Selecta, SOBI's Chronic Refractory Gout Program Meets Primary Goal, US Submission Expected Next Year

Selecta Biosciences Inc SELB and Swedish Orphan Biovitrum AB BIOVF announced topline results from the Phase 3 DISSOLVE I & II trials of SEL-212 in adult patients with chronic refractory gout.
Also Read: Analyst Says Selecta Biosciences' Gout Candidate Can Potentially Raise The Bar On Several Fronts.
The DISSOLVE I (the U.S. Study) met its primary endpoint, with 56% of patients receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response (defined as achievement and maintenance of reduction in serum urate (SU) <6mg/dL for at least 80% of the time during month six).
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.
SEL-212 combines Selecta's ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
In patients 50 years and older, the response rate with high dose SEL-212 was 65% in DISSOLVE I and 48% in DISSOLVE II.
75% of subjects in the DISSOLVE I extension phase on active treatment were responders through 12 months of therapy with no infusion reactions or new safety signals.
Favorable safety profile with 3.4% of patients with infusion reactions at high dose.
Regulatory submission in the U.S. is anticipated in the first half of 2024.
Price Action: SELB shares are down 5.56% at $1.21 on the last check Tuesday.