FDA Clears Sorrento's STI-1558 Phase 1 Study To Treat COVID-19 Infection

The FDA has signed off Sorrento Therapeutics Inc's SRNE Phase 1 study of its oral main viral protease (Mpro) inhibitor, STI-1558, in patients with impaired renal and hepatic function.
The Phase 1 study will examine the PK in patients with moderate renal and hepatic impairment.
Using a cross-over design, two doses of STI-1558 (300 mg and 600 mg) will be studied in 12 subjects across three cohorts.
Related: FDA Gives Green Signal To Human Trial For Sorrento's STI-9167 Against Omicron.
This is a required study in the approval process and is expected to enable Sorrento to proceed with the remaining studies that may be required to apply for an Emergency Use Authorization for STI-1558 for COVID infections.
A previously announced Phase 1 study of STI-1558 is proceeding in Australia. The drug has been dosed in patients in the first 3 cohorts with doses of 300, 600, and 1,200 mg. Dosing in the final cohort (2,000 mg) is ongoing.
STI-1558 has been well tolerated with only a few related adverse events, all of which have been transient, mild in severity, and required no treatment.
Price Action: SRNE shares are up 12.30% at $3.06 during the market session on the last check Wednesday.