Hough Ear Institute's Hair Cell Regeneration Project

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

    1. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      If I’m not better in 6 months and someone wants to do this with me, assuming it’s easier working in tandem, I volunteer to be one buyer. I have the money, I’m sure procuring the non-NAC component is another story.
       
    2. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      I have found sources for NPH-07 online.

      All the info you need is on Hough Ear Institute patents which I found while researching. In another study I found the max dose the Hough Ear Institute tested on patients was 1500 mg.

      https://www.freepatentsonline.com/y2018/0117115.html

      Here's a source for Disufenton Sodium. I am seriously thinking about doing this along with adding NGP-555 (oral gamma-secretase modulator) which also enhances synaptogenesis. I was thinking of getting 6 grams of Disufenton Sodium, same amount of NAC and 500 mg of NGP-555.

      Take 1500 mg of NAC and Disufenton Sodium each and 125 mg of NGP-555 for 4 days. All up will cost around $2300 - $2400.

      Starting to really struggle with tinnitus. My mother doesn't take my hearing loss seriously either and that it has caused me some difficult depression so I'm willing to give it a go.

      https://www.alibaba.com/product-detail/NXY-059-Disufenton-sodium-168021-79_60811961857.html
       
      • Like Like x 3
      • Hug Hug x 1
      • Informative Informative x 1
    3. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      I’m going to give my ears another few months - I am a little short of 2 months in, but I will very seriously consider this if I progress without improvement. I’m going to try a laser + fasting + time first.
       
    4. Born To Slay
      Depressed

      Born To Slay Member

      Tinnitus Since:
      10/2019
      Cause of Tinnitus:
      Loud concert
      Can you speak to the reliability of the source? It’s dramatically cheaper than everywhere else it seems.

      Also, I would’ve thought you’d need more then 1500 mg of NAC. Earlier in the thread it said 300 mg per kg of body weight.

      Overall though, good luck and do update us on any results.
       
    5. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      They might have been using the rodent mg/kg NAC dose but it's almost never directly scalable.
       
    6. Born To Slay
      Depressed

      Born To Slay Member

      Tinnitus Since:
      10/2019
      Cause of Tinnitus:
      Loud concert
      Makes sense. So how many grams of Disufenton sodium would be required in a human?
       
      • Good Question Good Question x 1
    7. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      I have been talking to them for a couple weeks. I have sourced peptides from similar biotech companies before for peptides like BPC-157 and it was good quality.

      Yes, I have read on the Hough Ear Institute's patent that 300 mg/300 mg per kg of body weight of NAC/NPH-07 was used but this was for mice.

      "To promote or enhance synaptogenesis and neuritogenesis, 2,4-DSPBN can be administered at a dose of, for example, between about 1 mg/kg to about 500 mg/kg body weight, or between about 5 mg/kg to about 400 mg/kg body weight, or between about 10 mg/kg to about 300 mg/kg body weight, or at about 10 mg/kg body weight, or at about 20 mg/kg body weight, or at about 50 mg/kg body weight, or at about 100 mg/kg body weight, or at about 150 mg/kg body weight, or at about 200 mg/kg body weight, or at about 250 mg/kg body weight, or at about 300 mg/kg body weight."

      "To promote or enhance synaptogenesis and neuritogenesis in a human subject, 2,4-DSPBN can be administered at a daily dose of, for example, between about 100 mg to about 20,000 mg, or between about 500 mg to about 10,000 mg, or between about 1,000 mg to about 5,000 mg, or at about 100 mg, or at about 200 mg, or at about 500 mg, or at about 1,000 mg, or at about 2,000 mg, or at about 3,000 mg, or at about 5,000 mg, or at about 8,000 mg, or at about 10,000 mg."​

      These parts of the patent suggest that 300 mg/300 mg isn't the only therapeutic dose. It suggests that even 100 mg of 2,4-DSPBN can have therapeutic benefit.

      I am at the stage where I am happy with the source but am unsure of what dosage and duration will facilitate meaningful results. Perhaps I will be surprised with the results and can go a second round with more of an idea.

      NGP-555 and 2,4-DSPBN both pass the blood brain barrier and blood cochlear barrier, much more than other substances. I also read in another patent that 2,4-DSPBN was actually used for drug delivery.

      Here is the patent:
      https://patents.justia.com/patent/20180256756

      So there is pure evidence that this works, the only problem I have is I am not rich enough to just throw 10s of thousands of dollars at this so I must be calculated with my approach.

      "Male Long-Evans pigmented rats with body weights between 360 and 400 g"​

      The doses they were given seems like absolute overkill considering it's 300 mg of NAC and NPH-07 per kg of body weight and these rats only weigh 360-400 grams.
       
      • Like Like x 2
    8. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      I forget where, but I remember reading in another thread that the dose from mice to humans was mentioned at 1/12 conversion.
       
    9. Brians81
      Gloomy

      Brians81 Member

      Location:
      Indiana
      Tinnitus Since:
      April 23 2020
      Cause of Tinnitus:
      Noise induce trauma
      I don't know if this question can be answered but, out of curiosity, how many decibels can the Hough Ear Institute pill help regain on one's audiogram? And is there any information on how much patients' tinnitus was reduced by?
       
    10. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Hough Ear Institute has said that their pill would apparently grow more than a normal amount of synapses based off of their lab work and so this would mean normal synapse function would return, a 15 dB hearing improvement as well as treat tinnitus too. The question is whether the tinnitus is treated by the additional compound put into the pill or whether the synapse treatment is what treats tinnitus. This is not yet known.

      The Hough pill is predominately a synapse treatment and as a result this has only a minimal benefit in hearing volume. The tinnitus question is so far unanswered as it is currently being tested on rats through the proof of concept study and human trials are yet to commence.

      It is very unlikely that the information provided by Hough Ear Institute would be wrong. They must be fairly confident it is accurate. Otherwise they would face criticism and possibly penalties from the FDA for making false comments about the treatment outcomes.
       
      • Like Like x 2
    11. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      "To promote or enhance synaptogenesis and neuritogenesis in a human subject, 2,4-DSPBN can be administered at a daily dose of, for example, between about 100 mg to about 20,000 mg, or between about 500 mg to about 10,000 mg, or between about 1,000 mg to about 5,000 mg, or at about 100 mg, or at about 200 mg, or at about 500 mg, or at about 1,000 mg, or at about 2,000 mg, or at about 3,000 mg, or at about 5,000 mg, or at about 8,000 mg, or at about 10,000 mg."​

      Who the hell wrote this? Also, it looks increasingly likely that I'm going to try this as my tinnitus is unceasing and I'm running out of time a bit...
       
    12. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Hough Ear Institute had an info/Q&A session today on Facebook. They didn’t talk about much other than to say that:

      - There would be delays to research and also possibly to clinical trials due to COVID-19

      - They mentioned that the pill improves hearing by 13-16 decibels, and helps with synapses and also tinnitus.

      - They suggested that it takes 2-4 years to run a phase 2 trial and phase 3 trial (hence the possible 7-year wait for release).

      - They also mentioned that the pill needs to be taken as a course. So I'm not sure if this means that you can take one pill and then subsequent pills until you obtain the optimum results or whether you need to take multiple pills to complete the course of treatment.

      Most interesting take away for me was the time it takes them to complete clinical trials and that you will need to have a course of pills.

      I think that four years to complete a phase 2 trial seems to be quite long especially when we compare this to the time other clinical trials have taken.

      Also if a bigger benefit is gained from taking more pills then this would be an interesting and highly beneficial development. It would be nice to obtain further clarity on this.
       
      • Informative Informative x 4
      • Like Like x 2
      • Helpful Helpful x 2
      • Good Question Good Question x 1
    13. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      Hough Ear Institute seem to be going much slower than Frequency Therapeutics.
       
      • Agree Agree x 3
    14. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      Isn't it because they made the decision to get involved with insurance, which means lots of additional research before human trials can even start?
       
      • Good Question Good Question x 2
    15. Born To Slay
      Depressed

      Born To Slay Member

      Tinnitus Since:
      10/2019
      Cause of Tinnitus:
      Loud concert
      I am shocked they’re not pushing to speed this up. Isn’t Otonomy pretty much doing the same thing with synapses and getting their drug out sooner?
       
    16. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member Podcast Patron Benefactor

      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      An improvement of 13-16 decibels is huge. Let's hope it really does.
       
      • Helpful Helpful x 1
    17. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      I want this to work more than anyone, but I find their chronic inability to meet relatively modest fundraising requirements a bit of a red flag, despite the rhetoric around patents and monetization.

      Anyone else think something is a bit fishy?
       
      • Agree Agree x 3
      • Like Like x 1
      • Useful Useful x 1
    18. NewLionel

      NewLionel Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      headphones
      Shouldn’t there be a race to get the first hearing drug one out to market? There seems to be a few drugs that are relatively close to market and Hough Ear Institute are going to take another 7 years with clinical trials?

      Something doesn’t add up here?
       
      • Agree Agree x 8
    19. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Yes this is correct. Current commentary suggests that insurance approval isn't guaranteed. Going off of the wordings used by Hough Ear Institute they have also used words such as 'may' when referring to their actual ability to obtain insurance cover.
      I am not 100% certain if their treatment is the same as Otonomy's. Otonomy's treatment is also targeting synapses, however the question is whether whatever additional compound Hough Ear Institute has mixed in to their treatment actually has any benefit or not. If this additional compound does assist with making Hough's treatment better then they are not the same.

      However from what we know both Hough Ear Institute's Pill and also Otonomy's injection theoretically will target synapses and also will presumably provide an identical amount of hearing gain in dB. The only outstanding question is if Otonomy's treatment provides tinnitus benefit too.
      I agree that this dB gain is substantial, especially when we theoretically know that the dB gain from synaptic treatments tends to be a lot lower than the gain from the hair cell based treatments. The biggest benefit would be if this treatment provided gains in the lower frequency areas as at present we know that these are the hardest to reach with hair cell based treatments. At least for now anyway.
       
      • Like Like x 1
    20. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member Podcast Patron Benefactor

      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      There has been plenty of doubt posted in the thread for sure. I must admit,
      I don't really understand why the relatively small amount of money that needs to still be found can't be found.

      Surely even one relatively rich businessman with bad tinnitus or hearing loss would fork up the money in an instant?

      At the same time, I want to believe that this drug is going to hit the market! I need to hang on to something.
       
      • Agree Agree x 5
      • Like Like x 1
    21. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      I agree re: needing hope and I’ve been in too much of a daze to think critically these past months, but it seems INSANE to me that these guys would have a way to restore synaptic connections and improve hearing and decrease tinnitus, and yet they have to scrounge for dollars to even get things off of the ground. I can almost guarantee something about this is not as rosy as they have portrayed...

      @Justin De Moss - with all due respect, why does investor/corporate enthusiasm seem so subdued for this pill? Surely you can see why someone might be skeptical. If the thing has the efficacy claimed, it would investable as a medical/humanitarian breakthrough, never mind profit seeking motives. Any philanthropist worth their salt would be chomping at the bit to fund the $700k buy-in or whatever relative pittance was mentioned.
       
      • Agree Agree x 6
    22. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      noise, whiplash; 08/20 H
      I want to see their revolutionary way of objectively measuring tinnitus volume.
       
      • Agree Agree x 2
      • Winner Winner x 1
    23. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I have a feeling that the biggest problem with Hough Ear Institute has to be the fact that there is likely to be apathy towards investing in their pill, unless these potential investors are actually going to obtain a return on their investment.

      I have donated some money to Hough Ear Institute myself, however I am actually potentially (and most likely) not going to get any major return for doing so. However the interest from a business group or a business person to donate might be somewhat non-existent also for the very fact that they will not gain any commercial benefit from doing so.

      Essentially a major element of contributing to and/or investing in pharmaceutical companies is to obtain a return on investment if the treatment is successful and can be sold. Since Hough Ear Institute has seemingly not been willing to agree to this, there is likely to be a real apathy to contributing when compared to privately operated companies who will offer potential revenue providing shares in exchange.

      I also wonder whether the fact the Hough Ear Institute's proof of concept study has been commenced has also actually inadvertently indicated that the outstanding amount for this study can be funded internally? I make this assessment on the basis that I do not believe that Hough Ear Institute would cut off the research work midway now that they have started it.

      I am not sure what the rules and operation criteria are for not-for-profits in American are, however in Australia it is possible to act and also operate as a not-for-profit company, while offering services for profit. This is seemingly the case with Hough Ear Institute as they are running the study/research, however the American pharmaceutical company who has rights to Hough Ear Institute's pill is Otologic Pharmaceuticals which would be headed up also by the Hough Ear Institute CEO.

      Clearly anyone with any business nose would wisely investigate the companies involved in the development and manufacturing of the treatment, identify the connections between these organisations and the individuals involved, and be able to work out what is being done in relation to the pill development and who is going to benefit from the treatment's sale.

      Therefore I can consequently assume that anyone who would consider investing in the research for this pill probably would not be interested. This would be for the simple fact that on face value, it appears that the set up of the pill's development and sale is somewhat loose and unclear. This is because someone cynical may believe that Hough Ear Institute and its not for profit identity may be getting used as a front for Otologic's operations. Therefore the money that they are donating is really going to be assisting Otologic Pharmaceutics. I am not saying this is happening, however this is a reasonable conclusion someone could come to, especially with the vagueness of the commercial operations setup that exists presently.

      Thus if Hough Ear Institute wants to garner further funding for the pill, then I would certainly suggest that they come out clearly and explain things openly and in good detail too. This particularly relates to connection between Hough Ear Institute and also Otologic Pharmaceuticals and also again why they simply don't take the treatment through trials now for one of the indications which has already gained enough data from research.
       
      • Like Like x 2
    24. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      Respectfully I disagree - the amount of money they have set as a target is so small, in light of the potential benefit, I think the argument that fundraising is a genuine challenge is spurious. You could go to non-profits, institutional investors, pharmaceutical companies, individual angel investors, or philanthropists - if they had a compelling pitch the amount of money at stake is very small. Something doesn’t seem quite right to me.

      I don’t work in this space but work adjacent to it, and what I do know tells me they should not[/BI] have to be raising individual crowd contributions - it’s very weird to me.
       
      • Agree Agree x 4
      • Informative Informative x 1
    25. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      To my knowledge, it's never been tested on humans, but mice I'm assuming. So all this 13-16 dB and improves tinnitus talk is speculation at this point.

      They are working on a proof of concept. There's nothing fishy about them. They're a non-profit. It costs a lot of money to do the testing.
       
      • Like Like x 1
      • Agree Agree x 1
    26. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      So how about you answer these questions?

      The medicine has already gotten both pharmaceutical agreements in place both in America and also globally with Otologic Pharmaceutics and Oblato, respectfully. Why would further pharmaceutical companies be willing to invest or why would the current companies be willing to relinquish some of their control over the medicine?

      Furthermore, why would anybody donate and/or invest to a not-for-profit organisation like Hough Ear Institute that seems to be disingenuously producing a for-profit product in this Pill when they are obtaining no financial return on their investment? The company in the US is directly connected to Hough Ear institute as the managers of both organisations are the same and therefore anyone with business nose would see this connection and have questions immediately.

      The fact that one can even raise the above questions about their business relationships to begin with raises legitimate concerns that Hough Ear Institute is using their not-for-profit status and also image to raise the funding for the development of the pill which in turn will yield profits for Otologic Pharmaceutics and Oblato when it is available.

      At this stage I would say forget asking questions about the benefit of the medicine, when the clear issue is with the business relationships. Right now anyone with business nose can see the disingenuous nature of Hough Ear Institute in their business operations. The business relationship questions need answering first before I would consider giving $100,000 to help fund their proof of concept work.

      I actually think that Hough Ear Institute can fund this internally but is trying not to. They're not going to ditch the study now that it has commenced.
       
      • Like Like x 1
    27. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      I basically agree.
       
      • Like Like x 1
    28. GBB

      GBB Member

      Location:
      NYC
      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Microsuction / Additional Acoustic Trauma in Close Proximity
      Isn’t the title of this thread wrong as it’s a synapse regeneration drug?
       
      • Agree Agree x 1
    29. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      You guys are saying what I said a while back. It's a red-flag that they are trying to panhandle crowdfunding style when a company like Frequency Therapeutics already has a stock ticker symbol.
       
      • Agree Agree x 3
    30. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Kind of. Hough also have a hair cell regeneration drug in pre-clinical but this thread has mostly discussed their pill, which is for synapses.
       
      • Informative Informative x 1

Share This Page

Loading...