Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients
March 2, 2021 at 4:02 PM EST
FDA granted IND clearance today for the commencement of a Phase 1 safety and pharmacokinetic study for STI-2099 (COVIDROPS™) in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of STI-2020 (COVI-AMG™).
Initial trials are expected to be followed by a Phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration.This is the first FDA clearance of a clinical trial of intranasal administration of a neutralizing antibody against the SARS-CoV-2 virus.
SAN DIEGO, March 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it has received clearance from the FDA for its Investigational New Drug application (IND) for its Phase 1 study of the safety and pharmacokinetics of intranasal (IN) STI-2099 (COVIDROPS) in both healthy volunteers and patients with mild COVID-19.
As previously announced, Sorrento is currently evaluating an intravenous formulation of this potent antibody, STI-2020 (IV), in a Phase 1 study in healthy volunteers and COVID-19 patients with mild symptoms. This small volume IV-push formulation is being tested against the dominant strain of the SARS-CoV-2 virus in the U.S. as well as the emerging UK variant. Sorrento expects to evaluate STI-2099 (IN) alone or in combination with STI-2020 (IV) to treat newly diagnosed patients.
Treatment with STI-2099 has the potential to halt the COVID-19 infection at the earliest stage in the nasal passages before it has a chance to spread to the lungs, and, if the infection has already hit the lungs, prevent the development of severe infections. If found to be safe and effective following clinical trials, STI-2099 i has the potential to prevent hospitalization or discharge hospitalized COVID-19 patients faster. “We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies,” said Dr. Henry Ji, Chairman and CEO of Sorrento.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers 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”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
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 post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com