Sound Pharmaceuticals files IND to test SPI-1005 in Phase 2 COVID-19 trials

SEATTLE, July 30, 2020 /PRNewswire/ -- Sound Pharmaceuticals (SPI) is pleased to announce the filing of an Investigational New Drug Application with the FDA to begin Phase 2 studies to prevent and treat COVID-19. Adult patients with moderate disease will be randomized in a double-blind trial and treated for 7 days, while patients with more severe disease will be treated for 14 days. In these initial safety and exploratory efficacy studies, two different oral doses of SPI-1005 (400 and 800 mg, twice daily) will be tested and compared to placebo over a 30-day period of follow-up.

In a recent study published in the scientific journal Nature,¹ Jin and colleagues detailed three major findings involving nCoV2, the virus responsible for COVID-19. First, they crystalized the main protease (M^pro) structure, a critical enzyme responsible for viral replication. Second, they identified several potential pharmacologic agents or drugs that inhibit M^pro activity, utilizing a structure-based virtual screening of >10,000 compounds including approved and investigational drugs, and other pharmacologically active compounds. Among the six compounds that showed significant inhibition of M^pro activity, ebselen demonstrated the lowest inhibitory concentration or IC₅₀. Third, they screened the >10,000 compound library for viral load reduction in an in vitro cell-based assay, where ebselen demonstrated the lowest effective concentration or EC₅₀. M^pro may be the first identified specific nCoV2 drug target that, when inhibited, could reduce viral load or virulence, and potentially mitigate the devastating course of COVID-19. "In addition to ebselen's potential anti-viral activity, we will test if SPI-1005 can reduce the inflammatory response and cellular injury that is devastating to the lungs and kidneys of COVID-19 patients," said Dr. Jonathan Kil, MD, Co-Founder and CEO of Sound Pharmaceuticals.

SPI-1005 is an investigational new drug that contains ebselen, a novel small molecule that mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney. SPI-1005 represents a novel class of anti-inflammatory and is under clinical investigation in several neurotologic diseases where GPx activity is reduced including sensorineural hearing loss, tinnitus, ototoxicity, Meniere's disease, and neuropsychiatric illness including bipolar mania. SPI-1005 is currently being tested in a Phase 2b study where Cystic Fibrosis patients with acute pulmonary exacerbations are receiving IV antibiotics to treat their respiratory infection. In this study, three different oral doses of SPI-1005 are being compared to placebo following 21 days of treatment.

For more information regarding these Phase 2 trials please see clinicaltrials.gov and NCT04484025. ¹ https://www.nature.com/articles/s41586-020-2223-y

SOURCE Sound Pharmaceuticals

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