SPI to commence enrollment in SPI-1005 clinical trial to prevent hearing loss induced by loud music

Sound Pharmaceuticals (SPI) will begin recruiting a new clinical trial testing the oral drug SPI-1005 to prevent the hearing loss induced by loud music. Exposure to loud music or noise can induce temporary and permanent auditory threshold shifts (TTS or PTS). In some people, a repeated TTS will ultimately give way to a PTS that is irreversible. As people age, this level of PTS grows and results in a loss of speech perception and discrimination. According to a recent US study of 12-19 year olds between 1994 and 2006, the incidence of hearing loss increased 30%. Now one in five teenagers has a hearing loss of at least 16 decibels. In an Australian survey, 71% of respondents believed that listening to loud music through headphones would have the largest impact on their hearing.

In this clinical trial, young adults will listen to music that has been recorded onto personal music players (pmp). Volunteers will take either a placebo or SPI-1005 starting two days before and then listen to the pmp for four hours to induce a mild TTS. SPI-1005 is an oral capsule that contains a proprietary formulation of ebselen, a small molecule that mimics the activity of Glutathione Peroxidase (GPx), a critical enzyme in the inner ear that protects it from loud sounds. After noise exposure, the activity of GPx decreases in several inner ear structures including the auditory hair cells. In several preclinical studies, ebselen treatment was shown to improve the function of auditory hair cells and reduce the TTS induced by intense noise exposure. "The goal of this clinical trial is to determine if SPI-1005 can prevent the TTS induced by an environmentally relevant exposure to sound," said Dr. Jonathan Kil, President and CEO.

Currently there are no FDA approved drugs for the prevention and treatment of sensorineural hearing loss including noise-induced hearing loss. SPI hopes to address this unmet medical need with its first in-class first in-indication drug.