Sound Pharmaceuticals, Seattle, has started a 32-patient Phase 1 study of SPI-1005—an oral capsule containing a selenium-based molecule mimic of the enzyme glutathione peroxidase as an active ingredient—in normal, healthy volunteers. In multiple preclinical studies, low oral doses of SPI-1005 have been shown to be effective in preventing and treating noise induced hearing loss, the company reports.
“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,” says Eric Lynch, PhD, vice president and director of research for Sound Pharmaceuticals.
“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,” says Bret MacPherson, vice president and director of clinical operations for Sound Pharmaceuticals.
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, the company says.
Currently, there are no drugs available for the prevention and treatment of hearing loss, the company says.