Sera Prognostics Announces Primary Endpoint Criteria Met

Sera Prognostics Inc. today announced that the Data Safety Monitoring Board (DSMB) overseeing its pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. The Company has adopted the DSMB’s recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.

“We are excited by this report of efficacy from the DSMB,” said Zhenya Lindgardt, President and CEO of Sera Prognostics. “It is unexpected for trials to stop early for efficacy since most statistical power is typically reserved for the final analysis, which makes this event that much more encouraging. We look forward to sharing top-line results once we have had a chance to analyze the interim look data. We believe this will add to the PREVENT and AVERT studies in the growing, consistent body of evidence for our PreTRM® test that advances our mission to save lives and improve health for mothers and babies across the globe.”

SERA PROGNOSTICS ANNOUNCES PRIMARY ENDPOINT CRITERIA MET | Sera Prognostics