SEATTLE--(BUSINESS WIRE)--Sound Pharmaceuticals is pleased to announce that it will make four presentations at the upcoming Association for Research in Otolaryngology MidWinter Meeting in Orlando, FL.
“The Development of SPI-1005 for the Treatment of Hearing Loss and Tinnitus” at the Pharmaceutical Interventions for Hearing Loss (PIHL) Satellite Symposium organized by the Defense Health Agency (DHA) Hearing Center of Excellence (HCE) committee that will provide a comprehensive overview of investigational medicines for hearing loss prevention and hearing restoration. This PIHL symposia will be held on Friday, Feb 21, at 1-5pm ET.
“SPI-1005 Improves Auditory and Vestibular Deficits in Meniere’s Disease in a Multi-Center Phase 3 Randomized Placebo-Controlled Trial (STOPMD-3)” scheduled for Sunday, Feb 23, at 4:45pm ET.
“Ebselen-Eluting Silicone Strips Reduce Low Frequency Hearing Loss in a Guinea Pig Model of Cochlear Implantation” scheduled for Monday, Feb 24, at 1:30-3:00pm ET
“Ebselen Permanently Reverses Noise-Induced Tinnitus in Young and Older Mice with Age-Related Hearing Loss” scheduled for Tuesday, Feb 25, at 9:45am ET.
About the STOPMD-3 trial
STOPMD-3 screened 254 participants for eligibility at 11 sites, including some of the leading academic centers in the US. Eligible participants (221) were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed up to day 84. 201 participants continued on to SPI-1005 OLE for 1-6 months (153 completed) and 107 participants continued on to 7-12 months (82 completed). To our knowledge, STOPMD-3 is the largest Meniere’s disease trial and the longest continuous treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication including MD. 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. Dr. Lambert, Dr. Shaun Nguyen, director of clinical trial research in the Dept. of Otolaryngology-HNS at MUSC, and their colleagues also led the successful Phase 2b RCT involving SPI-1005 and MD patients.
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 the prevention and treatment of aminoglycoside-induced ototoxicity co-funded by the CF Foundation and hearing preservation in cochlear implant patients co-funded by MED-EL. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or www.soundpharma.com. Please contact info@soundpharma.com for further information.
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