Hough Ear Institute's Hair Cell Regeneration Project

[GBB]

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

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?

 

[NewLionel]

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?

 

[tommyd87]

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?

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 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?

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.

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

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.

 

[all to gain]

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?

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.

 

[GBB]

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.

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.

 

[weab00]

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.

I want to see their revolutionary way of objectively measuring tinnitus volume.

 

[tommyd87]

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.

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.

 

[GBB]

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.

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.

 

[Rb86]

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.

 

[tommyd87]

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.

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.

 

[GBB]

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.

I basically agree.

 

[GBB]

Isn't the title of this thread wrong as it's a synapse regeneration drug?

 

[GlennS]

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 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.

 

[FGG]

Isn't the title of this thread wrong as it's a synapse regeneration drug?

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.

 

[all to gain]

Isn't the title of this thread wrong as it's a synapse regeneration drug?

Yeah, when I made the thread I had no idea about the drug really, just that it wasn't getting much attention. I presume the mods could change the name if they wanted.

 

[tommyd87]

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.

It is incredibly obvious that they are trying the panhandle route. There's also something that they are not letting up about this either.

 

[weab00]

It is incredibly obvious that they are trying the panhandle route. There's also something that they are not letting up about this either.

Yeah like why does Justin De Moss selectively answer questions when he pops in the thread once every few months?

He clearly scrolls by 10 people all asking how do you measure tinnitus objectively, why are you crowdsourcing donations, etc. but instead ignores them which arises suspicions.

 

[tommyd87]

Yeah like why does Justin De Moss selectively answer questions when he pops in the thread once every few months?

He clearly scrolls by 10 people all asking how do you measure tinnitus objectively, why are you crowdsourcing donations, etc. but instead ignores them which arises suspicions.

Not to mention the fact that there still isn't a clear answer as to why they need to take this through the tinnitus indication first and not through the other indications like ototoxic medication impact even though this data is available now.

If this medicine is the only option and also it does prove itself to work then great. However at this time I am actually wondering whether we will see something else surpass it like PIPE-505 that seemingly also might do some similar stuff? This lack of transparency is interesting and also probably the reason some people do not have much faith in it.

 

[tommyd87]

So it seems that based off of the latest Hough Ear Institute post that their medicine most likely is a synapse drug doing the same things that OTO-413 and PIPE-505 are purportedly doing.

I definitely do think that the only things which seem different about their methodology is to try to test specifically for tinnitus.

 

[weab00]

So it seems that based off of the latest Hough Ear Institute post that their medicine most likely is a synapse drug doing the same things that OTO-413 and PIPE-505 are purportedly doing.

I definitely do think that the only things which seem different about their methodology is to try to test specifically for tinnitus.

What will the advantage of Hough Ear Institute's Pill be if OTO-413 comes out several years before they even hit the market? Pricing?

 

[Lucifer]

So it seems that based off of the latest Hough Ear Institute post that their medicine most likely is a synapse drug doing the same things that OTO-413 and PIPE-505 are purportedly doing.

I definitely do think that the only things which seem different about their methodology is to try to test specifically for tinnitus.

Another difference is that Hough Ear Institute's synapse drug is a tablet whereas PIPE-505 is an injection. I wonder what the side effects of these synapse drugs will have between a pill and an injection.

 

[tommyd87]

What will the advantage of Hough Ear Institute's Pill be if OTO-413 comes out several years before they even hit the market? Pricing?

I'd assume a successful PIPE-505 or OTO-413 would be able to possibly charge a higher price if they had less treatments to compete against and therefore they would benefit from being the first available.

I can't see that there would be any benefit for Hough Ear Institute if they released their treatment after Pipeline or Otonomy on account of the fact that they are really just another option to treat synapse regrowth. Right now it seems that their treatment is no different to the others and also at this stage there tends to be no indication that they will do anything more for tinnitus either. The only benefit might be that this treatment from Hough Ear Institute can be used to treat tinnitus through insurance, as apparently this is a possible benefit from their Proof of Concept trial. Though this benefit might be totally negated if it is correct that tinnitus is caused by stuffed synapses since it might be possible to get one of the other treatments through insurance under the guise of stuffed synapses to truly treat tinnitus.

Another difference is that Hough Ear Institute's synapse drug is a tablet whereas PIPE-505 is an injection. I wonder what the side effects of these synapse drugs will have between a pill and an injection.

I don't know if there are any side effects or noticeable differences between the treatment types aside from the risks associated with the injection like a burst ear drum. However I think that the thing which doesn't matter as much when it comes to synapse medicine is the fact that there are no issues with extra growth like with a hair cell medicine. Therefore this tends to be why you are allowed to take this in a tablet form unlike a hair cell medicine like FX-322 where it leads to uncontrolled growth.

I have got a feeling that one of the best outcomes we could potentially see from a synapse drug injected such as OTO-413, is that it will actually also demonstrate the effectiveness of Otonomy's theory that the treatment can correctly treat you throughout the ear due to their delivery process. Essentially this also will provide good indications that OTO-6XX may work within the entire hearing range if it is effective because it will demonstrate that their delivery technique can really go deep.

I definitely think that the treatment result from OTO-413 will help hugely with Otonomy's progression for OTO-6XX too.

 

[wwtsai]

I received an update as a donor earlier today:

"I wanted to give you this special update on our research since you have been so gracious to support this work.

Our hair cell regeneration technology continues to demonstrate its effectiveness in significantly restoring hearing function in our preclinical studies. Now, we are looking ahead at the specific considerations that we will need to accommodate for testing this technology in a clinical setting.

With this focus in mind, HEI researchers will be performing several quick and strategic studies. These will help us to better predict how our technology will respond in human subjects in order to better anticipate the optimal therapeutic effects and potential side effects.

We will also be testing whether strategic modifications to both the drug structure and the carrier which encapsulates it has any effect on the efficacy, stability, ease of delivery, and operational precision in the inner ear. The results from these studies will allow us to refine our formulations and clinical approach to create the safest, most effective, drug product that we can."​

I can't really make heads or tails of the update other than that it's progressing? Regardless, I wanted to post it here.

 

[tommyd87]

I received an update as a donor earlier today:

"I wanted to give you this special update on our research since you have been so gracious to support this work.

Our hair cell regeneration technology continues to demonstrate its effectiveness in significantly restoring hearing function in our preclinical studies. Now, we are looking ahead at the specific considerations that we will need to accommodate for testing this technology in a clinical setting.

With this focus in mind, HEI researchers will be performing several quick and strategic studies. These will help us to better predict how our technology will respond in human subjects in order to better anticipate the optimal therapeutic effects and potential side effects.

We will also be testing whether strategic modifications to both the drug structure and the carrier which encapsulates it has any effect on the efficacy, stability, ease of delivery, and operational precision in the inner ear. The results from these studies will allow us to refine our formulations and clinical approach to create the safest, most effective, drug product that we can."​

I can't really make heads or tails of the update other than that it's progressing? Regardless, I wanted to post it here.

Hough Ear Institute seems to be moving much more quickly than they tended to previously. I wonder whether this has anything to do with the fact that there is so much going on this area.

 

[weab00]

We want answers Justin.

 

[tommyd87]

We want answers Justin.

View attachment 41147

I don't think that there will be much out of them till the study is complete.

It will be interesting to see whether Pipeline Therapeutics or Otonomy can attain an improvement in tinnitus from their comparable treatments.

Especially since Hough Ear Institute has not stated the reasons why their treatment treats tinnitus.

 

[weab00]

I don't think that there will be much out of them till the study is complete.

It will be interesting to see whether Pipeline Therapeutics or Otonomy can attain an improvement in tinnitus from their comparable treatments.

Especially since Hough Ear Institute has not stated the reasons why their treatment treats tinnitus.

Why are Hough Ear Institute keeping a way to measure the true loudness of tinnitus hidden away in a lab? Are they lying? This is knowledge that could be used to advance research for thousands of researchers.

 

[frpp]

Why are Hough Ear Institute keeping a way to measure the true loudness of tinnitus hidden away in a lab? Are they lying? This is knowledge that could be used to advance research for thousands of researchers.

Money talks, altruism walks.

 

[tommyd87]

Why are Hough Ear Institute keeping a way to measure the true loudness of tinnitus hidden away in a lab? Are they lying? This is knowledge that could be used to advance research for thousands of researchers.

Money talks, altruism walks.

It is I think one of two things:

- Hough Ear Institute is staying silent because their treatment will help tinnitus but it is a synapse treatment that is the same as PIPE-505 and actually doesn't have any different benefits to the other treatments. For example their pill doesn't specifically treat tinnitus any differently to the others.

- Hough Ear Institute has got a really good thing going on and as a result it is incredibly likely that they are keeping quiet on it until they have sufficiently validated results.

Either way I think that the reality is that Hough Ear Institute might not be coming out and saying anything directly about it because they have a history of not being direct about these things.

 

[GBB]

Why are Hough Ear Institute keeping a way to measure the true loudness of tinnitus hidden away in a lab? Are they lying? This is knowledge that could be used to advance research for thousands of researchers.

I'll bet 100 bucks with someone they haven't found a real way to do this that doesn't have some messy assumptions/critical flaw/massively limiting factor. Basically there is an Achilles heel here or it's just flat out wrong. If you discovered this you could get a Nobel prize honestly - no reason to just mention it in passing and do nothing...