Seattle — Sound Pharmaceuticals (SPI) will begin recruiting teenagers for a new clinical trial that tests the oral drug SPI-1005 to see if it can prevent hearing loss from 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. 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.

In this clinical trial, young adults will listen to music that has been recorded onto personal music players. Volunteers will take either a placebo or SPI-1005 starting 2 days before and then listen to their music players for 4 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.

The company says that 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 Jonathan Kil, MD, president and CEO of SPI.

Sound Pharmaceuticals is a privately held biopharmaceutical company with a focus on developing the first drugs for hearing loss.

SOURCE: Sound Pharmaceuticals