Selecta Biosciences Inc (NASDAQ:SELB) found its shares backpedaling Thursday morning, on disclosing that its Phase 2 COMPARE trial did not meet its primary endpoint of statistical superiority.
The Watertown, Mass.-based Selecta Selecta and Swedish Orphan Biovitrum AB, today announced topline data for the Phase 2 COMPARE trial comparing the efficacy of SEL-212, a combination of Selecta’s ImmTOR™ immune tolerance platform and a therapeutic uricase enzyme (pegadricase), to pegloticase (KRYSTEXXA®), the currently approved uricase in the US, for the treatment of chronic refractory gout.
Per FDA guidance on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency (June 2020), the statistical analysis plan was modified and submitted to FDA prior to database lock to address the potential impact of the COVID-19 pandemic on statistical analysis. This was necessary due to increased protocol deviations in the intention-to-treat (ITT) population observed during the ongoing COVID-19 pandemic. Data are therefore presented per protocol (PP*) and ITT.
Topline results from the Phase 2 COMPARE trial are as follows: SEL-212 showed a numerically higher response rate on the primary endpoint during months three and six combined , but did not meet the primary endpoint of statistical superiority.
SELB shares lost 88 cents, or 35.4%, in the first hour Thursday to $1.60.
