Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

[Nucleo]

I think you make some valid points there Nucleo. I also think damage to the "outer" haircells has some contribution to the development of H &T aswell, but this damage would neither be shown in an audiogram. As their function is as I believe to attenuate loud sounds and louden the perception of low sounds. I took a test that confirmed outer haircell damage. And the T-expert seemed to be more concerned about that than my audiogram.

You took a distortion product oto-acoustic emission test I presume?

 

[dan]

The issue is that if you really wanted to see which people have neural deafferentation then you need to do ABR tests. Not audiograms. While you can most likely assume that people with higher hearing thresholds also have some degree of neural damage you are still excluding all the people with normal hearing sensivities which could very well have neural degeneration.

The point is audiogram is a crap method to base anything tinnitus related on. It was made to detect hearing loss and is used as a basis to custom fit hearing-aids to users.

There is now recent evidence that the neural pathways relaying the electrical signals from the cochlea are more fragile than the hair cells themselves. If hair cells remain intact and nerve degeneration occurs then you get auditory symptoms (fullness, T, H etc...) with normal sensitivity. This is the ''hidden hearing loss'' term that seems to pop up more and more in the field of audiology.

Hey I am just telling u why, not how...
Autifony hires audiologist consulting professionals, hence their cluelessness.

 

[grate_biff]

You took a distortion product oto-acoustic emission test I presume?

I guess thats what its called. They put a thing in my ear that made a continous ta-ta-ta sound and some graphs generated at the computer.

 

[ruben ruiz]

Sound test question. What if your T is loud enough to dampen the audio tone? To the point you dont hear the tone because the loudness of the T? How do they classify that?

 

[nills]

Sound test question. What if your T is loud enough to dampen the audio tone? To the point you dont hear the tone because the loudness of the T? How do they classify that?

That is simple, it means you don`t hear that tone and level ... your brain has created phantom sound on those frequenscies .. it`s the principal of Tinnitus and deafness and audiometry.

 

[lost horizons]

Well, when is this drug going to get on the market? How long?

 

[Geo]

Sound test question. What if your T is loud enough to dampen the audio tone? To the point you dont hear the tone because the loudness of the T? How do they classify that?

I would fail that test my sounds are too powerful for that beep.. Thats when you know your in the shit like me..

 

[Nucleo]

Hey I am just telling u why, not how...
Autifony hires audiologist consulting professionals, hence their cluelessness.

I wish audiologists knew more than to press buttons on their sound consoles and plot 6 points on a graph.

The only advice I got from audiologists was to stop caffeine and alcohol and that masking my tinnitus would help. Even when I explained I needed to use damaging levels of sound to mask it.

Apparantly unmaskable tinnitus is a foreign concept to them.

 

[Zechariah]

Well, when is this drug going to get on the market? How long?

Optimistic estimation is 2-3 years but don't go off topic. This thread is for the participant experiences.

This one is for "more general" discussion:
https://www.tinnitustalk.com/thread...-treatment-of-hearing-loss-and-tinnitus.6516/

 

[Danny Boy]

Optimistic estimation is 2-3 years but don't go off topic. This thread is for the participant experiences.

This one is for "more general" discussion:
https://www.tinnitustalk.com/thread...-treatment-of-hearing-loss-and-tinnitus.6516/

They did say they would fast-track! I just hope people can survive for the time being.

 

[Zechariah]

They did say they would fast-track! I just hope people can survive for the time being.

Yet you still haven't provided link/source and no one else remember such a strong statement from autifony?

I'd glady read the source. It would bumb up my hopes aswell...

EDIT: And to be clear, I mean that Autifony may wish that they could fast track it but fast tracking isn't Autifony's decision and therefore no one can say "they will fast track it" because no one really knows if the drug works and will the authorities approve fast tracking.

 

[Danny Boy]

Yet you still haven't provided link/source and no one else remember such a strong statement from autifony?

I'd glady read the source. It would bumb up my hopes aswell...

"Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The preclinical work looks very positive and exciting but, until we have done this first clinical study in people with tinnitus we have no idea of whether those models will be predictive of its activity in humans. So we shall have to wait until this study finishes before we know. Clinical research just takes a long time, certainly a number of years. However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account."

 

[Zechariah]

"Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The preclinical work looks very positive and exciting but, until we have done this first clinical study in people with tinnitus we have no idea of whether those models will be predictive of its activity in humans. So we shall have to wait until this study finishes before we know. Clinical research just takes a long time, certainly a number of years. However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account."

Here is my EDIT from the last message:

And to be clear, I mean that Autifony may wish that they could fast track it but fast tracking isn't Autifony's decision and therefore no one can say "they will fast track it" because no one really knows if the drug works and will the authorities approve fast tracking.

 

[Rube]

"Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The preclinical work looks very positive and exciting but, until we have done this first clinical study in people with tinnitus we have no idea of whether those models will be predictive of its activity in humans. So we shall have to wait until this study finishes before we know. Clinical research just takes a long time, certainly a number of years. However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account."

This statement in no way infers they will fast track. Yes everyone knows there is a critical unmet need and will take it into account. Not sure how that implies it will be fast tracked.

 

[Danny Boy]

This statement in no way infers they will fast track. Yes everyone knows there is a critical unmet need and will take it into account. Not sure how that implies it will be fast tracked.

They can apply to fast track and it will be reviewed simple as that.

 

[Rube]

They can apply to fast track and it will be reviewed simple as that.

Sure they can apply but in no way shape or form has Autifony DECLARED they are going to fast track anything. Let's keep the speculation to a minimum here.

 

[Danny Boy]

Sure they can apply but in no way shape or form has Autifony DECLARED they are going to fast track anything. Let's keep the speculation to a minimum here.

Look, let's just wait and see and leave it at that.

 

[nills]

 

[Zechariah]

Look, let's just wait and see and leave it at that.

How about: "Sorry that I was spreading false information" instead of escaping discussion with comment like that, cherry picking or copy pasting semi-irrelevant text?

 

[Carlos1]

I would rather have false hope then no hope at all

 

[stelar]

How about: "Sorry that I was spreading false information" instead of escaping discussion with comment like that, cherry picking or copy pasting semi-irrelevant text?

Hey stop cherry picking on @dannyboy buddy. He's got nothing to apologize for.
What is this the Nuremberg trials?

 

[Danny Boy]

How about: "Sorry that I was spreading false information" instead of escaping discussion with comment like that, cherry picking or copy pasting semi-irrelevant text?

I asked in the Q&A if they would fast-track and they said this ". However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account" which would indicate they would if the results are positive. The fast-track programme is intended to help drugs get fast-tracked if the drug meets an unmet medical need, which tinnitus certainly is. So calm down, wait till the results come out and we'll see what happens.

 

[Jokko]

Also "fast tracked" mesn that aut is in 5 years on the market?

 

[Zechariah]

Hey stop cherry picking on @dannyboy buddy. He's got nothing to apologize for.
What is this the Nuremberg trials?

I have to disagree but I'll leave it there...

 

[111]

They did say they would fast-track!

Sure they can apply but in no way shape or form has Autifony DECLARED they are going to fast track anything. Let's keep the speculation to a minimum here.

So just to add a bit of information, directly from Charles Large himself on this topic, back in 2014 I asked him this exact question and below is a copy of my question and his response via email. For those interested the link below explains what the ema's adaptive licence actually is

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000601.jsp




-----Original Message-----
From: Charles Large
To: xxxx
Sent: Jun, 2014 9:12 pm
Subject: R: re aut 00063

Dear xxx,
Thanks for your note and comments. It is too early to determine the future development path for AUT00063, but needless to say we are hoping for positive results from our future trials. We will be aiming to post more information regarding the two trials in due course via our web site.
Best regards
Charles
Charles Large, PhD.
Chief Executive Officer
Autifony Therapeutics Limited
________________________________________
This message and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this message in error please delete it and any files transmitted with it, after notifying info@autifony.com

Da: xxxx
Inviato:
A: Charles Large
Oggetto: aut 00063

Hello Charles
Just seen the latest update to the trials for AUT 00063 for tinnitus. I was wondering if given the results you have from your phase one trial, and if phase two shows more good results as well, could this product go through the EMA's adaptive licence process, given the fact that no other product is available specifically for tinnitus, which would mean quicker access to this product to the general public ?
regards
xxx

 

[noisebox]

Oh well that was a year ago and still no news.

 

[grate_biff]

Is it safe to say now that Autifony wont be answering our questions any time soon? And we have to wait for a public announcement? Atleast there is no "fast-tracking" regarding any replies. I really hoped they would treat this forum as somewhat "special" since we are so incredibly interested in theire work and dying to get some info from them. I guess we arn´t. "Special" that is!

 

[Silvio Sabo]

Is it safe to say now that Autifony wont be answering our questions any time soon? And we have to wait for a public announcement? Atleast there is no "fast-tracking" regarding any replies. I really hoped they would treat this forum as somewhat "special" since we are so incredibly interested in theire work and dying to get some info from them. I guess we arn´t. "Special" that is!

It's not that surprising that they won't answer a certain type of questions. If they gave the people on this board information that isn't public then we would get an advantage and might use that information to perhaps invest money or not, depending on the answers. They are a company and aren't allowed to share information however. They have to follow protocols when sharing information to the public.

In other words: patience, patience, patience...

 

[noisebox]

Patience is something I don't have. I'm already day dreaming of T free days and being able to go normal places again without punishment. I have a very long list......................

 

[noisebox]

Does anybody think that this new drug may work in just a month and not need to be repeated or do we think it will be a lifelong need?