Sound Pharmaceuticals submits positive Phase 2 clinical trial data on SPI-1005 for the prevention and treatment of sensorineural hearing loss
, Feb. 18, 2014
/PRNewswire/ -- Sound Pharmaceuticals (SPI) has submitted a scientific abstract for presentation at the American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting in Orlando FL.
The Phase 2 clinical trial enrolled 83 subjects with normal hearing or slight hearing loss in an iPod®
music protocol that induces a slight but temporary hearing loss or threshold shift (TTS). Subjects were randomized in a double-blinded manner to either placebo or three different dosages of SPI-1005 and treated before, during, and after the music exposure. Repeated hearing tests were conducted to determine the incidence, severity and duration of the TTS over the course of one week. The data indicate that SPI-1005 treatment dramatically reduced (>50%) the incidence, severity and duration of the TTS induced by loud sound vs placebo controls. In addition, all doses of SPI-1005 were well tolerated with no observed or reported adverse events related to study drug. SPI-1005 is an oral capsule that contains ebselen, a novel 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 reduce the TTS and permanent threshold shift (PTS) caused by intense noise exposure or ototoxic drug exposure such as cancer chemotherapy.
"These clinical data support the critical role of GPx activity in noise-induced hearing loss and warrant further investigation in noise exposed populations," said Jonathan Kil, MD, Chief Medical Officer and lead author of the paper. SPI is a privately held biopharmaceutical company in Seattle with a focus on developing the first drugs for the prevention and treatment of sensorineural hearing loss. Noise induced hearing loss is a significant disease and effects over 31 million in the US according to the CDC.
"SPI is advancing its proprietary technology for hearing loss prevention and treatment through proof of concept in a clinically relevant population with growing unmet medical need," said Eric Lynch, PhD, President and co-author of the study.
Details of the SPI-1005 clinical trial can be viewed online at www.clinicaltrials.gov, or by visiting www.soundpharma.com or by calling Eric Lynch at 206-634-2559.
SOURCE Sound Pharmaceuticals