FDA gives green signal to Equillium's late-stage COVID-19 trial

• Equillium (NASDAQ:EQ) jumps 18% after-hours after receiving a Study May Proceed letter from the FDA to begin a Phase 3 clinical trial, named EQUINOX, evaluating itolizumab in hospitalized COVID-19 patients suffering from acute respiratory distress syndrome (ARDS).
• The company plans to start enrollment during Q4, initial clinical data are expected mid-year 2021.
• The Phase 3 EQUINOX trial will enroll a total of 800 patients and include interim assessments at 20% and 50% of enrollment.
• The primary endpoint is to evaluate the benefit of itolizumab on recovery in patients hospitalized with COVID-19; key secondary endpoints include mortality benefit and other measures of clinical improvement.
• The FDA has indicated that the trial, if successful, could support BLA filing.
• Additional details will be provided at an upcoming Analyst Day to be conducted on December 4.
• https://seekingalpha.com/news/3628876-fda-gives-green-signal-to-equilliums-late-stage-covidminus-19-trial