SEATTLE — Sound Pharmaceuticals (SPI) is pleased to announce the completion of study enrollment in its Phase 2b clinical trial involving Meniere’s Disease (MD). MD is diagnosed by episodic vertigo, fluctuating hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling or inflammation of the inner ear. The majority of MD patients are initially diagnosed in their 40s, 50s and 60s, and the auditory symptoms of hearing loss and tinnitus often involve one ear. MD is managed with low salt diets, thiazide diuretics, and oral and/or locally injected steroids. Unfortunately, this type of treatment or medical management has not proven to be effective. As patients age into their 50s, 60s and 70s, the hearing loss and/or tinnitus become progressively worse. Currently, there are no FDA approved drug treatments for MD, or any other inner ear disease. SPI-1005 is an investigational new drug that mimics and induces glutathione peroxidase activity and is given orally. In earlier stage clinical trials, SPI-1005 demonstrated strong proof-of-concept in preventing and treating sensorineural hearing loss involving noise induced hearing loss and Meniere’s disease.
In this randomized double-blind placebo controlled multi-center Phase 2b clinical trial, 149 volunteers with active MD were screened for inclusion/exclusion criteria critical to the diagnosis and management of MD. Eligible patients were then randomized to either placebo or one of two different doses of SPI-1005 and treated for 28 days. “We are excited to have completed enrollment of this second study involving Meniere’s disease,” said Dr. Paul Lambert, Principal Investigator of the study. Dr. Lambert is a leading neurotologist and Chairman of the Dept. of Otolaryngology-HNS at MUSC in Charleston, South Carolina.
In the Phase 1b clinical trial involving MD, 40 subjects were randomized to either placebo or one of three doses of SPI-1005 and treated for 21 days. SPI-1005 was found to be safe, well tolerated and shown to improve both auditory and vestibular symptoms including hearing loss. These study data were presented at the Association for Research in Otolaryngology meeting in 2018. “This second study should confirm and extend the novel findings from the first study, and indicate whether SPI-1005 can improve auditory and vestibular function in a chronically affected complex patient population,” said Jonathan Kil, MD, Co-Founder, CEO and CMO.
Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov.