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

[Gael11]

Let's wait before hitting the panic button but IF Aut00063 is not the treatment we expected, it might be time that we (tinnitus sufferers) rethink the role we can play in that story. Remember the ice bucket challenge? It has helped to raise over $ 110 million for the benefit of the research on ALS. It also draw attention on this disease worldwide. It is estimated that about one in ten people suffers form tinnitus, while we are all waiting for a treatment, we can combine our efforts and try to do something about it. Social networks can be surprisingly effective weapons and I see that there are many brilliant people here. Why don't we share ideas to create something like a viral advertising campaign that might help to raise funds for research or draw attention of new pharmaceutical companies like Autifony. Who knows? Tinnitus might become the next philanthropic marketing sensation! Let's hope there will be some good news from Aut. But it is perhaps time to think about this type of initiative. I will conclude with @Markku 's quote : Change won't come if we wait for some other person or some other time. We are the ones we've been waiting for. We are the change that we seek. - Barack Obama

 

[attheedgeofscience]

Social networks can be surprisingly effective weapons and I see that there are many brilliant people here. Why don't we share ideas to create something like a viral advertising campaign that might help to raise funds for research or draw attention of new pharmaceutical companies like Autifony. Who knows?

"Who knows"? Well, I do (actually). As part of [USERGROUP=11]@Team Trobalt[/USERGROUP] we submitted - with the help of TRI - a manuscript to a peer reviewed journal of science on the Trobalt study (the most viewed thread ever on TT):

www.tinnitustalk.com/threads/retigabine-trobalt-potiga-%E2%80%94-petition-to-the-ata.6896/page-7#post-95890

In addition, and as part of Team Trobalt, I was lead correspondent with a group of researchers in the USA who were a source of competency in relation to undertaking a study of Trobalt (to prove/disprove efficacy against tinnitus). Team Trobalt wrote up a post as a message of awareness - which - back then, became the most highly rated post ever on TinnitusTalk (out of 100,000 posts!) - a pretty solid achievement (needless to say):

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

In return, we asked for the same kind of commitment on the social media platforms. Now TinnitusTalk has over 100k visitors per month - and here is the output of that "commitment" in relation to that update:



Just 3 people rated the post. Yes... that's THREE out of 100,000 visitors! And yes, the request to rate the post on Facebook was alerted left, right, and centre all over the forum - here is one example of that:

www.tinnitustalk.com/threads/retigabine-trobalt-potiga-%E2%80%94-petition-to-the-ata.6896/page-9#post-107511

One click with a mouse button was too much to ask for (apparently). Unfortunately this poor show of commitment is the rule (rather than the exception) - there are countless other examples I could mention. Truly.

attheedgeofscience
12/OCT/2015.

 

[valeri]

The lethargy of tinnitus community is disgusting!
Truly!!!

But this is a completely different topic

 

[David Ho]

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.

 

[attheedgeofscience]

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.

Many thanks for the update!

To the rest of TinnitusTalk: I have spoken with Autifony earlier this morning. I do not wish to relay the content of the conversation, but, I can confirm that there will be an official update posted by Autifony Therapeutics "very soon" on their website (at the latest within a couple of days, but most likely earlier).

In addition, I have tried to contact Prof. Deborah Hall for a comment (but it was not possible to reach her today). Sorry about that.

attheedgeofscience
12/OCT/2015.

 

[Silvio Sabo]

Many thanks for the update!

To the rest of TinnitusTalk: I have spoken with Autifony earlier this morning. I do not wish to relay the content of the conversation, but, I can confirm that there will be an official update posted by Autifony Therapeutics "very soon" on their website (at the latest within a couple of days, but most likely earlier).

In addition, I have tried to contact Prof. Deborah Hall for a comment (but it was not possible to reach her today). Sorry about that.

attheedgeofscience
12/OCT/2015.

So it is true then. The trial has failed. Now there is no hope for anything before at least another 5-10 years.
May God help us all...

 

[ady]

today i might use my Glock 9mm and put a bullet in my brain.

 

[valeri]

This was my biggest fear from the beginning that they won't even try higher dosage or increase the time that the drug is taken.
Even antidepressants need at least 6 weeks to work.
I'm not a researcher but it was a mistake from the beginning not to have different trial groups to test various dosages and for the different time length.

I'm so down I'm just wondering what now?
What's there now to hold onto???
Utter devastation

Maybe Nagler was right from the start when he said no cure will ever be found!

 

[amandine]

I'm so down I'm just wondering what now?
What's there now to hold onto???
Utter devastation

Well trobalt works...we know it does for a lot of people

 

[monacco]

may be TRT lobby behind
I am wondering why retigabine cured some of us and autifony failed

 

[Steve]

Pending the announcement I think everybody needs to take a step back here. The "all or bust" attitude is doomed to failure, you can't just sink your whole being into waiting for one wonder drug that will instantly make everything okay.

Life isn't perfect, science moves forward and tries to learn from mistakes and apparent failures. For every "miracle" you think you know there has been an amazing amount of hard work and failure leading up to that point. It's a learning curve so even if this speculation is all true then it will still provide valuable data moving forward.

 

[amandine]

may be TRT lobby behind
I am wondering why retigabine cured some of us and autifony failed

How insane is it that they just opened a new bristol site and had just started fresh recruitment......I wonder if it is because they did not have enough trial people. Does this mean that they are also cancelling their trials in USA too?

 

[Silvio Sabo]

Pending the announcement I think everybody needs to take a step back here. The "all or bust" attitude is doomed to failure, you can't just sink your whole being into waiting for one wonder drug that will instantly make everything okay.

Life isn't perfect, science moves forward and tries to learn from mistakes and apparent failures. For every "miracle" you think you know there has been an amazing amount of hard work and failure leading up to that point. It's a learning curve so even if this speculation is all true then it will still provide valuable data moving forward.

I agree with you on the part that it's a learning curve and that it takes time. I understand that. It's just that the drug was so far into testing that a release date was within grasping range and it showed so much promise. Loosing that really, really sucks since - as I've stated earlier - there is nothing else in the pipeline that is going to get anywhere for at least 5 years. And that's a minimum. It could be even longer!

Knowing that doesn't bring comfort. And one also has to understand that it's perfectly natural to feel devastated when thinking that we will have to endure this torture for another minimum of 5-10 years. That's what you get sentenced to for killing someone here in Sweden!

 

[monacco]

How insane is it that they just opened a new bristol site and had just started fresh recruitment......I wonder if it is because they did not have enough trial people. Does this mean that they are also cancelling their trials in USA too?

do you think that they stoped trial beacause they have not enough trial people ?

 

[Silvio Sabo]

do you think that they stoped trial beacause they have not enough trial people ?

That would just be insane! There is at least 100 people here on TT that would gladly sign up for the trial, with me being one of them. They stated that they would have about 150 people in the trial.

If this is the case then it's just mindblowingly stupid!

 

[amandine]

do you think that they stoped trial beacause they have not enough trial people ?

Yes I do because they were supposed to finish the trials in the summer but they carried on as they did not have enough trial people. That is why it was extended to end of the year..........are they cancelling the trials in USA?

That would just be insane! There is at least 100 people here on TT that would gladly sign up for the trial, with me being one of them. They stated that they would have about 150 people in the trial.

Not insane. Their inclusion process was strict and stringent but also changed during the trial so maybe they screwed up their own data....a small company owned by a scientist who developed trobalt in the first place. Auris Medical owned by a businessman....says it all doesnt it..........

 

[monacco]

As I see we have only one solution
is to get a new version of retigabine.(witouht side effect)

 

[valeri]

Time to find a lab in china!

Since everything else is "made in China" they can do this one too

 

[amandine]

As I see we have only one solution
is to get a new version of retigabine.(witouht side effect)

And you intend to get this where? What is the point? Autifony WAS the new trobalt without side effects !!!!!!!!!!!

 

[grate_biff]

How come Mrs. D had such relief from AUT, then? It just doesn´t add up. Placebo?
I wonder what she makes of this?

 

[amandine]

How come Mrs. D had such relief from AUT, then? It just doesn´t add up. Placebo?
I wonder what she makes of this?

There was another person who also had some relief too...

 

[David Ho]

I cannot being to imagine how people who were in the trial and got good/some results feel...

Truth is that due to the diverse etiologies of Tinnitus it is very difficult for a drug to get enough statistical evidence to progress further in trials. It is as if a tailored approach for every individual is needed.

I'm sure Autifony is not going down without a fight. They probably have other combinations of molecules to try. Let's wait for the report and then maybe Team Autifony can engage with them and see what their plans are for the future.
Look at SF0034, a simple fluorine atom changes the effect of Retigabine.

 

[vasil]

I'm sure Autifony is not going down without a fight. They probably have other combinations of molecules to try. Let's wait for the report and then maybe Team Autifony can engage with them and see what their plans are for the future.
Look at SF0034, a simple fluorine atom changes the effect of Retigabine.

Thats for sure, but with new molecule its all over again from animal testing, which takes time.
Its just strange that they cut it midair, without warning, after they secured some funding and even extended the trial.

 

[David Ho]

Thats for sure, but with new molecule its all over again from animal testing, which takes time.

I'm pretty sure they work in parallel and not in series.

 

[Danny Boy]

I just called the active sites and they have told me the reason the trial has ended is because the active sites are full, so there is no reason for them waste cash on new sites. So no worries Autifony has not been cancelled.

 

[Silvio Sabo]

Thats for sure, but with new molecule its all over again from animal testing, which takes time.
Its just strange that they cut it midair, without warning, after they secured some funding and even extended the trial.

I'm pretty sure they work in parallel and not in series.

I'm sure there is work being done that we might not even have heard of yet. Something that might come to surface in 2016 or 2017 but is being worked on as we speak. And not only by Autifony or other known companies. But even if it is so, there will not be any drug that will have a potential release date before 2020. Autifony was the only one that could possibly have made it in that time frame. Which brings me to my conclusion: we will have to endure for at least another 5-10 years at minimum. And that is a scary thought!

I just called the active sites and they have told me the reason the trial has ended is because the active sites are full, so there is no reason for them waste cash on new sites. So no worries Autifony has not been cancelled.

I pray to God you are right! And I'm not a religious person.

 

[valeri]

I'm sure it wasn't just two people, who reported here, that got some improvement so it really doesn't make sense to just stop the whole trial and conclude it doesn't work.
Well it obviously did something!

Maybe they wanted a CURE but even some relief is as good as cure when it comes to tinnitus!

 

[Danny Boy]

I'm sure there is work being done that we might not even have heard of yet. Something that might come to surface in 2016 or 2017 but is being worked on as we speak. And not only by Autifony or other known companies. But even if it is so, there will not be any drug that will have a potential release date before 2020. Autifony was the only one that could possibly have made it in that time frame. Which brings me to my conclusion: we will have to endure for at least another 5-10 years at minimum. And that is a scary thought!



I pray to God you are right! And I'm not a religious person.

It's what the Birmingham hospital told me.

 

[Silvio Sabo]

I'm sure it wasn't just two people, who reported here, that got some improvement so it really doesn't make sense to just stop the whole trial and conclude it doesn't work.
Well it obviously did something!

Maybe they wanted a CURE but even some relief is as good as cure when it comes to tinnitus!

I would also find that strange that they would just abandon the trial. I would understand if there were 0 patients with benefits. But if there are any people at all that were helped such as Mrs. D who's tinnitus returned to previous levels after going off the drug. I would at least investigate what the cause for success is in these patients. Since tinnitus is a condition that can be caused by a variety of things and there probably isn't a "cure for all" then maybe another trial might be conducted where only people that have that specific type of tinnitus, with that specific cause and nature are included.

 

[monacco]

May be they stopped the trial because they had enough good results and they are going to analyze it ,who knows ?so there is plenty scenario to imagine