Sound Pharmaceuticals (SPI-5557 & SPI-1005)

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

    1. swc5150

      swc5150 Member

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      Click the "quote" button on the lower right of the posting box.
       
    2. Nate

      Nate Member Benefactor

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      WOW! I can't believe I didn't see that! :) Thanks again!
       
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    3. jdjd09

      jdjd09 Member

      So, are there any release dates on this? Have they put any messages out on how many DB's this may bring back?
       
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    4. Aaron123

      Aaron123 Member

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      If you look at the pipeline page on their web site, SP-5557 seems to be the drug candidate for regeneration. They say they are looking at an IND filing in the fourth quarter 2017. (Looking around, it has been in the pre-clinical stage since at least 2009...) If that is accepted, then they will start phase 1 trials sometime after that. Of course that drug is targeted at people with severe to profound hearing loss. They have other drugs that are farther along for other indications.

      Regarding dBs, the Walters et al (2014) paper that they cite on their technology page reports that they were able to essentially restore hearing (as measured by ABR) to deaf mice by "knocking out" a particular protein (p27). Looking around, there seems to be a number of papers focusing on p27. There's a article at hearing review that describes a bit about how this work http://www.hearingreview.com/2015/12/molecule-discovery-may-help-advance-hearing-restoration/
       
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    5. Aaron123

      Aaron123 Member

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      There's some new information on SPI-1005. Possibly good news for folks with Meniere's Disease. I don't usually post links to press releases, but there is no paper at this time: http://www.prnewswire.com/news-rele...ical-trial-in-menieres-disease-300530256.html

      The claim is positive Phase 1 test results, but we won't really know what that means until the results are published. Nonetheless, they are starting a Phase II trial. No info on that trial in clinicaltrials.gov, but here is the info on the Phase 1 trial: https://www.clinicaltrials.gov/ct2/show/NCT02603081
       
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    6. jer

      jer Member

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      Someone stated that this was an ear and brain disease. What if the difference between the acute and chronic phases are that the tinnitus moves from the ear into the brain and it settles there. And that is the difference between these.

      And may I also point out that we already had some sort of a treatment/cure for tinnitus in the form of trobalt/retigabine. The only problem was the side effects in that it was not sustainable for longer periods.
       
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    7. Fabrikat

      Fabrikat Member

      Tinnitus Since:
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      Otosclerosis then volume then viral infection
      It is indeed an exciting bit of news @Aaron123, not just for Meniere's Disease but, by the sounds of it, a few other inflammatory inner ear conditions as well, including noise induced hearing threshold shift, if I read it correctly.

      Crucial, is the sentence; 'SPI-1005 treatment also resulted in improvements in word recognition, tinnitus loudness,......', linking cochlear salvage with improvement in T loudness. Though it doesn't say complete elimination.

      This is good news for acute early treatment, but I wonder what they have in the works for us long time chronic sufferers?
       
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    8. Frédéric

      Frédéric Member Benefactor

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      I missed (and nothing was published on this forum) this phase 2 trial entitled:
      Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
      https://clinicaltrials.gov/show/NCT01444846

      Although, it is listed in the company website pipeline:
      https://soundpharma.com/pipeline/

      However sadly, tinnitus is only listed as a possible condition, but not as a secondary outcome (improvement or not).

      Results:
      http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31791-9/fulltext
      @Aaron123 : thanks for the source (prnews article)
       
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    9. VRZ78

      VRZ78 Member Benefactor

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      I think this is different than the trial Aaron were talking about for Ménière's Disease ?
      This seems to be for protection
       
    10. Frédéric

      Frédéric Member Benefactor

      Location:
      Marseille, France
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      I know we are not talking about the same clinical trial. I am talking about the clinical trial which is mentioned at the end of the article provided by prnewswire: http://www.prnewswire.com/news-rele...ical-trial-in-menieres-disease-300530256.html

      Quote :" In an earlier Phase 2 clinical trial, SPI-1005 was shown to prevent the temporary threshold shift due to acute noise exposure or noise induced hearing loss in young adults (average age 20 years old). These data were published July 14, 2017 online in The Lancet, a leading medical journal." End quote.
       
    11. HomeoHebbian
      Question it

      HomeoHebbian Member Benefactor

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      That's not how tinnitus works. Damage to the ear has virtually immediate effects on the brain. The perception of tinnitus -whether acute or chronic- obligatory involves the brain, though does not always involve the ear.
       
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    12. Contrast

      Contrast Member Benefactor Hall of Fame

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      Cause of Tinnitus:
      injury from noxious noise
      Tinnitus starts out in auditory regions of the brain and then spreads to other regions of the brain.

      This is where the mystery arises.
       
    13. dpdx
      Disappointed

      dpdx Member Benefactor Hall of Fame

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      I think Tinnitus damages the brain or re-wires it somehow, making us more prone to other brain conditions like eye floaters (which I have), visual snow, insomnia,etc
       
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    14. dpdx
      Disappointed

      dpdx Member Benefactor Hall of Fame

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      If I were to compare myself last year during this time and now, it is like sky and earth in every sense. I feel always tired now, forgetful, tired, etc.
       
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    15. Flamingo1

      Flamingo1 Member Benefactor

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      This thread had been trending since 2012. I can see why you feel this way!!
       
    16. FGG

      FGG Member Podcast Patron Benefactor

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      For anyone still following Sound Pharmaceuticals, they finished Phase 2b for SPI-1005 to treat vertigo and hearing loss associated with Meniere's a few days ago. May not apply to many people on this forum but I think SPI-1005, a glutathione peroxodase inducer is still being additionally tested for multiple pathologies/applications.

      Not sure when they will announce results, hopefully soon.
       
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    17. FGG

      FGG Member Podcast Patron Benefactor

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    18. ChrisBoyMonkey

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    19. Chinmoku

      Chinmoku Member Benefactor

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      It would work mostly on low frequency tinnitus cases, apparently.
       
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    20. Fabrikat

      Fabrikat Member

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      Cause of Tinnitus:
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    21. Ken219
      Frustrated

      Ken219 Member

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      Cause of Tinnitus:
      Noise exposure?
      I'm with you. As much as I'd like my hearing back stop the tinnitus!
       
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    22. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      Wow, never heard of this company before. Great to know more groups are working on hair cell regeneration.
       
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    23. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      nah.
       
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    24. RODRIGO

      RODRIGO Member

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    25. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      upload_2019-8-18_16-46-42.png
      Sound Pharmaceuticals announces positive topline results from the SPI-1005 Phase 2b Meniere’s Disease clinical trial

      SEATTLE — SPI-1005 hits pre-specified endpoints resulting in a significant improvement in hearing loss of 65% and 95% relative to placebo

      Sound Pharmaceuticals today announced positive top-line results from a randomized, double-blind, placebo-controlled, multi-center Phase 2b study in Meniere’s Disease (MD). The study consented 149 adult patients with active MD, including a hearing loss at baseline of >30 dB in one of three low frequencies, to receive either placebo, 200, or 400 mg SPI-1005 by mouth, twice daily for 28 days, with follow-up assessments at 4 and 8 weeks after the start of treatment. The pre-specified audiometric endpoints were to determine if SPI-1005 could improve hearing sensitivity or thresholds in dB by a clinically relevant difference vs placebo.

      In the trial, clinically relevant improvements in hearing loss (≥10 dB gain from baseline at one low frequency) using pure-tone audiometry (PTA) were significantly higher in the 400 mg dose group vs placebo (61% vs 37%, p<0.023), a relative improvement of 65% over placebo at 8 weeks. Clinically relevant improvements in word recognition (≥10% increase in word recognition from baseline) using the words-in-noise test (WINT) also showed higher responses when compared to placebo (75% vs 56%, p<0.060), a relative improvement of 34% over placebo at 8 weeks. Secondary efficacy endpoints were also tested using stricter responder criteria involving PTA and WINT. Using stricter PTA criteria (≥10 dB gain from baseline at two adjacent low frequencies), the 400 mg dose group showed higher relative response rates (39% vs 20%, p<0.044), a 95% improvement over placebo. Using stricter WINT criteria (≥4 words improvement from baseline), the 400 mg dose group showed higher relative response rates (60% vs 34%, p<0.017), a 76% improvement over placebo. Results from the Intent-to-Treat (ITT) analysis showed that SPI-1005 was well-tolerated in the 124 patients that received at least one oral dose of study drug during the 28-day dosing period. No serious adverse events occurred, and the majority of adverse events were mild to moderate, and consistent with those observed in prior studies. A more detailed presentation of the ITT and Per-Protocol analyses will occur at a scientific meeting later this year.

      “This clinical trial indicates that SPI-1005 may have the potential to significantly improve the loss of hearing and loss of word recognition in Meniere’s, a complex and chronic inner ear disease,” said Jonathan Kil, MD, Co-Founder and CEO."

      "SPI-1005, a proprietary oral formulation of ebselen, is a small molecule mimic and inducer of glutathione peroxidase (GPx)"

      https://www.sigmaaldrich.com/catalog/product/sigma/e3520?lang=en&region=US
       
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    26. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      THIS IS A PILL.

      Damn it says acute.
       
    27. Paulmanlike

      Paulmanlike Member Hall of Fame

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    28. Rb86

      Rb86 Member

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    29. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      This is really exciting news for Meniere's sufferers, but also possibly for people with newly onset acute tinnitus and hearing loss. It may potentially be able to short circuit some of the damage that most of us now have to live with.

      Most heartening however, for future possible hearing loss drugs, is that the FDA is willing to grant Fast Track Status for otological medicines.
       
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    30. Striveon

      Striveon Member

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      So how many more trials do they need?
       

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