Auris Medical (AM-102)

This will be the "official" TinnitusTalk kick-off thread for AM-102.

After a fair bit of research via financial sources I am able to at least shed a little light on what the so-far undisclosed compound of Auris Medical's secret AM-102 tinnitus "weapon" might be. The addition of two new drugs to the overall pipeline of Auris Medical created some interest, this past Summer.


Source: http://www.aurismedical.com/product-candidates/pipeline

My initial own - incorrect - intrepretation was that this new compound to combat tinnitus would not be an otologic application but instead most likely an orally delivered medication such as a new potassium channel modulator (ie. a direct competitor to AUT00063). This idea became increasingly likely when I recently learned that a new version of a Kv7.2/3 potassium modulator will hopefully soon head into clinical trials (something which remains unpublished at the moment). The background for this (incorrect) assumption of mine was the timing of events - something I have commented on in this thread earlier today:

https://www.tinnitustalk.com/threads/retigabine-trobalt-potiga-—-general-discussion.5074/page-105#post-81478

But it would now definitely seem that AM-102 is not a new novel potassium modulator, but yet another intratympanic delivered compound (the nature of which remains undisclosed - but read on!). What is also surprising - to me - is that this compound has actually been under development since at least 2010 (and possibly earlier). Why it has not been disclosed - or even mentioned in the official pipeline - until this Summer may have to do with the fact that Auris Medical AG is now a publicly listed company (EARS) and is therefore required to present more information in public; it may also simply be because the pipeline is progressing to a point where a "break-through" is imminent (ie. an upcoming phase-I trial).

Here is the financial information that I have found:

It would therefore seem that AM-102 is not one, but two(?) compounds, and that XIGEN is the supplier (a fact that is not new). And indeed it would seem that this is another intratympanicly delivered application (which is a surprise to me because AM-101 already exists...).

Now people of this forum will hopefully understand why a background in finance is what counts in life...!

(Disclaimer: please be aware that the information I have found may not be 100% correct, but I have done my best to ensure the accuracy of the data and my own comments above).

 

@attheedgeofscience Great information--thanks.

What are your thoughts on the efficacy of the intratympanic method in general? It seems like the consensus here is that the potassium modulators (i.e. Retigabine / AUT00063) hold more "permanent" promise and that the intratympanic may provide some relief at best but not necessarily as strongly as the potassium modulators do. I'm pondering entering the AM-101 trial myself but am not convinced (yet) that the potential benefit outweigh the risks. (For me it might be moot anyway as my ear drums might not be able to handle the intratympanic method anyway.) And my tinnitus is generally not overly bothersome to the point where it is significantly affecting my day-to-day life.

 

A bit more information along with my original post above (which seems to re-confirm the I.T. injection aspect of AM-102 and timeline of development, at least to some degree):

(Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832848/).

What amazes me is the timeline involved here: I am mean this stuff has been underway for - what - four years, at least...! And the mechanism of application is identical to AM-101 (ie. I.T delivered).

I would assume that AM-102 is geared towards chronic(?) tinnitus or is being developed as a substitute to AM-101 in the use of acute tinnitus(?). If indeed AM-102 is supposed to be able to fight chronic tinnitus, this would assume that researchers maintain that tinnitus has an otic component even in the chronic stage (at least in some cases).

But as always, it is early days, so let's not get ahead of ourselves before the facts are known.

 

I know what you mean, but strictly speaking this board could not possibly have any consensus on anything, because even the top-level researchers that I have been in contact with are hesitant to make any promises in terms of efficacy. The basic verdict from these folks is that it is still early days. "Everyone" is assuming that AUT00063 will become a success - but how do you know that when the phase II trial has only just begun? I was in touch - twice - with a researcher with direct insight of the AUT00063 trial and he/she said that it was still early days when I asked about topics such as the curative aspect of AUT00063 (as opposed to patients requiring life-long suppressive medication). You can read about the statements I have obtained in the AUT00063 phase-II trial thread (created in my name).

But here is what I do know to a reasonably certain degree: the sooner you get the AM-101 injections, the greater the chance of a successful outcome. There are certain physiological processes that take place right after damage to the inner ear and it is during this phase that there is a chance of reversing some of the damage. After that, it is wait-and-see (to the best of my knowledge, but I am not a doctor - although I do not believe that disqualifies me in this particular case!).

Source: Auris Medical AG

So if I were you, I would not wait around. As for safety, well, AM101 is now in phase-III (since a while) and so safety does not appear to be an issue (I have commented on that aspect many times in the dedicated thread on Auris Medical's AM101 trial - and with reference to the study that has been released on the evaluation of the phase-II trial).

 

Thank you sir. I'm waiting to hear back from the AM-101 clinic nearest me in the next couple days. I'm not too worried about the safety in general but am not sure that I will qualify because of my reaction to previous intratympanic procedures.

 

A tiny bit more information from my financial sources:

Based on this distinction between AM-101 and AM-102, I therefore speculate/assume what I stated in an earlier post, above, that AM-102 is likely to target inner ear chronic tinnitus (although I do not know how that might work ie. the physiological processes behind it - needless to say).

 

Probably worth mentioning that if AM102 does work it will likely only work on tinnitus caused by long-term noise exposure or acoustic trauma...cases specifically caused by hair cell damage. Seeing as it targets the cochlea.

 

Was particularly interested in today's TT newsletter re this:

"You have probably heard of AM-101. Did you know that there is AM-102 in the works too? We invite you to take part in the Auris Medical Q&A. Check Tinnitus Talk this Friday!"

What's happening this Friday?

Is there any more news from the edge of science what AM102 is all about? Another Kv pottassium voltage gated channel modulator, that will make whacky races look slow, in the competition to crack the t code?

Here's hoping in anticipation.... that it is some new inspiring info. Am101 looks like it only works in early stages. Autifony still unknown ... we all await results of the 1 guy on it. PLs let AM102 enter the ring and put the pressure on CEO's of Auris / Autifony to be #1 to find the cure, or rake soaring profits (i don't care who gets rich from it, as long as they find it) and give a good competitive PUSH to all researchers!! Nobody remembers who came 2nd. Let the games begin.

 

I started a thread for letters to the company expressing the seriousness of this condition and the need for them to Fastrack progress. It was moved under another thread group. If you look for it this may be a good place for everyone to express their views to the company's doing this research.

 

I think it means they are hosting a Q&A with the Auris Medical people the same way they did with the British Tinnitus Association. Very cool! I'm really looking forward to it.

 

On Auris Medical home pages: Early-stage development programs focus on a second generation tinnitus treatment (AM-102). http://www.aurismedical.com/product-candidates/pipeline

AM-102 is for chronic tinnitus? What does second generation mean here?

 

First generation was AM-101 and it is for acute tinnitus only. According to Auris Medical there are no (or very small) benefits with AM-101 if you have had tinnitus for more than 6 months.

AM-102 is for chronic tinnitus and is the second type of drug that they make. Hence the term "second generation".

However I'm guessing that AM-102 might also work for acute tinnitus as well or might be a good combo together with AM-101 eventually. That is if AM-102 works and is safe to use on humans. They have to do all the testing first.

 

Second generation just means it is their second drug targeting tinnitus. Quite the buzzword if you ask me. It is not known at the moment if it is for chronic or not.

 

I have limited knowledge about this but I just don't get how it would be possible for another injection in the ear to help with chronic T. It doesn't say specifically for chronic so I guess we will have to wait and see.

 

Is this drug currently in clinical trials? I see that this thread was created a year ago and I just wonder if there's been any progress.

I personally don't know what to think about intratympanic application of drugs to treat chronic tinnitus, but I assume Auris Medical wouldn't spend a boatload of money chasing a dead end....

-Steve

 

Can't stop thinking about the fact that we're the first humans in our 200.000 years of existance who will receive any kind of treatment for this disease. Exciting stuff!

 

No. It is not in clinical trials yet. According to clinicaltrials.gov, Auris Medical has these trials: https://clinicaltrials.gov/ct2/resu...try3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=
Additionally, if you compare the pipeline in the original post to the pipeline at http://www.aurismedical.com/product-candidates/pipeline they have removed the late 2014 milestone for AM-102 and have not included a new date.

 

Every day has to be one day closer...

 

So AM 102 is going to phase 2 in Q4 2017?

 

No. Phase 1.

 

Yes that was what i actualy mean. So long..

 

Is there an updated chart of this somewhere? This one is almost a year old now.

 

Its Q4 2016 now : )

 

What? Unless Switzerland is really weird, it's Q1 2016, not Q4

 

102, not 101.

 

What's going on with AM-102? Is it esketamine or a different drug that functions in a similar matter? The timing seems odd as they are extending the AM-101 phase 3 trial and still awaiting the results on that.

I think they are having some big meeting about the clinical trials at the end of January. Lets hope it's good news for those of us hoping to get in.

 

Oh sorry, I thought he was referring to the current date as Q4/2016. My bad

 

So to date we don't know how you'll take AM-102, or what kind of T it's for