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

Im not sure now where a did read that they know if they have T just because of their behavior, rats with T act different than others, eat less, are more afraid and inactive. I guess that the scan is an option but maybe didn't use because of some other reasons like its too expensive, takes lot of time or maybe the thought watching behavior is just enought, anyways we can do anything else that trust them, and if we do, im pretty sure that the fact the is working in rats will work also in humans as we share the same DNA in a 99%
 
so in theory this should be able to make our tinnitus desapear since we have 99% of the same dna as rats i think autifony knows it works there just testing it for side effects
thats exactly what I said

About side effects, they are not testing now, as they did already, thats the aim of Phase I and it was succesful, no adverse side effects. Phase I was tested only with "healthy people"
Now in phase II they are testing the effectivity of the med with T people, I guess they are pretty sure it's gonna work as it did with rats and probably with some person off label
 
hi guys, I am not sure what to do. My T is getting louder each day and I am obsessing about it.
I have applied for the trials am 101 - but not sure whether to wait for the autifony trials.
Went to see local rural doctor yesterday. He was really rude and shouting at me and just plain horrible and gave me no help whatsoever. I left his office worse than when I went in which was pretty anxious and terrified.
I took xanax 3 times day at 0.125mg each time....(half a pill of 0.25mg) .then yesterday afternoon i took one whole pill so 0.25mg.
Have taken nothing since then.
Yesterday morning I took one pill of Betahistine 24mg but have not taken since then.
Dont know what to do as stabbing in the dark with this and feeling like cannot go on.
Partner is totally stressed out now with this.
If i go for the am 101 trials does this mean that i wont be able to do the autifony trials.
How good is the am 101?
Cannot stop the anxiousness and fear....
Please help me
 
Reading this I was not quite clear how the controls were used. It does not seem that they controlled for rats getting better naturally (they all got the drug). (?)

Other thoughts... that is quite a small sample size. The evidence for the rats having tinnitus is to do with their response to sound stimulus, so I wonder whether they just learned over time to discern more accurately the difference between internal and external sounds (same way I can now watch a movie without focussing throughout on my tinnitus whereas at first I could not). They claim that the drug abolished evidence of tinnitus but that is not the same thing as saying that the drug abolished tinnitus, especially with such a crude test. And if all 30 rats got the drug, to my mind they did not prove that it was the drug that caused the improvement.

I hope someone can tell me the flaws in my reasoning... and give me more cause for optimism.

BTW, I did the Acoustic Neuromodulation trial and they did EEGs to provide objective evidence of tinnitus. But as I understand it these did not quantify the tinnitus, only proved there was significant activity in auditory regions of brain when you were actually sat alone in an ultra-quiet soundproofed room.
 
Reading this I was not quite clear how the controls were used. It does not seem that they controlled for rats getting better naturally (they all got the drug). (?)

Other thoughts... that is quite a small sample size. The evidence for the rats having tinnitus is to do with their response to sound stimulus, so I wonder whether they just learned over time to discern more accurately the difference between internal and external sounds (same way I can now watch a movie without focussing throughout on my tinnitus whereas at first I could not). They claim that the drug abolished evidence of tinnitus but that is not the same thing as saying that the drug abolished tinnitus, especially with such a crude test. And if all 30 rats got the drug, to my mind they did not prove that it was the drug that caused the improvement.

I hope someone can tell me the flaws in my reasoning... and give me more cause for optimism.

BTW, I did the Acoustic Neuromodulation trial and they did EEGs to provide objective evidence of tinnitus. But as I understand it these did not quantify the tinnitus, only proved there was significant activity in auditory regions of brain when you were actually sat alone in an ultra-quiet soundproofed room.
I agree they should gave med to a part of the rats and not all of them but they dont specify, we cannot know. Anyways as I understand, the rats with T were acting as T rats (behaviour) during the 30 days, others acting normally. Then gave AUT3 to all the rats, and 2 days later, normal rats remain the same and suddently T rats become to normal rats. I think its quite clear. In case of natural or spontaneous cure, it wouldn't happen to all rats in the same time and exactly 30 days after having T, exact the time when had meds. Its clear that the change back to normal behavior is related to the taking of the drug
 
hi guys, I am not sure what to do. My T is getting louder each day and I am obsessing about it.
I have applied for the trials am 101 - but not sure whether to wait for the autifony trials.
Went to see local rural doctor yesterday. He was really rude and shouting at me and just plain horrible and gave me no help whatsoever. I left his office worse than when I went in which was pretty anxious and terrified.
I took xanax 3 times day at 0.125mg each time....(half a pill of 0.25mg) .then yesterday afternoon i took one whole pill so 0.25mg.
Have taken nothing since then.
Yesterday morning I took one pill of Betahistine 24mg but have not taken since then.
Dont know what to do as stabbing in the dark with this and feeling like cannot go on.
Partner is totally stressed out now with this.
If i go for the am 101 trials does this mean that i wont be able to do the autifony trials.
How good is the am 101?
Cannot stop the anxiousness and fear....
Please help me
First thing to do is make a complaint about your doctors behaviour. That is not acceptable behaviour for any supposed professional person.

Apparently the AM101 is worth trying up to 2.5 months since onset.

I'd check the medication you are on to see if it might be ototoxic if your tinnitus is progressively getting worse. If you are not sleeping and stress is increasing then this also might explain tinnitus increase (temporary). Melatonin might be helpful to aid sleep.
 
I agree they should gave med to a part of the rats and not all of them but they dont specify, we cannot know. Anyways as I understand, the rats with T were acting as T rats (behaviour) during the 30 days, others acting normally. Then gave AUT3 to all the rats, and 2 days later, normal rats remain the same and suddently T rats become to normal rats. I think its quite clear. In case of natural or spontaneous cure, it wouldn't happen to all rats in the same time and exactly 30 days after having T, exact the time when had meds. Its clear that the change back to normal behavior is related to the taking of the drug
I really hope this is so, I just wanted to suggest caution about getting too excited with this. Optimism & hope are essential, but I've seen things that look similarly positive not work out so great before. Nothing in that experiment convinced me they had completely removed tinnitus in those rats, and if they did it was at 30 days since onset, so maybe not chronic.
 
First thing to do is make a complaint about your doctors behaviour. That is not acceptable behaviour for any supposed professional person.

Apparently the AM101 is worth trying up to 2.5 months since onset.

I'd check the medication you are on to see if it might be ototoxic if your tinnitus is progressively getting worse. If you are not sleeping and stress is increasing then this also might explain tinnitus increase (temporary). Melatonin might be helpful to aid sleep.

I have been on only Xanax and some sleeping pills which i stopped a couple of weeks ago and only took them for a few days. So basically xanax....which i am not taking as of today.
any thoughts welcome.....
 
@dboy
to make a complaint against a doctor here is nigh on impossible and would no doubt cause me more problems. I now have to find another doctor cos his last comments or shouting at me with the door open so all could here it was: Dont come back...! Great! I was not rude to him or indeed had any way of even speaking with him. He just kept going on and on about him and he prescribed xanax and why havent i taken all the xanax without even giving me a chance to reply. So he was just simply dreadful!
I wonder if anyone out there knows if there is any specialists in france, Dordogne for this problem
I am high and dry here with no help.
From today no more meds. Going to try and get up and not obsess about it.
Please let me know anyone out there
thank you
 
probably the completely wrong page to put this. So sorry and please forgive me! Is there anyone in FRANCE who knows where i can find anyone who is involved with helping with this. Not just the ear nose and throat cos they are useless. Anyone who does TRT or anything that can help me please. If you are in france then please give me some ideas.
Thank you to all and everyone and anyone
 
@amandine, dboy gave good advice about melatonin. Please don't discount that as many of us have found sleep to be essential to our ability to cope. Since you are in France, the AM-101 trial is the best experimental opportunity open to you, so stick with that. In the meantime, consider starting NAC and ALA, both antioxidants that have helped some people. Look at possible causes for your tinnitus, if you are not sure. Have you had any recent injuries to your neck or head? Then a chiropractor may be able to help. Do you also get jaw pain and or headaches? Then you may benefit by seeking out a TMJD specialist. I am not sure what is available to you in France, but there are certainly resources you can try, and the Internet knows them all. If you cannot find someone in your area, is it possible to travel to the UK or Germany? The same goes for TRT as these other treatment modalities.

Remember that though you do not currently have a solution, you do have hope. Picture yourself looking back through a doorway at the difficulties you have come through, and survived, and which do not seem as terrible now. You will likely have several such doorways in front of you, some closer than you think.

Stop by the Retigabine thread if you would consider trying that medication. It is unavailable in France, but quite easy to obtain in Spain and some other European countries, according on user experiences. It is also not a sure thing, but if you are in an especially difficult situation now, it may be worth your effort.
 
yes i read all about this retigabine - seems someone took it and thought it had worked but no....
no pain in jaw or mouth.
Normal living...
Always been the stong one...now contemplating taking all the meds that i have been given and finish this once and for all.....
Help in france is a joke
doing the am 101 trials - yes possible - far away and would have to take camper van to stay there so pretty difficult - what is concerning me is that i have seen no one who has said that he or she did the am 101 trials and had any success - if i can find that there is success then would go for it
going to the uk was exactly what i was attempting to do before i got this. I have nowhere to go in the uk. No family all died or those that are alive are somewhere else in their own lives and would not offer help i am sure so no point in trying to ask them. Hopeless situation for me
 
Another company looking into a similar style of medication as 063, and they are also improving a trobalt style compound as well, to improve its safety and to reduce it to one a day dosing, the more that get involved the better the outcome.

http://knoppbio.com/research/show.php?2

And this companies aim is below

Knopp Biosciences seeks to discover, develop, and deliver breakthrough medicines for urgent unmet medical needs. Our goal is to accelerate and advance treatment, change the course of devastating diseases, and improve the lives of patients and their families.
 
Reading this I was not quite clear how the controls were used. It does not seem that they controlled for rats getting better naturally (they all got the drug). (?)

Other thoughts... that is quite a small sample size. The evidence for the rats having tinnitus is to do with their response to sound stimulus, so I wonder whether they just learned over time to discern more accurately the difference between internal and external sounds (same way I can now watch a movie without focussing throughout on my tinnitus whereas at first I could not). They claim that the drug abolished evidence of tinnitus but that is not the same thing as saying that the drug abolished tinnitus, especially with such a crude test. And if all 30 rats got the drug, to my mind they did not prove that it was the drug that caused the improvement.

I hope someone can tell me the flaws in my reasoning... and give me more cause for optimism.

BTW, I did the Acoustic Neuromodulation trial and they did EEGs to provide objective evidence of tinnitus. But as I understand it these did not quantify the tinnitus, only proved there was significant activity in auditory regions of brain when you were actually sat alone in an ultra-quiet soundproofed room.
I get what your saying.. Idk its been a while since a guy named @benryu has been on here, but he explains everything so well and to the point where he really thinks that autifony is gonna do great. You can re-read his posts, theres alot but we did discuss alot about autifony awhile back and even though i understand where your coming from, im still as optimistic about the drug. The fact that some had postive results with trobalt which is a kv7 pottasium channel moderator makes me feel even more optimistic about aut0063 because it is a kv3 channel which is a channel directly related to tinnitus. So im expecting even greater results with it. I think autifony knows they have something here, other companies are already following there footsteps like auris medical is coming out with a am102 which is a pottasium channel moderator for chronic, so either way one of these pharmas will get it, if autifony doesnt fully.
 
Hey all, just another question about Autifony:

Does anyone have access to results of the first trial where they show the drug doesn't have side effects on healthy volunteers? If it alters potassium channels which presumably the whole brain uses, one would expect side effects.

Thanks. Thinking about this one.
 
Hey all, just another question about Autifony:

Does anyone have access to results of the first trial where they show the drug doesn't have side effects on healthy volunteers? If it alters potassium channels which presumably the whole brain uses, one would expect side effects.

Thanks. Thinking about this one.
They don't give detailed descriptions, but you can find a brief summary on the Autifony website. They said it was well tolerated. Unlike other potassium channel modulators, AUT-0063 targets a single, highly specialized channel that is expressed almost exclusively in the auditory system.
 
probably the completely wrong page to put this. So sorry and please forgive me! Is there anyone in FRANCE who knows where i can find anyone who is involved with helping with this. Not just the ear nose and throat cos they are useless. Anyone who does TRT or anything that can help me please. If you are in france then please give me some ideas.
Thank you to all and everyone and anyone

the same site as the am-101 trial, http://www.imerta.fr/index.php .
 
Another company looking into a similar style of medication as 063, and they are also improving a trobalt style compound as well, to improve its safety and to reduce it to one a day dosing, the more that get involved the better the outcome.

http://knoppbio.com/research/show.php?2

And this companies aim is below

Knopp Biosciences seeks to discover, develop, and deliver breakthrough medicines for urgent unmet medical needs. Our goal is to accelerate and advance treatment, change the course of devastating diseases, and improve the lives of patients and their families.
It seems that other companies are getting on the potassium channel bandwagon and that link was so good I had to paste it out :

Ion Channel Discovery Platform
Ion Channel Biology
Pursuing Novel Drug Treatments
Ion channels, proteins that regulate the excitability of cells, represent an important class of drug targets. Drugs that modulate ion channels play an important role in treating a variety of neurological and cardiovascular conditions. Among ion channel targets, potassium channels play a key role in the pathophysiology of neuropathic pain, epilepsy, and other unmet needs in diseases of the nervous system.

Knopp has reached the lead optimization stage of identifying novel selective modulators of a voltage-gated potassium channel family known as Kv7, building on the significant experience of its scientific leadership in characterizing and exploiting the pharmacology of this target. The Kv7 program provides the opportunity to secure composition-of-matter patent positions for development candidates. Knopp chemists have synthesized a library of novel compounds that modulate ion channel activity relevant in indications of persistent unmet need related to neuronal excitability.

  • In neuropathic pain, we are using translational studies to better understand Kv7 channel profiles in specific pain indications and to explore the potential for topical skin administration as well as oral administration.
  • In epilepsy, we have synthesized Kv7 subtype selective agents with improved potency vs. ezogabine, the only approved Kv7 channel modulator, with the goal of an improved safety profile and one-daily oral dosing.
  • In tinnitus, we are developing potent Kv7 subtype activators for proof-of-concept studies in animal models.
 
It seems that other companies are getting on the potassium channel bandwagon and that link was so good I had to paste it out :

Ion Channel Discovery Platform
Ion Channel Biology
Pursuing Novel Drug Treatments
Ion channels, proteins that regulate the excitability of cells, represent an important class of drug targets. Drugs that modulate ion channels play an important role in treating a variety of neurological and cardiovascular conditions. Among ion channel targets, potassium channels play a key role in the pathophysiology of neuropathic pain, epilepsy, and other unmet needs in diseases of the nervous system.

Knopp has reached the lead optimization stage of identifying novel selective modulators of a voltage-gated potassium channel family known as Kv7, building on the significant experience of its scientific leadership in characterizing and exploiting the pharmacology of this target. The Kv7 program provides the opportunity to secure composition-of-matter patent positions for development candidates. Knopp chemists have synthesized a library of novel compounds that modulate ion channel activity relevant in indications of persistent unmet need related to neuronal excitability.

  • In neuropathic pain, we are using translational studies to better understand Kv7 channel profiles in specific pain indications and to explore the potential for topical skin administration as well as oral administration.
  • In epilepsy, we have synthesized Kv7 subtype selective agents with improved potency vs. ezogabine, the only approved Kv7 channel modulator, with the goal of an improved safety profile and one-daily oral dosing.
  • In tinnitus, we are developing potent Kv7 subtype activators for proof-of-concept studies in animal models.

I had a look at the company. Knopp Biosciences LLC was founded in 2005. Their lead product is in phase III of the clinical trial phase, but it does not say what that product is - nor does the financial source which I normally use contain any information on their pipeline (which is unusual). They are officially listed a neurology company.

They have secured $26,6M in capital (which is similar to eg. Autifony Therapeutics, but far less than eg. Otonomy or Auris Medical).

Knopp's own homepage mentions 5 different pipeline programs (probably using the same drug in several cases). Tinnitus is not listed as an indicated disease for treatment for any of those pipelines.

http://knoppbio.com/about/?9
 
I had a look at the company. Knopp Biosciences LLC was founded in 2005. Their lead product is in phase III of the clinical trial phase, but it does not say what that product is - nor does the financial source which I normally use contain any information on their pipeline (which is unusual). They are officially listed a neurology company.

They have secured $26,6M in capital (which is similar to eg. Autifony Therapeutics, but far less than eg. Otonomy or Auris Medical).

Knopp's own homepage mentions 5 different pipeline programs (probably using the same drug in several cases). Tinnitus is not listed as an indicated disease for treatment for any of those pipelines.

http://knoppbio.com/about/?9

Its under the KV7 platform.
 
Its under the KV7 platform.

I understand but, I don't believe they are looking into tinnitus specifically (that was the underlying message I was suggesting in my post). They are into neurology.
 

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