Seattle, WA and Charleston, S.C.
Sound Pharmaceuticals (SPI) is pleased to announce that first-patient-in has been achieved in the STOP Ototoxicity Phase 2 clinical trial. This novel interventional study with SPI-1005 is aimed to prevent and treat ototoxicity in Cystic Fibrosis (CF) patients undergoing intravenous (IV) tobramycin for the treatment of acute pulmonary exacerbation.
Sound Pharmaceuticals (SPI) will present data on the incidence and severity of ototoxicity in cystic fibrosis (CF) patients who received tobramycin for the treatment of acute pulmonary exacerbations.
The presentation, which was accepted as a late-breaking abstract, will be given at the upcoming North American Cystic Fibrosis Conference (NACFC), taking place Oct. 18-20 in Denver.
Seattle, WA and Oxford, England
The University of Oxford and Sound Pharmaceuticals (SPI), are pleased to announce the initiation of a Phase 2 clinical trial of SPI-1005 for the treatment of patients with bipolar disorder. SPI-1005 is an oral drug that contains ebselen, which mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear and brain. SPI-1005 is under clinical investigation in several neurotologic diseases where GPx activity is reduced including sensorineural hearing loss, ototoxicity/neurotoxicity, and Meniere’s disease. In addition to these neurotologic diseases, GPx activity is thought to be diminished in several neuropsychiatric disorders including bipolar, schizophrenia and autism. Bipolar disorder involves both mania and depression, and has been difficult to treat chronically. Lithium, a mainstay of bipolar treatment has significant dose-limiting side effects. Read More
Sound Pharmaceuticals (SPI) is pleased to announce positive topline results from its recently completed Phase 1b SPI-1005-151 clinical trial involving Meniere’s Disease (MD). SPI-1005 is an investigational new drug that mimics and induces glutathione peroxidase activity, and has demonstrated strong proof-of-concept in preventing sensorineural hearing loss. MD is diagnosed by episodic vertigo, fluctuating hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling or inflammation of the inner ear. Currently, there are no FDA approved drug treatments for MD, or any other inner ear disease. Many with MD are managed with low salt diets, thiazide diuretics, and oral or locally injected steroids, although these treatments have not proven to be effective. Read More
The first study of cystic fibrosis (CF) patients who received antibiotics that caused inner ear disease or ototoxicity is enrolling participants, according to Sound Pharmaceuticals.
The Phase 1b STOP Ototoxicity study (NCT02819856) is led by Dr. Patrick Flume, MD, professor of medicine and pediatrics at the Medical University of South Carolina in Charleston, where the study is taking place. He is an expert in pulmonary disease and cystic fibrosis. Read More