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

[dan]

Here is the bottom line.
We all know the new VNS (Vagus Nerve Stimulation) trials.
Well as it turns out, their pre clinical rat model trial proved that all rats treated with VNS were totally cured from tinnitus. Then they went onto human trials. Well it turns out that they had a success rate of 40% - 4 out of 10 patients haved tinnitus eliminated or significantly reduced.
Now they say that the patients that were not responsive were on medications and that interfered with the treatment. I don't buy that too much, but the point is a 40% success rate in humans,after a 100% rat model success rate. Now keep in mind what VNS is - its a implanting an electrode on the vagus nerve and then stimulating it while playing a frequency at above and below your actual tinnitus pitch. Now think how many errors can go wrong here - they might improperly match your tinnitus, or they might play the wrong frequency.
So its a trial and error thing - with the rats they didn't really care they just blasted them and stimulated the shit out of their vagus nerves. Well we aren't rats so they had to be careful.
Anyways the point i'm trying to make is that with a pill that worked 100% in a rat model, the odds are at least 40% success and probably much higher in humans.
We'll find out next year, but we can still speculate and hope.

 

[dan]

P.S. don't quote me on the 4 out of 10 success rate of VNS - just from my memory - not verified.

 

[rtwombly]

I base my opinion on reading studies from the ATA and PubMed over a period of many years and there is not a single drug or treatment that has been proven to cure tinnitus. I have also read many times Dr Nagler say he felt there never would be a cure as such. Definition of cure meaning tinnitus is eliminated.

What if people had that attitude about small pox 100 years ago, or polio 50 years ago? What if Louis Pasteur had decided he couldn't create a vaccine for rabies because no one had done so before?

Nothing is ever cured until somebody cures it.

 

[RichL]

locoyeti wrote:
Could you elaborate on these three opinions with reference to any scientific studies or data?

Of course not I said it was only my opinion and people can agree or disagree but I see the latter is what almost everybody here thinks. I base my opinion on reading studies from the ATA and PubMed over a period of many years and there is not a single drug or treatment that has been proven to cure tinnitus. I have also read many times Dr Nagler say he felt there never would be a cure as such. Definition of cure meaning tinnitus is eliminated.

I'm not trying to sink anybodies boat here , what I'm saying is don't pin your hopes on something that may or may not work and considering tinnitus has about 20 etiologies I'd say the chance of it working is akin to hitting a bulls eye from about 50 ft with a pop gun. Much better to work on a plan or strategy for healing yourself and a good starting point is reading Success Stories.

cheers

@Magpie , With all due respect I think you have offered your opinion without understanding or maybe even reading the science behind Autifony.
The science is sound and their theory has been tested and proven to be correct in animal models so it follows that while it may not be proven in human study yet, I think from the science, that it soon will be.

Rich

 

[Telis]

@Magpie , With all due respect I think you have offered your opinion without understanding or maybe even reading the science behind Autifony.
The science is sound and their theory has been tested and proven to be correct in animal models so it follows that while it may not be proven in human study yet, I think from the science, that it soon will be.

Rich

Damn I hope so Rich!! I can't even begin to imagine how this would change lives. I still remain skeptical but hopeful.

 

[RichL]

Damn I hope so Rich!! I can't even begin to imagine how this would change lives. I still remain skeptical but hopeful.

Your skepticism is warranted bro, If it doesn't, I really don't know if I can handle living life like I'm doing now.

 

[Eric Fridley]

dont worry guys if this does not work we still got other pills coming out like am102 there are going to be potassium channels in my opinion we will be seeing a cure in the next 5 years if not lesser they have come along way to how tinnitus works and how to treat it

 

[Stina]

What if people had that attitude about small pox 100 years ago, or polio 50 years ago? What if Louis Pasteur had decided he couldn't create a vaccine for rabies because no one had done so before?

Nothing is ever cured until somebody cures it.

Agreed. However, most neurological and psychiatric conditions nowadays can not be "cured": they can be treated. I think that is the difference here. I myself also have a chronic condition that can not be cured, however I take my weekly pills + supplement due to side effects and Im fine. I also have chronic depression in my family and my sister has it so bad that she most likely have to be on drugs for decades. It could be the same with Autifony - that it has to be taken regularly or after intervals. Maybe it will only reduce tinnitus. However, I have very mild tinnitus and living with it like living without tinnitus. I believe many sufferers would be happy to have that kind of tinnitus and if Autifony is able to make the sound quieter, that is very good for a start (esp. if it solves the H problem).
But of course great discoveries are made easily and science, like everything else, has often not to so so much with logic but with thinking out of the box and most of all, belief.

 

[bedouin]

All,
Please keep me posted of any dates for this trial as I do qualify for this trial.
I have had tinnitus for 12 months
I have hearing loss.
I also live in London, so I'm all over this trail.
If I am selected for the trial I will of course post daily updates on this site.

Regards
Carl

Hi @Carloflogical. You may be the only one on this board that qualifies! Excellent to have you aboard. If you don't mind me asking, does your hearing loss fit this criteria:

4. Sensorineural hearing loss (Pure Tone Average (of thresholds at 250, 500, 1000, 2000 and 4000Hz) >20 and <60 dB Hearing Loss (HL))

Taken from the inclusion criteria on the NHS website:

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

 

[Juan Carlos]

Agreed. However, most neurological and psychiatric conditions nowadays can not be "cured": they can be treated. I think that is the difference here. I myself also have a chronic condition that can not be cured, however I take my weekly pills + supplement due to side effects and Im fine. I also have chronic depression in my family and my sister has it so bad that she most likely have to be on drugs for decades. It could be the same with Autifony - that it has to be taken regularly or after intervals. Maybe it will only reduce tinnitus. However, I have very mild tinnitus and living with it like living without tinnitus. I believe many sufferers would be happy to have that kind of tinnitus and if Autifony is able to make the sound quieter, that is very good for a start (esp. if it solves the H problem).
But of course great discoveries are made easily and science, like everything else, has often not to so so much with logic but with thinking out of the box and most of all, belief.

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

 

[Telis]

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

You make it sound so simple

 

[bedouin]

mag pie I'd love for you to walk in my shoes. I recently gave up a band /musical entertainment company which I had to do because it was making my t and anxiety seriously worse. I did CBT with Dr Hubbard in NYC and regardless I found my concerns were not "unrealistic" thinking . I just couldn't take the thought of making my future worse. I know I am sad that I can't do what I love but I do enjoy other things and will transition to another field. But please don't tell me to do what I did before T when it's not possible.

The idea that your life will just go back to normal seems far off for me right now and I am almost 11.5 months into t. Each day is a struggle. I have had to give up playing live music. I have had to give up my demanding job because I can't sleep or concentrate anymore. My life has done a 180 for the worst. I have tried medicating.... all the usual suspects. Even doing am101. Still to no avail of being able to "cope" like i used to. So the old "learn to live with it" is a hard pill to swallow right now.

I would be happy just to cope. The very real cause and effect with serious consequences, are perhaps making it more difficult for me to accept. I would love to be able to habituate. mag pie that is great you managed to get that right. You make it sound so easy. However, there is validity in the Kv channel trials too.

On the one hand i'm reluctant to hang my hope on a pill and have my hope crushed when the results come up zilch. On the other hand i'm reluctant to not exhaust all these options first. I have to be honest, habituation (and habituation only) will be my last stop before am101, autifony and retigabine. I do though understand the psychological attachment / obsession towards "looking for a cure". Does this hinder habituation? I'm not 100% sure yet. Maybe a process of trying to habituate, with a general ear to the ground around "chemical fixes" might be the way to go.

 

[bedouin]

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).

NHS site has this title for the trial:
A clinical study to demonstrate an improvement in tinnitus severity after 28 days dosing of the study drug AUT00063 compared to placebo, in participants with subjective tinnitus.

So i think it is for 4 weeks of dosing.

Also. if you see the link to the clinical trial website, re the recruitment status, it says this:
Recruitment status: Authorised-recruitment may be ongoing or finished

So, let's hope it's "ongoing" and that they have not updated their website with the telephone numbers yet. It would be bad form if they have "finished" recruiting already :-(
However, i doubt it.

@amandine - where did you here that 27 Oct was the day they would release the telephone numbers?

 

[amandine]

@bedouin

Hi there
Got the October 27 date from their website info

 

[amandine]

didnt say would release phone numbers - just said that they would be going live giving out the info etc..for these trials on oct 27 ie today

 

[bedouin]

didnt say would release phone numbers - just said that they would be going live giving out the info etc..for these trials on oct 27 ie today

Do you have the link? I don't see anywhere on their website that references oct 27?

 

[amandine]

@bedouin

Sorry I got mixed up with the antinnitus that I read about and the autifony trials.....it was the antinnitus is 27 october

 

[Stina]

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

Im sorry but I have to disagree with the depression example - if it is clinical depression it is not curable in most cases. It can be curable if you start treating it as a child, however, if you are too late it is often not curable, although treatable. Depression due to certain life situations and difficulties is often curable, but clinical depression is a result of the brain construction.
However, given that tinnitus is indeed a kind of injury (so to say), it could be easier to treat that so it might be fixed easier - and perhaps only require to take the drug for a short period.

 

[Juan Carlos]

However, given that tinnitus is indeed a kind of injury (so to say), it could be easier to treat that so it might be fixed easier - and perhaps only require to take the drug for a short period.

Thats indeed what happened to MTP from Retigabine thread, he got cured after 3 months treatment , got completely off and 3 or more weeks later still has Zero tinnitus. None of us bornt with tinnitus. Retigabine is a drug from same family than Autifonys, but with more side effects, and hard to get a prescription because is meant to treat epilepsy

 

[jeannie]

any information on trials yet? im going crazy with this noise....

 

[RoadToSilence]

Hello all. I am approaching the one year anniversary of T onset due to sudden noise trauma. Like many, I have been watching the developments with AUT00063 and given the recent conversations here, I thought it was time for a first post.

Hope.

Whenever we are suffering - physically, mentally, or due to something happening in our environment…it is hope that allows us to continue living. The hope that "things will improve" or that we will not always be suffering is what gets us through our darkest times.

When we have lost hope, when we have fully given up, when we believe that we will always be suffering just as much as we are now, this is when our lives become nothing but despair. This is when we may even ask ourselves, "Is life worth living?"

A simple example we can all relate to:

Everyone probably knows what it feels like to get a calf cramp - that extremely painful tightening of lower leg muscles which sometimes happens in the middle of the night and lasts about 30 seconds. I'm not sure what other people do when this happens, but all I can really do is hold still and wait for the pain to pass. I can do this because I know that the pain will stop. I know that I will not experience this for the rest of my life. I have hope.

For those of us who are suffering from this horrible illness called tinnitus, we all need something to hope for. To live our lives, we need to believe that one way or another, our suffering (just like the pain described above) will subside. For some, this is the hope of habituation and actual progress toward this goal. For others, this is the belief that we are possibly (finally) moving toward a real treatment for tinnitus - not just habitation, not just TRT, no snake oil miracles, but a genuine medical / drug treatment that significantly decreases or even eliminates this cursed noise. Let's face it - this is what we all really want. This is what we dream of.

Based on everything I have read, I see no reason not to be hopeful about AUT00063. When it comes to tinnitus, I think we need to be really careful not to dash the hopes (whatever they may be) of those who are excited and optimistic about a certain treatment. Sometimes this hope is all we are holding on to.

One year into this, I have made progress. My life is no longer the nightmare it was at the four month mark. Some days (usually after poor sleep following a spike in T) it can still seem like a bad dream. But I am hopeful. I am hopeful not only because of the gradual adaptation I have made to living with T (I still hate it more than anything else I have ever experienced), but also because of the possibility of true treatments like AUT00063 (and later, AM-102 and others!).

So, until we have evidence to suggest otherwise, I am optimistic that AUT00063 will work - that it will eliminate or significantly decrease T - period. I am not worried about being "too optimistic" - expecting failure so as not to be disappointed has never felt like a good strategy in life. I can handle disappointment, but I will not live without hope.

After far too long without a truly effective treatment for tinnitus, I believe that there is every reason to be excited and optimistic about genuine relief in the near future - most likely in the form of medication rather than new therapies or risky surgery.

One final thought - when (not if, but when) tinnitus can be effectively treated this will be one of the best days of your life…definitely something to look forward to and something you certainly will not want to miss.

Thanks everyone, and stay hopeful.

 

[Champ]

I'm with you @RoadToSilence.

Honestly, I feel pretty great already when I can control my environment with ACRN. A long term treatment that doesn't force me to be in front of a device... that will be a magical experience.

 

[hoper]

Just a moment
are there any official results of aut00063?

 

[SoulStation]

Thats indeed what happened to MTP from Retigabine thread, he got cured after 3 months treatment , got completely off and 3 or more weeks later still has Zero tinnitus. None of us bornt with tinnitus. Retigabine is a drug from same family than Autifonys, but with more side effects, and hard to get a prescription because is meant to treat epilepsy

He didn't say zero. This is how things get out of hand and hyped up on forums. He said he has to put his fingers in his ears to hear it and listen for it.

 

[Stina]

He didn't say zero. This is how things get out of hand and hyped up on forums. He said he has to put his fingers in his ears to hear it and listen for it.

So perhaps its better to say he was treated effectively?
I am not very well informed about the Retigabine thread, but I do remeber reading that some people had pretty bad side-effects. Am I correct?

 

[Juan Carlos]

He didn't say zero. This is how things get out of hand and hyped up on forums. He said he has to put his fingers in his ears to hear it and listen for it.

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

 

[Juan Carlos]

So perhaps its better to say he was treated effectively?
I am not very well informed about the Retigabine thread, but I do remeber reading that some people had pretty bad side-effects. Am I correct?

yes of course, in this kind of drugs, you get dizzines, tiringness, coloured urine, lose balance, and maybe some others. It's choice of every one if it worths to give it a try. Normally effects are more noticeable when increasing the dosage and partly go away in some time. Anyways when we are more sure about its effect on tinnitus (still have no many testers) I think it really worths if it cures in a high chance. This went off topic if wanna know more, go to Retigabine thread

Autifony is meant to have very little side effects as its specific for Tinnitus. Retigabine is -too wide- about K channels. Choice now is, wait around 4-5 years with T for Autifony to go on market, or risk with Retigabine and its side-effects

 

[Telis]

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

I wonder if it was retigabine that helped him get rid of it

 

[Juan Carlos]

I wonder if it was retigabine that helped him get rid of it

I'm 99% sure of that. How many people that had continuos T for more than 6 months and got spontaneous cure do you know ?
Also, for around 9 people testing (not sure, talking from memory) only 2 had no benefits on their T
Also, there is a real scientific background on this, we are not talking about miracle pill

 

[Telis]

I'm 99% sure of that. How many people that had continuos T for more than 6 months and got spontaneous cure do you know ?
Also, for around 9 people testing (not sure, talking from memory) only 2 had no benefits on their T
Also, there is a real scientific background on this, we are not talking about miracle pill

Mpt was under six months actually. Me personally, I know of 2 people that have had it go away completely early in, there are also a couple on this site as well.

I guess I read the results differently than you do...two people have had very good results, two had worsening of their condition (maybe just temporarily), and the remaining are mixed between discontinuing the drug due to side effects or supply issues and the others had very mild improvements in their condition. Have you read through the entire retigabine thread? If you haven't, might be worth doing so.

We need more people on this drug to come to any real conclusions.

SoulStation is right....this is how things get out of control and hyped up on forums.

Anyway...this is running off topic here.