Audion Therapeutics Trial

[Fabrikat]

Will this help cure chronic tinnitus?

That's the million dollar question! Presumably, if they can grow functioning hair cells, the hope is that tinnitus will also be diminished.

 

[Paulmanlike]

I suppose until hearing restoration comes out, that if all goes well, it could be within 5 years (they've completed phase 1 showing safety). The next big thing will be efficacy results in phase 2 and hopefully by this phase we will have answers to 1.) does it improve hearing and 2.) does it resolve tinnitus? Then a couple more years demonstrating safety and efficacy in larger populations with a phase 3. A whole load of potential setbacks can prolong this however, I must say over the last 5 years there has been considerable progress and we are closer to a cure than 5 years ago.

Now we've got bi-modal neuromodulation to hope for if tinnitus is the main problem causing you difficulties until further advancements. There has been emerging evidence this works with a product (Neuromod) already lined up to go on market this year.

What concerns me, is that, all this progress can lead to nothing. I don't see any other treatment targeting tinnitus coming anytime soon, the new epilepsy drug (Trobalt redesigned) I would imagine is 10 years away along with any new drug developed by Cognosetta (the new company formed in Florida). This could take up to 10 years, if ever...

 

[tomytl]

We should be very happy to see, that Phase I has passed and two/three trials are in progress with the aim to regenerate hair cells or part of this structure in the inner ear.

It's far better than still speculating about things that are for many years in preclinical state.

I'm happy there is Audion Therapeutics & Frequency Therapeutics which have these programs ongoing...

I would be ultimate happy even if such a treatment would help my condition 10%.

 

[Silvio Sabo]

I suppose until hearing restoration comes out, that if all goes well, it could be within 5 years (they've completed phase 1 showing safety). The next big thing will be efficacy results in phase 2 and hopefully by this phase we will have answers to 1.) does it improve hearing and 2.) does it resolve tinnitus? Then a couple more years demonstrating safety and efficacy in larger populations with a phase 3. A whole load of potential setbacks can prolong this however, I must say over the last 5 years there has been considerable progress and we are closer to a cure than 5 years ago.

Now we've got bi-modal neuromodulation to hope for if tinnitus is the main problem causing you difficulties until further advancements. There has been emerging evidence this works with a product (Neuromod) already lined up to go on market this year.

What concerns me, is that, all this progress can lead to nothing. I don't see any other treatment targeting tinnitus coming anytime soon, the new epilepsy drug (Trobalt redesigned) I would imagine is 10 years away along with any new drug developed by Cognosetta (the new company formed in Florida). This could take up to 10 years, if ever...

Actually the Trobalt redesigned is being developed by Prof. Tzounopoulos att University of Pittsburgh. He recently secured funding from the US military to go ahead with a trial of his potassium ion channel drug aimed for tinnitus.

 

[Paulmanlike]

Actually the Trobalt redesigned is being developed by Prof. Tzounopoulos att University of Pittsburgh. He recently secured funding from the US military to go ahead with a trial of his potassium ion channel drug aimed for tinnitus.

What stage is the trial at?

 

[Silvio Sabo]

What stage is the trial at?

Stage 1 I think. But not started yet. He just got the money for it.

 

[tomytl]

What stage is the trial at?

Phase 1 is finished and they now are recruiting for Phase 2.

 

[grate_biff]

Phase 1 is finished and they now are recruiting for Phase 2.

Crossing my fingers this will work without the fear of destroying ones eye-sight or turning your skin blue!

If it works, they should call it Dannygabine after Dannyboy who had great belief in Potassium channel modulators for tinnitus.

 

[Paulmanlike]

I think Silvio Savo was talking about the latest Trobalt while tomytl is talking about the Audion Therapeutics regeneration trial.

The new Trobalt has not even started clinical trials yet - is there a link to the latest news?

I want to get rid of tinnitus but I don't want to turn into a smurf with milky man tits.

 

[Tigo]

The new Trobalt is XEN-1101 and it is almost in phase II.

https://www.xenon-pharma.com/product-pipeline/xen1101-for-epilepsy/

 

[grate_biff]

The new Trobalt is XEN-1101 and it is almost in phase II.

Does XEN-1101 have the exact same compound as the Greek professor's

 

[Rafaa]

I'm 10 minutes from Regain, but I'm too scared to take part in the trial when there could be some unforeseen side effects.

Only thing that makes me want to do it, is the little statement that there's a therapeutic window where we could be treated that I might miss out on.

 

[JohnAdams]

I'm 10 minutes from Regain, but I'm too scared to take part in the trial when there could be some unforeseen side effects.

Only thing that makes me want to do it, is the little statement that there's a therapeutic window where we could be treated that I might miss out on.

Ask yourself, if other people take the initiative and show it is safe, would you then take the treatment?

 

[Contrast]

I'm 10 minutes from Regain, but I'm too scared to take part in the trial when there could be some unforeseen side effects.

Only thing that makes me want to do it, is the little statement that there's a therapeutic window where we could be treated that I might miss out on.

Do it, you will regret forever if you turn down this once in a life time opportunity.

 

[Paulmanlike]

I'm 10 minutes from Regain, but I'm too scared to take part in the trial when there could be some unforeseen side effects.

Only thing that makes me want to do it, is the little statement that there's a therapeutic window where we could be treated that I might miss out on.

Just think, you can have the treatment in the next couple of months while we all wait years.

Seriously, it has to be your choice though, they've already done a phase 1 safety trial. However the sample is small, but so far no problems. It could be life changing or there may be a small risk of complications.

Please keep us updated whatever you decide to do, you may be one of the first 100 to regain your hearing and you never know, if you have tinnitus, you may hear silence again.

 

[Johan_L]

I'm 10 minutes from Regain, but I'm too scared to take part in the trial when there could be some unforeseen side effects.

Only thing that makes me want to do it, is the little statement that there's a therapeutic window where we could be treated that I might miss out on.

In most cases with our body it is best to fix things sooner rather than later for a good prognosis. That goes for knee pain, nerve pain, tendinosis, etc (which I happen to suffer from, and deeply regret not fixing early on). This might not or might be the case for tinnitus.

The experience is also that damaged ears such as ours are prone to MORE damage from relatively weak noise insults. That's another reason to act sooner rather than later.

 

[Paulmanlike]

In most cases with our body it is best to fix things sooner rather than later for a good prognosis. That goes for knee pain, nerve pain, tendinosis, etc (which I happen to suffer from, and deeply regret not fixing early on). This might not or might be the case for tinnitus.

The experience is also that damaged ears such as ours are prone to MORE damage from relatively weak noise insults. That's another reason to act sooner rather than later.

This has not been proven has it?

 

[Johan_L]

This has not been proven has it?

No. This is just reasoning... It might not be the case for tinnitus.

 

[Rafaa]

Does Audion Therapeutics promote nerve repair as FX-322 claims to do?

 

[Drone Draper]

Registered my interest for this. Hope springs...

 

[Drone Draper]

Just got knocked back because my hearing loss isn't big enough.

"For the REGAIN clinical trial, you need to have a mild to moderate hearing loss with a PTA average of between 25 – 60 dBHL in each ear at specific frequencies. Because of this we will unfortunately be unable to take the screening process any further and will not be able to complete the pre-screening telephone call."​

Also, worthy of note for any Tin Men and Women who want to partake, they sent me a participation information sheet which states:

"The injections will be carried out by experienced ENT surgeons within the research team. The risks of the method of delivery, by injection through the eardrum, are known. They include:
• Change in hearing: There is a very small risk that your hearing may get worse. This happens in less than 1% of patients. Tinnitus (head noise) may be temporarily more pronounced or tinnitus may develop.
• Change in balance: Some temporary unsteadiness or dizziness may occur during the first few days after the procedure. In rare cases, the unsteadiness may last for more than a few days or be permanent.
• Facial nerve function: A very rare complication of the injection is temporary or permanent weakness of the face.
• Change in taste: A temporary change in taste and/or a dry mouth may occur.
• Eardrum perforation: A perforation (hole) in the eardrum membrane may develop in less than 1% of patients."​

Finally, they state on the sign up form:

"If you also suffer from tinnitus, and this is more of a problem to you than your hearing loss, you will not be eligible to take part."​

So it looks like there would be a chance of developing tinnitus or possibly exacerbating it - I'd still take part if given a chance though, lol.

 

[gadsie]

Where are the trials done? I couldn't find it on their website.
My dad recently got significant hearing loss. We live in the netherlands, maybe he wants to participate.

 

[gadsie]

Just think, you can have the treatment in the next couple of months while we all wait years.

Seriously, it has to be your choice though, they've already done a phase 1 safety trial. However the sample is small, but so far no problems. It could be life changing or there may be a small risk of complications.

Please keep us updated whatever you decide to do, you may be one of the first 100 to regain your hearing and you never know, if you have tinnitus, you may hear silence again.

The thing about changing stem cells into hair cells is scary though, if that means future treatments won't work.

 

[JohnAdams]

This happens in less than 1% of patients. Tinnitus (head noise) may be temporarily more pronounced or tinnitus may develop.

I'd like to know where they got that stat.

 

[Drone Draper]

Me too, friend. It did kind of stop me in my tracks for a second.

 

[Drone Draper]

@gadsie - UK Trials are held in London

https://www.regainyourhearing.eu/trial/

 

[gadsie]

@gadsie - UK Trials are held in London

https://www.regainyourhearing.eu/trial/

You think they'd accept someone from another country?

 

[Drone Draper]

If your dad satisfies the PTA standard (-25 to -60 dB), I don't see why not. I see on the Amplifon website they are also running trials in Tübingen, Germany and Athens. Would those be easier for you to get to?

Please note they need you to come in once for an in-person assessment, three treatments visits, then follow up meetings, two mandatory, two optional. Someone needs to come with the person for the three treatment visits. So that's a lot of travel!

 

[Drone Draper]

 

[gadsie]

Thank you @Drone Draper! Germany would probably be easier depending on where it is exactly. Only "concern" is that my dad does have hearing loss in that range, but only in one ear. Guess we'll see.