Sound Pharma completes enrollment of Open Label Phase 3 study of SPI-1005 in Meniere’s Disease

SEATTLE--(BUSINESS WIRE)--Sound Pharmaceuticals is pleased to announce that it completed enrollment of its second Phase 3 open label study of SPI-1005 for the Treatment of Meniere’s Disease (MD). SPI-1005, a novel oral anti-inflammatory drug, received Breakthrough Therapy Designation (BTD) in late 2025. MD is a complex inner ear disease that involves low to mid frequency hearing loss, tinnitus, vertigo, and dizziness. SPI-1005 is the first drug to receive BTD for MD and for the treatment of sensorineural hearing loss, the most prevalent disease involving the nervous system. Sensorineural hearing loss is documented using pure-tone audiometry (PTA) and speech discrimination testing including the words-in-noise (WIN) test that are the gold standards for diagnosing and grading hearing loss and other auditory dysfunction. “We look forward to advancing SPI-1005 as the first approved treatment for Meniere’s later this year and early next year,” said Dr. Jonathan Kil, Co-Founder and CEO.

This open label Phase 3 study was performed to accrue additional safety data to allow for chronic daily dosing of SPI-1005 and enrolled 191 participants at 9 US sites in 8 months’ time. The four MD trials have now enrolled a total of 578 adults with probable or definite Meniere’s. To our knowledge, this represents the greatest number of MD participants enrolled in an investigational new drug trial over the last 10 years. SPI-1005 trials have also achieved favorable safety and efficacy results in a Phase 2 RCT in acute noise-induced hearing loss, and a Phase 2 RCT in aminoglycoside-induced ototoxicity.

About SPI-1005

SPI-1005, an oral capsule taken twice daily contains ebselen, a new chemical entity that mimics and induces glutathione peroxidase (GPx) activity. GPx1 is a critical enzyme that repairs injured and aging cells in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is reduced during and after exposure to environmental insults such as noise, ototoxic drugs, or aging. Consequently, neuroinflammation can progress throughout the peripheral and central nervous system leading to neurodegeneration and/or maladaptive plasticity. SPI-1005 is being developed for several neurotologic indications beyond MD including, noise-induced hearing loss and tinnitus, and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin). To date, no significant drug-drug interactions have been observed across multiple study populations including MD, cystic fibrosis, bipolar mania, and treatment-resistant depression. Fifteen ongoing and completed SPI-1005 trials have enrolled more than 980 patients with 200+ more enrolled patients anticipated over the next year.

About Sound Pharmaceuticals

Sound Pharma is a private biotechnology company studying SPI-1005 under five active INDs involving several neurotologic indications. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or www.soundpharma.com. Please contact [e-mail] for further information.