Sound Pharmaceuticals, Inc. (SPI) has received a Cooperative Grant award from the National Center for Advancing Translational Sciences (NCATS) at the NIH for $3.1 milion to support the testing of SPI-1005 in two Phase 2 clinical trials for the treatment of COVID-19. 

SPI-1005 is an oral capsule containing ebselen, a small molecule with novel anti-inflammatory properties being developed for several neurotologic, neuropsychiatric, and respiratory indications. Ebselen was recently shown to inhibit SARS-CoV-2 in three separate in vitro studies involving two different cell lines and in vivo in a rodent model of COVID-19. This anti-viral activity is due to the binding and inhibition of the main protease (Mpro) and papain-like protease (PLpro), two enzymes critical for viral replication, in SARS-CoV-2.

The NCATS funding will support two randomized, double-bind, placebo-controlled clinical trials involving 120 adults with moderate or severe COVID-19, who will be treated for 7 or 14 days with SPI-1005 or placebo.

SPI-1005 represents a novel class of anti-inflammatory with Glutathione Peroxidase (GPx) activity. GPx is a new therapeutic target for several neurologic diseases of the peripheral and central nervous system including sensorineural hearing loss, tinnitus, ototoxicity, Meniere's disease, bipolar mania, and treatment-resistant depression.

SPI-1005 has advanced to pivotal Phase 3 trials for the treatment of Meniere's Disease and is currently in an ongoing Phase 2b study involving Cystic Fibrosis patients with acute respiratory infections receiving IV aminoglycoside antibiotics, known for causing ototoxicity.