Hough Ear Institute's Hair Cell Regeneration Project

[MRItechssuck]

With the 1800 mg of NAC, I have also been taking between 1000-3000mg of Turmeric (no difference), 300 mg of TRU Niagen a day (only the last 6 months), B complex vitamin, Astaxanthin (a saint on here took it) but I had to stop that because it seemed to worsen things a bit.

Was the FDA going to reclassify NAC as a controlled medicine? I thought I read that.

I'm not familiar with NPH-07 (2,4-DSPBN)...

Maybe there will be a miracle pill in the future, but there have been too many disappointments.

 

[tommyd87]

With the 1800 mg of NAC, I have also been taking between 1000-3000mg of Turmeric (no difference), 300 mg of TRU Niagen a day (only the last 6 months), B complex vitamin, Astaxanthin (a saint on here took it) but I had to stop that because it seemed to worsen things a bit.

Was the FDA going to reclassify NAC as a controlled medicine? I thought I read that.

I'm not familiar with NPH-07 (2,4-DSPBN)...

Maybe there will be a miracle pill in the future, but there have been too many disappointments.

I reckon right now there is no real reason to be taking NAC solo or other medication for that matter either. There's something telling me that these medicines firstly don't work solo and secondly there is probably something done with the way Hough Ear Institute has made up their mix which supposedly makes it work.

 

[Justin De Moss]

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.

I can't speak for Oblato, but I can share with you what they have shared with us. They intended on starting phase 2 trials this year. They would still like to. However, there is a global pandemic that is effecting ALL research right now at the clinical trial level. We are still doing our part at the pre-clinical level to help usher in the treatment.

Yes, once approved you can take it for anything a doctor is willing to prescribe it for. The question then comes to whether or not insurance will cover it. That is why having it approved for the indication of tinnitus is so important - to make it more affordable to more people.

This is why NGOs are on the frontier of innovation in drug development. Generally speaking, their treatments are less expensive when they get to the market.

 

[Justin De Moss]

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.

PoC studies are not done on humans. The hope is to get it into a phase 2 clinical trial.

 

[Justin De Moss]

@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!

We have developed a novel way to objectively measure the presence of tinnitus.

The phase II study with our pill, it is hoped, will be for the primary indication of tinnitus.

 

[Justin De Moss]

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.

I don't think we have ever said 2024. If so, that would have been an error. We have consistently said mid-2020's. However some people thought that meant mid-2020, not 2020s - as in the decade. So we started messaging that it is hoped to be in the market 2025/26.

With the global pandemic and its effects on clinical trials for everything - I feel it best to say 2026/27 because of the delays related to the pandemic.

We don't run the trials, the biotech company does.

 

[Justin De Moss]

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.

We didn't choose cochlear implant trauma. Which indication they (the biotech firm) choose is still in the air right now.

The delays in clinical research has to do with the pandemic, and less with what indication is chosen.

 

[ajc]

We have developed a novel way to objectively measure the presence of tinnitus.

Presence of tinnitus?

As in binary 1 and 0?

Are you able to objectively rate the loudness of tinnitus?

And why do you keep this info hidden?

Many other companies and researchers would benefit from being able to have access to objective measurement of tinnitus.

Share the knowledge. If you are the good not-for-profit guys you claim to be...

 

[paul mclean]

Justin,

Any chance of your drug being fast tracked like FX-322 was? And how long does fast tracking take off time to hit shelves?

Funny, I was just watching a video with you in it explaining the FDA approval process.

 

[FGG]

We have developed a novel way to objectively measure the presence of tinnitus.

Is this a novel way that is applicable to just rodents (i.e. tells you whether they do or don't have tinnitus) or is it applicable to humans too?

And is it more descriptive than a binary yes or no? I.e. does it measure severity?

We didn't choose cochlear implant trauma. Which indication they (the biotech firm) choose is still in the air right now.

The delays in clinical research has to do with the pandemic, and less with what indication is chosen.

Understood, but Frequency Therapeutics has said the reason COVID-19 only delayed their trial slightly (a few months) was because they are able to carry their studies in outpatient ENT clinics which remain open and at capacity so, in that sense, indication seems to be a factor because they probably couldn't have done that if their study population was undergoing surgery.

 

[tommyd87]

We have developed a novel way to objectively measure the presence of tinnitus.

The phase II study with our pill, it is hoped, will be for the primary indication of tinnitus.

There are three questions I have which relate to your comment about the phase 2 study.

1. Out of interest, is Hough Ear Institute the party hoping tinnitus will be the primary indication for the phase 2 clinical trial of the pill?

2. What do you mean when you use the term primary indication and what does this mean in the context of clinical trials?

3. If tinnitus is the primary indication for the clinical trial, what effect does this have on the other potential indications (like ototoxicity) which the pill could be put through clinical trials for too?

I don't think we have ever said 2024. If so, that would have been an error. We have consistently said mid-2020's. However some people thought that meant mid-2020, not 2020s - as in the decade. So we started messaging that it is hoped to be in the market 2025/26.

With the global pandemic and its effects on clinical trials for everything - I feel it best to say 2026/27 because of the delays related to the pandemic.

We don't run the trials, the biotech company does.

This makes much more sense now regarding the timeline. The mid 2020/mid 2020s issue I was aware of and I knew it was the latter.

I absolutely understand why we would possibly have setbacks and also delays with what is going on currently.

 

[Born To Slay]

This is interesting. So this Hough Ear Institute pill is just a super high dose of NAC mixed with Disufenton Sodium? That doesn't sound that hard to mix together to be honest, just grind up the necessary dose of NAC and Disufenton Sodium and drink it.

Is it as simple as it sounds?

 

[FGG]

This is interesting. So this Hough Ear Institute pill is just a super high dose of NAC mixed with Disufenton Sodium? That doesn't sound that hard to mix together to be honest, just grind up the necessary dose of NAC and Disufenton Sodium and drink it.

Is it as simple as it sounds?

Totally doable if you have many thousands of dollars to spare.

 

[Born To Slay]

Totally doable if you have many thousands of dollars to spare.

Do we know yet if this is a pill you have to take regularly? Or would one dose be sufficient?

 

[GBB]

Totally doable if you have many thousands of dollars to spare.

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.

 

[paul mclean]

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

 

[GBB]

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

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.

 

[Born To Slay]

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

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.

 

[FGG]

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.

They might have been using the rodent mg/kg NAC dose but it's almost never directly scalable.

 

[Born To Slay]

They might have been using the rodent mg/kg NAC dose but it's almost never directly scalable.

Makes sense. So how many grams of Disufenton sodium would be required in a human?

 

[paul mclean]

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.

 

[GBB]

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.

I forget where, but I remember reading in another thread that the dose from mice to humans was mentioned at 1/12 conversion.

 

[Brians81]

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?

 

[tommyd87]

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?

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.

 

[GBB]

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.

"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...

 

[tommyd87]

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.

 

[paul mclean]

Hough Ear Institute seem to be going much slower than Frequency Therapeutics.

 

[weab00]

Hough Ear Institute seem to be going much slower than Frequency Therapeutics.

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?

 

[Born To Slay]

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.

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?

 

[all to gain]

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.

An improvement of 13-16 decibels is huge. Let's hope it really does.