SRNE - Sorrento rises as FDA clears Phase 1 trial for COVID-19 therapeutic
- San Diego, California-based biotech Sorrento Therapeutics ( NASDAQ: SRNE ) traded higher on Tuesday after the company announced that the U.S. Food and Drug Administration (FDA) greenlighted an early-stage clinical trial for its oral COVID-19 therapy STI-1558.
- The FDA has signed off the Investigational New Drug (IND) application allowing the company to run a pharmacokinetic (PK) study for the protease inhibitor in patients with impaired renal and hepatic function.
- Being a Cathepsin L inhibitor, STI-1558 can offer enhanced protection against COVID-19 due to its dual mechanism of action, the company said.
- A Phase 1 trial for the candidate designed to evaluate the single ascending doses (SAD), multiple ascending doses (MAD), and food effect is currently underway in Australia.
- After completing the trial, Sorrento ( SRNE ) plans to launch a global Phase 2 study for STI-1558 in COVID-19 patients with acute onset of symptoms.
- The company has received several FDA signoffs in recent months to begin COVID-19 clinical trials. In April, Sorrento ( SRNE ) announced regulatory clearance for an early-stage trial for intravenous STI-9167 (COVISHIELD) in healthy volunteers.
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Sorrento rises as FDA clears Phase 1 trial for COVID-19 therapeutic