CEO Jonathan Kil just updated via Linkedin 10 minutes ago: "We have already received fast track designation and will look to have an pre-NDA at the end of year. Hopefully they will be adequately staffed!" He seems active on Linkedin, so that could be a good place to get a hold of him with any of these questions regarding the new trial.
Could trials continue to be conducted to better understand the effectiveness and side effects of drugs that have already passed the required threshold for market entry? For example, could there be a clinical trial of ibuprofen to determine the side effects in people living at 5,000 meters above sea level? This is the only thing I can think of.
I just saw this: SPI-1005 for Meniere's Disease · Info for Participants · Phase Phase 3 Clinical Trial 2025 | Power | Power I don't see a date, so maybe it isn't current.
Thanks, Carlos! It's odd that the .gov site says it hasn't started recruiting, but the with power.com site has an "Apply Today" option on the website. The with power.com site also has another clinical trial for Meniere's for a drug (Anakinra) that is already approved for other conditions. Approved in European Union as Kineret for: Rheumatoid arthritis Cryopyrin-associated periodic syndromes Deficiency of interleukin-1 receptor antagonist COVID-19 Approved in United States as Kineret for: Rheumatoid arthritis Deficiency of interleukin-1 receptor antagonist Neonatal-onset multisystem inflammatory disease (NOMID) COVID-19 There's also a trial for Montelukast (Singulair) for people with allergies and Menieres. Trial OverviewThe study tests whether montelukast, a drug approved for allergic rhinitis and asthma, can alleviate vertigo and hearing loss in Meniere's Disease patients. Participants will either receive montelukast or a placebo to compare outcomes.
Does anyone who participated in the SP-1005 trial recommend applying for this trial? I know everyone is different and you have had various results/experiences, but I wonder if you thought it was worth it. Thanks!
I was in it it did nothing for my tinnitus which I was hoping for. I was allowed to stay on Betahistine which controls my vertigo. I think this drug is being over hyped on here and other places , mainly by the manufacturer.
If there is one thing we know about big Pharma, it is that they overstate benefits and understate side effects.
Read the comments on this topic. Several users participated and shared their experiences. There's also a thread on the forum about this drug during its Phase 2 phase, where a user participated and gave their opinion.
What made you think SPI-1005 might improve your tinnitus? SPI-1005 is not a cure for hearing loss. Its primary role is to help prevent or stabilize fluctuations in hearing/vertigo by reducing inflammation and oxidative stress in the inner ear. Tinnitus is a symptom, often chronic, that may stem from hearing damage that occurred long before SPI-1005 treatment begins. I just feel it's unlikely to expect that SPI-1005 would reverse tinnitus caused by long-standing auditory injury. I don't know what about the drug can do that (we don't have any hearing loss regeneration drugs) since the drug is intended more for protecting existing function. But, happy to be proven wrong if you wanna dive into the mechanism of action.
It's like you say, but I suppose that if parts of the inner ear are damaged but not dead, and this medication stops that damage, it would allow for regeneration and recover some hearing or reduce tinnitus. In any case, the most important thing about this medication is that it can stop the disease and prevent new damage. That's why I'm interested in it because I don't expect it to cure my right ear, but I do hope it protects my left ear in case I become bilateral. However, the latest information is very scarce or contradictory, and I'm losing faith because it seems that everything that has happened this year is more about trying to obtain public funding to continue researching new applications than it is about the third trial for Meniere having yielded the expected results. If that had been the case, it would have clearly been published a long time ago.
First of all, what is the source for this? SPI-1005 is a preventative. It mimics and boosts glutathione peroxidase—that will reduce inflammation and reduce free radicals causing oxidative stress (similar to how glutathione works), but as I stated above there is nothing "regenerative" about this process. There's maybe a chance the drug could improve some function, but we need to be precise about what that means and what we mean when we say "this medication stops that damage". It will do this if the damage is ongoing, but again, as a preventative, with the goal of preserving hearing and limiting progressing. The effects would probably be minimal for any damage that is long-standing. No, as I explained above, this is not what the drug does to my knowledge. Feel free to correct me if I'm wrong, but again, a regenerative drug would be an even bigger headliner in this field. Yes, this is the thinking--SPI-1005 will help protect the ear from future insults and attacks. I understand the feeling of losing faith, especially given how arduous the process can be. I'm a little curious what specifically is indicative of a change of course to you. Funding or future research is a big part of drug application and may even be necessary based on what the FDA is requesting. While we all want the drug on the market, I think we'd all value new information that could potentially refine or change the game even further. When you say "If that had been the case, it would have clearly been published a long time ago," I'm not sure if you're referring to the publication of the study results or the release of the drug itself. It could certainly be a while, but SP certainly has the goal of making the medication available as soon as possible. There may be bottlenecks out of the company's control.
The paperwork I received at the clinic states that it possibly would improve my tinnitus among other symptoms like restoring some hearing and controlling vertigo. I would not waste my time taking this drug if it becomes available UNLESS they prescribe a higher dose or possibly a dosage based on a persons weight that was higher than what I was taking. Honestly I don't think any of us will see it come to market based on what I heard at my study clinic. The audiologist that tested me there told me not one person reported better hearing or lower tinnitus - this was at the end of the trial. They would not make comments during the trail due to the "placebo effect" - IE putting something in your head so to speak.
Okay, but again this could mean a lot of things. If tinnitus occurs as a result of ongoing fluctuations that SPI-1005 successfully mitigates, that would reasonably "improve tinnitus". If tinnitus has/had occurred as a result of past trauma (SSNHL, neck injury), of which we have no current means of reversing this, then I simply am not sure what about the mechanism of action of SPI-1005 we could expect to improve tinnitus. The drug induces GPx to reduce neuroinflammation -- this could help modulate some hyperactivity that could be contributing to tinnitus, but remember tinnitus is more a brain problem, and when it's been around long enough, it's hard to look at it just in the context of a Meniere's attack (since damage has been long done). I'd be curious to take a look more specifically at what you were shown though. You're basing this on a small subset of anecdotal chatter in the face of positive phase 3 results. If phase 3 failed, sure, I'd be aligned on this conclusion. But phase 3 did not fail, so I've got some questions here. Primarily, to my point above — if someone is deaf, giving them SPI-1005 will not bring back their hearing. If someone is experiencing ongoing trauma to the inner ear (inflammation/Meniere's attacks, acoustic traumas even, etc), SPI-1005 could hopefully work wonders in mitigating the oxidative stress resulted from those attacks. It prevents. The key endpoints were likely assessing how much fluctuations of symptoms had diminished compared to placebo.
How do you know phase 3 did not "fail" ? - from the company news release ? We all know how honest drug companies are. When 23 people start a trial and only 3 finish it (and I was one of the 3) - that's ll I need to know. In plain language- I don't give a shit how it something works as long as it works - and it didn't.
I’m keeping the faith. My Meniere’s journey started last year and SPI-1005 was one of the few things that gave me hope. I know how fortunate I am to still be in the early stages of all of this, and maybe that’s why. I only had my second attack last October, and literally a week later a family member called me excitedly to tell me she met the CFO of Sound. I don’t feel comfortable sharing the specifics of their meeting online, but it was definitely hopeful.