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

[bill 112]

Hi, I just made an account to ask when we could expect to hear the results of the phase 1 trial autifony are doing? I am suffering alot right now and this is the one thing keeping me from giving up hope, so any replies would be greatly appreciated. Thanks.

Hi Tom they were suppose announce results in Q1 of this year but have not done so yet but they did announce that they do plan to progress to stage 2 trials which leads me to believe that no serious side effects occured during stage1 trials.Dont give up hope as far as research goes and treatments in the pipeline this is the closest we've ever come to curing this condition.Best wishes Bill

 

[benryu]

Hi, I just made an account to ask when we could expect to hear the results of the phase 1 trial autifony are doing? I am suffering alot right now and this is the one thing keeping me from giving up hope, so any replies would be greatly appreciated. Thanks.

I agree with @bill 112 they are most likely planning the phase 2 trial, it's generally a huge and long process. So many companies are now working on concrete treatment, and so much money is being invested, the cure or at least a good relief has never been so close. Keep the chin up

 

[lapidus]

One thing i wonder though is how the scientists knows that the mice has T. This goes for the vagus nerve research too where they used mice. Do they study the behaviour of the noise damaged mice and compare them to healthy mice? Are the mice with T more nervous in their behaviour? Or is there some kind of pavlov's dog thing going on?

 

[Valentin]

One thing i wonder though is how the scientists knows that the mice has T. This goes for the vagus nerve research too where they used mice. Do they study the behaviour of the noise damaged mice and compare them to healthy mice? Are the mice with T more nervous in their behaviour? Or is there some kind of pavlov's dog thing going on?

they see the same hyperactivity with their neurons.

http://www.sciencedaily.com/releases/2013/05/130527153701.htm

 

[Grace]

they see the same hyperactivity with their neurons.

http://www.sciencedaily.com/releases/2013/05/130527153701.htm

So they say if our neurons are returned back to normal and arent firing like crazy then that should stop the T? And it seem that no matter the cause of T, it all results in a misfiring of neurons which become abnormal creating these sounds?

 

[Valentin]

So they say if our neurons are returned back to normal and arent firing like crazy then that should stop the T? And it seem that no matter the cause of T, it all results in a misfiring of neurons which become abnormal creating these sounds?

from what i read, no matter the origin or cause of tinnitus, there's always this neuron hyperactivity.

that makes sense :

broken hair cell, loss of input = EEEEE
compressed audio nerve so loss of input = EEEEE
severed audio nerve so loss of input = EEEEE
cochlear implant so loss of input =EEEEEE

However some people's brain have no issues with loss of input (i believe that is defined as being normal)

 

[t-man]

Yeah the fact remains we're in the minority of people who's brains don't plasticize properly to deal with loss of input from the ear.

Frankly, I'd much rather they find a procedure to calm the neuron hyperactivity for the simple reason we're still prone to hearing loss as we age or unintentional noise exposure and the T will probably return.

 

[bill 112]

From speaking to a few researchers how they determine if a mouse has T or not is this,when a human has developed T they develop hyperactive neurons in the auditory brain.This can be seen through numerous scans and EEG tests.This can be seen clearly and is which finally proved that T is a physiological problem rather than a pshycological problem i.e the patient is not making it up it actually is there.They then expose a mouse to loud noise for a set amount of time enough to damage hearing.After this scans are taken of the mouse and some show increased activity in the auditory brain the same as it does in humans with T.The scans of the T mouse and T human are compared and the similarities were so identicle that this couldnt be a coincidence and this is how they concluded that mice develop T also.They also do a hearing test on the mouse to pin point its exact T frequency.They will play frequencies to the mouse and it usually reacts to the stimulous but when it doesnt react to the frequency they determine that the mouse can no longer hear this frequency it shows gaps in the mouses hearing.Now we will never no for certain that a mouse has T or not but its the closest human,animal similarities that weve ever gotton for T and its a good baseline for research.The important thing to remember is that the mice who had increased auditory brain activity were given Aut00063 and this increased activity was abolished completely which is why Autifony shows real promise as a cure for T and H as its evidence so far is amazing.

 

[t-man]

Screw mice, let's just tie-up a chimp and deafen him with Def Leppard.

 

[Stina]

From speaking to a few researchers how they determine if a mouse has T or not is this,when a human has developed T they develop hyperactive neurons in the auditory brain.This can be seen through numerous scans and EEG tests.This can be seen clearly and is which finally proved that T is a physiological problem rather than a pshycological problem i.e the patient is not making it up it actually is there.They then expose a mouse to loud noise for a set amount of time enough to damage hearing.After this scans are taken of the mouse and some show increased activity in the auditory brain the same as it does in humans with T.The scans of the T mouse and T human are compared and the similarities were so identicle that this couldnt be a coincidence and this is how they concluded that mice develop T also.They also do a hearing test on the mouse to pin point its exact T frequency.They will play frequencies to the mouse and it usually reacts to the stimulous but when it doesnt react to the frequency they determine that the mouse can no longer hear this frequency it shows gaps in the mouses hearing.Now we will never no for certain that a mouse has T or not but its the closest human,animal similarities that weve ever gotton for T and its a good baseline for research.The important thing to remember is that the mice who had increased auditory brain activity were given Aut00063 and this increased activity was abolished completely which is why Autifony shows real promise as a cure for T and H as its evidence so far is amazing.

Where did you get your information? Ir read a text online that researches said that they use behavioural studies, eg. observe how the mice/rats behave in the silence and in noise or smth like. Thats why its very inaccurate and there iss really no good way to determine whether they actually had tinnitus or not and if they did, whether it left or not. But maybe they use scans as well then.

 

[lapidus]

Thank you @bill 112 That was a superb explanation, and I really do hope you're right about that last part too. I really wish they could speed up things.

 

[bill 112]

Where did you get your information? Ir read a text online that researches said that they use behavioural studies, eg. observe how the mice/rats behave in the silence and in noise or smth like. Thats why its very inaccurate and there iss really no good way to determine whether they actually had tinnitus or not and if they did, whether it left or not. But maybe they use scans as well then.

From an audiological scientist at UCL scans were used in early experiments to determine similarities between human and mice.Once similarities had been established they had a good animal baseline to experiment and research with,this is how they know that mice have a similar auditory system as humans through anatomy and elevated activity in the auditory brain after prolonged noise exposure.Scans are not necessary as they were a proof of concept if you will in early experiments and is now conducted through as you said behavioural studies which may include stimulous testing.They will play ranges of frequencies to the mouse to which it will react and some it wont thus proving a hearing loss to some degree showing gaps in its hearing.I then asked him well how do we know that it might have T or not?He then said the best evidence Ive seen is when the mice have been exposed to loud noise for a set amount of time and the stimulous test has been conducted those showing a hearing loss behaviour will be studied.We have observed mice reacting to a sound stimulous that wasnt there thus indicating that mice may have the potential to develop T.It looked like the mice were reacting to sound in the absence of any sound stimulous indicating the presence of a phantom sound....T.Now im well aware that this may be BS but who am I to question him he has over 25 years experience in the field and graduated from UCL with full honourary degrees in audiological science he spent 15 of those years at UCL and is currently the lead professor at Irelands top eye and ear hospital.Every time I called a hospital in Ireland looking for a specialist I was always given the same phone number....his.So needless to say I respect what he says.

 

[Grace]

From an audiological scientist at UCL scans were used in early experiments to determine similarities between human and mice.Once similarities had been established they had a good animal baseline to experiment and research with,this is how they know that mice have a similar auditory system as humans through anatomy and elevated activity in the auditory brain after prolonged noise exposure.Scans are not necessary as they were a proof of concept if you will in early experiments and is now conducted through as you said behavioural studies which may include stimulous testing.They will play ranges of frequencies to the mouse to which it will react and some it wont thus proving a hearing loss to some degree showing gaps in its hearing.I then asked him well how do we know that it might have T or not?He then said the best evidence Ive seen is when the mice have been exposed to loud noise for a set amount of time and the stimulous test has been conducted those showing a hearing loss behaviour will be studied.We have observed mice reacting to a sound stimulous that wasnt there thus indicating that mice may have the potential to develop T.It looked like the mice were reacting to sound in the absence of any sound stimulous indicating the presence of a phantom sound....T.Now im well aware that this may be BS but who am I to question him he has over 25 years experience in the field and graduated from UCL with full honourary degrees in audiological science he spent 15 of those years at UCL and is currently the lead professor at Irelands top eye and ear hospital.Every time I called a hospital in Ireland looking for a specialist I was always given the same phone number....his.So needless to say I respect what he says.

Thats awsome.. I really hope hes right! Like you said hes got 25 years experience hes no dummy so its the best guess but damn wish rats could talk! Lol

 

[dan]

Pathogenic plasticity of Kv7.2/3 channel activity
is essential for the induction of tinnitus

http://www.pnas.org/content/early/2013/05/23/1302770110.full.pdf

I hope this doesn't mean its only for prevention.

 

[mmacabre]

Well, in the magic autifony rat cure study, the drugs were delivered 30 days after the noise exposure, after the mice had already developed tinnitus, so that "critical period" of induction might have already passed and yet there was still the extinction of tinnitus correlated behaviors in the rats. If I'm not mistaken?

 

[t-man]

Well, in the magic autifony rat cure study, the drugs were delivered 30 days after the noise exposure, after the mice had already developed tinnitus, so that "critical period" of induction might have already passed and yet there was still the extinction of tinnitus correlated behaviors in the rats. If I'm not mistaken?

Thirty days is not long enough to classify tinnitus as being chronic. We'll see when they start testing chronic patients, but they'll probably start their trials on onset tinnitus patients to better their results.

 

[dan]

I think somebody said one rat had tinnitus of 6 months and was cured.

 

[Hudson]

Thirty days is not long enough to classify tinnitus as being chronic. We'll see when they start testing chronic patients, but they'll probably start their trials on onset tinnitus patients to better their results.

30 days in a rat is long enough to be considered chronic. Their lifespan is no where near what ours is, so you have to extrapolate their time frames for having tinnitus. Their time frame for magically healing is much shorter than ours.

 

[RichL]

This is exciting, I hope it's not a let down!

 

[dan]

ATTENTION ALL TINNITUS SUFFERERS!
THIS JUST IN

My prayers have been answered today and I am proud to be the first tinnitustalk member to announce the successful phase 1, Aut00063 drug completion and public announcement.


Conclusions


• Autifony has first-in-class drug candidate for hearing disorders, which

has potential to be major new indication for pharmacological treatment

• Phase I successfully completed

• Two Phase IIa studies in age related hearing loss and tinnitus in detailed

planning

• Other differentiated Kv3 molecules have applications in schizophrenia

and will be developed to the CTA/IND stage with grant funding

• Early exploratory discussions ongoing with future potential partners to

understand expectations and potential fit
For complete announcement please refer to this link:
http://www.anglonordicbiotech.com/img/File/Comp Pres 2014/Autifony-session 1.pdf

GO AUTIFONY!!!

 

[Miss lavender]

This is wonderful news! Maybe things will progress faster than expected.

 

[lapidus]

Would be really great if someone from TT would participate in the phase II study. @bill 112 Werent you talking about maybe participating?

 

[Suresh]

Great news

 

[JohnDoe]

ATTENTION ALL TINNITUS SUFFERERS!
THIS JUST IN

My prayers have been answered today and I am proud to be the first tinnitustalk member to announce the successful phase 1, Aut00063 drug completion and public announcement.


Conclusions


• Autifony has first-in-class drug candidate for hearing disorders, which

has potential to be major new indication for pharmacological treatment

• Phase I successfully completed

• Two Phase IIa studies in age related hearing loss and tinnitus in detailed

planning

• Other differentiated Kv3 molecules have applications in schizophrenia

and will be developed to the CTA/IND stage with grant funding

• Early exploratory discussions ongoing with future potential partners to

understand expectations and potential fit
For complete announcement please refer to this link:
http://www.anglonordicbiotech.com/img/File/Comp Pres 2014/Autifony-session 1.pdf

GO AUTIFONY!!!

I hope Autifony will release more information about the results of their Phase 1 study on their site or in a journal. This is third party information.

 

[nills]

I like this part in the file that says

AutifonyCompounds
Autifony is targeting central auditory processing through the regulation of "Kv3" ion channels which control the activity of
key neural elements
• Kv3 channels are found at all levels of the auditory system
• The channels are important in neurons that must fire rapidly and with precise timing,
e.g. in circuits involved in decoding speech

Cause this is directly linked with the discovery or claim by Dr Susan Shore about `timing`. Seems like pieces of the puzzle are falling in place. I hope they are on to something.

here is an article about the `timing-tinnitus` concept

http://www.medicalnewstoday.com/articles/270408.php

 

[Grace]

If it comes pennsylvania like am101 did ill deff sign up!

 

[Hudson]

ATTENTION ALL TINNITUS SUFFERERS!
THIS JUST IN

My prayers have been answered today and I am proud to be the first tinnitustalk member to announce the successful phase 1, Aut00063 drug completion and public announcement.


Conclusions


• Autifony has first-in-class drug candidate for hearing disorders, which

has potential to be major new indication for pharmacological treatment

• Phase I successfully completed

• Two Phase IIa studies in age related hearing loss and tinnitus in detailed

planning

• Other differentiated Kv3 molecules have applications in schizophrenia

and will be developed to the CTA/IND stage with grant funding

• Early exploratory discussions ongoing with future potential partners to

understand expectations and potential fit
For complete announcement please refer to this link:
http://www.anglonordicbiotech.com/img/File/Comp Pres 2014/Autifony-session 1.pdf

GO AUTIFONY!!!

Great find @dan! They don't even have that in their news section on the website. I'm sure they will update their site once they enter into Phase II trials.

"Phase II plans:
• Planning well underway for:
• Age Related Hearing Loss Phase IIa in US
• Tinnitus Phase IIa in UK
• Aiming for 2H 2014 start for both trials"

Does 2H mean Q2 in the UK or something? It's too bad they won't be doing any tinnitus trials here in the US. Maybe some of us with hearing loss could get on to a trial with them here in the US though?

EDIT:

I should note that it is an encouraging sign that their compound was well tolerated at all dose levels. That's kind of relative though, it can be anyone's guess what "well tolerated" means exactly. I'm willing to put up with some side effects for tinnitus relief though, and I'm sure many others are as well.

 

[nills]

I`m also pretty stoked with the news because it seems to go really fast. I remember AM101 being in first trial in 2009. Took ages for them to continue. So all hopes that this thing is being pushed hard by their investers.

 

[mmacabre]

I wonder if/hope that these trials will be completed faster than am101 on account of that involving injections into the inner ear, and autifony only requiring that you ingest a pill every day of the trial.

 

[Hudson]

I wonder if/hope that these trials will be completed faster than am101 on account of that involving injections into the inner ear, and autifony only requiring that you ingest a pill every day of the trial.

Well, constant administration of therapeutic doses of a compound actually probably requires more oversight than what AM-101's compound does. I would imagine these Phase II trials will not be very fast at all. They will need to establish a long term safety profile as well as efficacy in these trials. So far, we have no idea if this thing is efficacious at all. They only tested it in healthy volunteers with no hearing loss or tinnitus. This thing could theoretically have no effect whatsoever. I think a bit of caution is warranted.