Hough Ear Institute's Hair Cell Regeneration Project

This thread is about the nonprofit research institution the Hough Ear Institute and it's hair cell regeneration project for hearing loss and tinnitus. The HEI is led by Dr. Kopke, an ex-US army veteran of 26 years.

https://houghear.org/

'The Hough Ear Institute (HEI) is a non-profit 501c3 organization committed to restoring hearing worldwide through research, teaching, and humanitarian efforts. At HEI, we are pursuing the dream “that all who have ears will hear.”'

Hope for a tinnitus treatment

World-Class Research at Hough Ear Institute

From some emails:

1.

"Hi,

Thanks for reaching out! I appreciate all your questions.

Our hearing loss pill is through Phase I clinical trials and ready for phase II. We hope to be in clinical II trials in the next 6 months to a year. Our hope is that we can run it through phase II and II clinical trials and have the drug on the market by mid-2020’s.

The hearing loss pill regenerated the nerve endings that have been damaged due to a variety of reasons. This not only helps treat people with acquired hearing loss, but our studies show that it is very effective in treating tinnitus. This lines up with the prevailing theory of the cause of tinnitus being rooted in the nerve endings and overcompensating for the lack of “stimuli”, similar to phantom pain from an amputated limb but with the brain and cochlea.

Government grants are highly competitive and more research is being done with the same, sometimes, less pot of money. It’s a somewhat complicated process. What it comes down to is this: patents. We either have to wait for government money to come in and then move the research forward (which means people like you and me suffer longer) or we can solicit private donations to get us through Phase II clinical trials and attract “big pharma”. If we wait, the patent could run out before FDA approval. What that means, is that the treatment/cure will never make it to market. No pharmaceutical company will license it knowing that the day they do – it becomes generic and insurance companies won’t pay for the name brand drug. Does that make sense?

A little over a year ago we received funding from the DOD. It was for our hearting loss injection (hair cell regeneration) study. There were 73 applicants and we were the only one’s funded. To me, that speaks volumes about our research and data. NIH and other government grants are a very complicated and drawn out process. You can find more information by going to the NIH website, DOD website, etc..

I hope I answered all your questions. I too suffer from tinnitus, but nothing like you and many others do. I read a lot of the comments from people on the forums. For the most part they are very sad to me. They represent real people suffering in a real way. Many people and organizations have said to them, “I have the cure” only to find out they were selling snake oil so to speak. They have been taken advantage of and in their desperation are anxious to believe the cure is right around the corner. Not to mention all the false information about tinnitus and assumptions on how drug commercialization works.

We are scientists on a quest to discover, to heal people. Our research speaks for itself. We were featured in in Molecular Therapy in May of 2018 with a hair cell regenerated in an adult mammal. We want to help you. I’m happy to take anyone’s call, email, etc. to help spread the word and to raise the funds necessary to get these drugs through the clinical approval process.

You have my contact information below. Please consider liking our Facebook page and keeping up to date there: https://www.facebook.com/houghear/

If there is anything else I can answer or do for you, don’t hesitate to ask.


At your service,
JUSTIN DE MOSS, M.A., CFRE
Director of Development"

2.

"Hi,

Please feel free to share my name and use the email info@houghear.org. For those that want to have an authentic conversation – I’m happy to reply and give my personal professional email like I did with you.

We also have some other amazing research going on – in the end those that support our mission are those that support innovation to help people.

At your service,
JUSTIN DE MOSS, M.A., CFRE
Director of Development"

3.

"Hi,

The drug is extremely safe and well tolerated as evidenced by our Phase I clinical trial data.

It is difficult to compare our drugs with others because they are completely different. What I can say is our approach is very novel. It’s a combination of two compounds (one of which is already FDA approved). Additional, from an efficacy point of view – I’d say our data is more robust and further along. For example, we didn’t have to increase our sample size to attain statistical significance. That’s huge in science. Plus, we look to have a commercial product by the mid-2020’s.

At your service,
JUSTIN DE MOSS, M.A., CFRE
Director of Development"


* I have no idea how legit their research is, but I thought at least it is worth discussing.

 

Get this guy in the Tinnitus Talk Podcast immediately. Lol.

 

Very interesting, and the fact he took the time to write out such a long, detailed response shows how passionate he is about this, didn't seem as cold/clinical as some...

For example, I've messaged Auris Medical about the AM-101 trials and received rather short responses that seemed very dismissive.

Mid 2020s is a bit of a punch in the gut, but there's lots of promising stuff on the horizon it seems.

 

We should gather a list of questions here for them since they seem open to address questions.

 

Here's some questions...

I scanned through the published results of the hair cell regeneration in guinea pigs in May 2018.

If I read correctly, they were subject to very loud noise for 24 hours to damage the hearing, and shortly thereafter they had the drug administered. Statistically significant levels of hearing were restored compared to the control group. My question is, how do we know some of the healing wasn't natural progression - considering the test started right after onset, rather than somebody with chronic losses.

And secondly, we're coming up on a year and a half since that publication. What progress has been made since? Are we purely waiting on money to continue?

Here is the article:
https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(18)30112-6

 

Super impressed with the response. If nothing else, just the way he treated the emailer as worthy of his time and respect. Go Hough!

 

Also, is there any possibility of an FDA fast track, and how much would that impact your estimated release date?

 

I have same thought

 

I scanned through the published results of the hair cell regeneration in guinea pigs in May 2018.

If I read correctly, they were subject to very loud noise for 24 hours to damage the hearing, and shortly thereafter they had the drug administered. Statistically significant levels of hearing were restored compared to the control group. My question is, how do we know some of the healing wasn't natural progression - considering the test started right after onset, rather than somebody with chronic losses

The pdf that I'm reading refers to "sham" treatment that showed no recovery. I'm too lazy tonight to excerpt it but just go there and search for sham. (If English isn't your first language, sham = fake). So a type of control group.

https://houghear.org/wp-content/upl...-siRNA-Nanoparticles-in-Adult-Guinea-Pigs.pdf

What if anything has happened since 2018 is a good question, indeed, are they just trying to raise funds?

 

There is already a thread about the Hough Institute. Can all this be shifted to one thread to streamline traffic and information?

 

Wait so does this mean we will have something in the middle of 2020?

 

That is perhaps the most genuine email from a researcher to patient I have ever seen. I really hope all goes well and we can all give this guy our business by getting ourselves treated with his work.

 

They've emailed back and forth with me as well. Equally as genuine. You can message them on Facebook as well.

 

Mid 2020’s, so no, years away unfortunately.

 

Questions:

- Are your treatments targeted also for tinnitus and hyperacusis?
- We understand that phase 1 trial is completed and was "extremely safe". While we acknowledge that Phase 1 is meant to test the safety of the medication, what were the results on hearing loss, tinnitus and hyperacusis? What is the level of improvement? Were they sustainable?
- Do you think there is potential for further improvement to the results of phase 1?
- Are you currently enrolling patients for phase 2? Would tinnitus sufferers without hearing loss qualify?
- How does your treatment work? Does it regenerate dead hair cells or does it multiply other healthy hair cells?
- In case you are aware of the treatments of other hearing loss generation companies (Frequency Therapeutics and Audio/Regain), how does your treatment differ?
- You claim that the drug might be on the market by mid 2020. Isn't it a very optimistic scenario given that you are still in the beginning of phase 2?
- Have you been able to secure capital from investors?
- How can the Tinnitus Talk community contribute to your work?

 

It means 2025 or thereabouts, so 2024-2027 give or take.

 

I must admit that I thought this as well. As much as I hope it's all genuine, and as much as I hope the deadline is genuine, it all seems a bit too good to be true. They obviously need money.

Let's hope for the best though, and let's wait to see what they say and do further.

 

Some guy from Hough Ear said mid (for the pill) to end (for the injection) 2020s, that is, 2025-2029, not mid 2020.

+A question: If Hough Ear Institute received enough funding, would they consider drug development in Europe or Asia? It is much cheaper, with less restrictions, as far as I know, and then if it is approved there, a single pivot trial might be all that's needed for US approval as well.

 

I read this as mid 2020, shit you are right it seems mid of 2020"s" meaning mid this decade

 

I want to know exactly why.

 

No funding + they just completed phase 1, so they need time to get it to market. Don't know exactly how long but let's say 5 years is reasonable.

The good thing is that in 5 years you have Frequency Therapeutics and Audio/Regain for hearing loss and possibly tinnitus, as well as Hough Ear Institute for tinnitus (they did mention their drug was "very effective for tinnitus and hearing loss". Not to forget about the three bimodal neuromodulation devices + others not that promising (Keyzilen reinvestigation + OTO-313).

So hopefully in 5 years, we can get tinnitus sorted our or at least significant reduced.

@PeteJ check out this thread - hope this gives you hope my friend.

 

I will do my best to answer or get the answers as quickly as possible. Our researchers and CEO are quite busy and it can take some time, even weeks, to get answers from them.

I am not a scientist. I'm just a person who has a personal, vested interest in these treatments/cures, like yourselves.

 

Your questions in order:

First, the model of the study would have had both groups with receovered hearing if it was a natural phenomenon. Additionally, we had statistical significance between the two groups - indicating an efficacious solution.

Second, Lots of progress has been made. We are currently running studies for formulaic optimization so that we can increase its efficacy.

Third, Yes. Research is expensive. To get the attention of "big pharma" we need to get the research through Phase I, possibly even Phase II clinical trials. That equates to roughly 30-40 million dollars over the course of 10-12 years.

With our hearing loss pill - we are through phase I clinical trials. Our hearing loss injection is in pre-clinical studies. Having the money to do the research, then hiring additional team members to accelerate things is the only way to move forward more quickly. The science will still need to be done with careful planning and oversight so as to ensure the data is valid and robust.

 

Thank you. I have 2 questions.
1. Have you seen any indications that hair cell regeneration will treat tinnitus in cases where tinnitus was a consequence of hearing loss be it noise induced or ototoxicity induced?

2. When do you plan to start human trials and how do you sign up?

 

Thanks so much for being willing to talk directly to us. I'm sure people have lots of questions. I'm glad I posted the thread now. I'm sure you'll get a lot of queries about your funding and your mid-2020s timeline.

 

Possibly, but unlikely that it would fit the criteria. Unless we seek approval in another country first, then fast track through the FDA. Again, I'm not a scientist, but our CEO is and he knows this landscape very well. We want a commercialized treatment ASAP! And one that is affordable so we can take it to the 600+ million people worldwide suffering right now.

 

Thanks.

For clarification, are you part of Hough Ear Institute since you said "our researchers and CEO"?

 

In the mid-2020s. So 2023-2026 hopefully! It depends first on funding, then on a biotech firm investing and pushing through the Phase III clinical trial.

 

@Justin De Moss

Why has Hough Ear Institute not published any papers in academic peer reviewed journals?

Is it possible you are just trying to raise funds for a miracle drug that will never see the light of day?