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

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.

"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.

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.