Summary: Sound Pharmaceuticals has completed a Phase 3 clinical trial for SPI-1005, a novel anti-inflammatory treatment for Meniere’s Disease, showing potential improvements in hearing loss and tinnitus.
Key Takeaways:
- SPI-1005 is an oral capsule taken twice daily, showing significant improvement in hearing loss and tinnitus based on previous Phase 1b and 2b studies.
- The Phase 3 trial, the longest for a hearing loss or tinnitus indication, enrolled 221 patients and included both a randomized controlled trial and an open label extension.
- The study was led by distinguished professionals and involved leading academic centers, with interim topline results expected to be presented this quarter.
Sound Pharmaceuticals announced 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 three months followed by an open label extension (OLE) of SPI-1005 for six months (OLE 6-mo) and an optional six 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, according to the company. RCT data unblinding and presentation of the interim topline results will occur this quarter.
Further Reading: Sound Pharmaceuticals Completes Enrollment for Meniere’s Disease Drug Clinical Trial
STOPMD-3 randomization began on August 2, 2022 and the last patient last visit (OLE 12-mo) was completed on July 25, 2024. A total of 254 patients were screened for eligibility at 11 sites including some of the leading academic centers in the US. 221 eligible patients were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed for 84 days. 201 patients continued onto SPI-1005 OLE for up to 6 months and 12 months.
“We are grateful to all the patients that participated in this pivotal trial of SPI-1005,” says Jonathan Kil, MD, co-founder and CEO. SPI-1005 is the only investigational new drug that was tested in a Phase 3 trial aimed at improving hearing loss, tinnitus, and/or dizziness over the last three years, according to the company.
Further Reading: Sound Pharma Gets Positive Data from Trial Treating Aminoglycoside-Induced Ototoxicity
STOPMD-3 was led by Dr Paul Lambert, Distinguished University Professor and Chair Emeritus of the Department of Otolaryngology-HNS at MUSC in Charleston, SC, and the past president of the American Neurotologic Society. “To our knowledge, this Phase 3 study is the longest continuous treatment trial to improve hearing loss/tinnitus in patients living with Meniere’s Disease,” Lambert says. Dr Lambert, Dr Shaun Nguyen, and their colleagues from MUSC 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, Sound Pharmaceuticals is testing SPI-1005 under five other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and cochlear implant patients co-funded by Med-El. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or by visiting www.soundpharma.com.
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