< Program

Technology Update Session

Session 3D
Development of SPI-1005 for the Treatment of Hearing Loss and Tinnitus
Jonathan Kil, MD, Sound Pharmaceuticals

Currently there are no FDA approved therapeutics or drugs that treat sensorineural hearing loss or tinnitus. This unmet medical need is the largest in all of neuroscience. Ebselen is a novel anti-inflammatory compound that mimics and induces Glutathione Peroxidase 1 (GPx1), a critical cytoprotective enzyme that is highly expressed in the cochlea, prefrontal cortex, lung and kidney. GPx1 activity and expression is reduced following noise and ototoxic insults that result in temporary and permanent hearing loss and tinnitus. SPI-1005 is a capsule that contains 200 mg of ebselen and is delivered orally twice daily for 7 to 28 days for the treatment of several neurotologic diseases including noise-induced hearing loss, aminoglycoside ototoxicity, and Meniere's disease. Currently, SPI-1005 is the only investigational new drug in an active Phase 3 clinical trial involving a hearing loss or tinnitus indication. The development of SPI-1005 will be reviewed across the 5 active INDs currently being investigated within the US and UK.

Dr. Kil is experienced in auditory neuroscience, drug development, clinical trials and otolaryngology. He has led the development of several investigational new drugs including SPI-1005, SPI-3005, and SPI-5557. He cofounded Sound Pharmaceuticals a private biotechnology company and has been the PI on several DoD, NIH and CFF grants/awards. Dr. Kil has active research collaborations with multiple research centers involved in neurotology, neuropsychiatry, and respiratory indications.