FDA allows Sound Pharmaceuticals to test SPI-1005 as a novel treatment for COVID-19

By August 31, 2020News Short

Sound Pharmaceuticals, Inc. (SPI) is pleased to announce that the FDA has allowed two Phase 2 studies to begin testing ebselen (SPI-1005) in COVID-19 patients. SPI is developing SPI-1005, a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication.

120 adults with moderate or severe disease will be enrolled in two randomized, double-blind, placebo-controlled trials (RCTs) and treated for 7 or 14 days with the oral drug. Separately, SPI will be utilizing the non-clinical and pre-clinical 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. “We are thrilled to announce the initiation of these critical Phase 2 RCTs and the continued testing of ebselen in non-clinical studies with the support of the NIAID,” said Dr. Jonathan Kil, MD, Co-Founder and CEO of Sound Pharmaceuticals.

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.

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 in neuropsychiatric disease including bipolar mania and treatment-resistant depression. SPI-1005 is entering pivotal Phase 3 trials for the treatment of Meniere’s Disease and is currently in a Phase 2b study involving Cystic Fibrosis patients with acute respiratory infections receiving IV antibiotics.

For more information regarding these Phase 2 trials please see clinicaltrials.gov and CT04484025.