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

[Hotspur]

They are still recruiting people for aut63 in Notingham:

http://www.nuh.nhs.uk/communications-and-media/news/2015/july/do-you-suffer-with-tinnitus/

Think we need to wait another 6 months for the results

Just dont get this,i finished this trial almost six months ago,and still cant find 150 people!
Theirs over 60 million people on this island!
Corrine had this huge improvement ,drop the damn hearing criteria and please get on with it!

 

[Nucleo]

Just dont get this,i finished this trial almost six months ago,and still cant find 150 people!
Theirs over 60 million people on this island!
Corrine had this huge improvement ,drop the damn hearing criteria and please get on with it!

Yeah the hearing criteria is completely unwarranted.

 

[Danny Boy]

Yeah the hearing criteria is completely unwarranted.

If they got rid of it, I would be on the trial asap...But since they wish to deter people, what can I do?

 

[dan]

Yeah the hearing criteria is completely unwarranted.

I disagree, there is a VERY important reason for this hearing loss criteria.

 

[Danny Boy]

I disagree, there is a VERY important reason for this hearing loss criteria.

Well, people do have hidden hearing loss...And they are doing a trial for age related hearing loss in America. Trobalt worked for me and I have hidden hearing loss.

 

[Nucleo]

I disagree, there is a VERY important reason for this hearing loss criteria.

I get that they're trying to limit the study to noise induced tinnitus but audiogram is a really crap way to diagnose tinnitus.

From their website:

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.​

So if you have hearing loss at frequency they won't test for you can't get into the trial. If you have hearing loss at 8500 hz you still can't get in the trial. If you are subject to an acoustic trauma with a temporary threshold shift, and your hearing comes back but tinnitus remains (quite common) you can't participate in the study.

Also from their website:

Q. Can a subject with hearing loss in only 1 ear still take part?
A. This will depend upon how large is the difference from one ear to the other; this will be checked by the audiologist before entry into the study.
​

If you have a firecracker popping next to one of your hears or someone yelled in your left ear, well guess what? You won't be able to participate either.

Given that audiograms are really poor indicators of anything tinnitus related I do not know why they chose these criteria. Seems like not much thought was put into that one.

With the following statement in mind:

Q. If I also suffer from hearing loss, can I expect to see an improvement in my audiogram, as I know AUT00063 is being tested also for Age Related Hearing Loss in the USA
A. No, we do not expect AUT00063 to improve the pure tone audiogram as the drug does not work on mechanisms is the cochlea itself. "063" is designed to improve auditory processing in the brain, and of course to reduce the central auditory activity that gives rise to tinnitus. A decline in central auditory processing is an important aspect of age related hearing loss, and gives rise to the difficult people have understanding speech in difficult listening environments, such as in a background of noise. In preclinical models, AUT00063 has been shown to improve central auditory processing.
​

Why bother with pure tone audiogram requirements if their drug won't even affect that? No idea.

 

[Danny Boy]

I get that they're trying to limit the study to noise induced tinnitus but audiogram is a really crap way to diagnose tinnitus.

From their website:

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.​

So if you have hearing loss at frequency they won't test for you can't get into the trial. If you have hearing loss at 8500 hz you still can't get in the trial. If you are subject to an acoustic trauma with a temporary threshold shift, and your hearing comes back but tinnitus remains (quite common) you can't participate in the study.

Also from their website:

Q. Can a subject with hearing loss in only 1 ear still take part?
A. This will depend upon how large is the difference from one ear to the other; this will be checked by the audiologist before entry into the study.
​

If you have a firecracker popping next to one of your hears or someone yelled in your left ear, well guess what? You won't be able to participate either.

Given that audiograms are really poor indicators of anything tinnitus related I do not know why they chose these criteria. Seems like not much thought was put into that one.

With the following statement in mind:

Q. If I also suffer from hearing loss, can I expect to see an improvement in my audiogram, as I know AUT00063 is being tested also for Age Related Hearing Loss in the USA
A. No, we do not expect AUT00063 to improve the pure tone audiogram as the drug does not work on mechanisms is the cochlea itself. "063" is designed to improve auditory processing in the brain, and of course to reduce the central auditory activity that gives rise to tinnitus. A decline in central auditory processing is an important aspect of age related hearing loss, and gives rise to the difficult people have understanding speech in difficult listening environments, such as in a background of noise. In preclinical models, AUT00063 has been shown to improve central auditory processing.
​

Why bother with pure tone audiogram requirements if their drug won't even affect that? No idea.

Well, the trial is poorly designed that's for sure. They better buck up their ideas in phase 3.

 

[earsnothappy]

It already exists...

https://www.tinnitustalk.com/threads/autifony-phase-ii-trial-participants-experiences.8339/

Yes, that's for participant experiences, but not news or updates. I'm surrendering. This thread is a mess and I'm going to stop looking at it. It simply makes me depressed as no one here really knows anything concrete other than the facts that have been released or reported (which in now 70 pages would be impossible for anyone to find). I wish there was a thread that could simply be factual updates.

I'm sure if there's any significant news I will hear about it somewhere else or some other way.

Good luck to you all on this. I hope for us all that this drug works and makes it onto the market as fast as possible.

 

[Rube]

Yes, that's for participant experiences, but not news or updates. I'm surrendering. This thread is a mess and I'm going to stop looking at it. It simply makes me depressed as no one here really knows anything concrete other than the facts that have been released or reported (which in now 70 pages would be impossible for anyone to find). I wish there was a thread that could simply be factual updates.

I'm sure if there's any significant news I will hear about it somewhere else or some other way.

Good luck to you all on this. I hope for us all that this drug works and makes it onto the market as fast as possible.

Sadly there has been very little in the way of news or updates, just 70 pages of speculation. What we do know is that the results of the quiet 1 phase 2 study will be available in 1st quarter of 2016 and we can hope the results are encouraging that they expand the study to the U.S. for phase 3.
Until then there's not much else we can do but sit and wait.....which sucks
Hopefully we do get some more positive experiences from people on the current trial.

 

[Christian78]

well , this is what i said on a start. This company say we will do it ist quoter, they do it 4th quarter. They hide and take money from government to fill their packets, and on the end no results.

 

[Christian78]

I disagree, there is a VERY important reason for this hearing loss criteria.

I agree that AUT063 sucks big time!

 

[derpytia]

Well, the trial is poorly designed that's for sure. They better buck up their ideas in phase 3.

I hope so too! I would hate to have them lose out on potential 'effectiveness' because they won't let people in. How horrible would it be if this was really the drug that could really help us all out and it doesn't go on market because they kept the sampling size to isolated and small and that ends up being the reason why it doesn't yield good results?

 

[Christian78]

I swear it was end of July, but I'm unsure.

they said it would star in end of summer, then december, then march then june, so trial takes 28 days and last 365. fucking autifony. they claim they know someting, only they know how to take money from companies that donate in hope there is something, some kind of help.

We still live in stone age of neuroscience, and brain is big black hole that no one understands. But everyone give their theory of it, like it is religion, 10 religion who brain works.

 

[jeannie]

this is making me very depressed.... I was hoping they would give more updates and get the ball rolling with this drug... sick of this damn tinnitus !

 

[valeri]

We should have already had results of this trial!
Now we wait another six months for something that may not even be positive at all.
Very disappointing!
They should have had 3-4 groups with different dosage and time frame, the way this is run it may take years before there's a drug on the market or they may simply conclude this drug doesn't help when instead it just needed few alterations!

 

[Rube]

Everybody should just chill out. They know what they are doing, these trials take time. I can't even imagine all the logistics, legal hurdles and red tape they have to go through........ In their own minds I'm sure everyone here could have run this trial better than the professionals. Be glad that at least someone is doing something for this condition.

 

[DebInAustralia]

I get you are all suffering, but I am with Rube on this. well saidX

 

[valeri]

Everybody should just chill out. They know what they are doing, these trials take time. I can't even imagine all the logistics, legal hurdles and red tape they have to go through........ In their own minds I'm sure everyone here could have run this trial better than the professionals. Be glad that at least someone is doing something for this condition.

Agree with you regarding logistics and possible legal hurdles they have to go through, it must be crazy and time consuming.
But when it comes to actual trial a bigger sample group would be better and would definetly cover more ground.
Taking 4 pills for a month may or may not prove beneficial for most people.
But if they had 3-4 groups going on at the same time, let's say one taking 4 pills for 2-3 months, another taking 6 pills for a month or whatever, it would definetly give better picture on what dosage works better.
I'm in no way saying I know better but just saying that more options is always better than just one.
Imagine how many years would be needed to test different options working at this pace?
Or the worse case scenario would be if they simply conclude this drug is not beneficial for tinnitus when it simply just needed a minor dosage/time modification.
I'm still hopeful but not unrealistically optimistic

 

[Christian78]

We should have already had results of this trial!
Now we wait another six months for something that may not even be positive at all.
Very disappointing!
They should have had 3-4 groups with different dosage and time frame, the way this is run it may take years before there's a drug on the market or they may simply conclude this drug doesn't help when instead it just needed few alterations!

I agree but then they would not have enough money to put in their pockets but they would spend it on patients.

It is same as banks, management get money, while people get skinned alive.

I hope so too! I would hate to have them lose out on potential 'effectiveness' because they won't let people in. How horrible would it be if this was really the drug that could really help us all out and it doesn't go on market because they kept the sampling size to isolated and small and that ends up being the reason why it doesn't yield good results?

Did you try sound therapy, high freq sounds if your tinnitus is there for 5-10 min so see will brain become lazy to return to tinnitus lvl

Agree with you regarding logistics and possible legal hurdles they have to go through, it must be crazy and time consuming.
But when it comes to actual trial a bigger sample group would be better and would definetly cover more ground.
Taking 4 pills for a month may or may not prove beneficial for most people.
But if they had 3-4 groups going on at the same time, let's say one taking 4 pills for 2-3 months, another taking 6 pills for a month or whatever, it would definetly give better picture on what dosage works better.
I'm in no way saying I know better but just saying that more options is always better than just one.
Imagine how many years would be needed to test different options working at this pace?
Or the worse case scenario would be if they simply conclude this drug is not beneficial for tinnitus when it simply just needed a minor dosage/time modification.
I'm still hopeful but not unrealistically optimistic

well they decide this, and i suppose this is why when i wrote mail to Dr. Large he said he may need more time for twitching this drug (AUT063), and that meant adding, changing making it better for who know how long time.

So as understood here no information until next year. It was promised that 1st phase result will be give 1st quarter 2014, and end of summer 2014 start, but start was december 2014 and 2x 28 days to give result in 2016?

Does is seem efficient...

And that other drug that is like trobalt, if you took trobalt you would know what is does to your brain. if you think after you take trobalt and tinnitus stops that you can work you are in big error. Trobalt cuts out your brain and makes you invalid, person with brain but without it. Remembering names, trying to read a book is useless, big sentences can be understood and remembered so that you understand a book. No fast talking, because you don't understand half.

 

[nills]

And that other drug that is like trobalt, if you took trobalt you would know what is does to your brain. if you think after you take trobalt and tinnitus stops that you can work you are in big error. Trobalt cuts out your brain and makes you invalid, person with brain but without it. Remembering names, trying to read a book is useless, big sentences can be understood and remembered so that you understand a book. No fast talking, because you don't understand half.

that all has to do with side effects ... it just has to do that the compound isn`t specific enough yet and influences other regions of the brain which might cause these experiences for their users ... when they tweak the compound better it can be very spicific without having the side effects ... or at least fewer ... stay a bit positive people, it`s all we have left. Too much negativity here and too much assumptions ... you`re all talking to the wind and who knows where it might blow?

 

[Rube]

I highly doubt the big wigs at autifony got to where they are now by being this inept. These people aren't rookies, they are professionals, give them a little credit.

 

[Danny Boy]

I highly doubt the big wigs at autifony got to where they are now by being this inept. These people aren't rookies, they are professionals, give them a little credit.

Just not fair, I have hidden hearing loss...I hope phase 3 abolishes the hearing component.

 

[Rube]

Just not fair, I have hidden hearing loss...I hope phase 3 abolishes the hearing component.

Did u attempt to get into the trial?

 

[Danny Boy]

Did u attempt to get into the trial?

Yep and my hearing was simply too good.

 

[Rube]

Yep and my hearing was simply too good.

That Stinks. We will Just have to wait and see what phase 3 brings.

 

[Danny Boy]

That Stinks. We will Just have to wait and see what phase 3 brings.

Well, hopefully they will also extend the trial for people with prolonged tinnitus not under 18 months.

 

[Rube]

Well, hopefully they will also extend the trial for people with prolonged tinnitus not under 18 months.

yeah cause I would be ineligible also! Now THAT would suck. But I'll still take the medicine when it's released eventually.

 

[Danny Boy]

yeah cause I would be ineligible also! Now THAT would suck. But I'll still take the medicine when it's released eventually.

Is Phase 3 even going to be extended to the US? I thought after phase 2 they could potentially fast-track?

 

[Rube]

Is Phase 3 even going to be extended to the US? I thought after phase 2 they could potentially fast-track?

I still haven't seen anything where they said they are fast tracking. It's too early to even speculate on aut00063's effectiveness so why would they even discuss fast tracking.

 

[Danny Boy]

I still haven't seen anything where they said they are fast tracking. It's too early to even speculate on aut00063's effectiveness so why would they even discuss fast tracking.

Well, they already mentioned they would fast-track...of course they will, there's monies to be made.