AM-101 TACTT1 Results Released

[James White]

I just read this, for anyone who is interested.

http://www.bioworld.com/content/auris-medical-gets-51m-hearing-disorder-drugs-1

Thanks for sharin Pipo but as a side note, please post this link in the AM101 thread to keep discussions organized. By the way, this is also an old news that has been posted last year on Tinnitus talk

 

[tom1989]

Is this trial still recruiting in the UK?

I signed up a few days ago but have not heard anything. O think I am eligible (< 3 months and noise induced)

Thanks

 

[tomm]

Hi @tom1989

You are eligible. A few weeks ago at least London and Cambridge were still recruiting. I have contact details for both - will PM you so they don't get spammed. Where are you based?

 

[tom1989]

Really appreciate this. Based in Leeds but happy to travel anywhere.

 

[attheedgeofscience]

Below, the most recent update from Auris Medical Holding AG regarding its financial statement, dated 03/DEC/2014. As an introduction to the financials, a short summary outlining product highlights is made. This includes a few brief details on the status of the AM101 trial (which of course is a core component to the company - along with AM111)

Overview

We are a clinical-stage biopharmaceutical company focused on the development of novel products for the treatment of inner ear disorders. Our most advanced product candidate, AM-101, is in Phase 3 clinical development for acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA. In two recently completed Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. We expect to have top-line Phase 3 clinical data for AM-101 in early 2016. We are also developing AM-111 for acute inner ear hearing loss (acute sensorineural hearing loss, or ASNHL). Following feedback from a pre-IND meeting with the FDA in September 2014, we are in the process of finalizing the design of the late-stage AM-111 clinical program and if all goes well and we obtain sufficient funding, we intend to start a placebo-controlled pivotal trial around mid-2015. Both acute inner ear tinnitus and hearing loss are conditions for which there is high unmet medical need, and we believe that we have the potential to be the first to market in these indications.

To date, we have financed our operations through our initial public offering of our common shares, private placements of equity securities and short term loans. We have no products approved for commercialization and have never generated any revenues from royalties or product sales. Based on our current plans, we do not expect to generate royalty or product revenues unless and until we obtain marketing approval for, and commercialize, AM-101, AM-111 or any of our other product candidates.

Since inception, we have incurred significant operating losses. We incurred net losses (defined as net losses attributable to the owners of the company) of CHF 15.0 million and CHF 4.6 million for the years ended December 31, 2013 and 2012, respectively. For the nine months ended September 30, 2014

Source: http://www.streetinsider.com/SEC+Filings/Form+6-K+Auris+Medical+Holding+For%3A+Dec+03/10064894.html

 

[Jean-Daniel Guay]

Alright, I know this thread has been here for a long time, but I still have to make a decision about going forward with the injections in a week and a half. By looking at all of the posts, I'm still very unsure because there doesn't seem to be a lot of positive regarding AM-101. My guess is that if no one on this post is reporting any success or positive stories with AM-101 trials, it is because there isn't any. It would be surprising that all of the people that participated to the AM-101 trials on TT received the placebo.

I'm getting slowly habituated (20-30%) and reporting my T level for the next 3 months doesn't seem like a good idea, especially if the treatment doesn't worth it. All I see on threads on AM-101 is negativity from the participants.

So, I would really really really appreciated if people that will see that message could report on the outcomes of their experience with AM-101.

Right now, It think that I will take a pass since I haven't seen anything convincing. The results of the Phase 2 study are not "earthshaking" as others have already said as they are based on self-reports. They could find anything with their primary outcome measure (Minimum Masking Level) and they reported improvement even for the placebo group (not such a big difference between the placebo and treatment groups). I'm a researcher and I always doubt results that are based on self-reports and such a small sample of participants.

I think that the numerous anecdotal stories on T habituation are far more convincing than the ones on the AM-101 trial.

Alright, so again, I'm asking participants that went through the AM-101 to report on the outcomes (positive, negative or neutral about it) to help a fellow T sufferer to make his decision regarding his participation to the study. This board is meant to help each other and I feel like I'm left in the dark. I really really need some advice.

A million thanks to those of you who will answer this post. It will clearly also help others to make their decision towards AM-101 participation.

You can also report your experience on this thread.

https://www.tinnitustalk.com/threads/am-101-participants-updates-and-q-a.6558/

Thanks!

 

[LoNicot]

This AM-101 depresses me. When are they going to think about treating someone with MANY YEARS of tinnitus, not under three months? How do they know that the tinnitus wasn't gonna disappear after a few months anyway? Those of us with T for YEARS know it's not.

 

[tomm]

I'm getting slowly habituated (20-30%) and reporting my T level for the next 3 months doesn't seem like a good idea[...]

You're a researcher, you've seen the phase I results and the limited anecdotal evidence on these forums so you know the what the probabilities look like.

When I spoke to the study lead at Guy's Hospital, Mr Obholzer, during my last followup I asked how much of the drop in loudness could be attributable to time and whether I should go again for the guaranteed drug in Feb.

He responded along the lines of that if you are habituating, having to fill in a journal every day won't help you. He also lightly touched on the idea that if you stop the habituation process so soon after onset by tracking it, you may end up making it worse (although there's no evidence of that).

If it helps, my T goes between 4 and 6 in loudness from a 7 when it started (10 being it is audible over a rock concert) . The annoyance and impact on my life varies from 5-8 (10 being 100% suicidal). Based on my response, I got the placebo in the trial, or the drug does not work on me.

You have all of the information the we have - we all just want a cure and it's understandable that you're frustrated at the lack of clear results. Remember this is a clinical trial, not a proven medicine.

I hope you are able to make a decision you are content with.

 

[marqualler]

Alright, I know this thread has been here for a long time, but I still have to make a decision about going forward with the injections in a week and a half. By looking at all of the posts, I'm still very unsure because there doesn't seem to be a lot of positive regarding AM-101. My guess is that if no one on this post is reporting any success or positive stories with AM-101 trials, it is because there isn't any. It would be surprising that all of the people that participated to the AM-101 trials on TT received the placebo.

I'm getting slowly habituated (20-30%) and reporting my T level for the next 3 months doesn't seem like a good idea, especially if the treatment doesn't worth it. All I see on threads on AM-101 is negativity from the participants.

So, I would really really really appreciated if people that will see that message could report on the outcomes of their experience with AM-101.

Right now, It think that I will take a pass since I haven't seen anything convincing. The results of the Phase 2 study are not "earthshaking" as others have already said as they are based on self-reports. They could find anything with their primary outcome measure (Minimum Masking Level) and they reported improvement even for the placebo group (not such a big difference between the placebo and treatment groups). I'm a researcher and I always doubt results that are based on self-reports and such a small sample of participants.

I think that the numerous anecdotal stories on T habituation are far more convincing than the ones on the AM-101 trial.

Alright, so again, I'm asking participants that went through the AM-101 to report on the outcomes (positive, negative or neutral about it) to help a fellow T sufferer to make his decision regarding his participation to the study. This board is meant to help each other and I feel like I'm left in the dark. I really really need some advice.

A million thanks to those of you who will answer this post. It will clearly also help others to make their decision towards AM-101 participation.

You can also report your experience on this thread.

https://www.tinnitustalk.com/threads/am-101-participants-updates-and-q-a.6558/

Thanks!

Hi Jean-Daniel, I did not participate in the AM-101 trial due to the intratympanic injection being a little riskier for me than for other patients disqualifying me, but I did learn a lot about the study, read the published results from phase 2, talk to the lead researcher on the study I was looking at, and interact with people on this message board about the study. It seems that while it is by no means a "miracle drug" (actually a quote from the researcher I talked with--that it is not a miracle drug), it did seem to show some positive results in phase 2. The main advice I got from the researcher as well as @Dr. Nagler is to participate if you feel motivated to help the science and research involved in the drug itself, and not to look at it as a potential cure, but any benefits you might receive take as a bonus, but also knowing that there are risks involved. With all that said, it is definitely a complex choice, and one you have to make alone. Remember too that the people on this board are a very small sample size of the total number of people who are participating in the study, so any positive or negative results you see from participants here are inconclusive. In fact, I'm not sure if anybody who has participated yet even knows for sure if they received the placebo or not.

Hope that helps, and best of luck to you!

 

[OddV]

Great responses guys, @marqualler I was told that I would not find out what I received until after the results were published... Just FYI.

 

[Anthony C]

In am an American living in Thailand. I got T recently due to noise. I would like to participate in this trial. I have family in US I can stay with but it is a very big deal for me to travel back to the states to do this. Financially and time wise for work. However if it is going to eliminate or lessen this noise I would be up for it. Does anyone have the link to the results of this trial so far?
I see they are giving this trial in Korea which would be closer to me but that part of the site is password protected. Anyone here taken this in Asia? Are there actual live people to talk to at Auris?
Any help is appreciated. May you all have better days ahead.
A

 

[nills]

hi all,

I have a friend who is on the trial and I joined him to see how the whole things works. He has had 2 or 3 injections with the real medicine already and is now going to get another 2 over the next months. He says he has slight improvement. Also he has had t for about 18 months now.

I asked a few small questions to the doctor. Overall she said they are not as thrilled by the effects as they were expecting. I don`t think anyone of their trialees had significant improvement. I will see her on the 3th as a patient and will ask a bit more.