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     120  0 Kommentare 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

    • 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.

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    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 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 …