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Outbyte Driver Updater FREEFix the driver behind crashes, sound loss and screen glitchesFind Drivers →Outbyte PC Repair FREERepair Windows errors before they cause bigger problemsFix Now →Sound Pharmaceuticals was seeking $30 million in 2016; the report did not say the company had closed a $30 million round. GeekWire reported that the Seattle biotech had raised more than $4 million toward that target and planned to use the funds to advance a Phase 2 trial of SPI-1005, an investigational drug containing ebselen. Since then, the company has reported Phase 3 results in Ménière’s disease, but the cited sources do not establish that SPI-1005 is approved or available to consumers.
What did the $30 million figure mean?
In a September 16, 2016 report, GeekWire said Sound Pharmaceuticals was “in the midst of a $30 million investment round” and had raised more than $4 million so far, citing co-founder and CEO Jonathan Kil. The $30 million was the round’s target, not a verified completed financing. The report does not establish whether the round later closed, its final amount, its investors, or its terms. GeekWire’s 2016 report said the planned use was to support a Phase 2 trial of SPI-1005.
What is SPI-1005?
SPI-1005 is an oral investigational drug containing ebselen. Sound Pharmaceuticals describes ebselen as mimicking and inducing glutathione peroxidase activity, an antioxidant enzyme. That is the company’s account of the candidate’s mechanism, not proof that it prevents or treats hearing loss. The company’s materials describe development programs across neurotologic conditions; its pipeline has listed Ménière’s disease and acute noise-induced hearing loss among them. Programs and stages can change.
The 2016 financing story focused on the proposed Phase 2 trial and the potential use of SPI-1005 for noise-induced hearing loss. Later development has prominently involved Ménière’s disease, a distinct indication. The funding report should therefore be read as a historical snapshot of the company’s plans, not as a current fundraising announcement.
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What did the company report about its Phase 3 Ménière’s disease trial?
On December 10, 2024, Sound Pharmaceuticals announced results from STOPMD-3, a randomized Phase 3 study in adults with definite Ménière’s disease. The company said 221 adults were randomized to 28 days of SPI-1005, at 400 mg twice daily, or placebo, with assessments through day 84. It reported that the study met co-primary efficacy endpoints involving hearing loss and speech discrimination. The following results are sponsor-reported; they should not be mistaken for independent confirmation or an FDA determination. The company’s announcement provides the results and study context.
| Reported day-84 measure | SPI-1005 | Placebo | How to read it |
|---|---|---|---|
| At least 10 dB improvement at one low frequency on pure-tone audiometry | 57.9% | 36.5% | Company-reported response rates; p=0.0037 |
| At least 10 dB improvement at two adjacent low frequencies | 41.1% | 13.5% | Stricter hearing-improvement criterion; p<0.0001 |
| Improvement in words-in-noise testing | 42.1% | 27.1% | Company-reported response rates; p=0.0336 |
These are percentages of participants meeting the reported criteria, not percentage-point increases in hearing ability. Pure-tone audiometry and words-in-noise testing measure different outcomes, so their response rates should not be treated as interchangeable.
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What the extension can—and cannot—show
The sponsor also reported observations from an open-label extension: 201 participants entered, 153 completed months one through six, and 107 continued into months seven through twelve, of whom 82 completed. The company said symptom measures improved from baseline during the extension. Because participants and researchers knew treatment was being given and there was no placebo comparison in this phase, those observations do not provide the same kind of controlled evidence as the randomized portion.
What happened after the 2024 results?
A July 14, 2026 report by Hearing Health & Technology Matters said Sound Pharmaceuticals had completed enrollment in a second Phase 3 study: an open-label safety study involving 191 participants at nine U.S. sites. Its stated purpose was to gather additional safety data for chronic daily dosing. The report also attributed to the company a total of 578 adults with probable or definite Ménière’s disease enrolled across four trials. Those are reported enrollment figures, not evidence that the treatment has been approved. The 2026 report said the FDA had granted SPI-1005 Breakthrough Therapy Designation in late 2025; that designation is not marketing approval.
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The same 2026 article quoted Kil saying the company looked forward to advancing SPI-1005 as “the first approved treatment for Meniere’s later this year and early next year.” That was an executive’s forward-looking expectation at the time of the report, not confirmation that approval occurred or would occur on that schedule. The cited sources do not establish an FDA marketing authorization, product launch, or consumer availability.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What this means for readers
- The 2016 headline describes a financing target and a planned trial, not a confirmed $30 million close.
- SPI-1005 remains an investigational candidate in the cited company materials; it is not established here as a consumer medicine.
- The company reported encouraging Phase 3 findings in Ménière’s disease, but its published announcement is sponsor-reported evidence, not regulatory approval.
- FDA Breakthrough Therapy Designation and enrollment in another Phase 3 study are development milestones, not permission to market a drug.
Sound Pharmaceuticals’ 2016 raise was part of an effort to fund clinical development. The subsequent results and studies show that the candidate continued through later-stage testing, while the available sources leave the financing outcome and eventual approval status unresolved.
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