Hough Ear Institute's Hair Cell Regeneration Project

[Tweedleman]

A technical question I have would be on the pill delivery method. How does enough of the drug in the capsule get from the bloodstream into the inner ear in order to deliver enough molecules to trigger the desired response?

This is what I'm wondering too. As I understood it, the BLB (blood-labyrinth barrier) is the big obstacle for delivering medicine vascularly to the inner ear.

https://stm.sciencemag.org/content/11/482/eaao0935

@Justin De Moss How does the Hough Pill overcome this?

 

[Justin De Moss]

The pill does not address hair cell damage. If you had synaptic damage, I'm not sure the cause would matter but maybe @Justin De Moss knows something we don't.

Our pill regenerates meaningful nerve connections between the cochlea and the auditory nerve.

Our hearing restoration injection regenerates the hair cells in the inner ear.

 

[Justin De Moss]

I think I can answer that. Excessive noise can burn out the synaptic ribbons in the ear, which is believed to be associated with hidden hearing loss (difficulty in understanding words in background noise), as well as tinnitus. The pill would regenerate that. If I recall correctly, it would also supposedly regenerate some regular hearing as well, but only slightly, like an "earmuff" worth, which I believe would be around 5-10 dB.

Unfortunately, the pill would not regenerate the noise damage done to hair cells. That's where the other drug they are working on comes in.

A little more like 10-15 dB It Sounds like we might have found another spokesperson!

I am very grateful for all of your questions, support, and your desire to end tinnitus!

 

[Justin De Moss]

From one perspective, it's incredibly frustrating that this already exists but I just can't get to it.

However... from another perspective, it's incredibly relieving that this already exists here in this physical reality, and is no longer just an idea on a drawing board which may or may not work. In an earlier thread, someone was imagining a future where tinnitus is like many illnesses today... you think to yourself "it sure must have sucked a hundred years ago when this had no treatment" as you walk to the pharmacy to get your pills which will cure you in a few days. Maybe this future is closer than we think!

Thanks for all you do @Justin De Moss!

You are most welcome! Thank you for your support.

 

[FGG]

Our pill regenerates meaningful nerve connections between the cochlea and the auditory nerve.

Our hearing restoration injection regenerates the hair cells in the inner ear.

Thanks but, just to clarify, my comment-question was about whether the cause of synaptic loss matters, not what the pill vs the injection treats.

 

[WickedCarnival]

Our pill regenerates meaningful nerve connections between the cochlea and the auditory nerve.

Our hearing restoration injection regenerates the hair cells in the inner ear.

Since I am not able to access clinical extended high frequency audiograms up to 16kHz, I can only guess that my tinnitus plus ear fullness (verified no physical blockage, wax, nor fluid) is due to damage of the synapses that are attached to high frequency detecting hair cells near the base of the cochlea, but possibly not hair cell death since I can still hear up to 17kHz at my age of 30: https://www.audiocheck.net/audiotests_frequencycheckhigh.php

I'm very responsible with noise exposure in my life and my tinnitus was caused by an ototoxic antibiotic which I don't know if if affected the synapses or hair cells.

If it becomes available, could I still take both treatments at the same time and have no adverse effects and possibly a slight improvement beyond 16kHz? I would prefer that for best results because again, nowhere in my area tests hearing up to 16kHz and and I'm a little concerned that under-educated clinicians would say my hearing is fine when they only test up to 8kHz.

 

[Artemis2K]

A little more like 10-15 dB It Sounds like we might have found another spokesperson!

I am very grateful for all of your questions, support, and your desire to end tinnitus!

Even better! That's a huge relief to hear.

Yoooo, y'all hiring? xD

 

[Daniel Lion]

This is what I'm wondering too. As I understood it, the BLB (blood-labyrinth barrier) is the big obstacle for delivering medicine vascularly to the inner ear.

https://stm.sciencemag.org/content/11/482/eaao0935

@Justin De Moss How does the Hough Pill overcome this?

Hello @Justin De Moss, thanks for checking in.

The above question in quotes is very special to me. Looking forward to your response.

Take care, and thanks again.
Daniel

 

[Jorge1984]

@Justin De Moss how will we test for the synapse disconnection or is that something you guys are trying to figure out?

 

[Justin De Moss]

Thanks but, just to clarify, my comment-question was about whether the cause of synaptic loss matters, not what the pill vs the injection treats.

Ah ha. Sorry about that. I don't believe the cause of the nerve damage matters because the pill has been shown to work with blast-induced trauma, sound-induced trauma, cytotoxicity, etc.

 

[Justin De Moss]

Since I am not able to access clinical extended high frequency audiograms up to 16kHz, I can only guess that my tinnitus plus ear fullness (verified no physical blockage, wax, nor fluid) is due to damage of the synapses that are attached to high frequency detecting hair cells near the base of the cochlea, but possibly not hair cell death since I can still hear up to 17kHz at my age of 30: https://www.audiocheck.net/audiotests_frequencycheckhigh.php

I'm very responsible with noise exposure in my life and my tinnitus was caused by an ototoxic antibiotic which I don't know if if affected the synapses or hair cells.

If it becomes available, could I still take both treatments at the same time and have no adverse effects and possibly a slight improvement beyond 16kHz? I would prefer that for best results because again, nowhere in my area tests hearing up to 16kHz and and I'm a little concerned that under-educated clinicians would say my hearing is fine when they only test up to 8kHz.

Sorry, I really don't know how to answer this. I have passed on the question to one of our researchers. They may take a bit to get back to me with all the COVID stuff and precautions we are having to take to ensure the safety of our researchers, and that the research continues!

 

[Justin De Moss]

@Justin De Moss how will we test for the synapse disconnection or is that something you guys are trying to figure out?

I'm not sure about the design study. I don't get that deep into it. I'll ask and see what they say.

 

[Ozwel]

Hi Justin, thanks for the excellent communication with all the members here.

I was being curious: do you plan to test it on yourself anytime soon? Or maybe have you already done that?

I'm not sure if the pill is still under improvement or if it's just being tested on trial common phases.

 

[all to gain]

Hi Justin, thanks for the excellent communication with all the members here.

I was being curious: do you plan to test it on yourself anytime soon? Or maybe have you already done that?

I'm not sure if the pill is still under improvement or if it's just being tested on trial common phases.

Even if he has tested it on himself, I very much doubt he would tell us. Probably outside of the rules and regs.

 

[Piney]

Good afternoon,

Since the clinical trials are funded, when can people expect the upcoming trial?

Will there be any locations listed in the Tri state area NY, NJ, PA?

 

[Daniel Lion]

This is what I'm wondering too. As I understood it, the BLB (blood-labyrinth barrier) is the big obstacle for delivering medicine vascularly to the inner ear.

https://stm.sciencemag.org/content/11/482/eaao0935

@Justin De Moss How does the Hough Pill overcome this?

Hello @Justin De Moss, thanks for checking in.

The above question is very special to me. Looking forward to your response.

Take care, and thanks again.
Daniel

 

[xyz]

In the title of the paper on the Hough pill it states "acute acoustic trauma". However in the paper it is also stated that chronic cases have recovered. Was there done an animal test with chronic cases? Most on here at Tinnitus Talk probably belong to the chronic category, so it would be important to know if the pill should also work for the ones where the ear injury lies somewhat in the past.

https://houghear.org/wp-content/upl...-cochlea-induced-by-acute-acoustic-trauma.pdf

How do you came up to use the compound HPN07? Is it already used in another pill for another patient group and it was observed that it also improves hearing and tinnitus or is it something brand new? In the paper I read that HPN07 was already used in a phase III trial for stroke patients so it seems to at least be well tolerated.

 

[Lucifer]

In the title of the paper on the Hough pill it states "acute acoustic trauma". However in the paper it is also stated that chronic cases have recovered. Was there done an animal test with chronic cases? Most on here at Tinnitus Talk probably belong to the chronic category, so it would be important to know if the pill should also work for the ones where the ear injury lies somewhat in the past.

https://houghear.org/wp-content/upl...-cochlea-induced-by-acute-acoustic-trauma.pdf

How do you came up to use the compound HPN07? Is it already used in another pill for another patient group and it was observed that it also improves hearing and tinnitus or is it something brand new? In the paper I read that HPN07 was already used in a phase III trial for stroke patients so it seems to at least be well tolerated.

Did they release the stroke drug into the market? We might be able to take both HPN07 + NAC right now to restore synapses.

 

[MrCrybaby]

Did they release the stroke drug into the market? We might be able to take both HPN07 + NAC right now to restore synapses.

No, it was not released because it was ineffective.

 

[xyz]

Did they release the stroke drug into the market? We might be able to take both HPN07 + NAC right now to restore synapses.

HPN07 seems very hard to obtain. Seems like @JohnAdams already did some research into this

Well, I found a mutual contact with a research lab that offered to buy some HPN-07 and mail it to me, BUT upon further examination we discovered that it has to be stored at -20 C. The only way to keep that temperature as far as I know is with dry ice, and you cannot put that in a closed container because it will explode the container.

Any ideas?

However we know nothing about dosage, so probably we have to wait until phase II is over and has proven efficacy. Maybe the pill will then be opened up for compassionate use.

 

[all to gain]

HPN07 seems very hard to obtain. Seems like @JohnAdams already did some research into this


However we know nothing about dosage, so probably we have to wait until phase II is over and has proven efficacy. Maybe the pill will then be opened up for compassionate use.

@Justin De Moss
I'm really interested to know what dosage of NAC they use in the pill. Maybe top secret though

A thread was started asking whether someone could make their own Hough Pill: https://www.tinnitustalk.com/thread...0-hough-ear-institutes-bomb-blast-pill.39589/

 

[Chriscom]

HPN07 seems very hard to obtain. Seems like @JohnAdams already did some research into this


However we know nothing about dosage, so probably we have to wait until phase II is over and has proven efficacy. Maybe the pill will then be opened up for compassionate use.

This does't have much to do with the main point here, but there's a comment about how getting down to -20C for storage requires dry ice. That doesn't appear to be so. In my search for a small home freezer, since they're hard to get a hold of right now, I started stumbling across medical-grade freezers and one of their selling points is having that capability. Did a quick search again right now for "medical freezers" and in the medical freezer biz that appears to be as common as power steering in a car.

 

[Piney]

I guess that was a dumb question, when is the clinical trial going to be open? Proof of concept is the reason maybe?

 

[Lucifer]

I guess that was a dumb question, when is the clinical trial going to be open? Proof of concept is the reason maybe?

I don't think it will happen anytime soon due to COVID-19. If they started around the same time as FX-322 Phase 2a trial they could have been halfway by now.

Still have no clue why it took them 5 years to get additional funding when they were already done with Phase 1 trials in 2015. They could have been in Phase 3 or releasing the drug out in the market by now.

 

[Piney]

I see it the other way, all these companies have are excuses. If safety passed and money is already in place and there are more FDA staff working then what's the delay? ENTs who probably get paid to host the trial aren't working during COVID-19. I think it's the optimal time to get paperwork through. Meanwhile the bottle sits on the shelf, or the sound stimulation machines cost $2500 and no ones cured. If you claim to have the answer, put it out.

 

[Rb86]

From a recent email with Hough Ear Institute:

"Great to hear from you! I'm sorry you are still suffering. I got sick early on during the COVID pandemic and my tinnitus, because of an antibiotic, got as bad as you and many others described. While I believe I was empathetic before, I now have first-hand knowledge and experience of how life altering it can be.

COVID hurt us from a fundraising perspective, but we are moving forward. I just met with a donor who is considering a gift of $5,000 for our tinnitus proof of concept study. What interests him the most is that it gives us an objective way to measure the effectiveness of the treatment. Unlike Frequency's Phase 2, which has a secondary objective in measuring tinnitus – through self-report data, we are trying to make it a primary objective to a Phase II study. What's more, even if the pill ends up not being effective – our new objective measuring of tinnitus will allow and encourage more research for tinnitus itself!

Oblato is still very interested in this and our OCAST grant is looking very promising.

Be assured I'm working as hard as I can to get us a treatment!

At your service,
JUSTIN DE MOSS, M.A., CFRE
Chief Philanthropy Officer"

 

[Justin De Moss]

Even if he has tested it on himself, I very much doubt he would tell us. Probably outside of the rules and regs.

No, I have not. I cannot because 1) it wouldn't be ethical, 2) it would jeopardize the research and the ability to get the drug delivered to help everyone.

 

[Justin De Moss]

Good afternoon,

Since the clinical trials are funded, when can people expect the upcoming trial?

Will there be any locations listed in the Tri state area NY, NJ, PA?

That's the rub and it is a little more complicated. I've explained it in previous posts but here is the short-short version:

1. Obalto has told us they hope to start trials this year.
2. With COVID-19 - I would assume that means some delay.
3. We have continued our research despite COVID-19.
4. Fundraising is down for obvious reasons.
5. We are starting to see movement on our peer to peer fundraising campaign for the tinnitus proof.
6. Oblato will test the indications that give it the highest chance of success (Cochlear implant trauma, cytotoxicity, hearing loss, etc.
7. The challenge with tinnitus as an indication is that there is currently no objective way to measure tinnitus, sort of!
   1. Frequency's trial has tinnitus as a secondary objective and is using self-report data.
   2. That is a very strong limitation to the study and may end up not helping get the drug approved for tinnitus or even get the drug approved in the first place.
   3. This is why having an objective method of testing for tinnitus is so important.
8. That is why we are trying to run a proof of concept study to prove our method of objectively tested tinnitus treatments.
   1. This will be helpful for all researchers - even if our pill doesn't work, if we are successful in objectively measuring tinnitus - other drugs can be tested and put through the process very quickly with solid empirical results.
9. Phase II studies for our pill with tinnitus will NOT happen until we can run this proof of concept study.
   1. Full disclosure - even if we do the study there is no guarantee that it will work or that the pill will work either, nor that Oblato will do a Phase II for tinnitus.
   2. However, it is unlikely if we are successful that Oblato would NOT want to run it through a tinnitus Phase II.

 

[Justin De Moss]

Hello @Justin De Moss, thanks for checking in.

The above question is very special to me. Looking forward to your response.

Take care, and thanks again.
Daniel

I mentioned it in a previous post. I'll try to find it and re-post it. If I can't I'll get back with the researchers. They know the answer like the back of their hand, whereas I do not and I don't want to mislead you.

 

[Justin De Moss]

In the title of the paper on the Hough pill it states "acute acoustic trauma". However in the paper it is also stated that chronic cases have recovered. Was there done an animal test with chronic cases? Most on here at Tinnitus Talk probably belong to the chronic category, so it would be important to know if the pill should also work for the ones where the ear injury lies somewhat in the past.

https://houghear.org/wp-content/upl...-cochlea-induced-by-acute-acoustic-trauma.pdf

How do you came up to use the compound HPN07? Is it already used in another pill for another patient group and it was observed that it also improves hearing and tinnitus or is it something brand new? In the paper I read that HPN07 was already used in a phase III trial for stroke patients so it seems to at least be well tolerated.

Your first question: Because we have done additional studies to show that it appears to be effective in chronic cases.

Second question: Yes, it was developed for stroke patients as well as Glioblastoma. It didn't work for stroke, but it did for Glioblastoma.