By Louise Gagnon
ORLANDO, Fla -- September 26, 2014 -- An oral glutathione peroxidase mimic and inducer referred to as SPI-1005 can treat noise-induced hearing loss, according to findings from a phase 2 trial presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting 2014.
The molecule for SPI-1005 contains ebselen, which mimics the activity of glutathione peroxidase, the enzyme in the cochlea that is crucial for hearing. “The drug works very well in a dose-dependent manner,” explained Jonathan Kil, MD, Sound Pharmaceuticals, Inc., Seattle, Washington, who presented the data here on September 21 at an oral session. “It is both anti-inflammatory and neuro-protective.”
Over a 1-year period, Dr. Kil and colleagues administered either placebo or 200, 400, or 600 mg of SPI-1005 twice daily for 4 days to 83 patients at the University of Florida (average age 20 years) in a randomised fashion. Patients were exposed to a single iPod sound exposure lasting 4 hours that induced a slight temporary threshold shift (TTS). The investigators used serial pure-tone audiometry to assess the incidence, severity, and duration of the TTS. They determined significance through 2-tailed t tests.
SPI-1005 provided a significantly greater decrease in TTS incidence (60% vs 20%, P
“Hearing loss is progressive,” Dr. Kil concluded. “This [therapy] could be used for acute situations [to return to baseline hearing], but patients could use it as a maintenance therapy to prevent further decline [in hearing].”
Funding for this study was provided by Sound Pharmaceuticals, Inc.
[Presentation title: Efficacy of SPI-1005 for Prevention of Noise-Induced Hearing Loss: Phase 2 Clinical Trial Results.]
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