Otonomy OTO-413 — Treatment of Hidden Hearing Loss

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

    1. Auron
      Dead

      Auron Member

      Location:
      Planet Earth
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      Spring
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      Did you get that in korea as well?Is this similar to,or the same thing that oto-413 is using.If so,did it help you?

      Damn,reading a little bit of otononmy history gives me great concern over the likely hood of oto-413 success.I guess that's true with any of these bio techs.They all have cures that only work on paper.
       
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    2. Sim-Lev

      Sim-Lev Member

      Tinnitus Since:
      2016
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      Party
      Does anyone know why the clinical trial for OTO-413 doesn't appear on the clinicaltrials.gov website?
       
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    3. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      You can’t find it because it’s for HIDDEN hearing loss...

      :D

      I apologize, couldn’t resist!
       
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    4. SouthKorean
      Amused

      SouthKorean Member

      Location:
      South Korea
      Tinnitus Since:
      2017/12/28
      Cause of Tinnitus:
      Stress, Shock
      https://clinicaltrials.gov/ct2/show/NCT04129775

      Is this a new clinical trial?

      Can someone tell me if it's a phase 1 or phase 2?

      And what's the difference between the phase 1 and phase 2?
       
    5. spingee
      Wtf

      spingee Member

       
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    6. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      Damn, a single dose? I have low confidence that one dose is going to really do much.
       
    7. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

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      Supposedly they've come up with this slow release kind of gel. OTO-313 is the same way.
       
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    8. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      That will certainly help. They could also mix it with platelet rich plasma. That stuff can setup in your head for a day.
       
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    9. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      FX-322 uses it as well. I doubt this single dose is all they will be testing. They’ll probably test multiple injections in Phase 2.
       
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    10. Chriscom

      Chriscom Member Podcast Patron Benefactor

      Location:
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      If "they'll" refers to FX-322, correct. From Frequency Therapeutics' Oct. 10 press release:

      The Phase 2a clinical trial is a multi-center, randomized, double-blind, placebo-controlled, single- and repeat-dose study of FX-322, expected to enroll approximately 96 adults aged 18 to 65 with stable SNHL at 12 sites in the U.S. Patients will be randomized to one of four groups, each of which will receive four injections, once per week, at weekly intervals starting at the initial visit. The key efficacy endpoints of this trial are word recognition (WR), words-in-noise (WIN), and standard pure tone audiometry. Exploratory efficacy endpoints are extended high frequency pure tone audiometry, the Tinnitus Functional Index (TFI), and the Hearing Handicap Inventory in Adults (HHIA).

      https://investors.frequencytx.com/n...eutics-commences-dosing-its-phase-2a-study-fx
       
    11. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      It sucks that tinnitus is an exclusion for their clinical trial.
       
    12. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
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      No it's not, they are officially testing the drug to see if it helps. They just want the main concern to be hearing loss.
       
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    13. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      Hold on, where did you read that?
       
    14. SouthKorean
      Amused

      SouthKorean Member

      Location:
      South Korea
      Tinnitus Since:
      2017/12/28
      Cause of Tinnitus:
      Stress, Shock
      Isn't OTO-313 a clinical trial for tinnitus?
       
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    15. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

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      Oh wait, for OTO-413 this seems to be right. It is an exclusion.. which I think makes no sense. This should be something they should officially measure to see if it helps. To me it seems like it's only logical that it would help.
       
    16. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      ABRACADABRA
      Just don't tell them you have tinnitus.
       
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    17. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
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      It's not testing on me I'm worried about, it's all the other people who will be turned away and the resulting lack of data/information that will follow from their exclusion.
       
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    18. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      I have a *sneaking suspicion* that it helps with tinnitus. :whistle:
       
    19. Chinmoku

      Chinmoku Member Benefactor

      Tinnitus Since:
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      But with all tinnitus patients out there why exclude tinnitus? From a business point of view it doesn't make sense, unless they fear concretely that the drug might aggravate tinnitus.
       
    20. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      I don't fear, concretely, that it will aggravate tinnitus. As a matter of fact I would not fear getting this stuff injected into my ears whatsoever.
       
    21. Jim51042

      Jim51042 Member

      Tinnitus Since:
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      That's probably not what they fear. What they are likely worried about is the objectiveness of tinnitus patients. Since there is not yet a way to measure numerical tinnitus without talking to the patient it adds some uncertainty for the company. That being said since this drug likely will help with tinnitus more than it will help for hearing improvement from a corporate perspective it is an extremely unwise exclusion to implement. But corporate upper management can be extremely dumb.
       
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    22. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      It's like "So sorry, we can't measure a disease that you definitely have, therefore we can't cure you."
       
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    23. Chinmoku

      Chinmoku Member Benefactor

      Tinnitus Since:
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      That's because you are one of the bravest daredevils in this forum. When I read the number of intratympanic injections you had in South Korea I almost fainted. However, I don't understand Otonomy's point of view really. I know you would go for the injections, what I don't understand is why don't they open the trial to tinnitus sufferers and record the effects on tinnitus with little additional work? It would broaden the use of the drug and that can only be good for them. Perhaps as @Jim51042 says it's just dumb management.
       
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    24. Chinmoku

      Chinmoku Member Benefactor

      Tinnitus Since:
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      But they could run a questionnaire or check minimum masking volume at the very least. Even if it does not give strong evidence, there is NOTHING that works for tinnitus at the moment, so even a medication that substantially lowers the tinnitus questionnaire score would be welcome and probably sell well. I can't believe the management is so dumb, I wonder what could be happening here.
       
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    25. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

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      I think they might not want it to cannibalize with their OTO-313. Which is still stupid, if this drug works to help with the tinnitus too then they could just brand the one that works better specifically for tinnitus as so.

      If this one works and the other doesn't work at all, then scratch the other one and sell this one as such.
       
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    26. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      Perhaps 313 and 413 are 90% similar drugs.

      They are doing two tests in parallel :)

      Hoping that for at least one of their groups it becomes a success...
       
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    27. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      They're not similar at all.
       
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    28. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      Can we read more about them somewhere?
       
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    29. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      Cause of Tinnitus:
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      Affirmative.
      OTO-313 is gacyclidine
      OTO-413 is BDNF
       
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    30. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
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      tinnitus patients have lower BDNF levels:
      "Serum BDNF level was found lower in the tinnitus patients than controls"
      https://www.ncbi.nlm.nih.gov/pubmed/28615544

      curcumin increases BDNF levels:
      curcumin at doses of 50 and 100 mg/kg (p.o.) increased BDNF protein levels by 78.0% and 95.1%, respectively, compared to the control group.
      https://www.hindawi.com/journals/mi/2017/6280925/

      This is more than likely why curcumin helps with tinnitus in some of us.

      Either the BDNF receptors are fried or our nerves aren't making enough. I'm leaning towards the receptors being fried.
       
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