Hough Ear Institute's Hair Cell Regeneration Project

[Justin De Moss]

@Justin De Moss

How will the current situation (coronavirus) affect your phase 2 trials?

So far, it won't. Doesn't look like it will slow the research down. However, and this is a big caveat: We are a non-profit and if funding slows down - as is likely with the economic slow down in process - I hope that we can keep the research moving forward at the current pace instead of slowing down.

Looking forward to getting back out there and meeting with people, inviting them to partner with us in this might endeavor to end hearing loss and tinnitus.

 

[Mentos]

That sure helps! That's why we are piloting a proof-of-concept study to show pharma companies that there is a model that can objectively test tinnitus. It is one of the major hurdles in getting drugs approved for the indication of tinnitus.

Can you disclose what the model is based on? Is it some form of brain scanning (like qEEG) or do you rather focus on the inner ear itself?

 

[all to gain]

The caveat to that is that Oblato is going to seek the indication(s) that are the most promising to get to the market. So Cochlear Implant Trauma is one of those, ototoxicity is another one. Tinnitus might be if we can get this proof of concept study going. They are interested in it for sure!

Could you explain why Cochlear Implant Trauma and ototoxicity are the most promising indiciations? Maybe you have said elsewhere, but I've missed it. I'm interested as you were calling it the Bomb Blast Pill originally, so I presumed its most promising indication would be acute hearing loss.

 

[Joly]

What is the difference between the Hough Ear Pill and OTO-413? They are both for synapses, one is a pill and the other is an ear injection.

In terms of efficacy, is it the same?

 

[Justin De Moss]

What is the difference between the Hough Ear Pill and OTO-413? They are both for synapses, one is a pill and the other is an ear injection.

In terms of efficacy, is it the same?

I'm not sure, they do sound very familiar but without knowing how the compound works and exactly what it is does it is very hard to compare. Additionally, without Phase II clinical results for both any comparison is purely a guess at this point.

 

[Justin De Moss]

Can you disclose what the model is based on? Is it some form of brain scanning (like qEEG) or do you rather focus on the inner ear itself?

I do not know. I will check and see what I can share.

 

[Justin De Moss]

Could you explain why Cochlear Implant Trauma and ototoxicity are the most promising indiciations? Maybe you have said elsewhere, but I've missed it. I'm interested as you were calling it the Bomb Blast Pill originally, so I presumed its most promising indication would be acute hearing loss.

It comes down to design. In clinical studies, it is important to be able to measure outcomes objectively. Since tinnitus is primarily subjective - it makes it more difficult to measure. This also makes the design of the study more costly while at the same time putting up more obstacles for a successful conclusion.

Obalto has asked HEI to continue to be a principal investigator in the research so we will continue working on various studies to help get the pill into the clinical and through the remaining clinical studies.

The pill was originally called the bomb blast pill. Primarily I'd say because scientists rarely have a knack for marketing and also because that was what we originally were studying. However, unlike most other drug development companies we pursued other possibilities as the data prompted. That when we found that it not only prevented hearing loss if administered within 24 hours of the trauma but would recover hearing as well if administered weeks later after the damage from the trauma had set in. Once again following the data, we thought it might be helpful in tinnitus. So we did studies on animals, a model (that cannot be replicated for humans), and found that it was successful for acute tinnitus and one study that measured chronic tinnitus! Again, following the data, we discovered that the drug also has some amazing effects on the build-up of toxic TAU proteins in the auditory nerve. It stopped it cold. This has implications for Alzheimer's, Parkinson's. ALS, and other neurodegenerative diseases.

The short answer is that it all comes down to research design that can control variables and be measured objectively.

 

[all to gain]

It comes down to design. In clinical studies, it is important to be able to measure outcomes objectively. Since tinnitus is primarily subjective - it makes it more difficult to measure. This also makes the design of the study more costly while at the same time putting up more obstacles for a successful conclusion.

Obalto has asked HEI to continue to be a principal investigator in the research so we will continue working on various studies to help get the pill into the clinical and through the remaining clinical studies.

The pill was originally called the bomb blast pill. Primarily I'd say because scientists rarely have a knack for marketing and also because that was what we originally were studying. However, unlike most other drug development companies we pursued other possibilities as the data prompted. That when we found that it not only prevented hearing loss if administered within 24 hours of the trauma but would recover hearing as well if administered weeks later after the damage from the trauma had set in. Once again following the data, we thought it might be helpful in tinnitus. So we did studies on animals, a model (that cannot be replicated for humans), and found that it was successful for acute tinnitus and one study that measured chronic tinnitus! Again, following the data, we discovered that the drug also has some amazing effects on the build-up of toxic TAU proteins in the auditory nerve. It stopped it cold. This has implications for Alzheimer's, Parkinson's. ALS, and other neurodegenerative diseases.

The short answer is that it all comes down to research design that can control variables and be measured objectively.

Thanks for the answer.

So can the pill repair damage to the auditory nerve in any way so it can become fully functioning again as if it were new?

 

[serendipity1996]

It comes down to design. In clinical studies, it is important to be able to measure outcomes objectively. Since tinnitus is primarily subjective - it makes it more difficult to measure. This also makes the design of the study more costly while at the same time putting up more obstacles for a successful conclusion.

Obalto has asked HEI to continue to be a principal investigator in the research so we will continue working on various studies to help get the pill into the clinical and through the remaining clinical studies.

The pill was originally called the bomb blast pill. Primarily I'd say because scientists rarely have a knack for marketing and also because that was what we originally were studying. However, unlike most other drug development companies we pursued other possibilities as the data prompted. That when we found that it not only prevented hearing loss if administered within 24 hours of the trauma but would recover hearing as well if administered weeks later after the damage from the trauma had set in. Once again following the data, we thought it might be helpful in tinnitus. So we did studies on animals, a model (that cannot be replicated for humans), and found that it was successful for acute tinnitus and one study that measured chronic tinnitus! Again, following the data, we discovered that the drug also has some amazing effects on the build-up of toxic TAU proteins in the auditory nerve. It stopped it cold. This has implications for Alzheimer's, Parkinson's. ALS, and other neurodegenerative diseases.

The short answer is that it all comes down to research design that can control variables and be measured objectively.

I would just like to say a massive thank you for coming on here and patiently answering all our queries. It's really heartening to see.

 

[BBakkers]

@Justin De Moss

Thank you for taking the time to answer all the questions really helpfull! Have a good day.

 

[Justin De Moss]

Thanks for the answer.

So can the pill repair damage to the auditory nerve in any way so it can become fully functioning again as if it were new?

The pill we are working on not only reconnects the inner hair cells to the auditory nerve but does so in a meaningful way. I'll try to find the research paper that showed the number of meaningful nerve connections made. There are three great pics that show a normal synapse, then one that has been damaged, then a third that received treatment. The one that received treatment has more nerve connections than the normal one!

This means hearing loss prevention, hearing recovery, better hearing acuity, and treatment/cure for tinnitus!

 

[Justin De Moss]

@Justin De Moss

Thank you for taking the time to answer all the questions really helpful! Have a good day.

You are most welcome! I suffer too, so while it is my job to care and help put a voice to people's values - this is very personal for me!

 

[Momme]

@Justin De Moss

Let's say if I were to get a treatment for FX-322, and it didn't help my tinnitus, would I still be able to get the Hough Ear Pill and could it help me?

 

[all to gain]

The pill we are working on not only reconnects the inner hair cells to the auditory nerve but does so in a meaningful way. I'll try to find the research paper that showed the number of meaningful nerve connections made. There are three great pics that show a normal synapse, then one that has been damaged, then a third that received treatment. The one that received treatment has more nerve connections than the normal one!

This means hearing loss prevention, hearing recovery, better hearing acuity, and treatment/cure for tinnitus!

Thanks.

A few more questions (some of which you may have already answered):

Is there any way that the Hough pill could be fast tracked by the FDA? Frequency Therapeutics has got their FX-322 fast tracked, so there is obviously interest in getting such drugs to the market.

Do you keep an eye on your competitors, i.e. Frequency Therapeatuics, Otonomy and Pipeline Therapeutics, to see how far along the pipeline they are? How do you feel you compare to them?

Since funding part of the study, has the DoD shown any interest in getting the pill out sooner rather than later, and if not, why not?

Like others have said, thank you very much for answering our questions. It is developments like Hough's that keep some of us motivated to fight the battle another day. Glad I started the thread and you started posting.

 

[WickedCarnival]

The pill we are working on not only reconnects the inner hair cells to the auditory nerve but does so in a meaningful way. I'll try to find the research paper that showed the number of meaningful nerve connections made. There are three great pics that show a normal synapse, then one that has been damaged, then a third that received treatment. The one that received treatment has more nerve connections than the normal one!

This means hearing loss prevention, hearing recovery, better hearing acuity, and treatment/cure for tinnitus!

Hi Justin! Have you been in contact with anyone from Frequency Therapeutics? As much as I understand there is competition in biotech markets, hearing loss and tinnitus are a devastating global phenomenon that may be better tackled with a collaborative effort. Sharing research between organizations in my opinion would help speed up things for the benefit of everyone.

Also, have you heard of Otomagnetics delivery methods of inner ear drugs? https://otomagnetics.net/about

 

[Justin De Moss]

@Justin De Moss

Let's say if I were to get a treatment for FX-322, and it didn't help my tinnitus, would I still be able to get the Hough Ear Pill and could it help me?

I really don't know. There are too many factors to be considered. Sorry.

 

[Justin De Moss]

Thanks.

A few more questions (some of which you may have already answered):

Is there any way that the Hough pill could be fast tracked by the FDA? Frequency Therapeutics has got their FX-322 fast tracked, so there is obviously interest in getting such drugs to the market.

Do you keep an eye on your competitors, i.e. Frequency Therapeatuics, Otonomy and Pipeline Therapeutics, to see how far along the pipeline they are? How do you feel you compare to them?

Since funding part of the study, has the DoD shown any interest in getting the pill out sooner rather than later, and if not, why not?

Like others have said, thank you very much for answering our questions. It is developments like Hough's that keep some of us motivated to fight the battle another day. Glad I started the thread and you started posting.

Yes, it is being fast-tracked. The hold up was funding Phase II and possibly III. That is no longer the issue.

I don't, but the researchers do keep up on the latest research. Each of them is approaching the problem from their own unique perspective. This is good because that means there are that many more chances that something will work and get approved. If we are super lucky, they will all be approved. This is good because hearing loss and tinnitus are different for everyone. Our pill might work for one set of patients, while the injection that Frequency Therapeutics is working on might work with another.

No, the DoD rarely funds clinical trials in Phase II and III.

 

[Justin De Moss]

Hi Justin! Have you been in contact with anyone from Frequency Therapeutics? As much as I understand there is competition in biotech markets, hearing loss and tinnitus are a devastating global phenomenon that may be better tackled with a collaborative effort. Sharing research between organizations in my opinion would help speed up things for the benefit of everyone.

Also, have you heard of Otomagnetics delivery methods of inner ear drugs? https://otomagnetics.net/about

We have not. Because of the competition, patents, and they are a for-profit v. a non-profit like us - there won't be any collaboration. Never will be. Our philosophies are entirely different. Our motivation is not money, it's you. A good example of that is how much I'm on here and the kind of response people have received from Hough Ear Institute. Others have shared that they haven't received anything like this from Frequency Therapeutics, or any other research firm.

I agree, sharing research would be ideal, but in the real world, it will rarely happen.

 

[WickedCarnival]

We have not. Because of the competition, patents, and they are a for-profit v. a non-profit like us - there won't be any collaboration. Never will be. Our philosophies are entirely different. Our motivation is not money, it's you. A good example of that is how much I'm on here and the kind of response people have received from Hough Ear Institute. Others have shared that they haven't received anything like this from Frequency Therapeutics, or any other research firm.

I agree, sharing research would be ideal, but in the real world, it will rarely happen.

Thank you for your response I really appreciate it! Although I am in a desperate position to jump with the first treatment that comes out, my core beliefs and views align with the models of non-profit organizations. Since I'm from Canada, I'm also curious about what the process would be like once you receive further FDA approval for additional trials and how that can be translated to getting treatment to both the U.S and Canada. I heard that if there is enough data and good results, Health Canada can expedite their process for breakthrough therapies as well, though I would need further information.

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?

 

[Jorge1984]

The pill we are working on not only reconnects the inner hair cells to the auditory nerve but does so in a meaningful way. I'll try to find the research paper that showed the number of meaningful nerve connections made. There are three great pics that show a normal synapse, then one that has been damaged, then a third that received treatment. The one that received treatment has more nerve connections than the normal one!

This means hearing loss prevention, hearing recovery, better hearing acuity, and treatment/cure for tinnitus!

Hi Justin I wanted to ask that I got tinnitus because of loud music do you know what type of damaged I did to myself? Also how will this help people who's tinnitus was caused because of excessive headphone/earphone use on loud volume?

 

[Mistertdog15]

Will Hough Ear Institute's pill benefit people with nerve damage or hair cell damage from ototoxic medication?

@Justin De Moss

 

[Artemis2K]

Hi Justin I wanted to ask that I got tinnitus because of loud music do you know what type of damaged I did to myself? Also how will this help people who's tinnitus was caused because of excessive headphone/earphone use on loud volume?

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.

 

[Artemis2K]

I still find it really astonishing that a pill would do so much good. It's a shame that so much work has to go into them and that they're not a natural thing. Would love to just be able to just grab it at a grocery store lol.

 

[FGG]

Will Hough Ear Institute's pill benefit people with nerve damage or hair cell damage from ototoxic medication?

@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.

 

[hans799]

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!

 

[Jorge1984]

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.

Wow you answered my questions that other people haven't been able too also it doesn't feel like I lost hearing so I bet I have hidden hearing lost. thank you so much I hope their pill is a success

 

[Artemis2K]

Wow you answered my questions that other people haven't been able too also it doesn't feel like I lost hearing so I bet I have hidden hearing lost. thank you so much I hope their pill is a success

I'm confident it works. It's just a matter of funding, though thankfully things seem to be okay now.

 

[ASilverLight]

I'm just wondering how likely this is to work if you have no measurable/detectable hearing loss and don't appear to have hidden hearing loss? I don't show or struggle with any of the defining characteristics of hidden hearing loss. I am aware there may still be damage that I am not aware of.

This is more of a general question too, but how many of these treatments will bring relief to people who may have inexplicable tinnitus, or tinnitus through other issues (like neck problems)?

 

[FGG]

I'm just wondering how likely this is to work if you have no measurable/detectable hearing loss and don't appear to have hidden hearing loss? I don't show or struggle with any of the defining characteristics of hidden hearing loss. I am aware there may still be damage that I am not aware of.

This is more of a general question too, but how many of these treatments will bring relief to people who may have inexplicable tinnitus, or tinnitus through other issues (like neck problems)?

Hidden hearing loss will only show up as speech in noise issues if it affects enough important speech frequencies. Unfortunately, there isn't great testing for it.

Extended audiograms are better for detecting "measurable" hearing loss due to hair cell loss and tinnitus is often at these higher frequencies.

Noise can cause either synaptopathy or hair cell loss but the synapses tend to be more sensitive. You can also have both and have a normal standard audiogram.

These regenerative treatments will only treat cochlear causes. So neck and jaw related tinnitus won't be helped but there are treatments that directly help those (and possibly indirect treatments with things like better bimodal stimulation).

 

[ASilverLight]

Hidden hearing loss will only show up as speech in noise issues if it affects enough important speech frequencies. Unfortunately, there isn't great testing for it.

Extended audiograms are better for detecting "measurable" hearing loss eu3 to hair cell loss and tinnitus is often at these higher frequencies.

Noise can cause either synaptopathy or hair cell loss but the synapses tend to be more sensitive. You can also have both and have a normal standard audiogram.

These regenerative treatments will only treat cochlear causes. So neck and jaw related tinnitus won't be helped but there are treatments that directly help those (and possibly indirect treatments with things like better bimodal stimulation).

Thanks, that's about what I figured. Everyone has a degree of hearing loss naturally, I have no issue with speech etc in noise besides what one would consider normal. I suppose there may be some hearing loss in the higher frequencies that is too minor to detect, but I genuinely have no hearing issues that I am aware of.

I wish I could get better treatment for my neck issues but it's impossible right now and worrying me a lot. I do wonder if bimodal stimulation is going to be useful if my noises are hard to match to frequencies but I haven't read into it enough.

Anyway, I won't derail this topic too much. I do hope this, or any pill, may restore whatever damage has been done which will hopefully quieten things some if treating my neck doesn't. Thanks for your response!