Sound Pharmaceuticals, Inc. (SPI) is pleased to announce that is has received a $1.1M supplement to its $3.1M National Center for Advancing Translational Sciences (NCATS) Award, bringing the total NIH funding to $4.2M. SPI is developing ebselen (SPI-1005), a new molecular entity with anti-viral and anti-inflammatory activity, and enrolling two Phase 2 clinical trials for the treatment of hospitalized COVID-19 patients.
Ebselen has been shown to inhibit SARS-CoV-2 by binding and inhibiting the main protease (Mpro) and the papain-like protease (PLpro), two enzymes critical for viral replication. SPI-1005 is given orally, twice a day, and is being tested in several neurotologic, neuropsychiatric, and respiratory indications.
The NCATS funding supports two randomized, double-bind, placebo-controlled clinical trials involving 120 adults with moderate or severe COVID-19. The additional NIH funds will support conducting these ongoing studies at more study sites, which are all leading academic/university hospitals in the US. Separately, SPI is pleased to announce that it will collaborate with ShanghaiTech University (STU) in the nonclinical testing of ebselen with other antivirals as potentially effective treatments in multiple viral respiratory infections including influenza. STU’s proven capability and expertise in COVID-19 make it an ideal partner for SPI. Inhibition mechanism of SARS-CoV-2 main protease by ebselen and its derivatives (nih.gov).
SPI-1005 is a novel class of anti-inflammatory compound with Glutathione Peroxidase (GPx) activity and has been tested in more than 450 patients in six completed randomized controlled trials and in four ongoing studies 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 being tested in an ongoing Phase 2b study of tobramycin ototoxicity in Cystic Fibrosis patients with acute respiratory infections.
Research reported in this press release was supported by the National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number U01TR003853. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. For more information regarding these ongoing COVID-19 Phase 2 trials please see clinicaltrials.gov, NCT04484025 and NCT04483973. To learn more about SPI please visit www.soundpharma.com