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.
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 (Mpro) 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.
The Phase 1 study cleared by the FDA will examine the 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. 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 the treatment of COVID infections.
As soon as the SAD/MAD study is completed, Sorrento will prepare for a global Phase 2 study in subjects with acute onset of symptoms due to COVID-19. "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," stated Henry Ji, Ph.D., Chairman, President and CEO of Sorrento.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), immuno-cellular therapies ("DAR-T™"), antibody-drug conjugates ("ADCs"), and oncolytic virus ("Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic test solutions, including COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com
