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Aerpio Pharmaceuticals' Razuprotafib Dropped From Collaborative COVID-19 Trial

  • Quantum Leap Healthcare Collaborative-sponsored I-SPY COVID Trial will not further test Aerpio Pharmaceuticals Inc's (NASDAQ: ARPO) razuprotafib.
  • Razuprotafib was chosen because it was believed to stabilize and repair the lung's blood vessels and improve gas exchange.
  • The I-SPY COVID Phase 2 Trial is an adaptive platform that is testing agents that promise to reduce the risk of death from and severity of illness after contracting COVID-19.
  • Aerpio's razuprotafib will not be evaluated because it was challenging to administer in the setting of COVID-19, with 30% of patients discontinuing the agent due to disease-related hypotension (low blood pressure).
  • A small decline in systolic blood pressure and mean arterial blood pressure by approximately 4–5 mm Hg was observed after two safety lead-in cohorts.
  • There was no indication that razuprotafib caused the hypotension that led to a clinical decline in systolic blood pressure.
  • There was no significant difference between the 10 mg and 20 mg doses in blood pressure decline was seen.
  • Blood pressure monitoring with additional scrutiny is challenging in the setting of a surge in ICU admissions from COVID-19. Hence, the Data Monitoring Committee recommended that razuprotafib not be advanced after the second safety lead-in.
  • Price Action: ARPO shares are down 5.8% at $1.46 in premarket trading on the last check Friday.

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Posted-In: Covid-19Biotech News Health Care FDA General

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