Omeros COVID-19 Treatment Reduced Mortality Risk, But Biased Data Rendered Analysis Meaningless

  • Omeros Corp OMER reported results from the narsoplimab arm of the I-SPY COVID Trial, sponsored by Quantum Leap Healthcare Collaborative (QLHC). 
  • Narsoplimab showed the largest reduction in mortality risk to date across all drugs reported from the I-SPY COVID Trial.
  • The company said that in approximately half of the patients died in the narsoplimab group, and narsoplimab was not given or was prematurely stopped, with those patients dying 9 to 35 days later. 
  • Omeros adds that despite narsoplimab treatment exposure in a limited number of patients, a substantial efficacy signal was observed in reducing mortality risk for critically ill COVID-19 patients.
  • Narsoplimab did not shorten the time to recovery in critically ill COVID-19 patients.
  • The study did not identify any new safety signals for narsoplimab.
  • The company says a substantial imbalance in the consented population was detected, creating a statistically significant bias against the narsoplimab arm, rendering analysis of the consented population meaningless. 
  • The I-SPY trial's data monitoring committee terminated the narsoplimab arm based on the biased analyses in the consented population before reaching the maximum of 125 patients. 
  • To avoid similarly biased outcomes in future trial arms, QLHC subsequently revised the protocol for its I-SPY COVID Trial to obtain patient consent before randomization.
  • Price Action: OMER shares are down 27.46% at $3.91 on the last check Thursday.
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