Sound Pharmaceuticals (SPI-5557 & SPI-1005)

[FGG]

I had just seen this Phase II trial which started in 2011.

Ah ok. I didn't see that one. I wonder what the results were.

They are recruiting now for a similar study (preventing hearing loss with acute noise injury) with a longer duration now (7 day course vs 4).

 

[Aaron91]

It's interesting to see this from the Clinical Trials page:

"Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds"​

This grabbed my attention because I remember someone on here mentioning once that they saw a huge difference in what NAC was doing for them when they combined it with Selenium. Don't know how relevant this is though to Ebselen.

 

[FGG]

It's interesting to see this from the Clinical Trials page:

"Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds"​

This grabbed my attention because I remember someone on here mentioning once that they saw a huge difference in what NAC was doing for them when they combined it with Selenium. Don't know how relevant this is though to Ebselen.

Maybe relevant. Like Ebselen, Selenium helps modulate Glutamate excess neuroexcitabilty but one difference is that Ebselen has a much better diffusion across the blood cochlear barrier than regular Selenium. I wonder how that person would so with Ebselen, possibly that much better.

 

[weab00]

Well, it's been 2 days and that guy still hasn't responded. I should also clarify some things:

* I don't know this person and I have no way of contacting them.

* In fact, I'm rereading the messages from the DM and it's actually a friend of a friend of a guy who contacted me. So pretty far down the chain.

I don't want to say it's fake yet but I just find it weird that this guy is not responding to any inquiries.

 

[Frédéric]

Ah ok. I didn't see that one. I wonder what the results were.

They are recruiting now for a similar study (preventing hearing loss with acute noise injury) with a longer duration now (7 day course vs 4).

Hi @FGG,

This could help you:
https://www.tinnitustalk.com/posts/503846/

 

[weab00]

Really hoping Sound Pharmaceuticals starts recruiting for Phase 3 soon. We're in the home stretch. Maybe someone can reach out to them?

 

[wwtsai]

Really hoping Sound Pharmaceuticals starts recruiting for Phase 3 soon. We're in the home stretch. Maybe someone can reach out to them?

I shot them an email about it. I inquired a few months ago about their COVID-19 trials and got no response so who knows if they'll actually get back to me. ¯\_(ツ)_/¯

 

[Keith Handy]

Hate to wish life away but if we all went to sleep tonight and woke up in 2025 I don't think too many of us would mind.

Assuming we could somehow survive that.

 

[wwtsai]

Got a reply from Sound Pharmaceuticals that they've already begun recruiting at some sites but didn't specify which. They asked for my location so I can probably find out if UCSF is recruiting.

 

[Jrblovsky]

Assuming we could somehow survive that.

Haven't you seen the movie Forever Young?

 

[Keith Handy]

Haven't you seen the movie Forever Young?

Hey, it's a lot more upbeat of a scenario than suicide. "See you in five years, everyone."

 

[BigNick]

A new drug could help improve age-related hearing loss. Preliminary studies have shown that it may also ease tinnitus and Meniere's disease, a neurological condition.

New pill that may help improve age-related hearing loss by protecting delicate hair cells in the inner ear

 

[Mica Rambin]

Does SPI-1005 also try to address inflammation?

 

[Mentos]

Where are you from? It's possible to buy Ebselen in Poland but delivery is only available around the Europe. I know nothing about chemistry, so you have to check if it's exactly the same thing you're looking for.

It's about $240 for 25 mg.

Here's the link:
https://pol-aura.pl/ebselen-980-60940-34-3-p-6813.html

Have you you tried it? I'm from Poland too.

I'm curious if Ebselen alone has potential to silence tinnitus.

 

[iGL0CK]

Have you you tried it?

Nah. It's too much money. In SPI-1005 trial they used 400mg per day, for 28 days (maybe not correct information).

If 25mg costs $240... I don't even need to count how much a full course of this stuff would cost.

 

[Mentos]

Nah. It's too much money. In SPI-1005 trial they used 400mg per day, for 28 days (maybe not correct information).

If 25mg costs $240... I don't even need to count how much a full course of this stuff would cost.

This would total up to $110,000USD a month. Indeed this exceeds my budget as well.

 

[Jrblovsky]

I tried to get into this trial but it was full.

 

[lis]

I tried to get into this trial but it was full.

Full at every location, even UCSF?

 

[Jrblovsky]

Full at every location, even UCSF?

I just tried here in Michigan. Not sure about elsewhere.

 

[Frédéric]

I don't think this has been already posted. It's an updated review. Below is the abstract (I can't get the full text).

Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus

Highlights

• Ebselen is the first investigational new drug to advance to Phase 3 in Meniere's Disease
• Ebselen was shown to be effective in a Phase 2 involving Noise-Induced Hearing Loss
• Ongoing studies in ototoxicity and other neuroinflammatory diseases show early efficacy
• Future studies will test if ebselen can mitigate central auditory dysfunction

Abstract
The global impact of hearing loss and related auditory dysfunction including tinnitus and hyperacusis on human health is significant and growing. A substantial body of literature has found that these hearing diseases and disorders result from significant number of genetic variations and molecular mechanisms. Investigational new drugs have been tested and several approved drugs have been repurposed in clinical trials, but no therapeutics for any auditory related indication have been FDA approved. A unique investigational new drug called ebselen (SPI-1005), that is anti-inflammatory and neuroprotective, has been shown to reduce noise-induced and aminoglycoside-induced hearing loss in animals. Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's Disease and acute noise-induced hearing loss. SPI-1005 is currently being tested to prevent and treat tobramycin-induced ototoxicity in cystic fibrosis patients with acute lung infections. This review summarizes the published and presented data involving SPI-1005 and other drugs being tested to prevent or treat sensorineural hearing loss. Additionally, recent clinical data showing the relationship between pure tone audiometry and words-in-noise test results in a Meniere's Disease are presented, which may have larger implications for the field of hearing research.

Source: https://www.sciencedirect.com/science/article/abs/pii/S0378595521000435

 

[weab00]

I don't think this has been already posted. It's an updated review. Below is the abstract (I can't get the full text).

Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus

Highlights

• Ebselen is the first investigational new drug to advance to Phase 3 in Meniere's Disease
• Ebselen was shown to be effective in a Phase 2 involving Noise-Induced Hearing Loss
• Ongoing studies in ototoxicity and other neuroinflammatory diseases show early efficacy
• Future studies will test if ebselen can mitigate central auditory dysfunction

Abstract
The global impact of hearing loss and related auditory dysfunction including tinnitus and hyperacusis on human health is significant and growing. A substantial body of literature has found that these hearing diseases and disorders result from significant number of genetic variations and molecular mechanisms. Investigational new drugs have been tested and several approved drugs have been repurposed in clinical trials, but no therapeutics for any auditory related indication have been FDA approved. A unique investigational new drug called ebselen (SPI-1005), that is anti-inflammatory and neuroprotective, has been shown to reduce noise-induced and aminoglycoside-induced hearing loss in animals. Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's Disease and acute noise-induced hearing loss. SPI-1005 is currently being tested to prevent and treat tobramycin-induced ototoxicity in cystic fibrosis patients with acute lung infections. This review summarizes the published and presented data involving SPI-1005 and other drugs being tested to prevent or treat sensorineural hearing loss. Additionally, recent clinical data showing the relationship between pure tone audiometry and words-in-noise test results in a Meniere's Disease are presented, which may have larger implications for the field of hearing research.

Source: https://www.sciencedirect.com/science/article/abs/pii/S0378595521000435

It doesn't seem like there are any studies on chronic tinnitus, but at least it has reduced or even cured acute tinnitus. Hopefully we can get further studies on both chronic tinnitus and hyperacusis, because it's still unclear whether or not the drug is merely preventative. But the over all tone of this paper seemed very optimistic, and I think SPI-1005 looks promising given that it's the only effective otoprotective treatment in phase 3 right now.

 

[FGG]

It doesn't seem like there are any studies on chronic tinnitus, but at least it has reduced or even cured acute tinnitus. Hopefully we can get further studies on both chronic tinnitus and hyperacusis, because it's still unclear whether or not the drug is merely preventative. But the over all tone of this paper seemed very optimistic, and I think SPI-1005 looks promising given that it's the only effective otoprotective treatment in phase 3 right now.

No studies but there was a blurb amount possibly settling neuro excitability and they saw a possible use for more chronic tinnitus (as well as bipolar and even Parkinson's -- @Jazzer keep an eye on this one for possible off label use since it's in Phase 3).

 

[Marin]

Hyperacusis Research just shared on Facebook that they are pursuing inflammation's role in hyperacusis. I have no doubt that SPI-1005 will help acute cases of hyperacusis. As @weab00 mentions above, the million dollar question is if it will help the more chronic cases, too.

I can't help but get angry when I think about how I probably wouldn't have horrifically debilitating hyperacusis if medications like this were already available when I lost my hearing over the summer. I just hope it can still help if/when it finally does become available. I do feel like the clock is ticking, though...

 

[annV]

I don't think this has been already posted. It's an updated review. Below is the abstract (I can't get the full text).

Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus

Highlights

• Ebselen is the first investigational new drug to advance to Phase 3 in Meniere's Disease
• Ebselen was shown to be effective in a Phase 2 involving Noise-Induced Hearing Loss
• Ongoing studies in ototoxicity and other neuroinflammatory diseases show early efficacy
• Future studies will test if ebselen can mitigate central auditory dysfunction

Abstract
The global impact of hearing loss and related auditory dysfunction including tinnitus and hyperacusis on human health is significant and growing. A substantial body of literature has found that these hearing diseases and disorders result from significant number of genetic variations and molecular mechanisms. Investigational new drugs have been tested and several approved drugs have been repurposed in clinical trials, but no therapeutics for any auditory related indication have been FDA approved. A unique investigational new drug called ebselen (SPI-1005), that is anti-inflammatory and neuroprotective, has been shown to reduce noise-induced and aminoglycoside-induced hearing loss in animals. Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's Disease and acute noise-induced hearing loss. SPI-1005 is currently being tested to prevent and treat tobramycin-induced ototoxicity in cystic fibrosis patients with acute lung infections. This review summarizes the published and presented data involving SPI-1005 and other drugs being tested to prevent or treat sensorineural hearing loss. Additionally, recent clinical data showing the relationship between pure tone audiometry and words-in-noise test results in a Meniere's Disease are presented, which may have larger implications for the field of hearing research.

Source: https://www.sciencedirect.com/science/article/abs/pii/S0378595521000435

Full paper below.

 

[100Hz]

I hope Ebselen does well. It was bad news about Otividex Phase 3 failing again and I sort of have this drug in the same category although they are different drugs.

Could the placebo effect also be similar for the SPI-1005 Meniere's trial? And fail in the same way that Otividex did? @FGG?

 

[FGG]

I hope Ebselen does well. It was bad news about Otividex Phase 3 failing again and I sort of have this drug in the same category although they are different drugs.

Could the placebo effect also be similar for the SPI-1005 Meniere's trial? And fail in the same way that Otividex did? @FGG?

They aren't at all in the same category. And besides that Otividex was only being assessed for Meniere's vertigo episodes (which is highly subject to placebo effects).

Here are the outcome measures for Ebselen and Meniere's:

Primary Outcome Measures:

1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 84 days ]
   Safety and tolerability assessed based on comparison of adverse events vs. placebo
   
   
2. Change in low frequency hearing thresholds measured by pure tone audiometry [ Time Frame: 56 days ]
   Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
   
   
3. Change in Words-in-Noise Test score [ Time Frame: 56 days ]
   Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

Secondary Outcome Measures:

1. Change in tinnitus severity [ Time Frame: 56 days ]
   Tinnitus Functional Index (0-100) where higher score is worse outcome
   
   
2. Change in vertigo severity [ Time Frame: 56 days ]
   Vertigo Symptom Scale (0-60) where higher score is worse outcome
   
   
3. Change in aural fullness [ Time Frame: 56 days ]
   Aural Fullness Scale (0-10) where higher score is worse outcome
   
   
4. Change in dizziness [ Time Frame: 56 days ]
   Dizziness Handicap Inventory (0-100) where higher score is worse outcome

 

[100Hz]

They aren't at all in the same category. And besides that Otividex was only being assessed for Meniere's vertigo episodes (which is highly subject to placebo effects).

Here are the outcome measures for Ebselen and Meniere's:

Primary Outcome Measures:

1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 84 days ]
   Safety and tolerability assessed based on comparison of adverse events vs. placebo
   
   
2. Change in low frequency hearing thresholds measured by pure tone audiometry [ Time Frame: 56 days ]
   Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
   
   
3. Change in Words-in-Noise Test score [ Time Frame: 56 days ]
   Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

Secondary Outcome Measures:

1. Change in tinnitus severity [ Time Frame: 56 days ]
   Tinnitus Functional Index (0-100) where higher score is worse outcome
   
   
2. Change in vertigo severity [ Time Frame: 56 days ]
   Vertigo Symptom Scale (0-60) where higher score is worse outcome
   
   
3. Change in aural fullness [ Time Frame: 56 days ]
   Aural Fullness Scale (0-10) where higher score is worse outcome
   
   
4. Change in dizziness [ Time Frame: 56 days ]
   Dizziness Handicap Inventory (0-100) where higher score is worse outcome

Thanks for clearing that up, and I'm really sorry to read about your recent symptoms.

 

[Joly]

What are the differences between acute and chronic hyperacusis?

 

[ajc]

What are the differences between acute and chronic hyperacusis?

Good question. @Marin, @Aaron91, @serendipity1996?

Or does it follow the same timeline as tinnitus, up to 12 months is considered acute? Although some say tinnitus is acute only up to 3 months.

 

[Marin]

Good question. @Marin, @Aaron91, @serendipity1996?

Or does it follow the same timeline as tinnitus, up to 12 months is considered acute? Although some say tinnitus is acute only up to 3 months.

I don't know, but I sure would like to. Being a total of about 8 months into this and 5 months into catastrophic hyperacusis, I can't help but feel like the clock is ticking for something like this to help.