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FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials

August 31, 2020

Sound Pharmaceuticals, Inc. (SPI) received clearance from the FDA to begin two Phase 2 studies of ebselen (SPI-1005) in COVID-19 patients. SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication. The two trials will enroll 120 adults with moderate or severe disease in randomized, double-bind, placebo-controlled trials and treated for 7 or 14 days with the oral drug.

Separately, SPI will be using the non-clinical and preclinical services program offered by the National Institute of Allergy and Infectious Diseases (NIAID). This will involve the expanded testing of ebselen both in vitro and in vivo, including a unique live animal model of COVID-19 transmission.

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