL-212 In Chronic Refractory Gout Meets Primary Goal

Swedish Orphan Biovitrum AB or Sobi (SWTUY.PK), a specialised biopharmaceutical company, and Selecta Biosciences, Inc. (SELB) announced Tuesday positive topline results from Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout.

In Sweden, Swedish Orphan Biovitrum shares were losing around 2 percent to trade at 236.90 Swdish kronor. In pre-market activity on Nasdaq, Selecta Biosciences shares were gaining around 16 percent to trade at $1.48.

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 met primary endpoint.

Under the deal terms, Selecta is eligible to receive additional development and regulatory milestone payments totaling $65 million and up to an additional $550 million in commercial milestones. Selecta is also eligible to receive tiered double-digit royalties on sales.

SEL-212 is a novel investigational combination medicine designed to reduce serum urate or SU levels in people with chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).

The Phase 3 DISSOLVE clinical program, run by Selecta and funded by Sobi, consisted of two double-blind, placebo-controlled studies of SEL-212.

The DISSOLVE I, the US Study, 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, the Global Study, also met its primary endpoint, with 47% receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response.

The 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.

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