Sound Pharmaceuticals has concluded subject enrolment for its second Phase III clinical trial assessing SPI-1005 in adults with probable or definite Meniere’s disease in the US.
The open label study enrolled 191 participants at nine sites across the country over eight months. Its purpose is to collect additional safety data supporting chronic daily dosing of SPI-1005, an oral anti-inflammatory medication.
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Meniere’s disease is a complex disorder of the inner ear characterised by low to mid frequency hearing loss, vertigo, tinnitus and dizziness.
SPI-1005 secured breakthrough therapy designation from the US Food and Drug Administration (FDA) in late 2025.
Sound Pharmaceuticals stated that it is the first drug to receive this designation for both Meniere’s disease and for sensorineural hearing loss, a nervous system disorder.
In total, four Meniere’s disease clinical trials involving SPI-1005 have now enrolled 578 adults.
Additional Phase II randomised controlled trials have examined SPI-1005’s safety and efficacy in acute noise-induced hearing loss and aminoglycoside-induced ototoxicity.
SPI-1005 is administered orally by capsule twice daily, with each capsule containing ebselen, a chemical entity designed to mimic and induce glutathione peroxidase activity.
This enzyme plays a role in repairing damage within a range of tissues, including the inner ear.
Sound Pharmaceuticals co-founder and CEO Dr Jonathan Kil said: “We look forward to advancing SPI-1005 as the first approved treatment for Meniere’s later this year and early next year.”
The company reports that more than 980 patients have so far participated in 15 completed and ongoing SPI-1005 trials, including cohorts with conditions such as cystic fibrosis, bipolar mania, and treatment-resistant depression.
It anticipates enrolling more than 200 additional patients in the coming year.
To date, no significant drug-drug interactions have been observed across study populations.
