FDA Accepts Sorrento's IND Application For Phase 1 Clinical Trials For IV STI-2020 - Quick Facts

Biopharmaceutical company Sorrento Therapeutics, Inc. (SRNE) announced Wednesday that the U.S. food and Drug authority or FDA, has accepted the Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG).

The trials will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and newly diagnosed COVID-19 patients with mild symptoms.

Sorrento previously announced that STI-2020 demonstrated a complete neutralizing effect at a very low dose in preclinical studies and high potency that may potentially enable rapid deployment and availability to patients.

STI-2020, a monoclonal antibody, has been engineered for ultra-high potency, which potentially translates to a smaller IV volume required to administer an effective dose.

Sorrento has initiated cGMP manufacturing to produce up to 100,000 doses in anticipation of a potential Emergency Use Authorization or EUA.

To expedite development toward a potential EUA submission, Sorrento is planning on initiating dosing in a healthy population.

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