Sound Pharma Announces Phase 3 Study Completion of SPI-1005 for the Treatment of Meniere’s Disease

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. [ABSTRACT FROM PUBLISHER]