Sound Pharmaceuticals (SPI-5557 & SPI-1005)

[DimLeb]

Do we know anything more about this? It sure is one of the most promising drugs for a lot of conditions here, even more so than Frequency Therapeutics and Otonomy. I don't know why it's not as much discussed about.

 

[Brian Newman]

I have no idea, and I was going through the beginning of this thread.

They passed the Phase 2 for ear problems in 2013.

What happened? I don't know too much about this drug or company. I'm guessing the Phase 3 failed? And the drug is being used for COVID-19 and other diseases. Then if it comes out we can try it. Just like the Hough Ear Institute pill, which is now called OKN-007.

 

[lapidus]

I have no idea, and I was going through the beginning of this thread.

They passed the Phase 2 for ear problems in 2013.

What happened? I don't know too much about this drug or company. I'm guessing the Phase 3 failed? And the drug is being used for COVID-19 and other diseases. Then if it comes out we can try it. Just like the Hough Ear Institute pill, which is now called OKN-007.

No, they presented the results from the SPI-1005 Phase 2 in June 2019 (the trial lasted between September 2017 - March 2019):

Sound Pharmaceuticals announces positive topline results from the SPI-1005 Phase 2b Meniere's Disease clinical trial

According to their pipeline they are either still preparing for Phase 3 or are in it now, hard to tell from the graphic on their website. The last news they gave us about it was in June 2020:

Sound Pharmaceuticals advances pivotal Phase 3 clinical trials in Meniere's Disease

But yeah, I'd also like some more updates from this company.

 

[Brian Newman]

No, they presented the results from the SPI-1005 Phase 2 in June 2019 (the trial lasted between September 2017 - March 2019):

Sound Pharmaceuticals announces positive topline results from the SPI-1005 Phase 2b Meniere's Disease clinical trial

According to their pipeline they are either still preparing for Phase 3 or are in it now, hard to tell from the graphic on their website. The last news they gave us about it was in June 2020:

Sound Pharmaceuticals advances pivotal Phase 3 clinical trials in Meniere's Disease

But yeah, I'd also like some more updates from this company.

SEATTLE, Nov. 5, 2013 /PRNewswire/ -- "Sound Pharmaceuticals (SPI) has successfully completed enrollment of its Phase 2 clinical trial with SPI-1005 at the University of Florida. This study enrolled 80 healthy subjects with normal or slight hearing loss and exposed the volunteer to calibrated music using an iPod®and insert earphones."

Go look on page one of this thread. Instead of Meniere's it was for hearing loss. They did a Phase 2 in 2013. It was Nick's post. But yeah this company is pretty confusing.

 

[lapidus]

SEATTLE, Nov. 5, 2013 /PRNewswire/ -- "Sound Pharmaceuticals (SPI) has successfully completed enrollment of its Phase 2 clinical trial with SPI-1005 at the University of Florida. This study enrolled 80 healthy subjects with normal or slight hearing loss and exposed the volunteer to calibrated music using an iPod®and insert earphones."

Go look on page one of this thread. Instead of Meniere's it was for hearing loss. They did a Phase 2 in 2013. It was Nick's post. But yeah this company is pretty confusing.

You're right, my bad. I completely missed that they were doing SPI-1005 for acute, mild to moderate NIHL too. I thought it was only for Meniere's (and now COVID-19). It's still listed on their pipeline chart and stuck between Phase 2 and 3. It's really strange it hasn't moved forward if Phase 2 was successful so long ago.

 

[Brian Newman]

You're right, my bad. I completely missed that they were doing SPI-1005 for acute, mild to moderate NIHL too. I thought it was only for Meniere's (and now COVID-19). It's still listed on their pipeline chart and stuck between Phase 2 and 3. It's really strange it hasn't moved forward if Phase 2 was successful so long ago.

Yeah so strange. This drug is good to fall back on. Definitely better than nothing. I'm not gonna put all hopes on it.

 

[OptimusPrimed]

Yeah so strange. This drug is good to fall back on. Definitely better than nothing. I'm not gonna put all hopes on it.

I too won't put a ton of hopes on this one.

I'm most hopeful about Susan Shore's device to be honest. But that is not a guarantee, and I cannot wait for these things for the rest of my life.

For now I will focus on self-improvement and controlling what I can control. I'm putting my effort into meditation, occasional fasting, daily cold-showers, grounding, avoiding processed foods and salicylate high foods, consuming fermented foods and raw meat, getting lots of sunlight, exercising, preventing further damage, and just living life as best as I can.

 

[Brian Newman]

I too won't put a ton of hopes on this one.

I'm most hopeful about Susan Shore's device to be honest. But that is not a guarantee, and I cannot wait for these things for the rest of my life.

For now I will focus on self-improvement and controlling what I can control. I'm putting my effort into meditation, occasional fasting, daily cold-showers, grounding, avoiding processed foods and salicylate high foods, consuming fermented foods and raw meat, getting lots of sunlight, exercising, preventing further damage, and just living life as best as I can.

Yea, well said. I'm lucky because my tinnitus is not horrible. I can live with it. My distortions that beep can be horrible but it's not always bad. The hyperacusis is killin me. Severe pain hyperacusis is not fun at all. Makes me wanna die. I hope it improves with time.

 

[Padraigh Griffin]

Nothing regarding Ebselent for nearly two years. 30% reduction in tinnitus loudness not to be sniffed at. Placebo controlled too. 10% reduction for placebo.

Anyone on here taking part in their Meniere's Phase 3 or COVID-19 Phase 2?

The company have been so quiet. I suppose it is a 'private' corporation.

 

[lapidus]

Anyone on here taking part in their Meniere's Phase 3 or COVID-19 Phase 2?

Not Phase 3 but this poster was in Phase 1 and 2 for Meniere's and posted about it in the Frequency Therapeutics thread. Check out his posts:

https://www.tinnitustalk.com/search/member?user_id=44454

 

[Padraigh Griffin]

SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)

Not yet recruiting for Phase 3 Meniere's unfortunately.

SPI-1005 Treatment in Moderate COVID-19 Patients

Still 'enrolling by invitation' (if you can call moderate and severe COVID-19 an invitation) for COVID-19 trials.

Interesting though the ClinicalTrials page was updated on 8th February 2022 and the estimated completion study completion date is now August 2022.

Also interesting is that the Meniere's study is for 400 mg of Ebselen BUT the COVID-19 trials are testing 400 mg of Ebselen and also n 800 mg dosing of Ebselen as well.

Will be interesting to see results in second half of the year if they hit the timeline.

 

[KoolKat]

Hey guys, look:

Sound Pharmaceuticals' NIH Grant for a novel oral COVID-19 treatment increases to $4.2M

They are getting additional funding!

 

[DimLeb]

Anyone knows what's happening with this one? Since it's got FDA Fast Track and is being tested for COVID-19, I suppose it might be one of first drugs that comes to market for hearing stuff.

 

[ThomasF]

I found this.

Development of ebselen for the treatment of sensorineural hearing loss and tinnitus

@DimLeb, might be something good as far as tinnitus goes.

 

[InNeedOfHelp]

Phase 3 started!

Sound Pharma initiates enrollment in pivotal Phase 3 clinical trial of SPI-1005 for the treatment of hearing loss and tinnitus in Meniere's disease

And for the record, it is a one year study. Second year is for additional safety points. They can prepare FDA approval after the primary checkpoints.

That would be one year + 3 months of prep for FDA + 4 months for approval due to fast track. Early 2024 we can beg our ENTs for SPI-1005/Ebselen instead of Prednisone after noise exposure. Not sure if the long term "brain" tinnitus will benefit.

 

[Nick47]

Phase 3 started!

Sound Pharma initiates enrollment in pivotal Phase 3 clinical trial of SPI-1005 for the treatment of hearing loss and tinnitus in Meniere's disease

And for the record, it is a one year study. Second year is for additional safety points. They can prepare FDA approval after the primary checkpoints.

That would be one year + 3 months of prep for FDA + 4 months for approval due to fast track. Early 2024 we can beg our ENTs for SPI-1005/Ebselen instead of Prednisone after noise exposure. Not sure if the long term "brain" tinnitus will benefit.

Nice spot.

 

[LovableGamer]

This is awesome! Does anyone know if this will help with sensorineural hearing loss?

I'm hopeful for treatment soon so that I don't have to wear hearing aids.

 

[ThomasF]

I wonder if this has potential for those not suffering from Meniere's disease?

 

[Gb3]

I wonder if this has potential for those not suffering from Meniere's disease?

From the article:

These improvements in auditory function further support the use of SPI-1005 to treat sudden sensorineural hearing loss, noise-induced hearing loss, and age-related loss, other indications where hearing loss and tinnitus are prominent features.

 

[Nick47]

The following is taken from Sound Pharmaceuticals' website:

In the Phase 2b study, clinically relevant improvements were observed in low frequency hearing by PTA and WIN scores at 8 weeks after the start of SPI-1005 when compared to placebo. The percentage of subjects showing significant auditory improvements using PTA (≥10 dB gain at one low frequency) in the SPI-1005 400 mg BID dose group rose from 47% at 4 weeks to 61% at 8 weeks, while the percentage showing significant improvements in WIN (≥20% increase in word recognition) rose from 57% at 4 weeks to 68% at 8 weeks. Additionally, SPI-1005 treatment also significantly reduced tinnitus perception or tinnitus loudness (TL) when compared to placebo (p < 0.05). Reductions in TL averaged 1.4 pts in the 400 mg group vs 0.7 pts in the placebo group (30% reduction vs 10% reduction, p <0.02). These Phase 2b data confirmed an initial finding from the Phase 1b trial, that SPI-1005 can reduce tinnitus loudness by clinically relevant levels. These improvements in auditory function further support the use of SPI-1005 to treat sudden sensorineural hearing loss, noise-induced hearing loss, and age-related loss, other indications where hearing loss and tinnitus are prominent features.

The take home for me is that it improved hearing loss at low frequencies and thus reduced tinnitus loudness.

This is what you would expect of a treatment for Meniere's disease, where key characteristic is low frequency hearing loss that fluctuates.

 

[Ben Winders]

I'm here to enjoy the brief moment of feeling fantastic about this update before the negative Nancy's come in to select anything from this list:

- this will never work because <insert reason X>
- this study is flawed because <insert reason Y>
- etc

 

[Nick47]

I'm here to enjoy the brief moment of feeling fantastic about this update before the negative Nancy's come in to select anything from this list:

- this will never work because <insert reason X>
- this study is flawed because <insert reason Y>
- etc

It's good news, just pointing out what it is designed to do.

 

[vttbx]

The take home for me is that it improved hearing loss at low frequencies and thus reduced tinnitus loudness.

This is what you would expect of a treatment for Meniere's disease, where key characteristic is low frequency hearing loss that fluctuates.

So no improvement in high frequencies as Meniere's only affects the low frequencies?

 

[Nick47]

So no improvement in high frequencies as Meniere's only affects the low frequencies?

I'm quoting from the company's website. I understand that Meniere's is classified by low frequency hearing loss, tinnitus and episodic vertigo.

 

[Damocles]

It's good news, just pointing out what it is designed to do.

I don't think @Ben Winders was referring to your post, @Nick47.

 

[Ben Winders]

I don't think @Ben Winders was referring to your post, @Nick47.

He wasn't

 

[AxEars]

If SPI-1005 can alleviate tinnitus in some patients, a lot of people with tinnitus are going to flock to this drug. That'll be the catalyst for more competition in the space.

Progress is slow, but there's now a treatment for Ménière's disease. Amazing.

 

[Nick47]

there's now a treatment for Ménière's disease. Amazing.

There is no treatment. It is in a clinical trial and may still fail.

 

[AxEars]

There is no treatment. It is in a clinical trial and may still fail.

Counting my chickens, sure. It's in Phase 3 and they've had impressive results thus far. I think this one gets through.

 

[Travis Henry]

So no improvement in high frequencies as Meniere's only affects the low frequencies?

So it will not help high frequency tinnitus? And would this drug help long term tinnitus sufferers?