Auris Medical (AM-102)

[Foncky]

Perhaps he was talking about

http://www.ncbi.nlm.nih.gov/pubmed/24979398
AM-111 0.4 mg/ml showed statistically significant, clinically relevant, and persistent improvements in hearing and speech discrimination and higher tinnitus remission compared with placebo. The study drug and the intratympanic injections were well tolerated.

The beginning of this sentence is important... :
"The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery. In severe-to-profound ASNHL patients (threshold ≥60 dB), [...]".

 

[whale]

The beginning of this sentence is important... :
"The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery. In severe-to-profound ASNHL patients (threshold ≥60 dB), [...]".

Crap ,who are these spontaneous T recover. I'm hoping for that. the reason it was unexpected was because it was uncommon. They ran many trials before and thats never happened.

 

[Michael Larsen]

Made great progress on our second generation tinnitus project

http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2248196

 

[The King]

Made great progress on our second generation tinnitus project

http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2248196

Hi Larsen; the tinnitus of second generation is chronical (after 3 or 6 month) or is acute tinnitus (before 3 months) Thanks

 

[Foncky]

Impossible to say. They will select the lead compound at the end of 2017. We'll have to wait a long time before anything is explained ! Auris didn't show great success after years of development on AM-101.

 

[Michael Larsen]

Hi Larsen; the tinnitus of second generation is chronical (after 3 or 6 month) or is acute tinnitus (before 3 months) Thanks

Meyer said (CEO) the targert is different from AM-101`s target, and have even
more therapeutic benefits than AM-101. so i hope chronical

 

[RaZaH]

There is a good reason (i think) that usually the go for early onset rather then chronic , if you think about it the test subjects .. rodents are usually given T so almost all test subjects have been early onset. It makes sense that they would want to roll this out focusing early onset and be close to their rodent test subjects..

 

[Foncky]

and have even more therapeutic benefits than AM-101

Since AM101 has proven to have none, shouldn't be difficult !

 

[JurgenG]

There is a good reason (i think) that usually the go for early onset rather then chronic , if you think about it the test subjects .. rodents are usually given T so almost all test subjects have been early onset. It makes sense that they would want to roll this out focusing early onset and be close to their rodent test subjects..

I thought I read that AM-102 is for chronical T. They'll have at least much more suitable humans to test it on.

 

[RaZaH]

oh, ok

 

[Samir]

I thought I read that AM-102 is for chronical T.

Where have you read this? If you look at the pipeline you will see that the stated indication is just "tinnitus". It's not specific about what kind or type it is. This is their second generation treatment, after AM-101. The AM-101 is said to target "acute inner ear tinnitus" as well as "post-acute inner ear tinnitus". They have two different trials running for AM-101. The trials for AM-102 have not started yet. They have not even selected a compound yet. It's still at pre-clinical stage.

They'll have at least much more suitable humans to test it on.

Not sure what you mean by this... They can't test it on humans until they enter human trials. You mean they will get more accurate and objective results once they do get to human trials?

Edit: I think I get it now! I had to explain it to myself first. The rubber duck effect!
You mean it's better that they test it on humans, despite the fact that they only test it on humans that have the less severe acute tinnitus. Once we have established that it works on acute tinnitus in humans, we can move on to chronic tinnitus in humans. Correct?

There is a good reason (i think) that usually the go for early onset rather then chronic , if you think about it the test subjects .. rodents are usually given T so almost all test subjects have been early onset. It makes sense that they would want to roll this out focusing early onset and be close to their rodent test subjects..

You mean they should do the human trials only with people that have acute tinnitus (less than 3 months since onset)? Because this is how they are testing the drugs in pre-clinical studies in animals? So in order to get matching results with human subjects, they should focus on the acute tinnitus group?

That does make sense. I will keep that in mind when reading research reports. I am not sure how important the window of opportunity is, and I am not sure if there has been any specific mention of this in the research reports I have read so far.

One thing I wonder is, what is "inner ear tinnitus"? I thought they didn't know the location of tinnitus. Some say it's in the ears, some say it's in the brain. It seems to me like the brain side is winning. Perhaps it's a combination of a little bit of both, and there might as well be individual variances.

 

[Samir]

Auris recently announced that they are extending the collaboration with King's College London in the development of AM-102.

Professor David E. Thurston of the Institute of Pharmaceutical Science is leading the team at King's to develop and optimize a range of specific small molecules for Auris Medical's AM-102 project. The project builds on earlier work performed at King's for Auris Medical by Professor Pat Doherty and Dr. Gareth Williams. The AM-102 compounds bind to a novel, undisclosed drug target for treating certain types of tinnitus.

Thomas Jung, MD, PhD, Auris Medical's Chief Development Officer:

Together with King's College London, we have made great progress on our second generation tinnitus project.

The team's drug discovery expertise has generated interesting leads that have been tested in vitro and in vivo. The extension of our collaboration allows for further development with the aim of selecting a lead compound for our AM-102 program by the end of 2017.

Source: http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2248196

 

[JurgenG]

Where have you read this? If you look at the pipeline you will see that the stated indication is just "tinnitus". It's not specific about what kind or type it is. This is their second generation treatment, after AM-101. The AM-101 is said to target "acute inner ear tinnitus" as well as "post-acute inner ear tinnitus". They have two different trials running for AM-101. The trials for AM-102 have not started yet. They have not even selected a compound yet. It's still at pre-clinical stage.


Not sure what you mean by this... They can't test it on humans until they enter human trials. You mean they will get more accurate and objective results once they do get to human trials?

Edit: I think I get it now! I had to explain it to myself first. The rubber duck effect!
You mean it's better that they test it on humans, despite the fact that they only test it on humans that have the less severe acute tinnitus. Once we have established that it works on acute tinnitus in humans, we can move on to chronic tinnitus in humans. Correct?


You mean they should do the human trials only with people that have acute tinnitus (less than 3 months since onset)? Because this is how they are testing the drugs in pre-clinical studies in animals? So in order to get matching results with human subjects, they should focus on the acute tinnitus group?

That does make sense. I will keep that in mind when reading research reports. I am not sure how important the window of opportunity is, and I am not sure if there has been any specific mention of this in the research reports I have read so far.

One thing I wonder is, what is "inner ear tinnitus"? I thought they didn't know the location of tinnitus. Some say it's in the ears, some say it's in the brain. It seems to me like the brain side is winning. Perhaps it's a combination of a little bit of both, and there might as well be individual variances.

Yeah, thought I read it on their roadmap somewhere, might be wrong.

I mean that it's harder to find willing subjects for acute T, (because everyone hopes it might dissapear) and some will be way longer than 3 months before even starting to realise there is something as clinical trials for this medicine.

 

[Samir]

Yeah, thought I read it on their roadmap somewhere, might be wrong.

I mean that it's harder to find willing subjects for acute T, (because everyone hopes it might dissapear) and some will be way longer than 3 months before even starting to realise there is something as clinical trials for this medicine.

So you mean they should do it on everyone with tinnitus, acute and chronic?

 

[JurgenG]

So you mean they should do it on everyone with tinnitus, acute and chronic?

Yeah, but they can't. Might screw with their succes results.

 

[Alue]

Yeah, thought I read it on their roadmap somewhere, might be wrong.

I mean that it's harder to find willing subjects for acute T, (because everyone hopes it might dissapear) and some will be way longer than 3 months before even starting to realise there is something as clinical trials for this medicine.

I signed up for AM101 within a week of me getting tinnitus.
Part of the hard process of finding subjects that have acute tinnitus is the screening process. It was nearly 2 months before I got my first injection. I also think the 3 month time frame is really optimistic. More likely tinnitus becomes 'chronic' much faster than that.

 

[RaZaH]

You mean they should do the human trials only with people that have acute tinnitus (less than 3 months since onset)? Because this is how they are testing the drugs in pre-clinical studies in animals? So in order to get matching results with human subjects, they should focus on the acute tinnitus group?

yes, makes sense

 

[Michael Larsen]

I signed up for AM101 within a week of me getting tinnitus.
Part of the hard process of finding subjects that have acute tinnitus is the screening process. It was nearly 2 months before I got my first injection. I also think the 3 month time frame is really optimistic. More likely tinnitus becomes 'chronic' much faster than that.

Has it has not helped you at all with the injection?

 

[Rasmus]

One of the big problem with something like AM101 Is when people get the injection people are listing for they T to see if its gone, but when you start to listen for it, it gets louder and louder, even people who dont suffer from T in daily life can hear T just by focus on it. This could be a reason something like this show bad result many time.
Again could also be because it simply does not work.

 

[Foncky]

One of the big problem with something like AM101 Is when people get the injection people are listing for they T to see if its gone, but when you start to listen for it, it gets louder and louder, even people who dont suffer from T in daily life can hear T just by focus on it. This could be a reason something like this show bad result many time.
Again could also be because it simply does not work.

It's supposed to be a cure or at least a huge relief.

The "If I listen to my T it's louder and louder" thing is not a good explanation. If there was a real benefit from AM101, people would know.

 

[Samir]

It's supposed to be a cure or at least a huge relief.

The "If I listen to my T it's louder and louder" thing is not a good explanation. If there was a real benefit from AM101, people would know.

I like that last part. "If there was a real benefit from AM101, people would know." I agree!

It's frustrating that they are treating us like we are hallucinating. They need to come up with a method to objectively measure tinnitus. I don't think tinnitus loudness and frequency matching, and questionnaires are a good way of doing that. But it's the only tools we have right now. Which shows just how little we know about tinnitus.

This doesn't make it right though. We need to demand for better ways of detecting and measuring tinnitus. For that, I'm afraid we will need a lot more money to be put into basic tinnitus research. Meanwhile, we can just hope they have enough money to develop and try out some new drugs that might work. If it does work however, I think we will know it. Because we will fail to detect the tinnitus when listening for it.

 

[Rings-a-Bell]

One of the big problem with something like AM101 Is when people get the injection people are listing for they T to see if its gone, but when you start to listen for it, it gets louder and louder, even people who dont suffer from T in daily life can hear T just by focus on it. This could be a reason something like this show bad result many time..

This is why having a placebo in the test is so important. Both the group with the placebo and the group with the drug will be listening harder than usual-- so if you see a difference in the groups, you can know it wasn't caused by that.

 

[Alue]

Has it has not helped you at all with the injection?

Minimal improvement. I stopped getting fleeting tinnitus in my ears, but my baseline tinnitus remained unchanged.

 

[SilverSpiral]

Is there any trial available to people 1 year after tinnitus onset in north america?

 

[Aaron123]

Is there any trial available to people 1 year after tinnitus onset in north america?

No trials anywhere for AM-102. No trials in North America for AM-101. I don't think anything has been trialed past one year. TACTT3 stratum B is up to 12 months.

 

[SilverSpiral]

No trials anywhere for AM-102. No trials in North America for AM-101. I don't think anything has been trialed past one year. TACTT3 stratum B is up to 12 months.

Don't suppose Auris has done any trials in canada? Or upper west coast US?

 

[bellringer]

Don't suppose Auris has done any trials in canada? Or upper west coast US?

Having been through the trial for Am-101 I would not recommend it as a) there is little proof it is beneficial b) it is not fun to have your ear drum punctured.

 

[SilverSpiral]

Having been through the trial for Am-101 I would not recommend it as a) there is little proof it is beneficial b) it is not fun to have your ear drum punctured.

What about this TACTT3 stratum B it sounds interesting.

 

[attheedgeofscience]

Since I started this thread more than two years ago, I wanted to inform those who have followed AM-102, that, today via a conference call concerning the full year 2016 results, Auris Medical stated that AM-102 is for the treatment of "acute tinnitus". The information is not in writing but was stated via the conference call only. The information was released by Thomas Jung as part of the slide covering AM-125 (slide #7 in the presentation).

This would seem to indicate that there is no immediate treatment for chronic tinnitus in the near (or distant) future therefore.

 

[Ecip]

Not surprised.. Chronic T is in the brain.