Sound Pharmaceuticals (SPI) has successfully completed enrollment of its Phase 2 clinical trial with SPI-1005 at the University of Florida. This study enrolled 80 healthy subjects with normal or slight hearing loss and exposed the volunteer to calibrated music using an iPod® and insert earphones. The sound level was established based on prior human studies where a slight temporary auditory threshold shift (TTS) was safely induced. The listeners were randomized to either placebo or SPI-1005 and treated before and after music exposure. The level of TTS was determined at several time points after the music exposure and all subjects and investigators were blinded to the intervention. SPI-1005 is an oral capsule that contains ebselen, a synthetic molecule that mimics and induces the activity of Glutathione Peroxidase (GPx), a critical enzyme in the inner ear that protects it from damage caused by loud sounds or noise. In preclinical studies, ebselen treatment was shown to improve GPx levels within critical cochlear structures thereby reducing the TTS induced by intense noise. Ebselen is also under clinical investigation for chemotherapy induced ototoxicity in adult cancer patients, a disease that involves both hearing loss and tinnitus. "Completing this proof of concept study is a significant milestone for SPI and we are pleased with the outcome," said Jonathan Kil, MD, Chief Medical Officer. SPI is a privately held biopharmaceutical company in Seattle with a focus on developing the first drugs for the prevention and treatment of hearing loss. "These data will be used to support our active IND with the FDA for the prevention and treatment of noise induced hearing loss," said Eric Lynch, PhD, President.
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