Sound Pharmaceuticals (SPI-5557 & SPI-1005)

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

    1. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      They haven't released a detailed report beyond a summary that I know of.
       
    2. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      You could pay a research lab now to make Ebselen if you are that desperate.

      Otonomy also has a drug finishing up Phase 3 that is very promising for Meniere's vertigo attacks that should be out middle of 2021.
       
    3. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      How much are they charging?
       
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    4. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      When results come out in April 2021, how soon can Ebselen be released?
       
    5. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      There are thousands of labs, I imagine it varies a lot. I would also factor in buying extra and getting it tested by an outside lab, too.

      The one lab I looked at (and cannot vouch for as it was just a Google search) would end up charging about $5k for the full 21 day course used in the trial.
       
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    6. frpp

      frpp Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
      $10,000-$20,000 for a month's dosing, going by the dosing Sound Pharmaceuticals did for the Meniere's trial.
       
    7. frpp

      frpp Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
      That's much cheaper than what I could find. Can you post the the link to that lab?
       
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    8. frpp

      frpp Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
      Hopefully the government will push for it right away. I'm tired of this pain and living this half life.
       
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    9. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      I didn't save that particular link. Sorry.
       
    10. wwtsai
      Tired

      wwtsai Member Podcast Patron Benefactor

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    11. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      First the positive OTO-414 results and now this, what a week. Hopefully it can come to market sometime in 2021.
       
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    12. Marin
      Depressed

      Marin Member

      Tinnitus Since:
      6/18/2020
      Cause of Tinnitus:
      SSNHL... probably previous noise exposure, too
      One of the trial sites is at a university very close to me. If only I could fake Meniere's to get my hands on it. Ebselen is so close yet so far away; it's maddening!
       
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    13. wwtsai
      Tired

      wwtsai Member Podcast Patron Benefactor

      Location:
      San Francisco
      Tinnitus Since:
      Mild (2016) Bothersome (8/20)
      Cause of Tinnitus:
      SNHL
      I feel you on this. I live right by UCSF and would love to participate, but I don't have Meniere's.
       
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    14. Momme

      Momme Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Loud noise?
      Is this for people with noise-induced tinnitus as well?

      Not Meniere's.
       
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    15. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
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      They are recruiting for acute noise-induced hearing loss now as a preventative.

      As to whether, like in Meniere's, it would help more chronic cases, it is theoretical.

      Read the thread.
       
    16. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      Is it really plausible that this drug comes to market in 2021? It has to complete Phase 3 and go through the data analysis, and then we have to wait for the FDA approval.
       
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    17. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      One question that needs to be asked is how long is the trial going to be in terms of duration. Another question is how long is Sound Pharmaceuticals going to take to prepare and deal with the results. Once this is proposed and we have been provided with this detail, we can then examine when it might end up getting released.

      We know that there tends to be a delay of 75 days or something between the time a company requests to submit a proposal with the FDA to do something like a new trial and when the FDA is required to respond by. Then there are the issues around manufacturing and distribution.

      In short, seems entirely possible that SPI-1005 could get released next year if the treatment shows beneficial outcomes. However the question is around what is going on and what will inevitably happen with the processes to get the treatment out there if it is granted approval. At this stage we don't have enough information on this and a lot of this is going to depend upon what actually happens. There could be a real possibility that Sound Pharmaceuticals simply cannot get this done next year.
       
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    18. Born To Slay
      Depressed

      Born To Slay Member

      Tinnitus Since:
      10/2019
      Cause of Tinnitus:
      Loud concert
      Depends on how the COVID-19 trial goes imo, if it’s approved for COVID-19 treatment, it should be approved next year.
       
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    19. Bambam0
      Cool

      Bambam0 Member Podcast Patron Benefactor

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      I was just doing some research on Sound Pharmaceuticals and why they had not gone public yet. ANYWAY... Our guy Dr. Jonathan Kil (CEO) is in the comments of

      this article hyping his work. Love his grit!
       
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    20. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      I love that he's commenting on some random internet entry.
       
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    21. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      I am too dumb to understand anything in that article. Can I get the ELI5 version?
       
    22. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      It's a blog from 2017 basically describing how structurally different the drug is from most drugs and how it's difficult to test in a lab because you need reducing agents to produce an ideal environment to study the effects but the ones they were using were paradoxically inhibiting Ebselen's effects (in vitro pre clinical stuff, not in vivo).

      The author then goes on to say, Ebselen has promise for so many things. If only it weren't so hard to test in a lab.

      But that's not really the main point. The point is that Jonathan Kil (from Sound) chimes in in the comment section of the blog (good find @Bambam0) with the following:

      "The Daichii ebselen stroke trials were probably the most advanced clinically, but were limited due to the sample size, the nature of that disease, and the approval of tPA in 1997. In addition, I thought you maybe interested in our ongoing clinical trials in sensorineural hearing loss and tinnitus with SPI-1005. We have completed a Phase 1 and Phase 2 in acute noise induced hearing loss which were highly successful. We are currently enrolling a Phase 1/2 in Meniere’s disease (hearing loss, tinnitus and vertigo) and preparing to enroll two ototoxicity studies involving chemotherapy or antibiotic receiving patients. In several different models of acute neurotologic injury, we and others have shown that ebselen is highly otoprotective through its action as a GPx1 mimic and inducer. This later effect is somewhat dependent upon Nrf2 activation. My feeling is that ebselen will find a home in diseases where decreases in GPx activity result in the establishment of acute injury and the progression to chronic disease and/or in specific organs where GPx is the dominant catalytic antioxidant enzyme such as the inner ear, retina, lung and some areas of the forebrain."
       
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    23. wwtsai
      Tired

      wwtsai Member Podcast Patron Benefactor

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      Did we ever figure out why they haven't advanced to Phase 3 for NIHL? It's been 6 years since their Phase 2 ended and in their press release, they reported positive results from it.
       
    24. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      They are "not yet recruiting" for Phase 2b now (you can look it up on clinicaltrials.gov) and have been for years.

      My speculation on this is that it would be very difficult (to near impossible) to recruit for this (noise-induced) study since it is a noise challenge to people with a history of NIHL and it is placebo controlled. Yeah, good luck. Better to try it off label.
       
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    25. Aaron91
      In pain

      Aaron91 Member Podcast Patron Benefactor

      Tinnitus Since:
      2007
      Cause of Tinnitus:
      Loud music/headphones/concerts
      This thing can't come soon enough. How long are we looking at until we can get this off-label?
       
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    26. weab00
      Alone

      weab00 Member Benefactor

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      Cause of Tinnitus:
      noise, whiplash; 08/20 H
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    27. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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    28. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
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      What facilities test Ebselen?

      Also, what is the dosing for this stuff and how much would it wind up costing?
       
    29. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      Here are the different doses they are using in trial:

      https://clinicaltrials.gov/ct2/show/NCT02779192

      Probably good to start with the lower dosing if you are going to do this.

      You'd have to call around to find pricing. It varies a lot. It seems to be on average a lot more than Alibaba--which concerns me about their authenticity (though things from China generally cost a lot less).

      My guess is it would be a few thousand from a US lab but nowhere near Hough Ear Institute Pill cost.

      You could call toxicology labs at universities near you and see if they would test a sample for you.
       
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    30. an1992

      an1992 Member Benefactor

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      Maybe antibiotics
      @weab00 do you think Ebselen will be good for hyperacusis? If yes, why?
       

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