BIOVF - Selecta's SEL-212 misses primary endpoint in mid-stage gout study shares fall 41%

Selecta Biosciences (SELB) and its collaborating partner Swedish Orphan Biovitrum (BIOVF) announced topline data from Phase 2 COMPARE trial comparing SEL-212, a combination of Selecta’s ImmTOR immune tolerance platform and therapeutic uricase enzyme (pegadricase), to Horizon Therapeutics's KRYSTEXXA (pegloticase), currently approved uricase in the US, for the treatment of chronic refractory gout.Though SEL-212 showed a numerically higher response rate on the primary endpoint during months 3 and 6 combined, but it failed to meet the primary endpoint of statistical superiority. Serum uric acid level of less 6mg/dL for at least 80% of the time stood at 59% in SEL-212 arm, compared to 46% in pegloticase group.But at month 3, statistically significant higher response rate for SEL-212 versus pegloticase was observed.Average reduction in serum uric acid levels was 6.68 mg/dL for patients treated with SEL-212 versus 4.51 mg/dL for patients treated with pegloticase.On the safety front, both SEL-212 and pegloticase showed favorable safety results and

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Selecta's SEL-212 misses primary endpoint in mid-stage gout study, shares fall 41%