Otonomy OTO-313 — Treatment of Tinnitus

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      -- like FX-322 it is for hair cell regeneration.

      -- their stained photo in the presentation shows both inner and outer hair cells regenerating (the inner hair cell row before and after is especially impressive).

      -- it is targeting "severe" hearing loss, unlike FX-322, which will be labelled for up to moderately severe.

      -- they haven't released yet how it works or what the compound is

      -- they have only recently selected a "lead compound" which means they are further along pre-clinically than they were.
       
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    2. Kam75

      Kam75 Member

      Location:
      FRANCE
      Tinnitus Since:
      26/02/2019
      Cause of Tinnitus:
      Noise induced trauma
      @FGG I have high frequency hearing loss that starts from 9Hz-10Hz and my hearing is very low from 11Hz-12Hz.
      Under 8 Hz, my hearing is normal.

      I do have "acute" tinnitus as you said, it is so acute that I can hear it everywhere, everytime (watching a movie, in the car, in the shower...).

      Why did you say that "acute tinnitus" does not apply to most of us? I read plenty of posts here of people saying that they can hear their tinnitus everywhere like me.

      So based on my profile, what should works best for me? FX-322 or OTO-313?
       
    3. Sloth
      Happy

      Sloth Member

      Tinnitus Since:
      03.05.2020
      Cause of Tinnitus:
      Blow to ear
      Acute doesnt describe the severity. Acute means recently acquired (~3 months)
      Although there is no clear scientific definition of when tinnitus is acute and when it isnt anymore
       
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    4. Kam75

      Kam75 Member

      Location:
      FRANCE
      Tinnitus Since:
      26/02/2019
      Cause of Tinnitus:
      Noise induced trauma
      Ah okay thanks, I didn't realize "acute" had another meaning.
       
    5. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      If you have had tinnitus longer than 3-6 months (and even 6 months is questionable), I highly doubt OTO-313 would help.

      FX-322 should help you.
       
      • Helpful Helpful x 1
    6. Jack V

      Jack V Member Benefactor

      Tinnitus Since:
      1/2020
      Cause of Tinnitus:
      Something Wicked This Way Comes
      We've talked about it here as for acute tinnitus only, and clinical trials cut off eligibility at 6 months, but I've heard elsewhere that OTO-313 is NOT intended just for acute tinnitus only.

      Jury's still out...
       
      • Like Like x 1
    7. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Where did you hear elsewhere it was for chronic? As far as I have heard the company has never suggested it for anything but acute.
       
    8. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      During one of Otonomy's investor presentations, they talked about the drug and the tinnitus "market", so one could speculate that it is for chronic cases as it would be a bit misleading for investors if they presented it otherwise. Acute and chronic are two pretty big number differences.
       
      • Like Like x 2
    9. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I don’t understand the acute vs chronic trial stuff. I would think if you could fix either it would work for both. Right now as we know there’s no cure for hearing loss, tinnitus, Meniere's, hyperacusis, all I can say to these companies is fix something, anything.
       
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    10. serendipity1996

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
      • Like Like x 3
      • Funny Funny x 3
    11. MadsWithT
      No Mood

      MadsWithT Member Podcast Patron Benefactor

      Location:
      Norway
      Tinnitus Since:
      1997
      Cause of Tinnitus:
      See bio
      • Like Like x 11
      • Informative Informative x 2
    12. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Wasn’t this the trial that @ChrisBoyMonkey got a worsening in his tinnitus from?

      Maybe it turns out he got a placebo instead of the real drug.

      It mentions Day 29 and Day 57 patients who got the real drug had improvements in their tinnitus.

      This decade is definitely the decade where we will have cures for hyperacusis and tinnitus.
       
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    13. Emgee

      Emgee Member Podcast Patron Benefactor

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Modern Society = Too Loud
      Thanks for sharing the update, @MadsWithT.

      Better results than I expected, to be honest. This makes me even more excited for the OTO-413 results to be announced at the end of this year.

      Though we’re not there yet, it seems we’re finally on the right track to alleviating the burden of this terrible condition. There seems to be light at the end of the tunnel.
       
    14. waly
      Chatty

      waly Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      unknow
      "43% of OTO-313 patients were responders at both Day 29 and Day 57 compared to 13% of placebo patients"

      Not bad. At that rate it's worth a try.
       
    15. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
    16. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      • A single intratympanic injection of OTO-313 was well-tolerated with lower incidence of adverse events than the placebo group.

      I refer to this as it was @ChrisBoyMonkey who was part of the trial and had a worsening in his tinnitus as a result. As it looks there is a proportion of 'adverse' events from this...

      It may be worth trying to get in touch with Otonomy (I tried a while back unsuccessfully) if they would be interested in an interview @Markku and @Hazel.

      I believe this company is definitely worth keeping an eye on for their long line of candidates in ear disorders. It seems Frequency has a lot more momentum with their single FX-322 in the pipeline but I would definitely be interested in hearing about Otonomy.

      A lot of unanswered questions remain about Otonomy...
       
      • Like Like x 1
    17. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      @ChrisBoyMonkey

      Hi @Diesel - This member was part of the trial and got worsening tinnitus from it...

      Also, I've been reading a lot of your posts lately and I just want to thank you for good knowledge and input into the threads...
       
      • Agree Agree x 1
    18. Emgee

      Emgee Member Podcast Patron Benefactor

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Modern Society = Too Loud
      Stronger results than I expected. Even more excited now for the OTO-413 results at the end of this year, which I’ve always felt more confident about.

      “Given these results, Otonomy intends to advance OTO-313 into full Phase 2 development which may include evaluation of a higher dose and/or retreatment with OTO-313.”

      Let’s see what increased dosage does in Phase 2. While I believe hearing regeneration will yield the best results, this is still good news. There appears to finally be some light at the end of this very long tunnel.
       
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    19. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      @ChrisBoyMonkey but apparently he stated he got a worsening from this drug.
       
    20. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      It's for acute (up to 6 months in this case) tinnitus only.
       
    21. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      @ChrisBoyMonkey did. Not sure if he got drug or placebo but he did not have good results.
       
    22. Christiaan
      Vegged out

      Christiaan Member Podcast Patron Benefactor

      Location:
      The Hague, the Netherlands
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Bloody headphones in 2016,worsened in 2020
      Correct me if I'm wrong, but I believe that @ChrisBoyMonkey did participate in the trials.
       
    23. MadsWithT
      No Mood

      MadsWithT Member Podcast Patron Benefactor

      Location:
      Norway
      Tinnitus Since:
      1997
      Cause of Tinnitus:
      See bio
      • Like Like x 7
      • Informative Informative x 1
    24. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      With just one injection. This could bode well for tinnitus patients.
       
      • Agree Agree x 1
    25. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      • Next steps for program:

      o Complete analysis and submit for presentation at a future medical conference
      o Consider higher dose and/or retreatment with OTO-313 (Day 30) to increase % of responders
      o Design Phase 2 that considers expanded tinnitus population (e.g., bilateral patients; > 6 months)


      Interesting. So in this trial they tested for acute cases and in the next they will include chronic cases.
       
      • Informative Informative x 1
    26. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Non-disclosure agreement does make it likely they will stay mum.
       
    27. aot
      Bookworm

      aot Member Benefactor

      Location:
      USA
      Tinnitus Since:
      2016. Worsened 11/2019.
      Cause of Tinnitus:
      Probably sound induced, worsened due to noise expouse + flu.
      I don't think they'd be allowed to talk about it.
       
    28. Selah1281

      Selah1281 Member Benefactor

      Location:
      Bustown, OH10
      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Unknown
      Yes, @ChrisBoyMonkey and he had a worsening immediately afterwards. It’s somewhere within this thread and you can look at his post on the Lenire user thread where he mentions it.

      I was scheduled to participate at WVU, but canceled my appointment after his report.
       
    29. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      Hough Hearing Institute better hurry up and stop with the excuses.
       
      • Agree Agree x 5
    30. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      They need to start the clinical trials now and not fuck around.
       
      • Agree Agree x 1

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