Sound Pharmaceuticals Receives FDA Breakthrough Therapy Designation for SPI-1005 in Meniere’s Disease
Sound Pharmaceuticals (SPI) has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational oral drug, SPI-1005, for the treatment of hearing loss in patients with Meniere’s disease (MD).
MD is a progressive inner ear disorder characterised by low-to-mid frequency hearing loss, tinnitus, vertigo, and dizziness. There are currently no FDA-approved drug treatments for the condition.
SPI-1005 is also the first drug to receive BTD for sensorineural hearing loss, the most common type of hearing impairment associated with aging and neurological conditions.
SPI-1005 demonstrated clinically meaningful improvements in co-primary endpoints, including pure-tone audiometry (PTA) and the words-in-noise (WIN) test, in a pivotal Phase 3 randomized, double-blind, placebo-controlled trial (STOPMD-3).
A second open-label Phase 3 trial is ongoing to gather additional safety data for chronic dosing in patients with probable and definite MD.
The drug has shown favorable safety and efficacy across five prior trials, including Phase 1b and 2b studies in MD and Phase 2 studies in noise-induced and aminoglycoside-induced hearing loss. SPI-1005 previously received Fast Track Designation for MD.
The drug contains ebselen, a compound that mimics and induces glutathione peroxidase activity, repairing injured cells in the inner ear and mitigating neuroinflammation.
SPI-1005 is being developed for multiple neurotologic indications, including Meniere’s disease, noise-induced hearing loss, and ototoxicity from aminoglycosides or platinum-based chemotherapy.
Over 790 patients have been treated in completed trials, with more than 400 additional patients expected to be enrolled in the next year.
