Ebselen

SEATTLE--(BUSINESS WIRE)--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. 5 th Inner Ear Disorders Therapeutics Summit on July 15-17 BTIG Virtual Biotechnology Conference July 29-30 Dr. Jonathan Kil, Co-Founder and CEO, will provide an update on SPI-1005, a novel oral anti-inflammatory drug. SPI-1005 is the first investigational drug to achieve its co-primary endpoints, involving pure-tone audiometry and words-in-noise test, in a pivotal Phase 3 randomized, double blinded, placebo-controlled trial (RCT) to treat Meniere’s Disease (STOPMD-3). There are no FDA approved drugs for the treatment of hearing loss, tinnitus, dizziness or vertigo, the primary or core symptoms of Meniere’s Disease (MD). SPI-1005 has also achieved favorable safety and efficacy results in five different RCTs involving MD, acute noise-induced hearing loss, and aminoglycoside-induced ototoxicity. An open-label Phase 3 is starting now that will enroll MD participants to accrue additional safety data to allow for the chronic dosing of SPI-1005 in MD. About SPI-1005 SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity that mimics and induces glutathione peroxidase (GPx) activity. GPx1 is a critical enzyme that repairs injured and aging cells in the inner ear, retina, prefrontal cortex, lung, and kidney, and is reduced during and after exposure to environmental insults such as noise, ototoxic drugs, or aging. Consequently, neuroinflammation can progress throughout the peripheral and central nervous system leading to neurodegeneration and/or maladaptive plasticity. SPI-1005 is being developed for several neurotologic indications including Meniere’s disease (hearing loss, tinnitus, intermittent dizziness, and episodic vertigo), noise-induced hearing loss (including tinnitus) 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 Meniere’s disease, patients with cystic fibrosis, bipolar mania, and treatment-resistant depression. Thirteen completed SPI-1005 trials have treated 790 patients with 400+ more enrolled patients anticipated over the next year. About Sound Pharmaceuticals Sound Pharma is a private biotechnology company studying SPI-1005 under five active INDs involving several neurotologic indications. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or www.soundpharma.com.

SEATTLE--(BUSINESS WIRE)--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. 24 th Annual Needham Healthcare Conference on April 9-10 25 th Life Sciences Innovation Northwest on April 23-24 Citibank Biotech Private Access Investor Day on April 24 Morgan Stanley Inaugural Private Company & Investor Day on May 5 Dr. Jonathan Kil, Co-Founder and CEO will provide an update on SPI-1005, the novel oral anti-inflammatory, the first investigational drug to achieve its co-primary endpoints in a pivotal Phase 3 randomized double blinded placebo-controlled trial (RCTs) to treat Meniere’s disease (STOPMD-3). There are no FDA approved drugs for the treatment of hearing loss, tinnitus, dizziness or vertigo, the primary symptoms of MD. SPI-1005 has achieved positive safety and efficacy results in five different RCTs involving MD, acute noise-induced hearing loss, and aminoglycoside-induced ototoxicity. About SPI-1005 SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity that mimics and induces glutathione peroxidase (GPx) activity. GPx1 is a critical enzyme that repairs injured and dying cells in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during and after exposure to environmental insults or aging. Consequently, neuroinflammation can progress throughout the peripheral and central nervous system leading to neurodegeneration. SPI-1005 is being developed for several neurotologic indications including Meniere’s disease (hearing loss, tinnitus, intermittent dizziness, and episodic vertigo), noise-induced hearing loss (including tinnitus) 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 Meniere’s disease, and patients with cystic fibrosis, bipolar mania, and treatment-resistant depression. Thirteen SPI-1005 trials have been completed treating 790 patients with 400+ more anticipated later this year. About Sound Pharmaceuticals Sound Pharma is a private biotechnology company studying SPI-1005 under six active Investigational New Drug Applications involving several neurotologic indications including the prevention and treatment of aminoglycoside-induced ototoxicity co-funded by the Cystic Fibrosis 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.