Sorrento Shares Gain Following FDA's Nod for Initial-Stage Covid-19 Study

Sorrento Therapeutics SRNE announced that the U.S. Food and Drug Administration (FDA) has cleared the Phase 1 study of its candidate, STI-1558, in patients with impaired renal and hepatic function.

STI-1558 is an oral SARS-CoV-2 main protease inhibitor which can block viral replication, is specifically designed as a standalone treatment of COVID-19.

The Phase 1 study cleared by the FDA is designed to examine the pharmacokinetic (PK) in patients with moderate renal and hepatic impairment.

Two doses of STI-1558 (300 mg and 600 mg) will be studied in 12 subjects across 3 cohorts, 12 normal subjects, 12 renally-impaired subjects and 12 hepatically-impaired subjects, using a cross-over design.

The ongoing Phase 1 Study of STI-1558 evaluating single ascending doses (SAD), multiple ascending doses (MAD) and food effect is proceeding in Australia, and the drug has been dosed in patients in the first 3 cohorts with doses of 300, 600 and 1,200 mg.

Henry Ji, Chairman, President and CEO, commented : "STI-1558 has the potential to be a highly effective antiviral treatment for acute COVID-19 and we look forward to seeing how it performs in the Phase 1 study and the planned Phase 2/3 study.”

Price Action : Sorrento shares are trading around 8 percent higher at $2.67 on Tuesday at the time of publishing.