Ebselen

SEATTLE, Jan. 30, 2024 /PRNewswire/ -- Sound Pharmaceuticals (SPI) will present the Phase 2b STOP Ototoxicity data that was selected for podium presentation at the Association for Research in Otolaryngology (ARO) Midwinter Meeting in Anaheim, CA (February 3-7). This initial safety and efficacy study of SPI-1005 (ebselen) to prevent and treat aminoglycoside-induced ototoxicity enrolled 60 adult CF patients undergoing intravenous (IV) tobramycin for the treatment of acute pulmonary exacerbation. Ototoxicity (hearing loss, tinnitus, vertigo or dizziness) is a common side effect of aminoglycoside antibiotics (tobramycin, amikacin, gentamycin and streptomycin). Currently, there are no FDA approved therapies for the prevention/treatment of aminoglycoside ototoxicity or the treatment of any other type of sensorineural hearing loss, tinnitus, or dizziness. In the Phase 1b observational study (N=20), SPI reported that a 14-day course of IV tobramycin resulted in ototoxicity rates of 89% and 93%, at 2 and 4-weeks after aminoglycoside treatment was completed (Harruff, Journal of Cystic Fibrosis, 2021). In the Phase 2b interventional study, adult patients were randomized in a double blinded fashion to 3 different doses of ebselen or placebo, taken orally for 21 days within 3 days of starting IV tobramycin. In the Phase 2b study (N=40), the ototoxicity rates were 73% and 63%, at 2 and 4-weeks after aminoglycoside treatment was completed, a statistically significant reduction when compared to the Phase 1b study (p-value <0.05). No significant differences in age, duration of IV tobramycin, concomitant medications, respiratory status, or baseline hearing loss were observed between the studies. Interim analysis of the Phase 2b results shows a dose proportional decrease in the ototoxicity rate (from placebo, 200, 400, to 600 mg ebselen), with the 400 and 600 mg dose having ototoxicity rates of 44% and 43% at 4-weeks (400 mg, p-value <0.05). "To our knowledge, these are the first positive results of an ototoxicity intervention trial in humans undergoing antibiotic treatment for pulmonary exacerbation," said Jonathan Kil, MD, SPI's Co-Founder and CEO. Results from two other preclinical studies involving ebselen treatment, a novel anti-inflammatory compound that has also shown positive results in clinical trials involving acute noise exposure, bipolar mania, and Meniere's disease, will be presented at the ARO. The CFF provided a $2.2M Therapeutic Development Award to SPI to support the studies. Details of this trial (NCT02819856) can be viewed online at , or by visiting . SOURCE Sound Pharmaceuticals

SEATTLE, May 3, 2023 /PRNewswire/ -- Sound Pharmaceuticals is pleased to announce that it has completed enrollment in its first Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere's Disease (STOPMD-3). SPI-1005 is given orally and is the only drug demonstrated to improve both hearing loss and tinnitus in Meniere's Disease (MD) patients following 3 to 4 weeks of treatment in two prior randomized double-blind placebo-controlled trials (RCT) involving over 165 patients. The STOPMD-3 RCT screened over 250 patients for eligibility at 12 sites including some of the leading academic centers in the United States. Demand for the STOPMD-3 trial was higher than anticipated and enrollment completed six months ahead of schedule with over 220 eligible patients randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment in 9 months. Currently, SPI-1005 is the only investigational new drug being tested in an active Phase 2 or 3 RCT aimed at improving hearing loss, tinnitus, and/or dizziness. "It's both encouraging and humbling to see the demand for this third SPI-1005 study involving Meniere's disease patients" said Jonathan Kil, MD, Co-Founder and CEO. While STOPMD-3 is no longer recruiting new patients, it will continue to follow randomized patients for 3 months, after which, subjects may be invited to participate in an open-label extension (OLE) safety study of SPI-1005 treatment for up to 12 months. During the OLE, both auditory and vestibular function will be reassessed every 3 months. To date, no FDA-approved therapies exist for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness, which together comprise definite and probable MD. STOPMD-3 is led by Dr. Paul Lambert, Distinguished Professor and Former Chairman in the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and past President of the American Neurotologic Society. Dr. Lambert, Dr. Shaun Nguyen, and their colleagues from MUSC also led the successful Phase 2b RCT involving SPI-1005 and MD patients. About Meniere's Disease (MD) MD is diagnosed by brief periods of episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear. Some patients experience aural fullness or pressure that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss or intractable tinnitus. For the definitive diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of ≥30 dB of low frequency hearing loss in at least one ear using PTA. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not been proven to be effective and is not FDA-approved for the treatment of definite or probable MD. 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 four other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and COVID-19 inpatients co-funded by the NIH. The leadership team consists of Jonathan Kil, MD, Co-Founder and CEO, Jacqueline Nguyen, MBA, VP Clinical Operations, John Sullivan, MBA, CFO, and G. Michael Wall, PhD, VP Pharmaceutical Development. Details of the SPI-1005 clinical trials can be viewed online at or by visiting . SOURCE Sound Pharmaceuticals