Sound Pharmaceuticals (SPI-5557 & SPI-1005)

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

    1. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Does anyone know if SPI-1005 will be made available first as a COVID-19 drug or will the STOPMD-3 trial be done first?

      The COVID-19 trials have a priority/urgency but I don't know how well Ebselen will do in them. On the other hand, Phase 3 for Meniere's isn't even recruiting.
       
    2. Barpis

      Barpis Member

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      SSRI
      Will Ebselen be effective for chronic tinnitus caused by reasons other than Meniere's disease?
       
    3. wwtsai
      Assassinator

      wwtsai Member Podcast Patron Benefactor

      Location:
      San Francisco
      Tinnitus Since:
      Mild (2016) Bothersome (8/20)
      Cause of Tinnitus:
      SNHL
      They actually are recruiting at some of the trial sites according to Jonathan Kil at Sound Pharmaceuticals. I believe the Michigan test site completed recruitment according to some of the other members here. If there's a test site you're interested in, I would reach out to Sound Pharmaceuticals to see if they're recruiting.
       
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    4. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      My thought:

      I would guess it would be highly individual and depend on how much neuro inflammation you have.

      I think there is a good chance it will at least help people with cochlear causes but the degree will vary a lot imo from minor to game changing.

      I don't think it will do much for middle ear, TMJ tinnitis etc, though.
       
    5. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      That is great news! Hopefully they can start the trial ASAP; I'd love to try it out but I don't have Meniere's nor am I US based.
       
      • Good Question Good Question x 1
    6. Gee82

      Gee82 Member

      Tinnitus Since:
      12/2018
      Cause of Tinnitus:
      Noise
      Does anyone know if SPI-1005 trial for COVID-19 has started yet?

      I thought it was supposed to start in December but the status says “not yet recruiting”.

      I was hoping this drug could make it to market pretty fast due to COVID-19 emergency, and that we might then be able to put our hands on it for off-label use.

      Do you guys think there is a chance?

      I am not even sure whether SPI-1005 could help with tinnitus tbh, but I desperately need a hope to look forward to in the near future, rather than years. The other drugs on trials are taking too long with all these delays, failures, repeated trials etc.
       
    7. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      They haven't listed locations yet on clinicaltrials.gov for the COVID-19 trial, so they definitely haven't started recruiting yet.

      They listed these contact names for the COVID-19 trial:

      Miriam Treggiari and Haifan Lin. Both out of Yale. Maybe someone can shoot them a line and ask where they are on recruitment?
       
      • Like Like x 2
    8. spacehunter

      spacehunter Member Benefactor

      Tinnitus Since:
      10/2019 (mild), 09/2020 (severe)
      Cause of Tinnitus:
      SSHL
      I just found this paper about the clinical trial of SPI-1005 where they evaluated its efficacy for preventing NIHL:

      Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial

      Interestingly, the 600 mg group showed far less efficacy than the 400 mg group and performed even worse than the 200 mg group. Not sure though, what kind of conclusions I should draw from this. Any ideas @FGG, @Diesel?

      Also, does anybody know the bioavailability of Ebselen? It would be interesting to know what 400 mg BID orally taken corresponds to in the end.
       
    9. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Their current otoprotection trial is here:

      A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

      And they don't include a 600 mg cohort. Seems there is an efficacy sweet spot, which wouldn't be too bizarre since its effects are indirect and on things like enzyme redux reactions in the cochlea. The conclusion I would draw is that 400 mg seems like the best dosing but they are retesting that with the current trial as far as the exact biochemical reason, you'd have to find a published paper and I'm not sure they have done that yet.
       
      • Informative Informative x 1
    10. Hazel
      Dreaming

      Hazel Director Staff Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      the Netherlands
      Tinnitus Since:
      10/2017
      Cause of Tinnitus:
      one-sided hearing loss (of unknown origin)
      Hi there, good news: Sound Pharmaceuticals agreed to come on the Tinnitus Talk Podcast :)

      We don't have a specific date set yet, but it might happen rather soon. Hence, we want to start collecting your input. Please fill in our survey below to provide us with any questions you might have for Sound Pharma.

      ➡️ Fill in the survey
       
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    11. Marin
      Depressed

      Marin Member

      Tinnitus Since:
      6/18/2020
      Cause of Tinnitus:
      SSNHL... probably previous noise exposure, too
      This is amazing news, and I’ve submitted a couple questions. I really, really hope that there is a focus on how this medication could help hyperacusis and how urgently it is needed by those of us who are suffering from it. It truly could save lives if it helps.
       
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    12. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Sound Pharmaceuticals agreeing to come on the Tinnitus Talk Podcast is a sign of confidence in their drug, which should be available late this year or early 2022.
       
      • Like Like x 1
    13. Marin
      Depressed

      Marin Member

      Tinnitus Since:
      6/18/2020
      Cause of Tinnitus:
      SSNHL... probably previous noise exposure, too
      I'd love for this medication to be available as soon as possible, but I fear it won't be available until sometime in 2023 because the Phase 3 Meniere's trials don't end until December 2022.

      Have you seen other information that gives you an earlier release date?
       
    14. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      The COVID-19 trials. The FDA is giving the OK to anything related to COVID-19.
       
    15. Gee82

      Gee82 Member

      Tinnitus Since:
      12/2018
      Cause of Tinnitus:
      Noise
      They haven’t even started recruiting for COVID-19 trial yet; who knows when/if they’re going to move forward with it.
       
    16. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      I struggle to know what to ask about any treatment other than FX-322, because even after perusing the threads, it's murky to me what they specifically do, or are intended to do. I'd like to have more than one horse to bet on in this race, but I need a clearer and more concise description of what each treatment does (e.g. "FX-322 reactivates the cells that normally only produce hair cells while we are in the womb, and in its current delivery method seems to only help with high frequencies due to how far it reaches into the cochlea."); I've been unable to find this sort of Cliff's Notes-style summation for the majority of drugs being tested and discussed.
       
    17. spacehunter

      spacehunter Member Benefactor

      Tinnitus Since:
      10/2019 (mild), 09/2020 (severe)
      Cause of Tinnitus:
      SSHL
      Does anybody know the approximate bioavailability of Ebselen when taken orally? I've skimmed many papers about Ebselen but so far I could not find any statement in that regard.
       
    18. David Vance

      David Vance Member

      Tinnitus Since:
      Jan 2018
      Cause of Tinnitus:
      Chemotherapy, imbalances with the body.
      Hey everyone.

      I got my doctor to write a letter to Sound Pharmaceuticals asking for compassionate use of Ebselen and seeing if trials will be coming to Canada, as nothing seems to be working for my hyperacusis & tinnitus.

      The e-mail was sent on Friday and hoping they will get back. Has anyone done this or thought about doing? Maybe if we can get enough doctors to write to Sound Pharmaceuticals we can get it sooner to possibly help us!

      I will keep everyone updated through the process.

      I am from Toronto, Ontario, Canada.

      Cheers!
       
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    19. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Please update us and if possible share what they say in their response. I think a lot of people would be interested in that. The drug should be available in 2022.
       
    20. frpp

      frpp Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
      You are the real MVP. I hope it comes through for you.
       
    21. David Vance

      David Vance Member

      Tinnitus Since:
      Jan 2018
      Cause of Tinnitus:
      Chemotherapy, imbalances with the body.
      I will definitely update. I sent them a personal email a few months ago with no response, so I am hoping that they get back to my physician at least. If they don't, next step is to get my physician to call them.

      Do you really think it will be available in 2022? And worldwide?
      Hoping so too, thank you!
       
    22. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      I don't want to be a big party pooper. But I did the same as you. Asking for compassionate use. Emailed them 3 times. Called 5 times. Let my doctor email 2 times. I never ever received one single response. So don't get your hopes up.

      "Boosting up the habutation :wacky: o_O"
       
      • Good Question Good Question x 1
    23. Marin
      Depressed

      Marin Member

      Tinnitus Since:
      6/18/2020
      Cause of Tinnitus:
      SSNHL... probably previous noise exposure, too
      There’s always Alibaba.com, and I’m close to being that desperate. I haven’t been able to find any other suppliers to either respond or that were affordable. I live in a major city, and my friend in biotech hasn’t been able to find a manufacturer in our area to make it, either.

      I was quoted $1,250 for 15 grams from Wuhan Hengheda PharmCo using the Alibaba app. I know it would need to be tested by a third party, though.
       
    24. weab00
      Gloomy

      weab00 Member Benefactor

      Location:
      Joe Dart's basement
      Tinnitus Since:
      05/2019
      Cause of Tinnitus:
      some good mf music
      Looks like Ebselen is the last man standing.
       
      • Agree Agree x 4
    25. Croaker
      Haunting

      Croaker Member Benefactor

      Tinnitus Since:
      01/2019 T, 04/2020 H
      Cause of Tinnitus:
      Headphones/Car Alarm/Immune Response?
      There’s still the Kv7 drugs like XEN-1101 and the Trobalt reformulation. Also Nav1.7 blockers, they seem far away but there’s a lot of money going into them. But yes, generally speaking we remain fucked beyond belief.
       
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    26. Fields
      Busy

      Fields Member

      Location:
      Netherlands
      Tinnitus Since:
      04/2020
      Cause of Tinnitus:
      Noise trauma
      Seeing as our joint flight to the US to get FX-322 is probably canceled for now, could you give me the rundown on SPI-1005?

      I've read they've seen improvements in perceived Tinnitus in Meniere's patients—but what about non-Meniere's patients?

      Also, how did you get a Dutch doctor (I'm assuming your huisarts) to e-mail them? I usually have a hard time convincing mine to do much of anything for me, really. :bored:
       
    27. TrevorSanders

      TrevorSanders Member

      Location:
      Ohio
      Tinnitus Since:
      09/2020
      Cause of Tinnitus:
      Noise Exposure/Ototoxic Medication
      I’m starting to understand where the pessimism of tinnitus veterans comes from.
       
      • Agree Agree x 2
    28. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      This company has a promising Nav1.7 blocker in pre-clinical. Seems roughly where the Trobolt reformulation is since they are starting to be talked about in biotech circuits:

      Tackling the Opioid Epidemic with a Novel Gene Therapy for Chronic Pain
       
      • Informative Informative x 2
    29. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
    30. Marin
      Depressed

      Marin Member

      Tinnitus Since:
      6/18/2020
      Cause of Tinnitus:
      SSNHL... probably previous noise exposure, too
      Thank you for sharing!

      Ah! I see they are in SoCal. Maybe I can volunteer to be one of their lab rats...
       
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