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

[attheedgeofscience]

Enrollment information for the phase II trial is now available on the Autifony website:

http://www.autifony.com/autifony-tinnitus-quiet-study.asp

Good luck to all.

From the staff of Tinnitus Talk on October 13th, 2015:

Autifony's QUIET-1 study has been terminated due to lack of efficacy.

Read More & Discuss

 

[lapidus]

Finally more info!
So the trial time is only 4 weeks? Why? Somehow I doubt that the drug will reach it's full potential in such a short time. But then again, I know nothing.

 

[Rube]

I wonder if they will let me participate if I take a leave of absence from work and go to England for a month.....I'm totally serious. I plan to look into this.

 

[dboy]

- Time since onset is up to 18 months although the wording was a little vague and seemed to say that they would prefer people up to 12 months initially. But up to 18 months is technically eligible as I understood the passage he showed me.

- Your hearing loss will be measured over several specified frequencies. I cannot remember exactly which they were but they started at 250Hz. Your AVERAGE hearing loss over those frequencies needs to be greater than 20db and less than 60db in order for you to be eligible.

Another thing I found out (not sure if this is covered elsewhere in the thread) is that the trial is for a one month course of medication.

A while ago I posted that I had got the above info from an ENT. Since my credibility was questioned, I just want to note that 2 of the 3 points I made are now confirmed. Lets hope that the point about the average hearing loss has been removed or made less stringent.

 

[SteveToHeal]

A while ago I posted that I had got the above info from an ENT. Since my credibility was questioned, I just want to note that 2 of the 3 points I made are now confirmed. Lets hope that the point about the average hearing loss has been removed or made less stringent.

That's pretty amazing dboy how spot on your ENT was. How was that leaked I wonder? You obviously have the right contacts ;-)

 

[Rube]

So when they mention eligibility criteria do you have to demonstrate hearing loss in the selected range? Or just the tinnitus between 6 and 18 months? Or both.

 

[dboy]

That's pretty amazing dboy how spot on your ENT was. How was that leaked I wonder? You obviously have the right contacts ;-)

My own take on this is that it was not massively restricted info, just that the company did not want to release any info that might then be subject to change as to do so would be unprofessional. But I certainly did not get the impression I was being let in on any big secret. I would not have thought that it was information that could have compromised anybody commercially or scientifically.

 

[SteveToHeal]

My own take on this is that it was not massively restricted info, just that the company did not want to release any info that might then be subject to change as to do so would be unprofessional. But I certainly did not get the impression I was being let in on any big secret. I would not have thought that it was information that could have compromised anybody commercially or scientifically.

I guess we have just waited so long for the official initial release on ec, it's as if it was top secret.

 

[dboy]

So when they mention eligibility criteria do you have to demonstrate hearing loss in the selected range? Or just the tinnitus between 6 and 18 months? Or both.

I do not think that we know that for sure yet. What I was referring to was from the draft protocol and (as regards the hearing loss) may well have been changed since then. I really hope it has.

The webpage says "Screening will be required to make sure that you meet certain eligibility criteria and the final decision on study enrolment will be taken by the trial doctor". If there is still a hearing loss criteria then this will be assessed by the doctor doing screening. But it is at this point not known for sure whether there will be such a criteria.

Please make your own enquiries and do not be discouraged by what I posted about hearing loss, as this may no longer be true. Good luck!!!

Edit P.S. - Apologies for excessive emphasis, just got worried by the thought someone might end up confused by my earlier post and miss a possible chance at a cure. Which would make me feel terrible. Best of luck Rube and anyone else who tries to get onto this trial.

 

[Zimichael]

Less than 18 months...

58 years - 1.5 years = 56.5 years.

Me + AUT00063 Trial = "BOOM!"

 

[lapidus]

@Lisa88
If I recall correctly, you are a UK citizen? Will you try to get into the trial? It seems like you at least fit the time criteria.

 

[NetroPhil]

Do we know how long this phase will go on for, at all?

 

[Robb]

Do we know how long this phase will go on for, at all?

People around the globe do me and others a pleasure and quickly report if this alleviates T at all, MEGA CURIOUS

 

[Martin69]

I live in Germany, but could drive to the UK in some hours. I have T for 11.5 months.
But I don't know if they would take me, how often I must see the doctor and so on.
Staying there for complete four weeks would be difficult.

Strange thing in my mind: We all set hope in this drug. If it does not work or does work for some, but not for me, this would be a big disappointment. I don't know if I could handle this at the moment. I am living with hope for a drug that helps, but fear it will not work for me. Strange, isn't it?

 

[Robb]

I live in Germany, but could drive to the UK in some hours. I have T for 11.5 months.
But I don't know if they would take me, how often I must see the doctor and so on.
Staying there for complete four weeks would be difficult.

Strange thing in my mind: We all set hope in this drug. If it does not work or does work for some, but not for me, this would be a big disappointment. I don't know if I could handle this at the moment. I am living with hope for a drug that helps, but fear it will not work for me. Strange, isn't it?

It is normal so do I think and many, that is why you like my previous post ))

 

[Rube]

I live in Germany, but could drive to the UK in some hours. I have T for 11.5 months.
But I don't know if they would take me, how often I must see the doctor and so on.
Staying there for complete four weeks would be difficult.

Strange thing in my mind: We all set hope in this drug. If it does not work or does work for some, but not for me, this would be a big disappointment. I don't know if I could handle this at the moment. I am living with hope for a drug that helps, but fear it will not work for me. Strange, isn't it?

We all probably think the same way. Better to stay positive.....it's gonna work!

 

[Rube]

Do we know how long this phase will go on for, at all?

The actual trial is 4 weeks. Not sure how many trials they will conduct or how long to collect data and produce reports. I would guess less than 1 year, does anyone else have any thoughts?

 

[lapidus]

The actual trial is 4 weeks. Not sure how many trials they will conduct or how long to collect data and produce reports. I would guess less than 1 year, does anyone else have any thoughts?

I think it depends on how many people there's gonna be in the trial. If it's 100 persons, and depending on how many sites there are, it could be done pretty fast. If it's around 1000 people it will take much longer. All in all, my guess is still a year to the end results are presented.

 

[Lisa88]

@Lisa88
If I recall correctly, you are a UK citizen? Will you try to get into the trial? It seems like you at least fit the time criteria.

OMG, Yes, just saw they put up the enrollment criteria. I am in the UK, and seem eligible. Although am tapering off a benzo. Very interested in participating. Will contact them and let you guys know.
Let the hope begin!

 

[inadmin]

That's it then - all of us with T longer with 18 months should forget about this drug?

 

[dan]

OMG, Yes, just saw they put up the enrollment criteria. I am in the UK, and seem eligible. Although am tapering off a benzo. Very interested in participating. Will contact them and let you guys know.
Let the hope begin!

If you're tapering off a benzo, that might be a problem.

 

[Champ]

That's it then - all of us with T longer with 18 months should forget about this drug?

Good question. Im curious why the time portion is involved as well. According to even their own documentation they specify this targets chronic t...

The 18 months part is either arbitrary or planned. If its planned, what's it mean?

 

[Lisa88]

Good question. Im curious why the time portion is involved as well. According to even their own documentation they specify this targets chronic t...

The 18 months part is either arbitrary or planned. If its planned, what's it mean?

This targets sub acute and beginning chronic t. Probably need to do that in Phase II. Then extend it in the next phase, to show differences, if any.

 

[Lisa88]

If you're tapering off a benzo, that might be a problem.

Not sure when the trials start, but I will be off the benzo soon. Crossing my fingers!

 

[Lisa88]

Just think Autifony are really onto something here. From their website:

For Tinnitus
Tinnitus is characterised by a range of empirical observations, several hypotheses exist to explain how altered central auditory processing leads to the emergence of phantom sounds. Studies to date confirm the importance of Kv3 channels at all levels of the auditory pathway. Profiling of our lead compound shows it can modulate function in both brainstem and cortex in ways that could be beneficial in the treatment of tinnitus. Our research with academic collaborators at UCL's Ear Institute (led by Dr Jennifer Linden) and at the University of Southern Illinois (led by Dr Jeremy Turner) shows that Autifony's drugs can reduce both the behavioural and electrophysiological correlates of tinnitus in preclinical models.

 

[dboy]

Strange thing in my mind: We all set hope in this drug. If it does not work or does work for some, but not for me, this would be a big disappointment. I don't know if I could handle this at the moment. I am living with hope for a drug that helps, but fear it will not work for me. Strange, isn't it?

This is actually an important thing to think about. I can confirm from experience that this disappointment can be massive. A couple of years ago Acoustic Neuromodulation was the thing that would rescue us all. I spent around 1k gbp on travel to take part in the trial, which did not help me at all. The emotional effects were huge. I would not advise to miss what might be your chance at getting better, but be as prepared emotionally as you can for disappointment.

 

[Stina]

I live in Germany, but could drive to the UK in some hours. I have T for 11.5 months.
But I don't know if they would take me, how often I must see the doctor and so on.
Staying there for complete four weeks would be difficult.

Strange thing in my mind: We all set hope in this drug. If it does not work or does work for some, but not for me, this would be a big disappointment. I don't know if I could handle this at the moment. I am living with hope for a drug that helps, but fear it will not work for me. Strange, isn't it?

I agree but I quite sure that it wont work for all people. No drug does. And if it does work, that doesn't mean that one can't have bad side-effects that make taking the drug impossible. However, for one thing you do not know whether it will work on you or not, and another thing is that if it works for lets say 40-50% this means money which means more research. One drug coming out could mean several drugs following.

 

[inadmin]

I agree but I quite sure that it wont work for all people. No drug does. And if it does work, that doesn't mean that one can't have bad side-effects that make taking the drug impossible. However, for one thing you do not know whether it will work on you or not, and another thing is that if it works for lets say 40-50% this means money which means more research. One drug coming out could mean several drugs following.

I.E. lets try staying fully passimistics from all aspects possible.

 

[Stina]

I.E. lets try staying fully passimistics from all aspects possible.

How more money into research and more than one drug pessimistic? Id say its a quite positive attitude, not optimistic/pessimistic.

 

[Rube]

it would be great if one or even many members from here were accepted into phase 2 trials.