Otonomy OTO-413 — Treatment of Hidden Hearing Loss

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

    1. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
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      Acoustic trauma - Repeated gun blasts
      OTO-413 has had better results than OTO-313 so far. The synapses readily respond to the medication and reconnect to the hair cell terminals. Easier to measure success too.
       
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    2. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

      Location:
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      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      Someone else, @attheedgeofscience I think, already said something about the OTO-413 trail being designed better. I don't know what it is but the info is in this forum if you care to search.
       
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    3. in_LA

      in_LA Member

      Location:
      Los Angeles
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Loud music
      These should reconnect to the brain once grown, right? Sorry, I'm not good with science stuff. I fear that they'll grow but not connect.
       
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    4. kingsfan
      Mellow

      kingsfan Member Benefactor Hall of Fame

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      turning everything up to 11
      Once the neurons die from excitotoxicity, I don't think there would be much that OTO-313 could help with. Therefore, OTO-413 is definitely the drug to have fingers crossed for.
       
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    5. Damocles
      No Mood

      Damocles Member Podcast Patron Benefactor Hall of Fame

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    6. CRGC

      CRGC Member

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      Montreal
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      From ClinicalTrials.gov page:

      Exclusion Criteria:

      [...]
      • Subject self-reports bothersome, subjective tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
      So much for our chances to be part of the trial.
       
    7. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      True but this is good. There will be no desperate people to affect the trial, trying to get in for tinnitus, causing a flop like FX-322. People with hidden hearing loss are not suffering like the people here. I wish we could all get this drug right now, but this is a good thing for Otonomy.
       
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    8. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
      The desperate have ruined things in the past.
       
    9. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      Yup, even though I have catastrophic noxacusis, I’m not going to try and lie to get into FX-322 or OTO-413 trials. I need those drugs badly but I’m not going to risk the entire trial and the future of a drug I may or may not get (I could get placebo). If I had the exact criteria they were asking for, couldn’t hurt, but again, there’s a chance you’ll get placebo.
       
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    10. IndyMLVC

      IndyMLVC Member

      Location:
      NYC
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      2009
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      Unknown
      I'm always on the lookout for new trials. I have *several* debilitating ailments (that, unfortunately, work in concert with one another) and I'm always completely honest with the people running the trial. I'm never going to bend the truth or flat out lie to get into something. It's not worth screwing up the entire study over for something that *MIGHT* help me.
       
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    11. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

      Location:
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      Cause of Tinnitus:
      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      All of these hearing regeneration trials are having massive difficulty with trial design as it is. So much of tinnitus/hyperacusis varies naturally that placebo groups are always going to have high positive results.

      At least OTO-413 has a better trial design than OTO-313.

      I did see some new trial was asking for people who only have stable tinnitus but you really are relying on people just being honest which is less than ideal. I can seriously understand why people will lie to get into these trials.
       
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    12. ThomasF
      Creative

      ThomasF Member

      Location:
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      Cause of Tinnitus:
      Probably loud music
      It is really cruel to lie to get into a trial. The effects are severe after doing so. Not only are your results not reliable but the difficulty in finding appropriate testing subjects is already substantial and adding a monkey wrench like that is not only shooting that person in the foot but as well extending the time of misery we all will experience. I genuinely think they need some type of criminal psychologist to help screen subjects. Tell when they're lying about their tinnitus and boot them from the program. I want us all one day to be cured but that isn't going to happen with people constantly putting their suffering above the well being of everyone else dealing with this inane condition. When the device for objectively measuring tinnitus is available that will hopefully screen out people with tinnitus where they shouldn't be and prove they have it for where they're needed.

      I'm not immune to this behavior though, I sometimes believe I have Meniere's despite the ENT I saw last year telling me I do not. I lie to myself hoping that SPI-1005 will help me with that. Perhaps its utility exists elsewhere and can aid my tinnitus differently but I'm not confident in it. One day a true treatment will exist and one day a cure. We won't get there if people like myself will be obstacles to progress instead of pushing it forward. When we choose to put ourselves ahead of progress we hurt so many others it's impossible to comprehend.
       
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    13. antonio77

      antonio77 Member

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      unknown
      I'm always on the lookout for new trials. I have *several* debilitating ailments (that, unfortunately, work in concert with one another) and I'm always completely honest with the people running the trial. I'm never going to bend the truth or flat out lie to get into something. It's not worth screwing up the entire study over for something that *MIGHT* help me.

      The problem is that it doesn't matter; many of us can be very honest but it is enough that several are not to completely spoil the study.

      You feel very helpless when this happens because you can't do anything.
       
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    14. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

      Location:
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      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      It all comes down to how they assess the patients. The speech in noise test for OTO-413 does seem like a solid test.

      I just noticed tinnitus is an exclusion criteria of this trial. I wonder why that is. It would be unfortunate if this drug healed hearing loss but didn't heal tinnitus. I was kind of assuming any of the regenerative type drugs would be good for anyone who has tinnitus or hyperacusis from loud noise exposure.
       
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    15. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      They should not have disclosed this but kept this a secret exclusion criterion.

      This just results in people with bothersome tinnitus to downplay or right about lie about their condition to get in.

      If they didn’t write this as exclusion criterion, these people would openly mention it, so they could still be excluded.
       
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    16. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      That’s a good point.
       
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    17. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
      Desperate people will lie under any circumstances. Having experts at spotting liars on a psychological level is a good filter to weed these people out of the testing groups. Until tinnitus itself can be objectively measured via some sort of tool or scan at least.
       
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    18. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
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      Unknown
      I think the goal is to remove those who are attempting to enter the trial for their tinnitus and not hearing loss. If the treatment is successful in treating hearing loss itself but the tinnitus crowd is unaffected, then the tinnitus crowd ruins the trial.

      It's clinically correct to try to fix actual hearing loss first, and then tinnitus. Tinnitus patients want to put the cart before the horse here. It's understandable as to why, but it could ruin an actual potential treatment.
       
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    19. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

      Location:
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      Tinnitus Since:
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      Cause of Tinnitus:
      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      That does make sense. There's probably a good chance that a drug that helps hearing loss would also help a large number of tinnitus cases.

      Are the results for the latest trial on OTO-413 coming out some time soon?
       
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    20. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      We have to remember that these companies first and foremost live and die by the success of their trials. So designing a good trial is really critical to getting a drug to approval.

      A major goal determining a clinical trial's success is the ability to control inputs by reducing variables that create outliers in the final outputs, which can unexpectedly ruin a trial. In the case of hearing loss, there are a ton of variables between each patient that enters the trial, any one of those variables could cause an issue in meeting the primary outcomes of the trial, and either cause it to fail or require a do-over (expensive and high risk.)

      Considering these companies live and die by the design of their trials; most likely, a patient with "bothersome tinnitus" presents some type of risk to the trial's success. Therefore, they decided to exclude patients with tinnitus.

      While I also agree that there's a good chance OTO-413 can help the population with noise-induced tinnitus (because hearing-in-noise issues share the same underlying classification), it's probably better for the success of the drug reaching the patient; it's better to exclude tinnitus for now. I'd rather find out in the future through people here trial-treating an approved product, as opposed to participants in the trial using unsavory methods to gain entry to trial, making a drug that might actually work unaccessible because they created outlier data and the trial failed.
       
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    21. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
      Cause of Tinnitus:
      Unknown
      Trial ends at the end of the year. Cleaning up the data could take another few months. We should look towards mid-2023 for results the latest (and not to get our hopes up too quickly for a fast report).

      Then Phase 3 would begin, which could be another full year of the trial.

      It's why 2025 is such an important year. If any of these trials are successful, they go to market by 2025-27. Once one of them figures it out, the competition will be on to grab a part of a market that is guaranteed to be around forever. Humans will always lose their hearing.

      We just need to keep going :)
       
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    22. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

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      I'm not going to get my hopes up too much since I don't want to be too disappointed if it fails.

      All of these companies talk about how the market will only be growing. The world is much more noisy now with increased use of headphones and AirPods.

      This drug does sound like it has better chances of passing than OTO-313 did. Just need to stay distracted until one of these are actually released.
       
    23. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

      Location:
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      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      Thanks for your detailed response. The designs of these trials do seem to be very important indeed.

      I would guess it probably wouldn't be hard to get this drug to try and treat tinnitus if it ever does hit the market anyway.
       
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    24. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

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      That's three of them that are that close, is it? Frequency Therapeutics, Otonomy, Sound Pharmaceuticals?
       
    25. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      @AxEars, the trial is finished as far as I am aware, with results due in the 4th quarter of this year.
       
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    26. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
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      You nailed it on the head, Diesel. That’s what it’s all about.
       
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    27. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
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      Thanks, Nick. Missed that detail. Even better news!
       
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    28. Nobody19

      Nobody19 Member Benefactor

      Tinnitus Since:
      2012
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      Clubbing
      Please properly inform yourself before saying things like this and giving people hope that this drug has a possibility to release in 2025. There will NOT be a Phase 3 trial yet. Direct quote from their Q2 results:
      Source: https://investors.otonomy.com/news-...rts-second-quarter-2022-financial-results-and
       
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    29. AxEars

      AxEars Member

      Tinnitus Since:
      05/2022
      Cause of Tinnitus:
      Unknown
      You're right, I wasn't clear. I've said in other threads that 2025-27 is an important timeframe, because if any company's tinnitus clinical trials currently going on prove successful, those years would be the ballpark range for it to be available. I should have said I was speaking in general terms about all trials and not specifically OTO-413

      I'm a firm believer that something will be available before 2028, even if it works for 30% of the tinnitus population.
       
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    30. Justin Mills

      Justin Mills Member

      Tinnitus Since:
      2 year
      Cause of Tinnitus:
      loud music
      So it looks like there are other places working on developing drugs to regenerate synapses, other than Otonomy and Pipeline Therapeutics. I guess it’s just a matter of time, although who knows how many years. Well @AxEars thinks it’ll be another 6.

      But I think it’s important to keep in mind it’s not just about tinnitus, it’s also about restoring hearing fidelity and quality. We should want both, and probably that’s the only way to do it, since tinnitus most commonly arises due to hearing damage that results in hearing “loss”:

      Mass Eye and Ear Researchers Awarded $12.5 Million NIH Grant to Continue Hidden Hearing Loss Research

      Drug therapy to repair cochlear synaptopathy - Associate Professor Andrew Wise & Dr. Sherryl Wagstaff
       
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