Sound Pharmaceuticals, Inc. (SPI) is pleased to announce a Cooperative Grant award from the National Center for Advancing Translational Sciences (NCATS) at the NIH for $3.1M to support the testing of SPI-1005 in two Phase 2 clinical trials for the treatment of patients with 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 anti-inflammatory and anti-viral activity of ebselen, its documented safety, and oral route of administration offer a unique potential as a new therapeutic for the treatment of COVID-19.
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. “We are honored to receive NIH funding for this novel therapeutic application of ebselen in COVID-19,” said Dr. Jonathan Kil, MD, Co-Founder and CEO of Sound Pharmaceuticals. “To our knowledge, these are the first Phase 2 studies of an Mpro or PLpro inhibitor in moderate and severe COVID-19.” In addition to testing whether ebselen can improve clinical outcomes, SPI will also test whether the body’s inflammatory and cellular immune response to COVID-19 infection will improve with SPI-1005 treatment. Unlike other anti-inflammatories, ebselen is not immunosuppressive, and may exhibit positive immunomodulatory effects during or after viral infections.
SPI-1005 represents a novel class of anti-inflammatory with Glutathione Peroxidase (GPx) activity and has been tested in >400 patients across six completed randomized controlled trials in the US and UK. 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. To date, improvements in sensorineural hearing loss, word recognition, tinnitus loudness, and the core symptoms involving bipolar mania have been documented following SPI-1005 treatment.
For more information regarding these COVID-19 Phase 2 trials please see clinicaltrials.gov, NCT04484025 and NCT04483973.