Angion Stock Falls As Lead Product Candidate Flunks In COVID-19 Trial

  • Angion Biomedica Corp ANGN has announced data from a small exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS).
  • The study failed to meet the primary or secondary efficacy endpoints
  • The 120-subject trial evaluated the safety and efficacy of four doses of ANG-3777 to reduce the severity and progression of acute lung injury in patients with COVID-19 associated pneumonia who are at high risk of progressing to ARDS. 
  • The trial's primary endpoint was survival-free from the need for mechanical ventilation or dialysis at 28 days. 
  • The active arm of the trial did not show a statistically significant difference over the standard of care arm. 
  • The number of adverse events, serious adverse events, and fatal events reported in ALI-201 were slightly higher than the standard of care control arm.
  • But no new or unexpected safety signals resulted from the trial. 
  • The company expects to report data from the ANG-3777 Phase 3 trial in transplant-associated acute kidney injury by the end of 2021. 
  • Data from the ANG-3777 Phase 2 proof-of-concept trial for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is expected in the second half of 2021.
  • Price Action: ANGN shares are down 10.4% at $12.94 during the premarket session on the last check Wednesday.
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