Sound Pharmaceuticals’ IND Involving Cochlear Implantation Allowed by the FDA
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Sound Pharmaceuticals is pleased to announce that it has enrolled the first patient in its Phase 3 clinical trial involving SPI-1005 for the...
SEATTLE, May 11, 2022 /PRNewswire/ -- 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.
Sound Pharmaceuticals to launch NIH-funded Covid-19 oral therapeutic trial
SEATTLE, April 6, 2021 /PRNewswire/ -- 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.
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.
SEATTLE, July 30, 2020 /PRNewswire/ -- Sound Pharmaceuticals (SPI) is pleased to announce the filing of an Investigational New Drug Application with the FDA to begin Phase 2 studies to prevent and treat COVID-19. Adult patients with moderate disease will be randomized in a double-blind trial and treated for 7 days, while patients with more severe disease will be treated for 14 days. In these initial safety and exploratory efficacy studies, two different oral doses of SPI-1005 (400 and 800 mg, twice daily) will be tested and compared to placebo over a 30-day period of follow-up.