Sorrento Therapeutics Announces the FDA IND Clearance of STI-1558, An Oral M(pro) and Cathepsin L Inhibitor to Treat COVID-19

• STI-1558, an oral SARS-CoV-2 main protease inhibitor which can block viral replication, is specifically designed as a standalone treatment of COVID-19.
• Studies to date indicate that STI-1558 does not require the co-administration of ritonavir as a booster for CYP3A4 inhibition.
• STI-1558 is also a Cathepsin L inhibitor, which can block effective viral entry into host cells and provides a dual mechanism of action in conjunction with protease inhibition to further protect against COVID-19.
• Patients have been dosed in the previously announced Phase 1 Study of STI-1558 in Australia with 300 mg, 600 mg and 1,200 mg, and dosing is currently ongoing with 2,000 mg.
• The FDA has cleared the Investigational New Drug (IND) application for a pharmacokinetic (PK) study in patients with impaired renal and hepatic function.

Excerpt from the Press Release:

SAN DIEGO, July 19, 2022 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced the FDA clearance of a Phase 1 study of its oral main viral protease (M^pro) inhibitor, STI-1558, in patients with impaired renal and hepatic function.

A previously announced 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. The study is currently dosing the final cohort in the study at a dose of 2,000 mg per patient. STI-1558 has been well tolerated to date with only a few related adverse events, all of which have been transient, mild in severity and required no treatment.

To date, the PK profile has matched the predicted values based on the animal studies, confirming that STI-1558 is readily absorbed by humans with high bioavailability and indicating that there is no need for ritonavir, a potent cytochrome P450 3A4 inhibitor, to block metabolic clearance to maintain effective blood levels. Avoiding coadministration of ritonavir significantly reduces the potential for drug-drug interactions. PK modeling suggests that a dose of 600 mg twice daily will maintain blood levels well above the range necessary to effectively inhibit viral replication.

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