Sorrento Touts Positive Early-Stage Trial Data From Oral COVID-19 Therapy

  • Sorrento Therapeutics Inc SRNE released topline Phase 2 SAD/MAD study data of its oral main protease (Mpro) inhibitor, STI-1558, conducted in 58 healthy volunteers in Australia. 
  • The SAD portion of the study evaluated doses from 300 mg to 2,000 mg, and the MAD portion evaluated 300 mg, 600 mg, or 800 mg BID (twice daily) for 7.5 days.
  • In addition to the Mpro inhibition, which can block viral replication, STI-1558 has cathepsin L inhibition, preventing viral entry into the host cell. 
  • Related: Sorrento's COVID-19 Main Protease Inhibitor Neutralizes Omicron.
  • Testing to date has demonstrated that the spike mutations of emerging variants do not impact the activity of STI-1558 on the Mpro protein.
  • STI-1558 was well-tolerated at the doses studied, with most subjects reporting no AEs. There was no dose-limiting toxicity and no severe or serious adverse events (AEs), premature discontinuation of STI-1558 due to an AE, or deaths. 
  • Most AEs were mild and unrelated.
  • A similar Phase 1/1b SAD/MAD study has been fully enrolled in China in both healthy subjects and COVID-19 patients.
  • The PK profile in China was similar to that seen in Australia. 
  • Preliminary safety and efficacy data found that the safety profile was comparable between healthy uninfected subjects and infected subjects and that STI-1558 resulted in a dramatic rapid reduction in viral load.
  • Price Action: SRNE shares closed higher by 1.63% at $1.25 on Tuesday.
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