Hough Ear Institute's Hair Cell Regeneration Project

Discussion in 'Research News' started by all to gain, Oct 2, 2019.

    1. Nonomat
      Wishful

      Nonomat Member Benefactor

      Location:
      France
      Tinnitus Since:
      06/2019 (mild) - 11/2019 (intrusive)
      Cause of Tinnitus:
      Noise induced
      They haven't tested in humans yet in terms of efficacy. They did the phase I safety test on healthy subjects so no indication on whether it works in humans as of now.

      The one month tinnitus test was done on mice models.
       
      • Informative Informative x 1
    2. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
    3. Ben S
      Curious

      Ben S Member

      Location:
      Connecticut
      Tinnitus Since:
      11/2015
      I truly hope they begin recruiting for Phase 2 ASAP! Additionally, I hope they will host clinical trials in the Northeast. Some of, if not all of my problems could be solved this year... or is that wishful thinking?
       
      • Like Like x 1
    4. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      It sounds like this year they are recruiting acute noise patients only. With hopes for further studies (tinnitus, synaptopathy) later. I'm not totally sure about this, though. @Justin De Moss, is this right?
       
    5. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Hello everyone!

      First, thank you all for your support, your patience, and your understanding! I'm writing to you from home because last Friday I got the flu, then it turned into two ear infections, a sinus infection, and pneumonia. I mention that because since this all started by tinnitus has been constant and really impacted me more like what many of you describe. I believe I had empathy towards y'all before now, but I can say for certain that I know what you are going through.

      The Phase II design will be determined by Oblato. I believe they are checked for the pill's efficacy on cochlear implant trauma. 1) Because it is easier to objectively test for, and 2) that pathway leads to the fastest way to get the drug approved by the FDA.

      That said, we haven't given up on the tinnitus piece of the equation. There is interests in conducting a Phase II study for the indication of tinnitus. To do that, however, they have asked us to do a proof of concept study to show that we can objectively measure efficacy in a Phase II trial. So, when we raise the money necessary for it - we can hopefully add it to the list of indications to be treated with the pill.

      Why is it important to do this? To get it into the hands of patients faster. A drug can be prescribed off label, but many insurance carriers won't cover off-label scripts. Which means people would have to pay the full price of the drug until that has been established.

      Hope that helps clear the things so to speak.
       
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    6. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Not to my knowledge. I will see if that is available.
       
    7. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      @FGG it appears I’m wrong, thanks Autumnly (srs). So their injection tech would better be compared to Regain than FX-322. Super cool that the pill can regenerate the connections between healthy hair cells and the damaged nerve endings. If I remember correctly, this was one of @brokensoul’s primary concerns about scope of regeneration tech.
       
    8. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Thanks so much for answering our questions.

      Does this mean that tinnitus would included in a potential phase 2b after the cochlear implant injury study if you can raise funds for a proof of concept study?

      Or will the aim be to release this drug with the indication of protecting against injury due to CI insertion so it can be released faster with off label studies being done later?
       
      • Good Question Good Question x 1
    9. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      I wouldn’t wish this on my worst enemy, let alone someone who is so proactive and engaging in our community. Ear-infection-induced/exacerbated tinnitus looks like it has close to the best recovery outcomes (coming from someone whose obsessively read the success stories at least three times over in efforts to cope). Hopefully this will be just a blip on the radar few months from now. Are you on any antibiotics? Some are more destructive than others. @FGG might be able to shed some light on that.

      Good luck man. We appreciate you.

      edit: one thing that’s interesting about this $735k proof of concept study for tinnitus is that the sole reason for this would be so that those with tinnitus could have this prescribed with approval by insurance. I inquired about the same application for insurance approval in the FX-322 thread since they are currently able to do so in a separate experimental arm, although it seemed like the consensus was that even if it showed considerable efficacy for tinnitus in the experimental arm, that it would have to be prescribed off-label for tinnitus and thus unlikely to be approved by insurance. Any thoughts?
       
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    10. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member

      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      I hope you recover quickly, sounds bad. Thanks for all the work you are doing.

      I would love to know approximately what the full price of the drug would be. Here's hoping you can get it onto the market as soon as possible.
       
    11. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Lol. He doesn't need my advice on antibiotics, he has Kopke :).
       
    12. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      If this pill worked I could care less about paying off label price. I would find a way for the VA to pay for it, and they can have their monthly debt to me cancelled.
       
      • Agree Agree x 2
    13. Adaś
      Curious

      Adaś Member Benefactor

      Location:
      Switzerland
      Tinnitus Since:
      02/2013
      Cause of Tinnitus:
      Headphones, Stress, Rock concerts
      I can't believe I have read again that funds have to be raised, and we need to wait while there is suffering. I believe many of us could potentially help help this kind of research if only we were given an opportunity to do so.

      I wish it was more accessible for us like Kickstarter campaigns. I can't believe I am able to fund some flying pet bicycle pocket device project but I cannot fund myself a drug that can potentially improve or even save my and others life.
       
      • Agree Agree x 4
    14. Artemis2K
      Kick ass

      Artemis2K Member Benefactor

      Location:
      South Carolina
      Tinnitus Since:
      2012
      Cause of Tinnitus:
      I had tinnitus for as long as I can remember. Got bad later.
      Hey, can Hough Ear Institute's pill help age-related hearing loss?
       
    15. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      I found that shocking.

      I thought with the new partnership with Oblato they have the funds for the clinical trials.

      Do they actually need more funding?
       
      • Good Question Good Question x 1
    16. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      They need $735k specifically for it to be potentially labeled as a tinnitus treatment, for insurance access.

      Without it you’d be able to get it prescribed but would have to pay out of pocket.
       
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    17. Jack V

      Jack V Member Benefactor

      Tinnitus Since:
      1/2020
      Cause of Tinnitus:
      Something Wicked This Way Comes
      I read that a little differently.

      My understanding is that by limiting the initial Phase II trial, and making it easier to earn FDA approval, there is a greater likelihood of bringing the drug to market as soon as possible.

      Then, once approved, it can be prescribed off-label so tinnitus-sufferers will at least have access while waiting for a mop-up trial to potentially enable insurance reimbursement - if it works.

      The alternative, that the clinical trial is overly broad means that even if the drug is successful for some indications, it can stall out and get delayed by years or worse.
       
      • Informative Informative x 1
    18. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      What I understood from the podcast the pill managed to restore synaptic connections and suppress tinnitus 4 weeks after acoustic trauma - tested on rodents.

      @Justin De Moss, is there any indication about therapeutic window, can this be effective also years after synapse damage? Or is it just speculation?

      Another question is about criteria for phase 2 clinical trial, do you plan to invite chronic tinnitus sufferers as well (years of tinnitus) or only acute cases i.e. up to 3 months from the trauma?
       
      • Good Question Good Question x 2
    19. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Thanks for the clarification.
       
    20. Buzzy1

      Buzzy1 Member

      Tinnitus Since:
      01/1983
      Cause of Tinnitus:
      Ear infection
      I’m not sure about all the facts, but I’m really hoping it will. If they need any volunteers for testing my hand is up and staying up After 38 years of gradually worsening t and hearing loss I think I’d sell my house to pay for the medication!
       
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    21. Tweedleman
      Depressed

      Tweedleman Member Benefactor

      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Unknown/Noise
      Here here! My hand also way up! I'm practically still in the acute phase, Hough! Pill me up already!
       
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    22. UKBloke

      UKBloke Member Podcast Patron Benefactor

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      Loud Music / family history
      This point prompted my main question as well. What does 4 weeks in a rodent equate to in humans?
       
      • Good Question Good Question x 2
    23. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      Yeah, I'm angry about this.

      I was led to believe Hough Ear Institute already had proof of concept in animal models for tinnitus, and that's how it acquired the new partnership for the next phase. That's why I invested at all in the first place.

      Now, this exciting top secret partner is a 5-year-old Korean subsidiary that has virtually no profile online, and is owned by GtreeBNT, whose stock went up in 2018 due to its acquisition of a possible brain cancer drug, and now has fallen back down to levels prior to that acquisition (presumably because they're not showing any progress).

      Now it's OUR burden to raise money, to prove to "Oblato" that it's worth studying as effective for tinnitus?

      Number one, don't waste your time or anyone's money. If you get it approved by the FDA to treat cochlear implant damage, the tinnitus community will quickly get their hands on the pill and tell the world it either works or doesn't. That's provided it's affordable for everyone, not just some, like you've said it would be.

      Number two, you get any kind of real proof of concept and you'll have your choice of pharma companies with REAL money knocking on your door.

      This drug was developed ten years ago now. It took 5 years to say it was safe. It's now taken another 5 years to be picked up by "Oblato" who's testing it for something else. Damnit.

      I'm over it. I need to learn to live my life with this and not wait on magic or waste money I don't have on it.

      I appreciate what Hough Ear Institute is doing, and I know it's hard to get funding, but lying isn't going to help you. Don't tell me you have evidence it's effective for tinnitus in animal models, and then your new partner needs you to prove it before they'll invest. What kind of BS is that?

      And yeah, I was up all night with loud ringing, and I came here for some good news.
       
      • Hug Hug x 3
    24. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      We are trying to get tinnitus as an indication for Phase II trials. That will get it in people's hands quicker and more cost-effective than waiting until it's approved by the FDA.

      I'll answer the CI trauma (?) in another post from another contributor.
       
      • Like Like x 6
    25. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      If we can show efficacy during the clinical trials - that makes it likely to be covered by insurance. If we don't, then it would not be covered by insurance for the indication of tinnitus.
       
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    26. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      It's hard to say, but the models that we have worked with show that, after the first two years from the initial release it should cost less than the price of a single hearing aid.
       
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    27. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Doubtful, but the hearing loss injection we are working on will!
       
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    28. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Oblato is funding Phase II and Phase III clinical studies. They pick which indication they want to pursue based on many factors.

      1) Which is the most likely to demonstrate success?
      2) How can we test for efficacy objectively?
      3) How expensive is each indication to bring through the trials?
      4) What is the size of the target demographic?
      5) and many others

      The reason we need to raise more money for a proof-of-concept study is to show 1) tinnitus can be tested objectively, demonstrate the cost of doing so, show that it can be successful, and illuminate the target demographic of those who suffer from tinnitus.

      We already have a model that has shown this several times with promising results. We now need to increase the size of the experiment and get outside validation of results to show justification for the additional Phase II and III expenses.

      The good news is that they have expressed an interest in helping pay for some of this new study! I'll have to wait and see but I believe we are looking at them matching half the cost.
       
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    29. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Not quite. We aren't limiting the Phase II trials, it just that CI trauma has the best path toward success. This does help get the drug quicker to market.

      By adding additional indications, we don't stall or delay approval, it just means that the drug can be FDA approved for more than one indication and insurance is more likely to cover.

      I believe insurance would have a healthy interest in covering the drug because tinnitus leads to a whole host of other issues like anxiety, depression, etc.
       
    30. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Aside from the insurance angle and indications that the pill can be approved for - this is exactly why we want the larger proof of concept study. Every indication of the data shows that it would be effective in chronic tinnitus sufferers. Now, we need to demonstrate that, while also having the results validated by an outside organization.

      As far as the criteria for the trials - that will be up to Oblato since they will be running the trials.
       
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