Hough Ear Institute's Hair Cell Regeneration Project

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

    1. urgentresearch
      Probing

      urgentresearch Member Benefactor

      Tinnitus Since:
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      I am confused and I wonder if the term "proof of concept" was used too loosely here. (In drug development, proof of concept has a specific/narrow meaning that is separate from proof of mechanism or proof of of principle.)
       
    2. urgentresearch
      Probing

      urgentresearch Member Benefactor

      Tinnitus Since:
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      Unknown (possibly withdrawal-induced)
      This is the confusing part.

      What does "is entering" mean here, exactly?

      I think it is important for statements like this to be much more clear... especially when they are presented in the context of a fundraising email (due to the legal implications that arise when soliciting funds).
       
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    3. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
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      What I don’t understand is why Justin would personally tell several select people that they are starting phase 2 clinical trials as well as the tinnitus “proof of concept study” via email without Hough first putting out an official announcement—it muddies the news. This is clearly an issue of communication; the only source we have right now is two 3rd-hand statements from TinnitusTalk users, so I don’t know if we should be celebrating quite yet (not that I think anyone is lying, but let’s tread carefully).
       
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    4. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Thank you for doing the research and putting this together.

      I agree - research is frustrating because it takes so long. Whenever we are frustrated or suffering, the character of a person is in how they respond. Character = civility.
       
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    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
      The PoC study is to test an objective measurement of tinnitus as well as to see if it works for chronic tinnitus. All of our previous studies indicated that it does, but for chronic tinnitus, the sample size was a little on the small side. Yet, we did have statistical significance.

      The biotech company agrees with us, hence the reason they are funding nearly half the study to find out if it is worth the millions to run a phase 2 study. If successful - this will be the first phase 2 study that has as it's PRIMARY objective the treatment of tinnitus. It will also be the first, to my knowledge, of objectively measuring tinnitus.
       
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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
      I wish Frequency Therapeutics the best. We are different in our approach and in what causes tinnitus. We both might be right! It's good to have several approaches in the pipeline.

      One difference between Frequency Therapeutics and Hough Ear Institute is that we hope to run a phase 2 study that has tinnitus as the primary goal/finding, not secondary. The second is objectively measuring results v. a self-report style which is extremely unreliable depending on sample size.
       
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    7. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      A PoC study is like a pilot study if you will. Before the biotech company spends millions of dollars for a phase 2 study for another indication, they desire to see some additional results from a larger than already done, but small than phase 2 study.

      In a lot of respects that is what Frequency Therapeutics has done with their phase 2a. Phase 2 studies involves hundreds of patients, not tens of patients.

      It's a good strategy to raise venture capital. I hope they are successful.
       
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    8. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      That is the question the biotech firm has. Before spending millions on a phase 2 study they want some more data.
       
    9. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      First off, Hough Ear Institute doesn't run the study. I'm not sure why people keep thinking that we do but we don't. The biotech company does. They will choose whatever indication they want to study. They can choose one, two, three, etc.

      To be clear - Phase 1 is complete. Phase II is funded and ready to start once they determine which indication(s) they want to do. Additionally - we are doing a proof of concept study because the biotech company has a desire to do a tinnitus phase 2 study as its primary objective.

      There are obviously some delays due to the global pandemic. How much of a delay - no one knows. Hopefully, phase 2 starts this year still. That will NOT be for tinnitus. The PoC study has to be done first before they will consider spending the money for a clinical 2 study for the indication of tinnitus.
       
    10. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      First off, if I said "we are starting phase 2 studies" that was a miscommunication. Hough Ear Institute doesn't run the trials. The biotech company, Oblato, who has exclusive license to the drugs will be running them. The process has started for a phase 2 study. There is a lot to the process.

      It's best not to read into what is said. Context is important. Because the process is started, doesn't mean that we are already at a point of selecting candidates for the trials :) Sometimes I say we have started and "we" have, as in Oblato. Sometimes I say they haven't started because of the context - people are wanting to sign up. That part has not started.

      Does that make sense?
       
    11. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
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      FDA approval often leads to a fast track with other country's equivalent to the FDA.

      Also, it fits in our mission. We can purchase the drugs and through our humanitarian efforts - deliver it to those in most need. Our founder and doctors have been to over 80 countries offering their services and medicine for free. But we have to have FDA approval first.
       
    12. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      @ajc - Thaun cleared up your previous statement in this thread already. I suggest you go back and read it to see how you misinterpreted it.
       
    13. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
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      Cause of Tinnitus:
      My sister, and a firecracker
      There is more data for hearing loss (cochlear implant trauma, NIHL, ototoxicity) than for tinnitus. It has nothing to do with confidence. The PoC study costs $735K. Oblato is paying for $300K of it, the state of Oklahoma is paying for $300K of it. That leaves $135K for us to raise for it. I'd say a lot of scientists are pretty confident in the work. :)

      Your burning question is actually a false assumption - they are paying, for nearly half of it!
       
    14. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      PoC study will take a total of about 12 months. We should finish by next September. Then it will probably take some time, unknown, for Oblato to decide whether or not they want to run a phase 2 study for the pill for the indication of tinnitus as the primary objective.
       
    15. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      I don't take it personally. I do however take it professionally when someone accuses me personally and the staff/researchers at Hough Ear Institute as liars. I get people get frustrated. I get frustrated. Heck, you got frustrated with me. But while frustration is expressed, it was always civil.

      It is quite offensive to see someone make such comments based on their misunderstanding about a group of people who have dedicated their lives to restoring hearing. Hough Ear Institute is co-responsible for the Cochlear implant, many surgeries that recover hearing, a lot of tech in hearing aides, and now some of the first pharmaceutical treatments for hearing loss and tinnitus, hopefully!

      Thank you Rob. I do care. It's a Holiday weekend and I'm on my Mac responding to comments and helping to clear the air where it is muddy. I have tinnitus and it is getting worse. I also believe in this research and this team. I have put my money where my mouth is as I am one of the top 10 donors to Hough Ear Institute. I don't say that to brag, but to say I got skin in the game.

      I can say that we have received lots of donations thanks to the Tinnitus Talk community. I don't recall the largest donation amount, but I'm pretty sure it isn't over $500.

      The skin I have in the game is a top 5 figure gift. Again, not bragging - but I do care and I want this to be successful.
       
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    16. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Started September 1st. Yay!!!!!

      We will reach the rest of the goal before the end of the year hopefully!
       
    17. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Hi Deb! The PoC study takes a total of 12 months.
       
    18. 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 complicated. Frequency Therapeutics is doing good work. There are more than likely multiple causes of tinnitus. Their approach might be helpful. Our approach might be helpful.

      Our hope is to have a phase 2 study, not a phase 2a, with the primary objective in treating tinnitus. We will have results in 12 months.
       
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    19. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Yes, it is the secondary objective in a phase 2a study. Not a full phase 2 study. It involved less than 100 subjects. A phase 2 study involves hundreds of subjects.
       
    20. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      The process of a Phase II study and the actual phase 2 study are different, somewhat. The process begins with the study design, funding, securing the research company, etc. Then once all the information is ready to go, it is announced via clinicaltrials.gov.

      So, the process has started even though the actual phase 2 study is yet to be announced.
       
    21. Mentos

      Mentos Member Benefactor

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      03/2015
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      Do I read it correctly that Oblato will initiate the phase 2 already this year, not for tinnitus but for hearing restoration only?

      And the clinical trial for tinnitus could only start once the proof of concept has been finalized?

      If so, there would be room for off-label use for tinnitus even if tinnitus was not indicated in the clinical trial measures.
       
    22. AnxiouslyWaiting
      No Mood

      AnxiouslyWaiting Member

      Tinnitus Since:
      03/2020
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      Anxiety maybe?
      Thanks for the information @Justin De Moss.

      Were these studies done on human or animal subjects?

      I’m just curious if we have any human anecdotes on tinnitus and the Hough Pill. If not, hopefully we will have soon.
       
    23. urgentresearch
      Probing

      urgentresearch Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Unknown (possibly withdrawal-induced)
      Thank you for the additional context, @Justin De Moss.
       
    24. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      @Justin De Moss, just to clarify, when you said:

      "One difference between Frequency Therapeutics and Hough Ear Institute is that we hope to run a phase 2 study that has tinnitus as the primary goal/finding, not secondary. The second is objectively measuring results v. a self-report style which is extremely unreliable depending on sample size."

      You mean to contrast your proof of concept study from Frequency Therapeutics' study because you will be using things like gap detection to objectively measure tinnitus in rodents and not that Hough Ear Institute have developed an objective measure for tinnitus that can be used in humans, right? You won't be using an objective measure in your phase 2 study on humans or will you? Because that would be huge news if so!
       
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    25. weab00
      Alone

      weab00 Member Benefactor

      Location:
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      Tinnitus Since:
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      Cause of Tinnitus:
      music, concerts, whiplash; 08/20 H worsening
      I messaged the Hough Ear Institute on Facebook asking for an approximate timeline and they said 2026-2027. 6-7 years is such a long time to continue suffering, hopefully drugs like Pipeline Therapeutics or Otonomy will be out much sooner...

      198-EA21-F-1-FD3-443-F-B6-BB-2-E44-CB7-F58-A4.jpg
       
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    26. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
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      tmj music
      It has gone from 2024/25 to 2025/26 to 2026/27. Something seems questionable. It could be that different people have been saying different things on behalf of Hough Ear Institute which is just an unfortunate situation. It could be that there have been further delays which have not been clearly communicated.
       
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    27. paul mclean

      paul mclean Member

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      2018
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    28. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      I think it's very likely they will.

      Hough Ear Institute chose cochlear implant patients as their study population which means the study can't be carried out at routine ENT centers (like Pipeline Therapeutics and Otonomy) and would be way more subject to delays from COVID-19 etc.
       
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    29. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Firstly, @Justin De Moss, I would like to apologise if any negative experiences were had as a result of the previous posts. It was not my intention to attack you personally but rather simply discuss the matters relating to Hough Ear Institute's Pill treatment.

      I think that part of the confusion around my incorrect claim that a drug could not be used off-label had stemmed from reading dodgy information and/or misinterpreting facts.

      I had read papers which seemingly indicated that off-label use also included early access use. I later found out that this is wrong and not what the definition of off-label use according to the FDA guidelines is.
      I wouldn't disagree with you that a lot of scientists are confident in the work.

      What I would disagree with however is whether the "burning question" is a false assumption.

      The questions around Oblato's confidence in the Hough Ear Institute's Pill treating tinnitus have been raised multiple times on multiple different platforms and by multiple different people.

      I think that rightly or wrongly, the reason people questioned Oblato's confidence in the treatment is because they believed that the information disseminated by Hough Ear Institute to explain the reasons for needing to complete a proof of concept study for tinnitus and the reasons Hough Ear Institute needs to fund part of this study themselves have been confusing, lacking and also even contradictory at times. This has ultimately meant that they have felt that they have not got clear answers to these questions.

      I think that these concerns about Oblato's lack of confidence in the treatment have been further supported and fuelled by the fact that there have been situations where people have misinterpreted what Hough Ear Institute has said. Also there have been examples of Hough Ear Institute needing to correct and clarify what they have said as well.

      While I don't disagree that the more recently posted information indicates that the scientists are confident in the treatment and that the science supports this Pill delivering positive outcomes, this still doesn't seem to completely answer the two key questions of

      - First, why does Hough Ear Institute need to fund part of the Proof of Concept study?
      Since Oblato appear to be the sole financial beneficiary from the sale of the Pill and since scientists seem confident that the treatment stacks up, one can logically deduce that this should lead to Oblato being willing to cover the remaining costs of the proof of concept study. This is because Oblato will be the company who stands to financially benefit from the sales of this apparently successful treatment and should be able to recoup the costs of this study from sales.

      and

      - Second, why does a proof of concept study for tinnitus need to be completed when there is already more data and positive data to indicate that the treatment might pass trials for designations other than tinnitus?
      Wouldn't it just be simpler and also possibly faster to have this medicine approved for one of the other designations and then simply just allow it to be used off-label for tinnitus?

      I would also note, looking at the process from a business perspective, alarm bells ring and concerns are raised when I see something which on the face of it has an excellent business case and appears to be a solid product which is well supported by evidence, but yet does not have its development fully funded by the company who is ultimately going to be selling it. This is even more of an issue when there is a lack of direct and detailed information explaining why this is the case.

      In relation to Hough Ear Insitute's Pill, this tells me one of three things:

      - 1) A company other than Oblato is going to be benefiting financially from the sale of the Hough Ear Institute's Pill and this has not been clearly disclosed at this time.
      For example, this could be Hough Ear Institute themselves or it could be the medical company that Dr. Kopke is currently the chair of.

      Thus it could be interpreted that the reason Hough Ear Institute needs to fund outstanding costs associated with the development of the treatment (like this tinnitus proof of concept study) is because Hough Ear Institute is currently the undisclosed second company that will benefit from the sale of the treatment. Thus by contributing to the development, it enables Hough Ear Institute to retain part ownership of the treatment and therefore gain revenue from its sale.

      - 2) Oblato has concerns about the effectiveness of the Hough Ear Institute's Pill for the treatment of tinnitus and as a result requires proof that this is effective.
      There has been some further evidence given to alleviate concerns around the effectiveness of the treatment. However, the glaring issue still is why hasn't Oblato funded the outstanding balance for the proof of concept study for tinnitus if they are the ones who will financially benefit from its sale.

      - 3) There is some unexplained reason or reasons why Hough Ear Institute's Pill needs to go through multiple trial designations for FDA approval (which includes tinnitus trials).
      This is opposed to going through only one designation such as ototoxic medication treatment and then being used off-label for other possible uses such as tinnitus. There has been some further explanation as to why there needs to be a further phase 2 trial for tinnitus, however there is still no clarity as to why it must go down the full proof of concept study route, followed by the trial route for multiple designations.

      I believe that all three of these concerns have also been raised at various points by multiple people when discussing the Hough Ear Institute's Pill. Thus I strongly believe that also addressing these issues will alleviate many concerns that people have had with the information provided in relation to the various aspects of the treatment.
      Yes, I am well aware that the medicine trials completed in one country usually lead to the medicine being approved in some other countries. I know that this happens with Australia and America and vice versa for example.
      I will let Justin De Moss answer this, although from what I have seen and what has been posted, it appears that the Pill trials are potentially getting done for multiple designations and not just the cochlear implant designation.

      It also seems that based off of the information that has been previously posted about the clinical trial process that the pill might be taken through one designation or five designations depending upon what Oblato decides.

      It should also be noted that I don't think that Hough Ear Institute is taking the pill through the trials at all and that Hough Ear Institute is not deciding what designations it should be trialled for either. Rather that decision is left to Oblato.
       
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    30. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I have a bottle of 600 mg NAC in my cabinet.

      What’s the other drug? A salt? I don’t get it. Am I missing something? Aren’t there other ingredients in the Hough Ear Institute Pill?
       

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