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

Vandana Singh
1 min read
0
In this article:

  • Selecta Biosciences Inc (NASDAQ: SELB) and Swedish Orphan Biovitrum AB (OTC: 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.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article Selecta, SOBI's Chronic Refractory Gout Program Meets Primary Goal, US Submission Expected Next Year originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories