FDA Gives Green Signal To Human Trial For Sorrento's STI-9167 Against Omicron

  • The FDA has cleared Sorrento Therapeutics Inc's SRNE investigational new drug application (IND) for intravenous (IV) STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers. 
  • STI-9167 is the IV formulation of the intranasal STI-9199 neutralizing antibody.
  • Also Read: Sorrento To Start Late-Stage Trial Of Abivertinib In Critically-Ill COVID-19 Patients.
  • The Phase 1 study will be conducted at a single clinical site in the U.S. and followed by multinational (the U.S., China, and Mexico) Phase 2/3 trials. 
  • Sorrento plans to discuss with the FDA the most appropriate endpoints for the pivotal study that could result in an Emergency Use Authorization if the trials meet the efficacy endpoints of the pivotal study.
  • STI-9167 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1.1, and Omicron BA.2.
  • Price Action: SRNE shares closed up 2.92% at $1.76 on Monday.
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