Sound Pharmaceuticals (SPI-5557 & SPI-1005)

Discussion in 'Research News' started by joe, Jan 26, 2012.

    1. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      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.
       
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    2. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      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.
       
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    3. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      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.
       
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    4. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      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.
       
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    5. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      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.
       
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    6. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      Yeah so strange. This drug is good to fall back on. Definitely better than nothing. I'm not gonna put all hopes on it.
       
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    7. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
      Cause of Tinnitus:
      Acoustic trauma - Repeated gun blasts
      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.
       
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    8. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      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.
       
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    9. Padraigh Griffin

      Padraigh Griffin Member Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      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.
       
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    10. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      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
       
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    11. Padraigh Griffin

      Padraigh Griffin Member Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      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.
       
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    12. KoolKat

      KoolKat Member

      Location:
      USA
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      HeadPhones/ Noise induced
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    13. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      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.
       
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    14. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
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    15. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      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.
       
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    16. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      Nice spot.
       
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    17. LovableGamer

      LovableGamer Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Hearing Loss
      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.
       
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    18. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
      I wonder if this has potential for those not suffering from Meniere's disease?
       
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    19. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      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.
       
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    20. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      The following is taken from Sound Pharmaceuticals' website:
      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.
       
    21. Ben Winders
      Pensive

      Ben Winders Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      acoustic
      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
       
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    22. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      It's good news, just pointing out what it is designed to do.
       
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    23. vttbx

      vttbx Member Benefactor

      Location:
      Los Angeles
      Tinnitus Since:
      01/2001
      Cause of Tinnitus:
      Noise Induced
      So no improvement in high frequencies as Meniere's only affects the low frequencies?
       
    24. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      I'm quoting from the company's website. I understand that Meniere's is classified by low frequency hearing loss, tinnitus and episodic vertigo.
       
    25. Damocles
      No Mood

      Damocles Member Podcast Patron Benefactor Hall of Fame

      Location:
      England
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Otitis media
      I don't think @Ben Winders was referring to your post, @Nick47.
       
    26. Ben Winders
      Pensive

      Ben Winders Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      acoustic
      He wasn't :)
       
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    27. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
      Cause of Tinnitus:
      Unknown
      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.
       
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    28. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      There is no treatment. It is in a clinical trial and may still fail.
       
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    29. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
      Cause of Tinnitus:
      Unknown
      Counting my chickens, sure. It's in Phase 3 and they've had impressive results thus far. I think this one gets through.
       
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    30. Travis Henry
      Cynical

      Travis Henry Member

      Location:
      Dallas,TX
      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      1 Moderna Vac, Noise and stress I guess, its killing me
      So it will not help high frequency tinnitus? And would this drug help long term tinnitus sufferers?
       
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