Sound Pharma completes enrollment in pivotal Phase 3 clinical trial of SPI-1005 for the treatment of Meniere's disease involving hearing loss, tinnitus, and dizziness.

2023-05-03

临床2期临床3期

SEATTLE, May 3, 2023 /PRNewswire/ -- Sound Pharmaceuticals is pleased to announce that it has completed enrollment in its first Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere's Disease (STOPMD-3). SPI-1005 is given orally and is the only drug demonstrated to improve both hearing loss and tinnitus in Meniere's Disease (MD) patients following 3 to 4 weeks of treatment in two prior randomized double-blind placebo-controlled trials (RCT) involving over 165 patients. The STOPMD-3 RCT screened over 250 patients for eligibility at 12 sites including some of the leading academic centers in the United States. Demand for the STOPMD-3 trial was higher than anticipated and enrollment completed six months ahead of schedule with over 220 eligible patients randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment in 9 months. Currently, SPI-1005 is the only investigational new drug being tested in an active Phase 2 or 3 RCT aimed at improving hearing loss, tinnitus, and/or dizziness. "It's both encouraging and humbling to see the demand for this third SPI-1005 study involving Meniere's disease patients" said Jonathan Kil, MD, Co-Founder and CEO.

While STOPMD-3 is no longer recruiting new patients, it will continue to follow randomized patients for 3 months, after which, subjects may be invited to participate in an open-label extension (OLE) safety study of SPI-1005 treatment for up to 12 months. During the OLE, both auditory and vestibular function will be reassessed every 3 months. To date, no FDA-approved therapies exist for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness, which together comprise definite and probable MD. STOPMD-3 is led by Dr. Paul Lambert, Distinguished Professor and Former Chairman in the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and past President of the American Neurotologic Society. Dr. Lambert, Dr. Shaun Nguyen, and their colleagues from MUSC also led the successful Phase 2b RCT involving SPI-1005 and MD patients.

About Meniere's Disease (MD)

MD is diagnosed by brief periods of episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear. Some patients experience aural fullness or pressure that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss or intractable tinnitus. For the definitive diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of ≥30 dB of low frequency hearing loss in at least one ear using PTA. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not been proven to be effective and is not FDA-approved for the treatment of definite or probable MD.

About SPI-1005

SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity, and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss 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 bipolar mania and treatment resistant depression.

About Sound Pharmaceuticals

A privately held biotechnology company is testing SPI-1005 under four other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and COVID-19 inpatients co-funded by the NIH. The leadership team consists of Jonathan Kil, MD, Co-Founder and CEO, Jacqueline Nguyen, MBA, VP Clinical Operations, John Sullivan, MBA, CFO, and G. Michael Wall, PhD, VP Pharmaceutical Development. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or by visiting www.soundpharma.com.

SOURCE Sound Pharmaceuticals