SEATTLE--(BUSINESS WIRE)--Sound Pharmaceuticals is pleased to announce that the Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere’s Disease (STOPMD-3) has been completed. SPI-1005 is an oral capsule taken twice daily and the only potential therapeutic to significantly improve hearing loss and tinnitus in Meniere’s Disease patients that was documented in two completed Phase 1b and 2b studies that enrolled over 165 patients. The STOPMD-3 study enrolled eligible patients into a randomized controlled trial (RCT) for 3-months followed by an open label extension (OLE) of SPI-1005 for 6 months (OLE 6-mo) and an optional 6 additional months (OLE 12-mo). STOPMD-3 is the longest treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication. RCT data unblinding and presentation of the interim topline results will occur this quarter.
STOPMD-3 randomization began on August 2, 2022 and the last patient last visit (OLE 12-mo) was completed on July 25, 2024. 254 patients were screened for eligibility at 11 sites including some of the leading academic centers in the US. 221 eligible patients were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed for 84 days. 201 patients continued onto SPI-1005 OLE for up to 6-mo and 12-mo. “We are grateful to all the patients that participated in this pivotal trial of SPI-1005,” said Jonathan Kil, MD, Co-Founder and CEO. SPI-1005 is the only investigational new drug that was tested in a Phase 3 trial aimed at improving hearing loss, tinnitus, and/or dizziness over the last three years.
STOPMD-3 was led by Dr. Paul Lambert, Distinguished University Professor and Chair Emeritus of the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and the past President of the American Neurotologic Society. “To our knowledge, this Phase 3 study is the longest continuous treatment trial to improve hearing loss/tinnitus in patients living with Meniere’s Disease,” said Dr. Lambert. 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 in the affected ear 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 pure tone audiometry (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 five other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and cochlear implant patients co-funded by MED-EL. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or by visiting www.soundpharma.com.
