FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease

Sound Pharmaceuticals (SPI) is pleased to announce that it began enrolling a clinical trial to test SPI-1005 in the treatment of Meniere's Disease (MD). MD or idiopathic endolymphatic hydrops is an inner ear disease that involves episodic vertigo, sensorineural hearing loss, and tinnitus. Patients with MD may also complain of aural fullness or pressure. SPI-1005 is an investigational drug that contains an orally available small molecule that mimics and induces Glutathione Peroxidase (GPx) activity. GPx1 activity is diminished after ototoxic insults that cause sensorineural hearing loss and tinnitus. In pre-clinical studies, SPI-1005 has been shown to prevent and treat different types of hearing loss that involve auditory hair cells and neurons. In a recent Phase 2 clinical study, SPI-1005 was shown to prevent sensorineural hearing loss due to noise. According to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), 600,000 people in the US have MD. This Phase 1b clinical trial will enroll 40 subjects at four centers in the US. This marks the third active IND sponsored by SPI for sensorineural otologic indications. Currently, there are no FDA approved drug treatments for MD, or any other sensorineural disease of the inner ear.

"Based on the anti-inflammatory activity of SPI-1005, we hope that it will be of benefit in Meniere's disease," said Jonathan Kil, MD, CEO. SPI is a privately held biopharmaceutical company in Seattle with a focus on developing the first drugs for the prevention and treatment of sensorineural hearing loss and tinnitus. According to the CDC, sensorineural hearing loss is the third largest chronic disease and affects over 31 million adults in the US. Tinnitus, is the abnormal perception of sound, and affects 10-15% of adults according to the AAO-HNS. Vertigo is a type of dizziness that involves a sense of spinning and affects millions of Americans.