AM-101 TACTT1 Results Released

The AM-101 is intratympanic because it's a localized glutamate blocker, but if the the AM-102 is targetting potassium channels, there is no reason it should be an injection, so most likely pills.

But again we are supposing a lot of stuff here ;)
Let's wait for more info!

I thought Auris was only developing I.T. drugs. But I could be wrong.
 
I thought Auris was only developing I.T. drugs. But I could be wrong.
There is no reason for a drug company to only produce I.T. drugs. They will produce whatever works. I also think (hope) Auris have seen Autifony are onto something with potassium channel Kv modulators and trying to replicate their own "version" in the race to find a cure. Like what @benryu said, that AM102 could be just that.

Speculation, I know but just maybe?

Maybe they have seen sufficient evidence in human "self-trial", just from looking at this forum (we know the Am101 thread has caught the attention of Auris already), that Retgabine @Mpt has worked, another potassium channel Kv modulators. Chances are, efforts from specific individuals here, have motivated AM102 and for it to go into pre-clinical trials. The guys here should get profit share if it works :)

Then again, providing the drug companies with any info that would speed up or point them in the direction, I am all for. Even if it is inspired by some very brave individuals on these forums.
 
There is no reason for a drug company to only produce I.T. drugs. They will produce whatever works.

Excellent point! I also see Auris has a rhinology drug in the preclinical stage. I initially missed that. :)
 
There is no reason for a drug company to only produce I.T. drugs. They will produce whatever works. I also think (hope) Auris have seen Autifony are onto something with potassium channel Kv modulators and trying to replicate their own "version" in the race to find a cure. Like what @benryu said, that AM102 could be just that.

Speculation, I know but just maybe?

Maybe they have seen sufficient evidence in human "self-trial", just from looking at this forum (we know the Am101 thread has caught the attention of Auris already), that Retgabine @Mpt has worked, another potassium channel Kv modulators. Chances are, efforts from specific individuals here, have motivated AM102 and for it to go into pre-clinical trials. The guys here should get profit share if it works :)

Then again, providing the drug companies with any info that would speed up or point them in the direction, I am all for. Even if it is inspired by some very brave individuals on these forums.

What are you refereing to? How do you know Auris has seen this thread?
 
What are you refereing to? How do you know Auris has seen this thread?
They've been in contact with us. As a result, we also added the notification at the top of the AM-101 threads.

They definitely are aware of the discussions here.
 
They mention that AM-101 works for acute inner ear tinnitus? what is that exactly? i don't know if mine is chronic of acute.. i just woke up with ringing in my ears 5 weeks ago.

And is there any date for this 'drug' to be released for the public?
 
They mention that AM-101 works for acute inner ear tinnitus? what is that exactly? i don't know if mine is chronic of acute.. i just woke up with ringing in my ears 5 weeks ago.

And is there any date for this 'drug' to be released for the public?
Yours is classified as acute.

Acute : 0 - 3 months
Post-acute : 3 - 12 months
Chronic : > 12 months

But these are probably just labels that have sprung up over time. I don't think anyone knows really if there are any differences between them, although the time since onset seems to be of great importance for entrance onto the trials.

Date for "drug" to be released -- no idea.
 
Yours is classified as acute.

Acute : 0 - 3 months
Post-acute : 3 - 12 months
Chronic : > 12 months

But these are probably just labels that have sprung up over time. I don't think anyone knows really if there are any differences between them, although the time since onset seems to be of great importance for entrance onto the trials.

Date for "drug" to be released -- no idea.

Pretty good definition, this is where we are at the moment but those are not definitive values, this is a first guess for research purpose. I expect those ranges to change a lot.
 
Got my second shots this morning. Ears feel fuller than previous shots, but no change in T so far.
Hi @benryu - it's the anti-hijacker here!! It's my pet hate so have moved the discussion here to its rightful place via the link below :)

https://www.tinnitustalk.com/threads/retigabine-trobalt-potiga.5074/page-27#post-60719

I refer to your link. Tx re the info on glutamate blocking and hair cell death. Ominous! I guess my question is ... Why do you think AM101 are trialing > 3 months in their TACTT3 study? If hair cell death has already occurred < 3 months. What do they hope to achieve > 3 months?

You said : "During the death process the excess of glutamate is being released but will go back to a normal level when hair cells are back on normal degenerative pace." --> I guess once the damage has been done by the excess glutamate, their is no hope for the already dead hair cell. Returning the glutamate production to normal levels and returning the hair cell back to its normal degenerative pace does not help the T... it is already too late. The hair cell is dead and we wish we were chickens!

However, from the complexity of every individuals inner ear physiology, you could just get some strong hair cells, seemingly impervious to excess glutamate past the 3 month marker, that could be saved. Its just a thought and a hope and maybe the reason AM101 people are trialing 300 people in the 3 - 12 month band.
 
They are testing with placebo's as well right?

I haven't really seen any positive results from this AM-101.. it seems everyone can't see a change in their T, makes me wonder if it has any effect at all.
Yes - they are testing with placebos. See the latest post (page 46) from @locoyeti . He has had some success. There are others too but you would have to scroll through all pages on this thread to see which ones. We need a wall of fame on the new site that Markhu and SteveH are busy with, to see who has had success and who hasn't.
 
@locoyeti sorry if this question has been asked before, but how long have you had your T before getting into the trials? was it acute or?

It's really sad if this works good against acute T but a lot of us won't have the acute phase anymore when the 'drug' gets released to the public, im still in only in week 5/6 but i'm sure it won't be for sale in the next months..
 
They are testing with placebo's as well right?

I haven't really seen any positive results from this AM-101.. it seems everyone can't see a change in their T, makes me wonder if it has any effect at all.

To my knowledge, there are no placebos in the follow-up study that I'm currently in. I was told I received the AM-101 for sure this time around.
 
Hi @benryu - it's the anti-hijacker here!! It's my pet hate so have moved the discussion here to its rightful place via the link below :)

https://www.tinnitustalk.com/threads/retigabine-trobalt-potiga.5074/page-27#post-60719

I refer to your link. Tx re the info on glutamate blocking and hair cell death. Ominous! I guess my question is ... Why do you think AM101 are trialing > 3 months in their TACTT3 study? If hair cell death has already occurred < 3 months. What do they hope to achieve > 3 months?

You said : "During the death process the excess of glutamate is being released but will go back to a normal level when hair cells are back on normal degenerative pace." --> I guess once the damage has been done by the excess glutamate, their is no hope for the already dead hair cell. Returning the glutamate production to normal levels and returning the hair cell back to its normal degenerative pace does not help the T... it is already too late. The hair cell is dead and we wish we were chickens!

However, from the complexity of every individuals inner ear physiology, you could just get some strong hair cells, seemingly impervious to excess glutamate past the 3 month marker, that could be saved. Its just a thought and a hope and maybe the reason AM101 people are trialing 300 people in the 3 - 12 month band.

The hair cell death process I mentionned was observed on rat, I assume it might be a bit longer for humans.
Now I believe they probably have some evidence that the excess of glutamate in most case can go up to 3 months so this is why they segmented the population.

The other group is in my opinion here to calculate the max time the drug can theorically work, the 4 to 12 months is probably going to be considered month by month and they want to draw some asymptotic curve to show the drecrease of the effect.

The derivative equal to 0 of the function of the curve mentionned above will indicate the sign change and max number of month.
 
The hair cell death process I mentionned was observed on rat, I assume it might be a bit longer for humans.

I believe damage occurs over a longer period--or so this is argued in at least one research article comparing animal to human models. Last year, I encountered this larger window hypothesis, but, unfortunately, did not include the article in my bibliography. Since I do tend to re-read articles, perhaps I'll stumble upon it again in those sidebar references on pubmed. Anyway, if I do find it, I'll post. It'll be interesting to get your opinion.:)

@benryu Just wanted to give you a shout out for all the expertise and detailed explanations you're providing to this thread and the one on Retigabine. You're the best! Thank you! :cat:
 
I believe damage occurs over a longer period--or so this is argued in at least one research article comparing animal to human models. Last year, I encountered this larger window hypothesis, but, unfortunately, did not include the article in my bibliography. Since I do tend to re-read articles, perhaps I'll stumble upon it again in those sidebar references on pubmed. Anyway, if I do find it, I'll post. It'll be interesting to get your opinion.:)

@benryu Just wanted to give you a shout out for all the expertise and detailed explanations you're providing to this thread and the one on Retigabine. You're the best! Thank you! :cat:
Hi Jaxx. If you do stumble upon that article, i'd love to see it. Holding out for AM101 being useful in the 3 - 12 month window.
 
The hair cell death process I mentionned was observed on rat, I assume it might be a bit longer for humans.
Now I believe they probably have some evidence that the excess of glutamate in most case can go up to 3 months so this is why they segmented the population.

The other group is in my opinion here to calculate the max time the drug can theorically work, the 4 to 12 months is probably going to be considered month by month and they want to draw some asymptotic curve to show the drecrease of the effect.

The derivative equal to 0 of the function of the curve mentionned above will indicate the sign change and max number of month.
Thanks benryu. I feared as much. I am hoping you are wrong ;-) Yet, i fear you are not as u seem to be gifted with an in-depth understanding of this far beyond myself. I am really hoping to see people benefit from AM101 in the 3 to 12 month window.
 
After some delays I finally got in for the first round of injections in the follow-up study today. This time they did it in both ears. T might have spiked a little, but nothing serious, and nothing I haven't heard in a quiet room before. Nothing else to report for now, as usual, but I'll keep posting as things develop.
Hey @StayPositive - did your ears remain blocked for some time after the injections?
 
Hey @StayPositive - did your ears remain blocked for some time after the injections?

Yes, the length that I could feel the fullness differed between ears too, and also differed from injection to injection. The first injection I received as part of the follow-up study didn't seem to make my ears feel too full at all. The second was different.

And of course, I just received the third round of shots today so it'll be some time before they unclog again. On average, I'd say it takes a good full 24 hours or more for the gel to feel like it's done it's thing and moved on. I say this with 9 total injections of experience so far.
 
Thanks benryu. I feared as much. I am hoping you are wrong ;-) Yet, i fear you are not as u seem to be gifted with an in-depth understanding of this far beyond myself. I am really hoping to see people benefit from AM101 in the 3 to 12 month window.

Don't fear too much, the literature is very weak on those glutamate excess mechanisms, or at least what I can find :p If they bothered doing a trial on such a time frame, there's maybe the possibility for some potential effect after a longer period than the 3 months.
That being said, as I mentionned before, I have much more hope for potassium channels treatment than glutamate blocker, even if I think the combination of the two early on will do very good, as the AM-101 may reduce drastically the period of treatment for the AU00063 as eg, and protect your inner ear. But the potassium channel "fix" will still work great alone for chronic T.

Chin up :)
 
Yes, the length that I could feel the fullness differed between ears too, and also differed from injection to injection. The first injection I received as part of the follow-up study didn't seem to make my ears feel too full at all. The second was different.

And of course, I just received the third round of shots today so it'll be some time before they unclog again. On average, I'd say it takes a good full 24 hours or more for the gel to feel like it's done it's thing and moved on. I say this with 9 total injections of experience so far.
Thanks StayPositive. Is it a blocked sensation that you feel like you have water in the ear? Is this the feeling that takes 24hrs before your ears are clear again and can hear properly again?
 
@benryu: i have a general question and hopefully you or someone else can give me an answer. :thankyousign:

It seems that there are many ways to get Tinnitus. Acustic trauma, neck trauma, medications, in my case the ENT tells me that stress may be a reason... because they found nothing else,.

Does all the reasons above lead in the same trouble with excessive glutamate mechanism in the inner ear, so AU00063 helped in any type of chronic T.?

Cheer up! :puppykisses:
 
Don't fear too much, the literature is very weak on those glutamate excess mechanisms, or at least what I can find :p If they bothered doing a trial on such a time frame, there's maybe the possibility for some potential effect after a longer period than the 3 months.
That being said, as I mentionned before, I have much more hope for potassium channels treatment than glutamate blocker, even if I think the combination of the two early on will do very good, as the AM-101 may reduce drastically the period of treatment for the AU00063 as eg, and protect your inner ear. But the potassium channel "fix" will still work great alone for chronic T.

Chin up :)
Eek ! 2nd pet hate besides hijacking threads ... the saying "chin up". I think an ENT said it to me once ;-)
 

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