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

[Danny Boy]

@Danny Boy , Please bro, their is no need for post's like this, we just have to be patient, it is far too early to say either way!

So it just seems everyone is negative about this drug...I personally think Doctor Charles Large wouldn't make a dud drug. But greece is making a drug which is based on a more precise trobalt made especially for tinnitus. KV3+KV7 seems like it'll be more suitable for tinnitus.

 

[Sharpfire]

Yes, the rat study is very encouraging (according to the authors, AUT63 "abolished evidence of tinnitus"). Strange that I am jealous of a rat…

Anyway, there are two TT members who are on the trial - @Hotspur & @chamferman, but no one knows whether they have received the drug or the placebo. They have been posting their progress here https://www.tinnitustalk.com/threads/autifony-phase-ii-trial-participants-experiences.8339/page-2, but there has not been much activity as of late. Any updates guys?

Do you have a link to the study? I'm curious to read it.

EDIT: Nvm, found the abstract http://www.autifonytherapeutics.com/publications/Turneretal2013-TRI_final.pdf

 

[rtwombly]

My mother has an appointment in Tampa, FL in the next 2 weeks to enter the autifony study for age related hearing loss. This is probably a screening, but she seems to fit all there criteria so I hope she is entered into the program. She does seem to have difficulty hearing someone in a noisy environment, but more importantly she has had tinnitus for 30 years. Her tinnitus started when she was taking aspirin for 2 years straight for sciatica pain, but it could have another cause. She says it gets louder based on the weather, humid days it gets louder, she isn't hindered by it though. If she starts taking the drug/placebo then I will keep in touch with her and relay her thoughts.

Thanks for keeping us informed.

 

[RichL]

So it just seems everyone is negative about this drug.

I can't for the life of me fathom why there is any negativity about this drug.

Two people from this forum have taken part in the trial and considering it is a double blind placebo trial, nobody except Autifony know what these two trialee's received.

Autifony have been more than accommodating with information regarding this drug through the hard work of the TT team in the Autifony Q & A section.

@Danny Boy , The only negativity being posted about this drug seems to be coming from the mind of certain forum members who are letting their frustrations cloud their common sense and rationale!

 

[Steve]

I can't for the life of me fathom why there is any negativity about this drug.

Two people from this forum have taken part in the trial and considering it is a double blind placebo trial, nobody except Autifony know what these two trialee's received.

Autifony have been more than accommodating with information regarding this drug through the hard work of the TT team in the Autifony Q & A section.

@Danny Boy , The only negativity being posted about this drug seems to be coming from the mind of certain forum members who are letting their frustrations cloud their common sense and rationale!

Agree Rich.

The thing is that when you set your mind this way, put everything down as pointless and that it'll never work, all you are doing is creating your own suffering.

 

[SteveToHeal]

Latest info in from trial ppl re the hearing loss amendment (might already be old news). Bit from what i read here, it looks like they are battling to recruit with such stringent criteria. Hence the relaxing of the hearing loss component. Hoo boy!

Limited information was sent – to ask us to stop screening new patients until changes were made.

See below:

We have a protocol amendment soon to be approved (MHRA and EC approval received already; pending several R&D approval). We anticipate that the change to the hearing loss criteria included in the amendment will help significantly with our screening pass/fail rate.

Sorry will let you know when we can

Kind regards

~Steve

 

[Gill Hayes]

Hi guys, I got through the phone screening stage for the Autifony trial but as I'm only 4.5 months in with T I can't be included yet. They're going to get back in touch with me (or I will them, in May - when I'll be 6 months in). Obviously I don't know whether I will get through the 2nd screening phase but if I do I will let you know how I get on. I have minor hearing loss, appropriate for my age, so who knows whether I will qualify or not . . .

 

[Danny Boy]

I got told this...

The hearing loss levels are not going to be abolished completely. They will only be altered so that there has to be a loss of 20dB or more at any one frequency instead of as an average across all frequencies. This change has not been fully approved yet so please don't make it widely known.

I've asked the Consultant to double check the audiogram you had here on 14/10/2014 and unfortunately you still don't fulfil the criteria. Your hearing is actually very good and the biggest loss you have is 15dB.

As it's just over 5 months now since that last audiogram it might be wise for you to have a repeat audiogram closer to home and see f there are any changes.

 

[Markku]

I got told this...

The hearing loss levels are not going to be abolished completely. They will only be altered so that there has to be a loss of 20dB or more at any one frequency instead of as an average across all frequencies. This change has not been fully approved yet so please don't make it widely known.

I've asked the Consultant to double check the audiogram you had here on 14/10/2014 and unfortunately you still don't fulfil the criteria. Your hearing is actually very good and the biggest loss you have is 15dB.

As it's just over 5 months now since that last audiogram it might be wise for you to have a repeat audiogram closer to home and see f there are any changes.

It's not actually totally new information, as the Autifony Q&A we posted on February 21st, already stated it:

https://www.tinnitustalk.com/threads/autifony-q-a.8331/
Q. Can I enter the study with normal hearing?
A. The study requires subjects to have a small (>20dB) hearing loss at one or more frequencies from 0.5kHz up to 8kHz; this is a minimal loss and most tinnitus sufferers will have this.​

 

[Danny Boy]

It's not actually totally new information, as the Autifony Q&A we posted on February 21st, already stated it:

https://www.tinnitustalk.com/threads/autifony-q-a.8331/
Q. Can I enter the study with normal hearing?
A. The study requires subjects to have a small (>20dB) hearing loss at one or more frequencies from 0.5kHz up to 8kHz; this is a minimal loss and most tinnitus sufferers will have this.​

And I don't...So not fair.

 

[nills]

I`m also told my hearing is fine but I will share my Audiometry to show what it looks like. I think I would fit their study. And to answer @Stink question below me without wasting more thread space ... unfortunately i`m a Belgian resident ... but if they come to Belgium I would join the study in the blink of an eye.

 

[Stink]

I`m also told my hearing is fine but I will share my Audiometry to show what it looks like. I think I would fit their study.View attachment 5514

it looks you qualify! congratulations! will you participate?

 

[dan]

And I don't...So not fair.

Take some ototoxic meds and within 2 weeks i guarantee you will qualify.

 

[nills]

And I don't...So not fair.

To be honest, it isn`t hard to trick the audiometry if you need to... when the sounds get low in volume just stop pushing the button ... but only do it in the 2 highest ranges or something like that... when I listened to my hearing test sometimes I was pushing but I actually did n`t even know if I was pushing because I hear the tone or the tinnitus. So I suspect my hearing is actually worse. When you are locked in those headphones there is a whole Tinnitus brassband playing!

 

[Danny Boy]

Take some ototoxic meds and within 2 weeks i guarantee you will qualify.

Lol, I did for 3 months still did nothing.

 

[dan]

Lol, I did for 3 months still did nothing.

lol

 

[dan]

To be honest, it isn`t hard to trick the audiometry if you need to... when the sounds get low in volume just stop pushing the button ... but only do it in the 2 highest ranges or something like that... when I listened to my hearing test sometimes I was pushing but I actually did n`t even know if I was pushing because I hear the tone or the tinnitus. So I suspect my hearing is actually worse. When you are locked in those headphones there is a whole Tinnitus brassband playing!

yeah so like this-

1st BEEEEEP - push
2nd Beeeep - push
3rd beeeep - push
4th beep - dont push
5th beep - push
6th beep - push
7th beep - dont push
8th beep - push
9th beep - dont push
10th beep - dont push
11th beep - DONT PUSH
12th beep - PUSH
13th+ (repeat beeps 9th-10)

 

[Christian78]

you are right animal activists should be blamed! http://en.wikipedia.org/wiki/Animal_testing_on_non-human_primates#Chimpanzees_in_the_U.S.

Lol, I did for 3 months still did nothing.

What ototoxic medicine did you take 3 months?

 

[amandine]

yeah so like this-

1st BEEEEEP - push
2nd Beeeep - push
3rd beeeep - push
4th beep - dont push
5th beep - push
6th beep - push
7th beep - dont push
8th beep - push
9th beep - dont push
10th beep - dont push
11th beep - DONT PUSH
12th beep - PUSH
13th+ (repeat beeps 9th-10)

@Nils made an important point re whether he was hearing the tone on the audio test or his own T. However.
dont think it is a great idea to encourage people to cheat the audio test. Dont think Autifony would be happy with such a suggestion. They have been kind enough to come here and answer questions by members They do follow the threads on TT as we all know so suggesting fiddling their tests to get onto the trial is nothing short of taking the mick out of them.
beep - push! What on earth does this mean? When you retake the audio test will you remember when you beeped and pushed or didnt!

 

[skoupidis]

Or maybe you should wait for the drug to come out like the rest of us...
Also, keep in mind this is an experimental drug, so you shouldn't be so eager to try it.

Patience... we all suffer every second of every day. People are working on this, we should not hinder their trials. They come up with results based on what people tell them. These results are important and it is imperative to be based on real facts...

 

[earsnothappy]

It's best to not lie your way onto a clinical trial. Let the drug pass or fail within the required criteria. False information will only cause problems in the data.

 

[Danny Boy]

It's best to not lie your way onto a clinical trial. Let the drug pass or fail within the required criteria. False information will only cause problems in the data.

How is faking an hearing test misleading their results? If my tinnitus reduces it reduces. The hearing loss component is only there so they can peddle their drug for age related hearing loss, nothing to do with tinnitus.

 

[skoupidis]

How is faking an hearing test misleading their results? If my tinnitus reduces it reduces. The hearing loss component is only there so they can peddle their drug for age related hearing loss, nothing to do with tinnitus.

You have an audiogram before which is bad and after you participate you have a good one. It is obvious how misleading that can be!

 

[Danny Boy]

You have an audiogram before which is bad and after you participate you have a good one. It is obvious how misleading that can be!

I'm not gonna fake one lol. I'm just saying it can't mess with their results, the only thing that could mess with their results is if I was faking having tinnitus or taking taking trobalt whilst being on Autifony's new drug, which I'm doing neither.

 

[valeri]

I'm not gonna fake one lol. I'm just saying it can't mess with their results, the only thing that could mess with their results is if I was faking having tinnitus or taking taking trobalt whilst being on Autifony's new drug, which I'm doing neither.

If they are testing the drug for hearing loss (as well as tinnitus) than any faking of the hearing test will definetly give false results!

I understand desperation but please let's be considerate of others and possible effects any cheating could have in the long run.

 

[DebInAustralia]

Why all the speculation? perhaps just wait for the preliminary results?

 

[Danny Boy]

They were going to do a trial for age related hearing loss for their drug in America which has nothing to do with tinnitus, but because of funding they scaled back and included it on their tinnitus trials so they can basically do a two in one. My hearing loss is minimal and yet trobalt works for me.

 

[valeri]

They were going to do a trial for age related hearing loss for their drug in America which has nothing to do with tinnitus, but because of funding they scaled back and included it on their tinnitus trials so they can basically do a two in one. My hearing loss is minimal and yet trobalt works for me.

Another member posted just few days ago that her mother was accepted into a hearing loss Autifony trial in USA!

 

[skoupidis]

They were going to do a trial for age related hearing loss for their drug in America which has nothing to do with tinnitus, but because of funding they scaled back and included it on their tinnitus trials so they can basically do a two in one. My hearing loss is minimal and yet trobalt works for me.

Also, you seem to be certain that tinnitus and hearing loss are not interconnected. Many would disagree. An acoustic trauma causes hearing loss and tinnitus at the same time. There is a connection there.

I cant help but wondering: If this drug works, apart from lowering tinnitus will it also cure sound distortion and hyperacousis? Recovering hearing could do that, but if the damage is in hair cells how will the AUT00063 exactly work on that part? Does acting on act on the Kv3 channels repair hearing loss? And what about damaged ribbon synapses? There is so much research going on on that parts, do Autifony claim to have an answer?

All technical questions, someone dare answer please

 

[Danny Boy]

Also, you seem to be certain that tinnitus and hearing loss are not interconnected. Many would disagree. An acoustic trauma causes hearing loss and tinnitus at the same time. There is a connection there.

I cant help but wondering: If this drug works, apart from lowering tinnitus will it also cure sound distortion and hyperacousis? Recovering hearing could do that, but if the damage is in hair cells how will the AUT00063 exactly work on that part? Does acting on act on the Kv3 channels repair hearing loss? And what about damaged ribbon synapses? There is so much research going on on that parts, do Autifony claim to have an answer?

All technical questions, someone dare answer please

Well keppra seems to have cured viking of h and it targets the same KV3.1 target. So could cure h. Although, they don't mention it lol