Sorrento Therapeutics Announces China National Medical Products Administration (NMPA) IND Clearance of STI-1558, An Oral Mpro Inhibitor for Phase I Trial In COVID-19 Patients
22 Aug 2022
AntibodyFirst in ClassVaccineSmall molecular drugADC
SAN DIEGO, Aug. 19, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the NMPA clearance of a Phase I study of its oral main viral protease (Mpro) inhibitor, STI-1558, in subjects with COVID-19 in a MAD study in China.
In a previously announced Australia Phase I study in healthy subjects, the SAD portion with four dose cohorts (300 mg, 600 mg, 1200 mg, and 2000 mg) has been completed. The MAD portion of the study is starting and STI-1558 has been well tolerated to date with only a few related adverse events, which have been transient and mild in severity. The PK profile has matched the predicted values based on the animal studies and confirms that STI-1558 is readily absorbed by humans with high bioavailability and no need for ritonavir, a potent cytochrome P450 3A4 inhibitor, to block metabolic clearance in order to maintain effective blood levels. In the NMPA cleared Phase I trial, STI-1558 will be administered to subjects with COVID-19 with mild or no symptoms in this MAD study, allowing for an evaluation of the safety, tolerability and efficacy of STI-1558 as a standalone treatment without ritonavir as a booster.
In the double blind and placebo-controlled MAD study, a total of 56 patients with mild or no symptoms will be enrolled into three dose cohorts (active: placebo, 3:1), 300 mg BID (n=8), 600 mg BID (n=24) and 800 mg BID (n=24). In addition to evaluation of the safety and tolerability, the viral load in patients will be examined to assess the antiviral activity of STI-1558 treatment in subjects with COVID-19 in comparison with placebo treatment. The trial will support seeking approval for an Emergency Use Authorization (EUA) in China and will be conducted by ACEA Therapeutics, Inc., a Sorrento company, and the Third Shenzhen Hospital in Shenzhen China. Dr. Lu Hangzhou, Professor and Fellow of American Academy of Microbiology, and President of The Third Shenzhen Hospital, is leading the trial in China.
“The trial in China will allow us to evaluate STI-1558 antiviral activity in patients together with safety, tolerability and pharmacokinetics in different dose levels. We are looking forward to seeing the results in COVID-19 patients, which we expect to facilitate our planned STI-1558 Phase II/III trials in Mexico and the U.S.,” stated Henry Ji, Ph.D., President and CEO of Sorrento.
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
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