Articles from Sound Pharmaceuticals

Sound Pharmaceuticals (SPI) is pleased to announce that the FDA has granted its investigational new drug, SPI-1005, Breakthrough Therapy Designation (BTD) for the treatment of hearing loss in patients with Meniere’s disease (MD). MD is a complex inner ear disease that involves low-to-mid frequency hearing loss, tinnitus, vertigo, and dizziness. This is the first BTD granted for the treatment of MD, for which there are no FDA approved drug treatments. Definite MD requires audiometric documentation of low-to-mid frequency hearing loss while probable MD does not. In addition, SPI-1005, an oral anti-inflammatory, is the first drug to receive BTD involving the treatment of sensorineural hearing loss, the most common disease of aging and of the peripheral and central nervous system. Sensorineural hearing loss is documented by pure-tone audiometry (PTA) and speech discrimination testing including the words-in-noise (WIN) test which together serve as the gold standards for determining hearing impairment and other auditory dysfunction. “We look forward to working closely with the FDA to get SPI-1005 ready for a future NDA filing,” said Dr. Jonathan Kil, Co-Founder and CEO of SPI.

Sound Pharmaceuticals is pleased to announce that it has been invited to present its R&D and financing goals at two upcoming industry conferences this month.

Sound Pharmaceuticals is pleased to announce that it has been invited to present its R&D and financing goals at four upcoming life science and healthcare investor conferences over the next month.

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.

Sound Pharmaceuticals is pleased to announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Meniere’s Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination. Meniere’s disease (MD) is an inner ear disorder that involves fluctuating hearing loss and tinnitus, and episodic vertigo and/or dizziness. There are no FDA-approved medical treatments for MD, nor for the treatment of hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple hearing loss and tinnitus indications including MD.

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.

Sound Pharmaceuticals (SPI) is pleased to announce that it has received FDA notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment and cochlear implantation (CI). The goal of this Phase 2 SPI-1005 (ebselen) trial is to reduce the loss of residual hearing during and after CI. Ebselen is a novel anti-inflammatory compound that mimics and induces the activity of Glutathione Peroxidase, an enzyme that is critical to hearing and balance. Ebselen has shown safety and efficacy in three different forms of acquired sensorineural hearing loss in adult patients, including loud sound exposure or acute noise induced hearing loss, Meniere’s disease, and antibiotic or aminoglycoside induced ototoxicity.