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

[SoulStation]

Doesnt hear in a silent room, have to put fingers one ears and EVEN THAT, he said, can't hear it half of the times.
He said also he could life with that all life before and never have noticed. Makes that a big diference to zero tinnitus? didn't want to make a too long post explaining all of that, the point is that he got rid of tinnitus and he is happier than ever before

This is an excerpt from his quote in his LAST post" I never hear my tinnitus anymore ever under any normal circumstances. It's literally just when plugging my ears to consciously look for it and even then I would say that I don't hear it probably half of the time, and when I do it's extremely faint evenwith ears plugged"
You changed "normal circumstances" into "Silent Rooms"
IMO -thats not the same thing and creates misinformation. Sorry for nitpicking but its important. Were on the same side. I get yout point though.

 

[Juan Carlos]

This is an excerpt from his quote in his LAST post" I never hear my tinnitus anymore ever under any normal circumstances. It's literally just when plugging my ears to consciously look for it and even then I would say that I don't hear it probably half of the time, and when I do it's extremely faint evenwith ears plugged"
You changed "normal circumstances" into "Silent Rooms"
IMO -thats not the same thing and creates misinformation. Sorry for nitpicking but its important. Were on the same side. I get yout point though.

Sorry for the "silent room" i readed in another post and my memory mixed it up because logically if he "has to" plug finger on ears its because normal silence is not enought. Wasn't my intention to mix up anybody
@Telis i dont remember the 2000 messages even i readed fast. but on first page there is a resume and i can count 5 that had an improvement: mpt, christian78, viking, (jamesdk), bodgan. I remember Zimichael had bad experience with hyperacusis but it came back to baseline after taping off. I agree even 2 or 5 or 10 is not enought to make conclusions
MTP was the only one that really could finish the treatment, others had supply problems or side effects (so counting only this now we have a 100% cured cases)

Finally, I dont want to give any fake hope to anyone, if im saying that is just because i share my opinion in this forum, that is what is for, and i really do belive that this family of drugs (Potassium channel openers) very probably will be the cure for Tinnitus. Besides I think this hope helps a lot (more than anything else for me) with coping with Tinnitus
I know many of you had T for many years and saw coming lot of new promising drugs wich finally failed, so the scepticism is very understandable, but one has to be "the one" and thats what i think about that drugs family
As soon as we will see the results of Autifony phase II this discussion is gonna end.
Sorry again for off topic, this a mix of Retigabine and Autifony (K channel openers)

 

[Telis]

Sorry for the "silent room" i readed in another post and my memory mixed it up because logically if he "has to" plug finger on ears its because normal silence is not enought. Wasn't my intention to mix up anybody
@Telis i dont remember the 2000 messages even i readed fast. but on first page there is a resume and i can count 5 that had an improvement: mpt, christian78, viking, (jamesdk), bodgan. I remember Zimichael had bad experience with hyperacusis but it came back to baseline after taping off. I agree even 2 or 5 or 10 is not enought to make conclusions
MTP was the only one that really could finish the treatment, others had supply problems or side effects (so counting only this now we have a 100% cured cases)

Finally, I dont want to give any fake hope to anyone, if im saying that is just because i share my opinion in this forum, that is what is for, and i really do belive that this family of drugs (Potassium channel openers) very probably will be the cure for Tinnitus. Besides I think this hope helps a lot (more than anything else for me) with coping with Tinnitus
I know many of you had T for many years and saw coming lot of new promising drugs wich finally failed, so the scepticism is very understandable, but one has to be "the one" and thats what i think about that drugs family
As soon as we will see the results of Autifony phase II this discussion is gonna end.
Sorry again for off topic, this a mix of Retigabine and Autifony (K channel openers)

Fair enough man...I respect your right to voice your opinion.

 

[attheedgeofscience]

Agreed. Disappointing. The information from Autifony has - all along - been rather "limited" (both the "official" website info + the e-mail correspondence). However, as far as I can tell, it is the treatment (and not the trial itself) which is four weeks long. I have seen this discrepancy mentioned a number of times within this thread. I am not sure which version is correct (for the reason(s) stated above), but my feeling is that the trial is not limited to just four weeks.

I am not planning to even attempt to participate in the trial at this point, but I will - in the interest of curiosity - try to dig out some information in the coming week (and post it on this board).

As promised, I have attempted to get some answers in relation to the clinical phase II trial of AUT00063. The person I spoke with is the same source as I have used earlier on (but whom I will not disclose the name of in public).

The URL* for the NHS study listing mentions that the first date of enrollment was 29/AUG/2014. This is incorrect. The study has not begun yet (which is also why the 10-12 different study sites have not been published on Autifony's own website). The error will be corrected, I am told.

The clinical trial committee has had to re-visit the option of allowing non-UK nationals to participate. This is no longer an option. The decision was apparently based on external consultant advice.

The person I spoke with does not believe that the real drug will be offered post clinical trial in the event that a participant receives the placebo. The reason is that there is not enough evidence - yet - to suggest if the drug works or not (no surprise there since this is a phase IIa trial evaluating efficacy).

The person I spoke with says it is not known if the drug will be curative or not (ie. whether a one-off course or continuous life-long therapy is required). That's what the whole clinical trial is there to answer - in part.


http://www.nhs.uk/Conditions/Tinnit...7-GB&Condition=Tinnitus~quiet&pn=1&Rec=0&CT=0

 

[SteveToHeal]

The person I spoke with does not believe that the real drug will be offered post clinical trial in the event that a participant receives the placebo. The reason is that there is not enough evidence - yet - to suggest if the drug works or not (no surprise there since this is a phase IIa trial evaluating efficacy).

Firstly, great powers of investigation or is it high contacts? Thanks for the info all the same. Not too encouraging that there is not enough evidence yet that their drug will work. This is the first time that it will be tested on humans with t though, so i do get it.

The fact that you don't get the real drug I think will deter quite a few people. Especially if the trial needs volunteers to be there on site for 28 days. A pill per day. Let's hope it is a 60/40 chance in favor of the real drug, that you will get the real drug. I would take those odds. But still a pity that there is no follow up

 

[attheedgeofscience]

Firstly, great powers of investigation or is it high contacts?

Contacts.

Not too encouraging that there is not enough evidence yet that their drug will work. This is the first time that it will be tested on humans with t though, so i do get it.

I don't quite see it that way. Medicine is all about testing things out in real life situations. The source I got my info from is simply being cautious. That's my take.

The fact that you don't get the real drug I think will deter quite a few people.

I don't really know about that. The reason they will not be giving the drug to anyone post clinical trial is because it probably would be considered irresponsible of them to provide a drug which has yet to be proven effective. That's my guess. Perhaps/probably that may change for the phase IIb and phase III trial.


I'd prefer not to answer any more questions based on my initial post above as I have already shared what I know. I don't want to provide speculative information on a public forum. So it's better not to provide any (further) information at all.

The phone call lasted about 5-7 minutes.

 

[SteveToHeal]

Contacts.



I don't quite see it that way. Medicine is all about testing things out in real life situations. The source I got my info from is simply being cautious. That's my take.



I don't really know about that. The reason they will not be giving the drug to anyone post clinical trial is because it probably would be considered irresponsible of them to provide a drug which has yet to be proven effective. That's my guess. Perhaps/probably that may change for the phase IIb and phase III trial.


I'd prefer not to answer any more questions based on my initial post above as I have already shared what I know. I don't want to provide speculative information on a public forum. So it's better not to provide any (further) information at all.

The phone call lasted about 5-7 minutes.

Keep the info flowing if possible. The more we have, the more we can prepare accordingly. Yes, it is speculative at this point but it is more than is posted on their website at the moment. It will come out in the wash when we know for sure. Its a pity they could not tell you when they will release site centers and telephone numbers. I hope it is soon.

 

[attheedgeofscience]

Keep the info flowing if possible. The more we have, the more we can prepare accordingly. Yes, it is speculative at this point but it is more than is posted on their website at the moment.

Autifony could take some cues from Auris Medical as to how to set up a structured information flow (eg. set-up a dedicated website such as the www.tinnitus-study.info website). It's not very well done... so far.

Just to be real clear - the information I provided earlier today is not speculative. But if I were to go beyond what I stated today (in follow-up posts such as this one), then it would become speculative.

Its a pity they could not tell you when they will release site centers and telephone numbers. I hope it is soon.

The person said "soon".

 

[rainman]

Taking your example, depression is curable in most of the cases. Tinnitus, despite is very annoying, scientifically is very mild illness, its just a reversible hyperactivity in the brain, and not in the whole brain, just in a very concrete and small area of it as is the auditory pathway, also it doesn't seem to expand to other parts of the brain

Depression is not curable. Antidepressants only relieve the symptoms. Usually you have to go back to them within two years. I lasted one at most. Novel antidepressants are coming like neural stem NSI-189, they are in human trials like many novel hearing treatments. They may not be the cure but they are more effective, less side effects and bringing our understanding closer that what is going on between our ears. Its interesting time never the less

 

[valeri]

This whole Autifony thing is starting to sound more and more depressing and discouraging

If their officials are not that hopeful in drug efficiency what hope is then left for us

 

[attheedgeofscience]

This whole Autifony thing is starting to sound more and more depressing and discouraging

Why?

If their officials are not that hopeful in drug efficiency what hope is then left for us

Their patent paper is some 200-pages long. Some science must have gone into that...

There is a difference between knowing something works in theory - and seeing it work in practice. Which is why flying to the Moon was one of the greatest engineering moments in history. If you ask me.

But we did fly to the Moon. With 1960s technology...

 

[valeri]

@attheedgeofscience

Overall it just sounds messy and disorganised, trial 2 nowhere near commencing, lot of grey areas!

But I'm still hopeful it's the cute we need!

 

[Viking]

It appear like neramexane fail

 

[jeannie]

so depressing if we have nothing to at least give us hop

 

[SteveToHeal]

It appear like neramexane fail

Wikipedia:
Neramexane is a drug related to memantine,[1] which acts as an NMDA antagonist[2] and has neuroprotective effects.[3] It is being developed for various possible applications, including treatment of tinnitus,[4][5] Alzheimer's disease,[6] drug addiction[7] and as an analgesic.[8] Animal studies have also suggested antidepressant[9] and nootropic[10] actions, so there are a wide range of potential applications this drug may be used for. It also acts as a nicotinic acetylcholine receptor antagonist.[11]

So this looks more like it was an AM101 type drug, acting as an NMDA antagonist. Nothing to do with Kv channels, which is the group of drugs that Autifony and Retigabine fall into.

 

[SteveToHeal]

Autifony could take some cues from Auris Medical as to how to set up a structured information flow (eg. set-up a dedicated website such as the www.tinnitus-study.info website). It's not very well done... so far.

Just to be real clear - the information I provided earlier today is not speculative. But if I were to go beyond what I stated today (in follow-up posts such as this one), then it would become speculative.



The person said "soon".

Agreed. They have not been that forthcoming with info and kept us all hanging.... You are just fortunate to have contacts willing to offer info. We then benefit from you sharing that info with us

And i know your style well enough (from your numerous posts) to provide that info to us, in its undiluted form. That is why when I read things like they do not have enough faith in their drug to offer it in an open label to trial participants, then it reduces my hope.

As it does for most people reading it as you can see from their responses. However, I would rather know than be left in the dark. Give me the stark reality of the situation any day. Then at least we have something to work with. It's better knowing your options than being strung along on hypothesis.

I understand there reasoning why they make that call. I get it.

Ok, soon. Let's hope so. All we can do is watch the website for updates.

 

[attheedgeofscience]

You are just fortunate to have contacts willing to offer info.

Some people are fortunate. Others have to work for it; I am no exception.

That is why when I read things like they do not have enough faith in their drug to offer it in an open label to trial participants, then it reduces my hope.

"Faith" is what differentiates science from religion; I am pretty sure the folks at Autifony have faith that their drug will work. But they do not have proof when it comes to human beings. And proof is what people-of-science care about.

 

[SteveToHeal]

Some people are fortunate. Others have to work for it; I am no exception.



"Faith" is what differentiates science from religion; I am pretty sure the folks at Autifony have faith that their drug will work. But they do not have proof when it comes to human beings. And proof is what people-of-science care about.

Just to be clear - I did not infer that you did not work for it to get those contacts. As i said, we benefit from you knowing them as well and for then sharing that info with us. I did say that

Re the faith thing - as i said "i get it". I know they need to prove it scientifically first. It is just a normal human reaction when you hear it to be disappointed. But as i said, i get why they said it.

 

[rtwombly]

All, ATEOS posted some time ago about how Autifony is awaiting regulatory approval (assumed to be nothing more than a formality). That well may still be what's going on. They are certainly not delaying the trial because of losing faith in the efficacy of the drug - that hasn't been tested - but most likely because they are a small company trying to organize a major undertaking with a metric ton of red tape. If they rush, they run the chance of their results not passing peer review, which would delay public availability of the drug still further (a whole 'nother clinical trial further).

We just have to wait, there's nothing else for it. The fact they haven't started yet has no bearing on whether the drug will do what we hope or not. It just reflects the caution Autifony is using and the difficulty of getting something like this off the ground.

If you're sick of waiting, try the following:

1) Research chiropractic specialties that may help with your symptoms (Atlas Orthogonal, SOTO, crainal manipulation).
2) Look into Chinese/Tibetan medicine. You may or may not get any benefit from acupuncture, but they have a lot of calming herbs.
3) Check your jaw and neck for trigger points.
4) Research TMJ disorder, its symptoms and treatments.
5) Beg a doctor for retigabine.
6) Try a course of Nexium.
7) Tinnitus Retraining Therapy
8) Get a second/third job to pay for all the above.

All the above (minus #8) are things I've read about on this forum. Some people swear by 'em, some have tried 'em and walked away with nothing but a lighter wallet. If nothing else, they help you not to focus too much on one treatment as the only thing that could possibly help you.

Point is, if you're sick of waiting, don't wait! There's plenty you can do for yourself in the meantime.

 

[RoadToSilence]

Actually, I don't see the recent updates from @attheedgeofscience (thanks by the way) as discouraging at all. In my mind, this news is pretty neutral.

So, Autifony has decided not to provide AUT00063 to the placebo group for the Stage-II study.

I don't think we can interpret this as a vote of non-confidence from the team. A close family member who works for a pharmaceutical company assures me that this is not uncommon - especially at Stage-II when the efficacy has yet to be established. She also mentioned that this could also be a way of keeping the project within budget. That is, offering AUT00063 to everyone (including those who have received a placebo), would add time and expenses to Stage II. Again, it is understandable that they would be reluctant to do this before having human evidence that the drug does what they are expecting it to do.

So, as hard as it is to be patient I have reminded myself that:

1) The study is still proceeding and is based on a sound scientific theory that has demonstrated very encouraging results in an animal model and has passed Stage I with regard to safety

2) It is impossible to make any conclusions about whetherAUT00063 will work until after we see some tangible results

I'm sure that Autifony has good reasons for not offering the drug to everyone in the initial trials, but I wouldn't assume this is because they lack confidence in it.

No need to abandon ship… I'm still looking forward to good news when the trials begin and the results start trickling in.

 

[SteveToHeal]

8) Get a second/third job to pay for all the above.

Thanks for the humor. So very true you just have to laugh!

 

[dan]

5) Beg a doctor for retigabine.

lol

 

[attheedgeofscience]

All, ATEOS posted some time ago about how Autifony is awaiting regulatory approval (assumed to be nothing more than a formality). That well may still be what's going on. They are certainly not delaying the trial because of losing faith in the efficacy of the drug - that hasn't been tested - but most likely because they are a small company trying to organize a major undertaking with a metric ton of red tape. If they rush, they run the chance of their results not passing peer review, which would delay public availability of the drug still further (a whole 'nother clinical trial further).

My take - although I am slightly guessing here - is that the study has been granted an approval. I am guessing that the formal approval date is indeed the 29/AUG/2014 - a date I mentioned in an earlier thread as the "first date of enrollment" (because that's what the NHS website states). But I believe it is not really the first date of enrollment (for sure - because no one has so far entered the study), but instead this is in actual fact the date the study was formally allowed to proceed. But again... I must stress I am slightly guessing here.

The source I spoke with mentioned something about the last 2 or 3 sites still not being fully ready for the study. I believe that's where the delay is. But I must state that this is a partial guess on my part. It could well be that Autifony has done all the right things, all the time - as the study sponsor - but, that the executive arm of the study (= the doctors) are not fully up to speed in their preparations at all sites.

 

[SteveToHeal]

hey all - just an aside here but can people have tinnitus without any hearing loss whatsoever? Just looking at the eligibility criteria there again.

 

[Juan Carlos]

hey all - just an aside here but can people have tinnitus without any hearing loss whatsoever? Just looking at the eligibility criteria there again.

In the thread of Autofony phase I, DBOY said the following
Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

I had a meeting with a very good ENT doctor yesterday. He will be involved in the Autifony trials and looked up the eligibility criteria for me. This is only from the draft protocol (so not finalised; needs approval from ethics committee etc.) and is also not complete - mainly as relevant to myself (I am not eligible).

- 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.

The second point seemed to me quite a stringent criteria. I have almost no hearing loss at lower frequencies such as 250Hz. To want >20db averaged out over the range I would guess they are looking for people with a fairly profound hearing impairment as well as tinnitus. Off the top of my head, I do not understand the rationale behind this criteria.

As I said, these criteria are not finalised nor are they likely to be the only criteria.

 

[rtwombly]

hey all - just an aside here but can people have tinnitus without any hearing loss whatsoever? Just looking at the eligibility criteria there again.

Yes, several on here do. Even I, who would qualify were in the UK, have no idea if my hearing loss is related to my tinnitus. I've been a bit hard of hearing for a long time, and am nearly identical bilaterally but have unilateral tinnitus.

But the doctors at Autifony are looking for a particular sub-population, and are quite confident they'll have too many volunteers rather than too few.

@dboy, hey mate, I wonder if you could check back with your ENT, seeing as his information was accurate, and see if he has any insight on the delay?

 

[SteveToHeal]

Yes, several on here do.

Sorry to be a stickler. Do you have any user names of ppl with tinnitus without any hearing loss whatsoever?
Tx

 

[rtwombly]

Sorry to be a stickler. Do you have any user names of ppl with tinnitus without any hearing loss whatsoever?
Tx

Thing is, I've seen people post to that effect, but very few of us have been tested about 8000Hz, so it's always possible that hearing loss above that range is present. Who knows?

I'm not clear why you're asking, really. The Autifony docs are aware there are people without measurable/measured hearing loss with tinnitus. They were advised by somebody to draft people with hearing loss in a certain range, so that's what they're doing. A couple of us have emailed about it, myself included, and the answer was just that they expect to get plenty of people, which I expect is true.

If you want a reason, they want to know if AUT00063 helps with hearing comprehension as well as tinnitus, so they're killing two birds with one stone.

 

[lapidus]

Sorry to be a stickler. Do you have any user names of ppl with tinnitus without any hearing loss whatsoever?
Tx

Me, but since they don't test above 8khz in a normal hearing test, I have no idea if I have some loss above that.

 

[SteveToHeal]

Me, but since they don't test above 8khz in a normal hearing test, I have no idea if I have some loss above that.

Ok, great thanks. Yes. I see the problem. Trying to get proof that T is due to hearing loss when there is no instrumentation in a standard audio practice.... I think ateos did have his hearing tested above that. At what frequency is your T? Apologies if off topic.