Sound Pharma Presents SPI-1005 Phase 3 Data Analysis That Supports the Treatment of Sudden Sensorineural Hearing Loss

SEATTLE--(BUSINESS WIRE)--Sound Pharmaceuticals is pleased to announce that its abstract “SPI-1005 Improves Low-to-Mid Frequency Hearing in Meniere's patients that supports treating Sudden Sensorineural Hearing Loss” received Best in Scientific Orals honors by the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS). The AAO-HNS Annual Meeting is the largest otolaryngology conference in the world and is currently being held October 17-20 in Los Angeles, CA. SPI-1005 is a novel anti-inflammatory drug, and the only investigational new drug to have received Fast Track and Breakthrough Therapy Designation (BTD) for the treatment of Meniere’s disease (MD) from the FDA. MD is a complex inner ear (otologic/neurotologic) disease that involves low-to-mid frequency hearing loss, tinnitus, vertigo, and dizziness. Sudden Sensorineural Hearing Loss (SSNHL) is similar to MD in that its predominantly unilateral, involves low-to-mid frequency hearing loss, and is treated with oral and locally injected steroids. SSNHL is different from MD in that its onset occurs over 72 hours and does not involve vertigo or dizziness. 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, speech discrimination, and other auditory dysfunction. “We are honored to receive this recognition from the AAO-HNS and thank the reviewing committee,” said Dr. Jonathan Kil, Co-Founder and CEO. 

The new analysis focused on three to four low-to-mid frequencies and scored each ear for a 10-dB average improvement from baseline following 28 days of treatment and 84 days of follow-up. Active participant improvement rates were compared to placebo rates at 28, 56, and 84 days. Highly significant differences (p-values <0.01) were found at multiple time points involving both PTA and WIN scores. To our knowledge these are the first analyses of a definite Meniere’s Phase 3 study population that supports the future treatment of patients with SSNHL.

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 the 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.

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.