Seattle, June 12 /PRNewswire/ Sound Pharmaceuticals has started a 32 patient Phase 1 study of SPI-1005 in normal healthy volunteers. SPI-1005 is an oral capsule, and contains as its active ingredient a selenium based small molecule mimic of the enzyme glutathione peroxidase. In multiple preclinical studies, low oral doses of SPI-1005 have been shown to be effective in preventing and treating noise induced hearing loss. "These animal studies have been replicated by three independent labs, all demonstrating that the active ingredient in SPI-1005 is effective in reducing both the temporary and permanent hearing loss associated with exposure to loud noise," said VP and Director of Research, Eric Lynch, PhD.
"This dose escalation safety study will lay the ground work for our Phase 2 safety and efficacy trials with the US Army and Navy later this year," stated VP and Director of Clinical Operations, Bret MacPherson. The goal of the current study is to confirm the known adsorption, distribution, metabolism, excretion and pharmacokinetic profile and to determine the safety of SPI-1005 at high doses.
According to OSHA and the CDC, 30-40 million Americans are exposed to hazardous sound levels on a daily basis. Combined with a burgeoning population of war veterans and the dangerous listening habits of the MP3 generation, the societal costs for hearing devices and compensation awards have soared into the billions. There are currently no drugs for the prevention and treatment of hearing loss despite the vast and increasing need. Sound Pharmaceuticals hopes to address this need with its first in class first in indication drug, SPI-1005.
Sound Pharmaceuticals, Inc., is a privately held biopharmaceutical company with a focus on developing the first drugs for hearing loss and brain injury. For more information please contact Jonathan Kil, MD, President and CEO 206-634-2559.
