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

[attheedgeofscience]

Information should either be shared or nothing should be said at all.

Information was shared:

I heard back from the hospital. I take the liberty to copy here the e-mail verbatim as it was sent to me:

Dear David

Unfortunately it is not just at Addenbrookes that the whole trial is being stopped. I became aware of the information as Autifony contacted us last week and all other sites are stopping, and as you have correctly understood the researchers found the drug had not been working.

I am aware that there was only a few months left however Autifony will be posting a statement on their website this week.

I will keep you in mind for any further trials that may appear in the future and stay in contact.​

Let's wait for the official statement. Hopefully we will learn the results and future plans.

 

[Mark662]

Think about it...

If Autifony - for one reason or another - is forced to terminate the trial, they have to inform the study centres. In turn, the study centres have to cancel the enrollment. And... the only way they can do that is to... call the folks who enrolled in the trial! Now these participants have a mouth, and, they also have fingers - which means - that they can type/share information. And that they do. Here on TinnitusTalk...!

.....and isn't it incredible that only 4 (?) trial participants out of the potential 152, came on this forum to express their experiences.

 

[Silvio Sabo]

Information was shared:

You might as well tell it now. You basically just confirmed that they have cancelled the trial and that the drug has failed. I don't know what the point is in talking in riddles.

There is a saying here in Sweden and it goes like this: If you say A you gotta say B. If you don't want to say B then don't say A.

That means if you say you have info you best be ready to share it if you say you have it or don't say anything at all!

.....and isn't it incredible that only 4 (?) trial participants out of the potential 152, came on this forum to express their experiences.

No, not at all. There are hundreds of millions of people that are affected by tinnitus world wide yet there are only 7 000 members on this forum. We have to deal with the fact that we who are members aren't even a fraction. Maybe we can be measured in ppm (parts per million).

 

[attheedgeofscience]

.....and isn't it incredible that only 4 (?) trial participants out of the potential 152, came on this forum to express their experiences.

On the surface, yes, I would agree. But then again... if you compare it with the phase-III trial of AM-101, I think (and I have not checked the figure - so could be wrong), but I seem to recall that they have enrolled 600 candidates so far (all-in-all). And again we are just seeing, say, 15-18 participants sharing their experience here on TT (give or take). So... it is what it is, apparently...

 

[attheedgeofscience]

There is a saying here in Sweden and it goes like this: If you say A you gotta say B. If you don't want to say B then don't say A.

But I am not from Sweden...

 

[papu]

This is my 2 cents in the speculation game:
1) a couple of british citizens died, trial stop
2) the drug works wonderfully and they are stopping and going with correct dose to phase III, no need to waste more time with more testing.
3) did not work at all and they stop the trial and will regroup to rethink another strategy or give out all together.

I think i will wait for the announcement

 

[dan]

I have contacted one of the test centres today and have been told that the trials have stopped because the drug is inefficient and is not giving good results to the participant of the trial, so it looks like its not working

Which center did you contact?

 

[bellringer]

Why beat up attheedgeofscience? He tried to get an official answer and wasn't successful. He is not going to throw an employee under the bus who told him something in confidence. In time whatever the story is will come out.

We have a handful of people now reporting the trial has been stopped because the various hospitals that managed the trial are telling participants that the trial has been canceled as the drug was ineffective. One guy we can question the validity, but multiple reports doesn't bode well.

 

[markoana]

It is clear what is FINAL information that ATEOS got today. It is obvious that Autifony stated they have failed at AUT63, just little summarizing of ATEOS statements:


about dr Negler sentence "There will be no cure for t, ever":

I wrote the exact the same thought to someone on the forum yesterday (in a PM). Whatever one's position, it is hard to argue that the man is not intelligent

About members statement that they stop trial because of collecting and analyze data:

Your line of thought reflects mine, but, the facts as I have found them out today, reflect something else

About member sentence of unprofessional Autifony:

In turn, the study centres have to cancel the enrollment. And... the only way they can do that is to... call the folks who enrolled in the trial! Now these participants have a mouth, and, they also have fingers - which means - that they can type/share information. And that they do. Here on TinnitusTalk...!

I do not believe that ATEOS is playing game with us (he is dedicated and serious person), he is trying to stay neutral (and I understand it, as part of confidence between him and persons that gave him right info today). But between his words it is obvious that trial has failed.

PS. If that is not correct, and AUT wants to proclaim (for example) that they stopped trial because of fast coming in phase III (or something positive like that), than I have to say that this day was little playing with us by ATEOS.
But personally I would not be mad on him, because I would be happy that AUT is still in the game

 

[dan]

This is my 2 cents in the speculation game:
1) a couple of british citizens died, trial stop
2) the drug works wonderfully and they are stopping and going with correct dose to phase III, no need to waste more time with more testing.
3) did not work at all and they stop the trial and will regroup to rethink another strategy or give out all together.

I think i will wait for the announcement

If it works wonderfully then the hospitals wouldn't say it was ineffective am i right.

 

[Bazz]

Please god let it still be running!!

 

[Sailboardman]

Man the conjecture, hypothesis, fear, doom, hope, statements without facts, etc., circling around this thread is absurd. I guess patience is truly a virtue. Can we all just WAIT, for the real dope on this thing! Really people.

 

[Zug]

@attheedgeofscience thanks for the info. May I give a suggestion? I don't know if the Tinnitus community is "lethargic". Some of us have reasons to use an avatar. I don't want to share with the more than a thousand people I have on my Facebook details about my health. You too must have your reasons not to put your "real" face. I don't know why "liking" stuff on Facebook would forward research on Tinnitus. What I do know due to professional reasons that you don't shame people into being engaged. There must be concrete, foreseeable benefits to do it. Also, I'm new to this Tinnitus thing, but from what I get the more we can forget about it on our daily lives, the better, so there's also good reason to not "go social" on having Tinnitus. I would suggest different methods of collaboration: crowdfunding, prize-setting, etc. Just my two cents. I respect what you're doing and really don't know what's going on behind the scenes, but I know a thing to two about communication, if you guys want some ideias just message me.

I also believe there are many paths towards a "cure". I'm still suffering from Tinnitus but some posts and people on this forum helped me a lot. No one gained anything for helping me and answering my questions, but they did and I'm grateful for it. I bet a lot of us can say the same. @Markku and the crew who run this forum helped me to get a little bit better, and that's no small feat, so I thank them from helping me in a way no drug yet can. Support like we have here is also "healing", so let's not beat each other up.

 

[Bazz]

I'll give the office a ring in the morning. Maybe they can clear it up

 

[papu]

If it works wonderfully then the hospitals wouldn't say it was ineffective am i right.

Oh dan oh dan until autifony pronounce itself I would not take as fate any info give out by one or two employee unless its doctor large itself who made the call or email however was told that. I am not saying its true but we simply don't know until autifony pronounces itself officially. Stop the speculation until the pronouncement and then if its true let the crying start *and I will be one of the first one because I was relying on it to work because although trobalt has work for me it has not cured me and I will in the near soon future stop taking it, and the wait for sf0034 its long.

 

[valeri]

I just don't know what more we can get from Autifony than what we already heard.
Drug not working, trial stopped, testing sites closed.... however they decide to wrap it it's still an utter dissapoitment.

I can see Nagler saying: I told you so hehehe! TRT is the only way to go!!!

Ok back to square one unless Chinese step in!

 

[marqualler]

I don't want to share with the more than a thousand people I have on my Facebook details about my health.

Not to get too off-track, and not to belittle the point that @Markku and @attheedgeofscience made but, the fact that we have over 2,000 folks who "like" the Tinnitus Hub page seem to contradict this assertion. This post I shared below was "seen" 3,500 times (meaning the # of people who already "like" us on FB who shared it with others on their own page was much higher than usual):



For reference, the "average" update receives a few hundred "reached" people--meaning the viral nature of those posts are not as strong.

My suggestion for increasing awareness? Come out from behind the avatar and be honest. I did the same with my post on my personal page on my 1 year "anniversary" of tinnitus and was shocked to find how supportive my friends and family were and to learn which of my friends and family also have tinnitus who I had no idea did.

Point being--it is hard to share "bad" news but it is the only way to truly raise awareness. My own opinion of the article above--it is interesting and superficially makes you feel good, but the apparent news we may be learning about AUT63 from the notes that have been shared here already makes you realize that the road to a cure is a potentially long one, and one where we with a common affliction need to stick together and raise our voices.

Just my two cents.

 

[attheedgeofscience]

@attheedgeofscience thanks for the info. May I give a suggestion? I don't know if the Tinnitus community is "lethargic". Some of us have reasons to use an avatar. I don't want to share with the more than a thousand people I have on my Facebook details about my health.

Well... that is your choice, then. Entirely. But in the same breath of air, I would then argue that tinnitus is not much of a problem, either. On the one hand, I see quite of lot of interest (and complaining!) about there not being a treatment/cure for tinnitus, and yet, on the other hand, I hear people - like you - saying "But I don't want to state my position on the matter on Facebook..."

And also, ask yourself, what exactly is so "dangerous" about rating the following post done by TinnitusHub?



I'd argue that the FB-update above is a pretty straight forward post to rate. It's a link to a journal written by top level scientists - no different than rating a post for any other disease like MS or breast cancer. And it's not like you are being asked to rate a product for erectile dysfunction, a pornstar, or a highly controversial political figure. Right?

And mind you, the reason the update above got 29 "likes" on Facebook was because it was a sponsored post (by Team Trobalt) - otherwise it would not have gotten more than 5 ratings. Which kind of contradicts the fact that the post Team Trobalt wrote here...

www.tinnitustalk.com/threads/team-trobalt-update-%E2%80%94-april-9-2015.9064

...was the most highly rated post ever on TinnitusTalk (back then) - and out of 100,000 posts in total!

If people and members of this community are not willing to do a simple mouse click, then tinnitus (obviously) is no big issue. You can't have it both ways. Because if you can, then you - and others - are not just lethargic, but also hypocrites.

attheedgeofscience
13/OCT/2015.

 

[Champ]

The thing with this thing is I can't enjoy things anymore. I can't watch a movie, read a book, sit on my computer and write some code or anything without it bothering me. If I sat in a wheelchair I would still be able to do all those things and ENJOY them.

I used to play football (or soccer in USA) but I quit that years ago when my knee gave up on me so the loss of my legs wouldn't be that big of a deal if I could trade it for getting rid of tinnitus.

Don't get me wrong it would still suck not being able to walk or do the doggystyle in the sack but I'd still prefer that over this.

Yeah my limbs are still pretty ok so I don't need to lose them tinnitus or no tinnitus.

I can understand feeling the way you do as I have this dumb affliction but even with it's downsides it's probably less impairing than having no limbs lol

I just don't know what more we can get from Autifony than what we already heard.
Drug not working, trial stopped, testing sites closed.... however they decide to wrap it it's still an utter dissapoitment.

I can see Nagler saying: I told you so hehehe! TRT is the only way to go!!!

Ok back to square one unless Chinese step in!

I laughed pretty hard reading this. Good work lol

 

[valeri]

@attheedgeofscience

There's no doubt you've done a huge amount of work in the past and no one should ever question that.
I agree that the lethargy of tinnitus community is present (read: disgusting) but I also think there must be other ways to do things, FB post could have had 10.000 likes but we would still be where we are now.
It's more complex than liking a post!

So what now?
Is there hope for us beyond autifony?

 

[Atlantis]

Is there hope for us beyond autifony?

That is a stupid question. Is there hope for neurodegenerative diseases such as ALS and Parkinson's? Yes

And so there is hope for tinnitus. Tinnitus is just one of many hard-to-treat conditions but years from now this will be treatable.

How long does it take? At least 10 years because Autifony screwed up. You better get habituated or you will waste precious years of your life in misery... and you could get killed in an accident tomorrow... so what's the point of waiting for your life to resume normal?

 

[chamferman]

@attheedgeofscience I have been trying to avoid using Facebook for years for several reasons, that is why I have not done the like thing. If doing the like thing is going make a difference then I will join facebook

 

[DebInAustralia]

stupid question or just a question coming from a despairing person? how about a little compassion here? this is meant to be a support forum.

 

[zoid]

Wow, I almost can't believe the trial is stopping because the drug isn't working, however everything points in this direction. At the moment I am on Trobalt and a higher dose really silences my T. The first time on a higher dose of Trobalt I was 100% sure AUT00063 also was going to work because it was more targeted to the auditory potassium channels. It gave me some hope. When reading this news I was quite disappointed.

Hope there is better news but at this time I'm afraid there isn't.

 

[Eltel]

Like I have previously mentioned I know around 50 people with T , none of them go on any support sites .
Being a postman I meet and talk to many people and its quite surprising the volume of people with it .
This possible development is not good but progress is inevitable ,just wish it was happening sooner

 

[Pumpkin]

Just had a peek on the autifony website and there is a notice there saying "recruitment closed".....nothing else is mentioned at present.

 

[Danny Boy]

Just had a peek on the autifony website and there is a notice there saying "recruitment closed".....nothing else is mentioned at present.

Great update that.

 

[monacco]

if the drug is ineffective he should say recruitment canceled and not closed, I hope I am right

 

[Tinnitus Talk]

Important Update on Autifony QUIET-1 Study

Statement from Autifony

Please find attached statement following the interim review of our QUIET clinical trial. We are all really disappointed, particularly on behalf of all the people with tinnitus for whom we hoped this could be an effective treatment. However, we are very grateful for all the support that we have received from everyone, and especially the volunteers who participated in our trial.

We can't say anything more until we have done the analysis of all the data generated by the trial, which will take a while. We hope that what we learn from the data will be of use to the tinnitus research community.

 

[Danny Boy]

Important Update on Autifony QUIET-1 Study

Statement from Autifony

Please find attached statement following the interim review of our QUIET clinical trial. We are all really disappointed, particularly on behalf of all the people with tinnitus for whom we hoped this could be an effective treatment. However, we are very grateful for all the support that we have received from everyone, and especially the volunteers who participated in our trial.

We can't say anything more until we have done the analysis of all the data generated by the trial, which will take a while. We hope that what we learn from the data will be of use to the tinnitus research community.

Well, I feel sad for everyone...Hopefully SF proves to be a better drug.