Sound Pharmaceuticals Inc - formerly known as Otogene USA Inc - is structured around development of biomedical therapeutic products designed to correct the underlying biological causes of hearing impairment and - ultimately - to enable doctors and patients to prevent and to treat hearing loss. Hearing loss is the third leading chronic disorder in the United States, exceeding the number of persons with either diabetes or visual loss combined. Otoprotection studies in animals have validated that the inner ear can be protected from the irreversible effects of noise damage by the systemic administration of pharmacologic agents or drugs. Sound Pharmaceuticls is ofcused on treating sensorineural hearing loss, or hearing loss caused by damage to the cochlea and nerves that communicate between it and the brain. SPI-1005, a proprietary oral formulation of ebselen, is a small molecule mimic and inducer of glutathione peroxidase (GPx), the dominant catalytic antioxidant enzyme in the cochlea and critical for hearing health. GPx reduces reactive oxygen species (ROS) by binding free radicals to Selenium moiety by reacting with glutathione. Additionly, ebselen has been shown to reduce cytochrome-C release from mitochondria and nuclear damage during lipid peroxidation. Several classes of therapeutic Chemoprotection agents including cancer chemotherapy drugs and aminoglycoside antibiotics cause oxidative stress in the inner ear resulting in irreversible cell death. Chemotherapies (cisplatin, carboplatin) are well noted and studied for their ototoxicity. Hearing loss due to ototoxic medications presents at high frequencies initially and subsequently progresses to the lower frequencies. Impaired hearing as a result of ototoxicity can be temporary, but usually is permanent. Clinical symptoms of ototoxicity are associated with hearing loss, tinnitus, and difficulty understanding speech. The lead product candidate, SPI-3005, has been shown to protect against chemotherapy induced hearing loss and neurotoxicity in several animal studies. Significant Chemoprotection was achieved without interfering with the tumor activity of the cisplatin in rat and mouse tumor models. Finally, for those patients who already have substantial hearing loss, SPI is developing drugs aimed to restore hearing. SPI is currently optimizing compounds that antagonize specific cell cycle proteins resulting in new cell division or proliferation. These newly dividing cells have the capacity to become replacement auditory hair cells, supporting cells, and neurons.
