SEATTLE, WASHINGTON — Sound Pharmaceuticals announced that it has completed enrollment in its second Phase 3 open-label study of SPI-1005 for the treatment of Ménière’s disease (MD).
SPI-1005, an investigational oral anti-inflammatory drug, received FDA Breakthrough Therapy Designation in late 2025. Ménière’s disease is a complex inner ear disorder involving low- to mid-frequency hearing loss, tinnitus, vertigo, and dizziness. According to the company, SPI-1005 is the first drug to receive Breakthrough Therapy Designation for Ménière’s disease and for the treatment of sensorineural hearing loss.
Sensorineural hearing loss is documented using pure-tone audiometry (PTA) and speech discrimination testing, including the Words-in-Noise (WIN) test, which are commonly used to diagnose and assess 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”
–Dr. Jonathan Kil, Co-Founder and CEO
Study Enrolls 191 Participants Across Nine Sites
The open-label Phase 3 study was conducted to collect additional safety data supporting chronic daily dosing of SPI-1005. The study enrolled 191 participants across nine U.S. sites over an eight-month period.
Across four clinical trials, Sound Pharmaceuticals has now enrolled a total of 578 adults with probable or definite Ménière’s disease. According to the company, this represents the largest number of participants enrolled in an investigational new drug trial for Ménière’s disease during the past 10 years.
SPI-1005 has also produced favorable safety and efficacy results in a Phase 2 randomized controlled trial evaluating acute noise-induced hearing loss and a separate Phase 2 randomized controlled trial involving 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 [email protected] for further information.
Source: Sound Pharmaceuticals
