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 (Mpro) structure, a critical enzyme responsible for viral replication. Second, they identified several potential pharmacologic agents or drugs that inhibit Mpro 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 Mpro 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. Mpro 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