Hough Ear Institute's Hair Cell Regeneration Project

@FGG, thanks. It seems like the Hough Pill has a small timeframe to work, which is quite disheartening. I guess that's why this thread isn't very popular.

 

It should work for chronic as well. Although it was designed originally as a bomb blast pill, the growth it produced in animal models should still happen in chronic cases. As for the thread not being as popular, they're not as far along as say FX-322, and there hasn't been more info. Hard to keep a thread going when there's not as much to talk about.

 

Yep, they used a time frame a few months out to mimic chronic cases in the rodent models they used. Apparently, in those animals chronic changes happen in that time frame.

Justin also reported that it did help tinnitus in their phase 1 human trial but what wasn't clear to me (or I just missed it) were whether these were acute or chronic human cases. Anyone know?

 

I just posted a message on their Facebook page to ask. As of now, they are saying 2025-2026 for the pill and 2029 for the shot.

I wonder whether their shot would still work when you've taken other things like their pill.

 

@FGG, as I'm almost finished listening to the Tinnitus Talk Podcast for the Hough Ear Institute, the phase 1 were tested on healthy individuals with NO hearing loss or tinnitus to measure safety. The only evidence it seems that they have is on animals where they induce hearing loss and waited for 4 weeks before using the drug, in which they saw improvement up to months. So unfortunately, their chronic hearing loss/tinnitus treatment is still in theory for humans.

Personally, in your opinion, is 4 weeks long enough to be considered chronic in animals that translates to human?

 

I would be interested in why they only used healthy people for their safety section of the trial.

It seems somewhat strange that they didn't try it with people who were suffering from the problem considering that there was nothing that would have prevented them from doing this as a phase 1 and 2 study.

 

Hey, thanks. I think I misremembered based on the discussion that Justin should take the pill since he has tinnitus and had seen evidence that it helped tinnitus.

Sorry for that. You are correct. All the evidence for tinnitus is pre-clinical in animals.

As for your last question, I would have no way to know that. My pure guess is there are probably histologic and physiological changes that happen chronically vs acutely and they used those as markers in their animal models.

 

Hough Ear Institute receives $300K grant to support research treatments for hearing loss

 

Question is, is it in addition to the previous $300k they got?? If it is, that's incredible. I hope they move on with it.

 

No, it's one and the same $300k OCAST grant.

 

So it still seems they need the $65,000 to fund the Pill. I pray that people donate or someone somehow wins the lottery and donates.

I do think that if the Pill and the injection they have in the making are good, like they should be, they should seek out funding for it and move on with it. I know it is hard for a not-for-profit to do this, though.

 

Yes and that's absolutely nutters! Justin De Moss is a great chap, but as Hough's head of fundraising, he should have no trouble raising such a modest sum.

Or is it the case of just nobody really caring about tinnitus? If it's that hard to get $65,000 together, maybe we don't deserve the cure...

 

@HootOwl brought up a good question. Is their US partner (Otologic Pharmaceutics) not willing to help? And if not, why not?

They would just need to visit forums like this to see the massive potential of the tinnitus market.

 

https://houghear.org/grants/

HEI got grants for phase 1 in 2013. It took them 7 years to finish phase 1 and that was with subjects who had neither hearing loss nor tinnitus. In addition, NAC and that other drug in the mixture has been shown with long term safety from a completely different treatment, as per the Tinnitus Talk Podcast. That is very slow progress just for phase 1, whereas Frequency Therapeutics took 1-2 years.

Additionally, where is this $65,000 figure from? If the pill has that much potential, then it will also have hundreds of millions of $$$ potential in the market. $65,000 investment is a cake walk compare to that, unless there are some serious reservations by the pharmaceutical companies.

 

I guess Tinnitus Talk members giving something like 5 bucks each would help hugely haha.

However, I wonder whether there is another actual reason they want this money.

My view is that there would be several charity organisations who would willingly donate for this thing and the other treatment for the big benefit it may provide.

Furthermore, from the fact that they tell us their pill is effective, getting it moving forward shouldn't be too hard, although I still sort of wonder why they don't give explain in greater detail why they need the funding and why they were not able to obtain it from other sources like the pharmaceutical partner company.

could it be that they had sigbed an agreement whereby they then had to prove its effects first or is it something else.

i really+would want to know this too the thing that we do know is it is likely companies like fx will proceed pretty much further more quickly because of their willingness to move on it. it is also the fact they are actually willing to fund finding things privately which will correctly assist and gain more interest.

 

I thought phase 1 was completed in 2015 and the hurdle forward was funding?

 

Some actual updates from Hough Ear Institute via Facebook:

Injection information:
No, the injection has NOT been picked up by a pharma group. We are currently looking for investors and or donations to do the phase I clinical study. That often helps attract a pharma company by demonstrating less investment risk on their behalf.
re: the proof of concept study for tinnitus - they have agreed to pay for nearly half as a match to the OCAST funding. So we only have $135K of the $735K left to raise!

Pill:
It can seem never-ending, but research does take time. Primarily because funding and partnerships take time.
The pill is funded for Cochlear Implant Trauma, hearing loss, and ototoxicity - depending on which indication they want to pursue.
Once approved for any of these conditions, it can be prescribed off label (leaving you to pay the full market price) for tinnitus.
That's why we are trying to get this tinnitus study off the ground. The pharma company is very interested in it and require a proof of concept study before entertaining a Phase II trial tinnitus.

For the pharma company to do a Phase II, they have requested one additional study. That is the study we are trying to get funded. $300K came from OCAST and was matched by the pharma company. The total cost is $735K so we only have $135K total to raise. We also have a matching grant, up to $400K of private donations, so we really only need to raise $65K for the tinnitus study to get going! That's
65 people with tinnitus giving $1,000 each or
130 people with tinnitus giving $500 each or
260 people with tinnitus giving $250 each or
520 people with tinnitus giving $125 each.
With 20 million people suffering from it - that shouldn't be hard!
But it is because we aren't connected to all of them and most people I have talked with are quick to spend $300-$500 on an essential oil or some other non-scientific "hope" but when it comes to supporting real science - they have all the excuses in the world why they shouldn't support real science. That's the challenge we have in hearing loss research - It's not the same in cancer research or heart disease.
We have given people the opportunity to set up and raise money for this - but only a 5 have signed up across the entire world. Check it out and consider joining us to end tinnitus.​

The question that is still outstanding is whether the pill treatment would work for all three indications it is supposedly designed for, i.e. ototoxicity, hearing loss, and cochlear implant trauma, or if it is going to be indicated for only one of the aforementioned.

OR

Does it mean that they are actually only examining one of these indications (e.g., ototoxicity) to pass the trial thresholds and requirements. Hence, providing the trial is successful, we can obtain the pill treatment for any of the three indications they have stated it is going to treat (ototoxicity, hearing loss, and cochlear implant trauma).

Thus I have hit them up with a follow-up question of what the pill treatment's indication will be.

 

The Oblato trial is for Cochlear Implant Trauma. I think they were using ototoxicity as an example of off label use.

 

This need of $65k from the community is so weird to me. Yes, the community could benefit from it if it went to market as a treatment, but having the consumer pay for the trial is just the weirdest thing, as they don't get monetary benefit out of it.

Further, many people don't have money to just throw around nowadays.

 

I don’t get why Oblato are being stingy as fuck and not contribute $65,000 for the tinnitus trial for the pill.

If they do believe that the pill works, why not put down the $65,000. Surely they will get their investment back once they release it in the market if it ends up being successful.

 

Also, who is spending $300-500 on essential oils?

This is an attempt to shame those that don't just donate.

 

The only thing I can think is that they want to see the demand for the product? But there's already a demand with the military, so asking for a demand out of the general public is... well strange.

 

It makes zero damn sense.

Tinnitus is a huge market up for grabs. If they had even a tiny bit of faith in the pill's efficacy for tinnitus, they would have paid the $65,000 up ages ago.

I honestly do not think Oblato believes the pill works for tinnitus. Any other scenario does not make sense.

 

Thanks. Has testing for the pill's efficacy on cochlear implant trauma then been confirmed for the phase 2 trial? Because it didn't sound as completely clear as what you have just informed me of. If it is being tested for that in the phase 2 trial, and in reality we can get it for tinnitus and hearing loss as well, then I will be happy with that.

 

Definitely military since Hough Ear Institute got funding from DoD, and didn’t they test the drug in Phase 1 which showed that the drug works? Do we know if any of those Phase 1 patients had either hearing loss or tinnitus or both of these conditions?

Surely if they knew any of those patients had an improvement in their tinnitus then Oblato should put down the $65,000.

 

Justin announced that in this thread if you go back far enough. It is apparently the easiest and quickest way to get it approved.

 

@Lucifer, read post #922:

Either way, if their animal studies show efficacy, it is promising for human trials for phase 2.

 

This is what I also want to know. Maybe it was a case of Hough saying that they would fund that part of it, or maybe Oblato was not going to offer to fund it more no matter what.

 

Further update on the pill from Hough Ear Institute via Facebook:

We believe it will work for all three. No, you don't have to be in one of those categories to obtain it. That's what I mean by off label.
Follow me here: Let's assume that it is 2026 and the pill is approved for ototoxicity. But you remember our claims that it helped with Tinnitus. So, you talk to your Dr. and he/she agrees with you and is willing to give you a prescription for the drug, even though you don't suffer from ototoxicity. What that means is that your insurance will most likely not cover the drug, but you can still get it if you are willing to pay the price.

Now, stay with me here. If we can get additional phase II and II trials for the indication of tinnitus - then you could get a prescription for the drug for tinnitus and insurance will cover it according to your prescription plan. It might still be pricey, but hopefully not as pricey as paying full price for the drug.
Now, $735,000 for a proof of concept study, divided by the # of people who suffer from tinnitus (20M) = 4 pennies per person. I think it's worth every penny if we can take something that could cost thousands per person and spend only 4 pennies per person and get the drug covered by insurance.​

 

Maybe I am putting the cart before the horse, however I really question the lack of information available about the effectiveness of the pill.

Maybe @Lucifer's position that Oblato doesn't fully believe it will work when taken for tinnitus is true.

Still $65,000 is such a small amount that I hope that they can get it in order to promptly proceed with the study.

In summary, Hough Ear Institute needs to tell us why the study needs to be done to satisfy Oblato, tell us why Oblato cannot fund it in the short term (because they could profit from it hugely if it's successful), and tell us what Hough Ear Institute are doing to hopefully obtain the funding required.

I feel that it would be fantastic to see Tinnitus Talk members to help with the funding, but I can see why people would be hesitant with the missing information.

Thanks for that!