The FDA has allowed two Phase 2 studies to begin testing ebselen (SPI-1005) in COVID-19 patients, Sound Pharmaceuticals, Inc. (SPI) has announced.
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.
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.
It 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.