Hough Ear Institute's Hair Cell Regeneration Project

[Kendra]

This has been discussed before but basically something seems fishy with what Hough Ear Institute is doing with the pill. It's pretty clear that they seem to be the ones directing what happens with the pill and not Oblato. One thing we know is Hough Ear Institute have not been transparent when it comes to explaining what is happening with the pill and why they need to do the proof of concept study. Seems that at least they have sped stuff up by starting the study now when prior to this they said it wouldn't be done until the study was funded entirely.

Essentially I reckon that the trials will start a lot sooner than they previously claimed, however Hough Ear Institute really need to be a lot more transparent. It explains why they struggled to gain the required funding for the study.

Agree. I'd be much more likely to donate to them if they answered the questions we have.

 

[FGG]

I think the bullshit is starting to show now. When companies can still continue to carry on with clinical trials, Hough Ear Institute and Oblato are using COVID-19 as an excuse for not starting. Definitely something fishy is going on.

To be fair, if their test subjects were cochlear implant recipients (i.e. using the pill to mitigate implantation trauma as was suggested for one of the trials) then COVID-19 would create a much bigger delay since these are surgical candidates and couldn't be recruited and treated at outpatient ENT practices like Frequency Therapeutics and Otonomy can.

It's apples and oranges.

I find the fact that they are having a bigger COVID-19 delay than others not spurious at all.

 

[tommyd87]

The vagueness from Hough Ear Institute continues. Currently they have more donation requests plastered on their Facebook page persistently over the last few days with the current message being about "Giving Tuesday"and "veterans", while not mentioning the fact that this this study has already commenced and is underway.

It appears that the key difference between Hough Ear Institute and the others is that Hough Ear Institute is content with fundraising and nothing else. Essentially I reckon Hough Ear Institute are starting to realise that they aren't as individual in the treatment that they are claiming to offer. Their lack of transparency is amazing and even if this pill is successful, I do not trust them compared to most other organisations in this space either.

Even if this pill is successful, I don't view Hough Ear Institute as being a very credible and/or transparent organisation with what they are doing. It does seem that every time they say they have come up with something wonderful like being able to measure tinnitus, it turns out that this is a widely identified thing.

 

[tommyd87]

To be fair, if their test subjects were cochlear implant recipients (i.e. using the pill to mitigate implantation trauma as was suggested for one of the trials) then COVID-19 would create a much bigger delay since these are surgical candidates and couldn't be recruited and treated at outpatient ENT practices like Frequency Therapeutics and Otonomy can.

It's apples and oranges.

I find the fact that they are having a bigger COVID-19 delay than others not spurious at all.

Didn't Justin De Moss put to bed the claim that the trial was being done on Cochlear Implant recipients and that the indication or indications that the pill was going to be tested for actually had not been chosen yet either?

Essentially this is exactly the sort of thing that tends to raise issues around transparency when it comes to what Hough Ear Institute is doing. We know they are conducting the Proof of Concept study now, however we don't know what they are doing when it comes to the trial process.

 

[FGG]

Didn't Justin De Moss put to bed the claim that the trial was being done on Cochlear Implant recipients and that the indication or indications that the pill was going to be tested for actually had not been chosen yet either?

Essentially this is exactly the sort of thing that tends to raise issues around transparency when it comes to what Hough Ear Institute is doing. We know they are conducting the Proof of Concept study now, however we don't know what they are doing when it comes to the trial process.

He said recently that they weren't completely sure yet but there was a point when they were at least planning for that indication as being a quicker route, which clearly it would not be at this point.

 

[tommyd87]

I just received another email about donating to Hough Ear Institute. It does ask to donate, however it doesn't tell you what they are actually doing. Definitely poor transparency.

 

[Piney]

I'm looking at the total timeline of this drug coming to market... How many years? 15-20?

The coordination between the ENT, the surgeon, the cochlear implant candidate, the paperwork, the trial exclusion... You could see this thing moving like burnt molasses.

If Oblato stands to make money from its success, I don't understand why they don't make some changes to their plan, if they have one.

I also wonder if Hough Ear Institute can motivate them to adjust or at the least have them post something on their plan.

I'm not donating to a plan I deem a cluster.

 

[tommyd87]

I'm looking at the total timeline of this drug coming to market... How many years? 15-20?

The coordination between the ENT, the surgeon, the cochlear implant candidate, the paperwork, the trial exclusion... You could see this thing moving like burnt molasses.

If Oblato stands to make money from its success, I don't understand why they don't make some changes to their plan, if they have one.

I also wonder if Hough Ear Institute can motivate them to adjust or at the least have them post something on their plan.

I'm not donating to a plan I deem a cluster.

After the various different emails I received today that were requesting me to donate with case studies attached and no information linked to what Hough Ear Institute was going to be engaging in, I am also agreeing with you on your unwillingness/lack of desire to contribute. Currently I am willing to give Hough Ear Institute until September to complete their proof of concept study before I call it a bust and/or raise questions with what is happening, however I agree with you and I don't see what Hough Ear Institute are aiming to achieve without actually outlining a plan.

Problem is that at the moment it seems that Hough Ear Institute is the one calling the shots on what is happening and Oblato hasn't actually said anything at all. Therefore I feel that the concerns and questions around what is happening can consequently be directed to Hough Ear Institute. After all this is the same organisation which stated that the proof of concept study couldn't be done until they got the full funding for it and now out of the blue it was started last September and will now take 6-12 months to do. I hope Oblato is the body putting pressure on Hough Ear Institute to get things done and that the trials proceed pretty promptly after the completion of the study.

Somebody or something has had to have made Hough Ear Institute shift their course in regards to their progress and also their processes on the pill.

That is unless Hough Ear Institute has simply been lying about matters such as the need to obtain full funding all along.

 

[weab00]

2027 is too long for me. Other stuff will definitely be out before then.

 

[tommyd87]

2027 is too long for me. Other stuff will definitely be out before then.

Hough Ear Institute is definitely going down the Susan Shore path of vagueness and delays without giving a reason.

Right now I think our best hope is having Oblato actually telling them to get a move on if it is the case that the treatment is successful because Oblato doesn't want to lose out on sales.

 

[tommyd87]

Another email newsletter from Hough Ear Institute talking about their pill in a generic and vague manner and also again asking for donations without telling us what they are for.

For me, the most interesting thing is that they tend to not say anything about what they are doing or what the funding is going to get used for. Maybe if they started stating what they are doing and explaining the process(es) in detail then we might see more being willing to actually help out. I also am actually finding it interesting that they have moved away from their statement that they need to gain $55,000 or whatever it was to fund the pill's study.

This is really starting to demonstrate the questionable and dodgy nature of what they are doing to try to get others to fund their commercial medicine research.

I think I'll certainly pass for now.

https://houghear.org/an-a-pill-ing-solution/

https://support.houghear.org/campaign/give-hope/c312955

 

[ActorFred]

Hough Ear Institute are taking their sweet ass time!

 

[weab00]

Another email newsletter from Hough Ear Institute talking about their pill in a generic and vague manner and also again asking for donations without telling us what they are for.

For me, the most interesting thing is that they tend to not say anything about what they are doing or what the funding is going to get used for. Maybe if they started stating what they are doing and explaining the process(es) in detail then we might see more being willing to actually help out. I also am actually finding it interesting that they have moved away from their statement that they need to gain $55,000 or whatever it was to fund the pill's study.

This is really starting to demonstrate the questionable and dodgy nature of what they are doing to try to get others to fund their commercial medicine research.

I think I'll certainly pass for now.

https://houghear.org/an-a-pill-ing-solution/

https://support.houghear.org/campaign/give-hope/c312955

Hough Ear Institute's ship has sailed. Long live Otonomy.

 

[GBB]

It's good to have multiple modalities if possible.

 

[tommyd87]

It's good to have multiple modalities if possible.

Not going to disagree with this. But the thing is, Hough Ear Institute needs to get this done soon or at least explain what is going on at present.

 

[Mica Rambin]

I signed up for Hough Ear Institute's quarterly newsletter to get updates. Does anyone know when their next newsletter is released?

 

[frpp]

Not going to disagree with this. But the thing is, Hough Ear Institute needs to get this done soon or at least explain what is going on at present.

They have been super shady lately, not even a single word on progress or a word on what they are doing, other than straight panhandling.

When established multimillion dollar companies need to beg to get funding for their product it just raises all kinds of red flags.

 

[Jrblovsky]

It would be an absolute shame to see a drug that works never be released due to corporate greed. Sounds like the people running development (funding) need to be fired.

 

[tommyd87]

They have been super shady lately, not even a single word on progress or a word on what they are doing, other than straight panhandling.

When established multimillion dollar companies need to beg to get funding for their product it just raises all kinds of red flags.

They have three things that they haven't yet addressed:

- The current status of their proof of concept study, started in September. Since this started, they have said nothing about what has been happening other than at the commencement, when we were informed it would take 6-12 months. Most probably there would have been less concern if they had said at least that they tend to not be able to comment on it until it gets finished.

- The panhandling and donation drive dissemination has actually been fairly generic and vague. I very much agree that zero details have been given on what they are doing or what the money will benefit. The question still remains, why has Hough Ear Institute said nothing on what the funding will be used for and why they need funding for fulfilling the proof of concept study requirements when they are going to eventually profit from a successful medicine treatment.

- Multiple claims that have been made by Hough Ear Institute about their findings have also been found out or been examined by other organisations overall. These include measuring tinnitus, the treatment of synapses, the essential effect of tinnitus and the synapses among others. Obviously it is incredibly beneficial that multiple groups have discovered the same things, however it also actually again questions the now seemingly mooted claims made by Hough Ear Institute about how they seemingly have been unique in what they have done.

This is coupled with the previously vague information that they had provided when pressed on other matters such as their timeline to complete things, questions around why they need to obtain donations and why they need to do things like completing the proof of concept study prior to engaging the clinical trials.

Thus there is very little credibility about what Hough Ear Institute is doing while they fail to address such questions and matters persistently.

 

[tommyd87]

More donation requests emailed by Hough Ear Institute.

I am actually amazed because the proof of concept study has supposedly started, so where has the talk about Hough Ear Institute needing the $135,000 (or whatever) gone.

Going by this, I am assuming at present that the funding for the study has been met or that Hough Ear Institute has covered this through some other mechanism. Now they are simply sending subsequent emails stating that you can help research by donating to them.

From what Hough Ear Institute has disseminated, the only thing that has been specifically mentioned is the fact that they need money to buy a new drill for Hanoi which we could say is completely independent to the other work that they are doing.

This just adds much more vagueness and makes me much more intrigued as to what the funding is going towards. I think that the time has arrived for either Justin De Moss or Hough Ear Institute to actually comment on what the funding is going to be used for...

 

[Mica Rambin]

Hough Ear Institute needs to do a better job of keeping the public up to date on their research. If their pill works, I think it may be one of the best NIHL drugs on the horizon.

I signed up for their quarterly newsletter in September but I never receive any emails or other communication from them aside from an email exchange I had with Justin a few months ago.

I see they have some promotional videos on YouTube that they uploaded this month but that isn't enough.

 

[tommyd87]

Question to Hough Ear Institute:

So just wondering where will the money donated if we do so get used? Usually I wouldn't have a problem donating, however at present none of the information or donation emails actually are stating where the money is going to be used or what the funding is going to be used for?
From what I can see the proof of concept study is fully funded from the fact that this tends to have already commenced and there is no mention of it in any emails.

Answer from Hough Ear Institute:

It depends on which research you support. If it is for tinnitus, which you reference with the proof of concept study, it will go there. If you give for hearing loss - it will go there. Where your money goes, is up to you. You can also just give to the organization in general and we will use the funds where it is needed most.
We've been sending updates about the various research we do. As far as the proof of concept study - no it is not fully funded as you can see here:
https://support.houghear.org/hopefortinnitus
The study has started because we have most of the money. However, until it is fully funded we can not validate the results. This will delay sending the data to the pharmaceutical company for them to decide whether or not to do a Phase II study for tinnitus.

Based off of this response, I believe that Hough Ear institute inevitably has been vague and rather unclear with what they have been communicating regarding the progression of the proof of concept study. It seems that they are now trying to distinguish hearing research and tinnitus research funding from one another, despite previously indicating that their pill treats both.

Since they have simply stopped sending marketing indicating that they require funding for the proof of concept study because it has started, this would indicate that they seem to have enough funds to proceed with this, though what we know now is that they supposedly don't have funding to finish this. This is despite Hough Ear Institute telling us that the study would be completed in 6 to 12 months.

There are two ways which this can be looked at. The first is that Hough Ear Institute has simply been poor in their communications by wording things in a manner which can imply multiple things or imply one thing but mean another. The second is Hough Ear Institute has deliberately been vague in their communication.

Either way the information provided by Hough Ear Institute has been confusing and vague and doesn't give me a clear understanding as to what they are doing.

 

[ajc]

There are two ways which this can be looked at. The first is that Hough Ear Institute has simply been poor in their communications by wording things in a manner which can imply multiple things or imply one thing but mean another. The second is Hough Ear Institute has deliberately been vague in their communication.

Either way the information provided by Hough Ear Institute has been confusing and vague and doesn't give me a clear understanding as to what they are doing.

Dear Tommy. You should forget about Hough Ear Institute. They're just trying to milk us for all our worth.

It's beyond laughable how Oblato requires Hough Ear Institute to do grassroots fundraising for a study that - if successful - will yield billions of dollars in profit.

Now they're hoping tinnitus sufferers foot the bill, and Oblato reaps the profits.

We shouldn't support shit like this.

 

[Jrblovsky]

Like I stated before, these guys have a steaming pile of shit for marketing and development (fundraising).

My guess is they have secured the funding.

I would guess that the MBAs in the Pharmaceutical are trying to figure out how to do a little trick called profit maximization.

Corporate greed at its finest.

The fact that they gave such a horseshit answer goes to show they will allocate the funds to whatever they want.

 

[Mica Rambin]

I'm not an expert on creating or selling pharmaceuticals - so I don't want to be too quick to judge the merits of what's going on at Hough Ear Institute. Those of us with damaged synapses/nerves from noise induced situations really need something like the drug Hough Ear Institute is proposing to address that damage to fix our tinnitus/hyperacusis/hearing loss. I feel bad for veterans dealing with this issue too, they need something to fix the damage from all those blasts they were dealing with. I just really want Hough Ear Institute to get their business in order and communicate with the ear issue community more frequently - especially if they want to solicit donations to us.

 

[serendipity1996]

I'm not an expert on creating or selling pharmaceuticals - so I don't want to be too quick to judge the merits of what's going on at Hough Ear Institute. Those of us with damaged synapses/nerves from noise induced situations really need something like the drug Hough Ear Institute is proposing to address that damage to fix our tinnitus/hyperacusis/hearing loss. I feel bad for veterans dealing with this issue too, they need something to fix the damage from all those blasts they were dealing with. I just really want Hough Ear Institute to get their business in order and communicate with the ear issue community more frequently - especially if they want to solicit donations to us.

I think Otonomy will help us if Hough Ear Institute doesn't since they're both essentially synaptopathy drugs and Otonomy is ahead anyway.

 

[Pete88]

If FX-322 and OTO-413 are successful, I think that leaves this Hough Ear Institute pill even further in the dust with possibly a final nail in the coffin.

As many people have been pointing out, this company is extremely vague and arguably sketchy with their behaviour. Maybe passable if they were the only player in the game and had a monopoly but when they are a distant 3rd in terms of potentially repairing hearing loss, a serious company wouldn't be pulling these stunts if they actually were confident they had a superior product. They can see Frequency Therapeutics' excellent example of "how to fund, market and produce" a hearing loss drug. All they'd have to do is follow their lead. Otonomy clearly thinks their product can compete with FX-322 by their behaviour and interactions. Hough Ear Institute seems like that kid who claims he has the coolest toy on the block but never demonstrates it actually exists.

I'm not a bio engineer or anything but even their mechanism of delivery doesn't sit as comfortable with me. I'd trust an injection to work better on my ear without causing other issues elsewhere than a pill. Consider that for example previous studies regarding FX-322 showed that consuming the drug can influence cancer for example but when delivered directly to the ear, it's fine.

I hope I'm wrong and Hough Ear Institute knocks it out of the park but based on their behavior, I wouldn't bet on it. I would however bet on Frequency Therapeutics with no issues as well as Otonomy with slightly less confidence.

 

[Paulmanlike]

This was addressed by a very well informed member @Aaron123 a couple of years ago.

Endless marketing pitches and unfounded claims.

I have never bothered and I wouldn't entertain @Justin De Moss.

Alarm bells were raised about these years ago.

Better off buying shares in companies to fund the clinical trials and donating to Tinnitus Talk and the BTA/ATA than giving money to Hough Ear Institute.

 

[frpp]

If FX-322 and OTO-413 are successful, I think that leaves this Hough Ear Institute pill even further in the dust with possibly a final nail in the coffin.

As many people have been pointing out, this company is extremely vague and arguably sketchy with their behaviour. Maybe passable if they were the only player in the game and had a monopoly but when they are a distant 3rd in terms of potentially repairing hearing loss, a serious company wouldn't be pulling these stunts if they actually were confident they had a superior product. They can see Frequency Therapeutics' excellent example of "how to fund, market and produce" a hearing loss drug. All they'd have to do is follow their lead. Otonomy clearly thinks their product can compete with FX-322 by their behaviour and interactions. Hough Ear Institute seems like that kid who claims he has the coolest toy on the block but never demonstrates it actually exists.

I'm not a bio engineer or anything but even their mechanism of delivery doesn't sit as comfortable with me. I'd trust an injection to work better on my ear without causing other issues elsewhere than a pill. Consider that for example previous studies regarding FX-322 showed that consuming the drug can influence cancer for example but when delivered directly to the ear, it's fine.

I hope I'm wrong and Hough Ear Institute knocks it out of the park but based on their behavior, I wouldn't bet on it. I would however bet on Frequency Therapeutics with no issues as well as Otonomy with slightly less confidence.

Agreed, Hough Ear Institute is done - in terms of synapse medicines OTO-413 will smoke it, and as an otoprotectant SPI-1005 will be out years before it.

Personally I wouldn't worry about its safety consumption wise as it's just two different antioxidants in a pill and one of them you can buy at just about any vitamin shop.

 

[tommyd87]

Question to Hough Ear Institute:

This is an interesting response. Recently we were wholly told by Hough Ear Institute that the study would be completed in 12 months and yet now it seems that you are telling us that without this funding getting met, the study cannot get completed. Consequently this seems to be rather contradictory.

Can I also ask why the funding is distinct for both hearing and also a tinnitus since the pill is intending on treating both matters too. Therefore something doesn't make sense here

Answer from Hough Ear Institute:

Not contradictory at all. Yes, the study was planned to last 12 months. No one, not even I, can promise that other factors won't come into play and delay things, factors like a global pandemic!

Also, we typically don't start studies until they are funded. However, because so much of it had already come in, and to get that funding we had to start - we did. Are you upset that we started before we were fully funded?

Could it still take 12 months. Yes! May it get delayed? Yes. Because of COVID? Yes! Because of lack of funding? Yes. Because of another unknown factor? Yes!

To answer your question about funding being distinct. The simple answer is because while they are related, they are distinct. You can have hearing loss without tinnitus. Likewise, you can have tinnitus without hearing loss.

The biotech firm is still planning the phase II trials. We have not yet heard if they are doing hearing loss, cochlear implant trauma, ototoxicity, or some other condition. As soon as we hear, we will of course let you and others know.

Please keep in mind that scientific research is complex and changes. Things change. It is no one's fault, it is a fact of life.

I'm sure most people are reasonable and understand that and would much rather we share what information we have than to with-hold it.

Hi Deb! The PoC study takes a total of 12 months.

Quality avoidance.

1. They avoid commenting on the fact that their treatment for tinnitus is also treating hearing loss and tries to walk around this by informing us that they are two different things even though this pill is being worked for both conditions.

2. They have said on here that the time taken for the study will be 12 months and has subsequently now backtracked on this through the excuse of COVID-19. Something which they were well aware of prior to the study's commencement.

3. From all accounts, I have seen no information or communication which stated that Hough Ear Institute needed to start when they did in order to avoid losing funding. Fairly handy reason to delay it if it cannot get completed by the required date.

I definitely do think that there is some really interesting information coming from Hough Ear Institute if you press them on it.