NEW YORK – Sera Prognostics on Wednesday said it will stop enrollment in a randomized study of its preterm birth biomarker test in light of the study meeting its primary endpoints.
The Salt Lake City-based diagnostics firm's decision follows a recommendation from the data safety monitoring board overseeing the Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study. In its recommendation, the board said the co-primary endpoints met the stopping criteria for statistical significance at the interim analysis.
Investigators in the study assessed the efficacy of Sera's blood-based PreTRM Test to improve outcomes by predicting risk of spontaneous premature delivery in asymptomatic pregnancies. The test, which is commercially available, analyzes insulin-like growth factors binding protein 4 (IBP4) and sex-hormone binding globulin (SHBG) as biomarkers predictive of preterm birth.
Patients enrolled in the prospective study were randomized to receive either standard pregnancy management care or care informed by the PreTRM Test. The study had two co-primary endpoints comparing reduction in composite neonatal morbidity and mortality and reduction in length of neonatal hospital stay between the two study arms.
Sera will stop study enrollment to focus on analyzing and reporting available data, according to company officials.
"We are excited by this report of efficacy from the DSMB," Sera President and CEO Zhenya Lindgardt said in a statement. "We look forward to sharing top-line results once we have had a chance to analyze the interim look data."