Auris Medical AG Secures $50.6 Million Series C Financing

Good news, especially for those with acute issues. Hopefully some day soon we wil have similar new for chronic tinnitus and hearing loss

 

Apologies Markku I want thinking about AM101 , I was contemplating out loud how much we need some good news from wherever about chronis tinnitus / hyperacusis. Good new for Auris though and the whole field in general that they have good a relatively big chunk of funding.

 

Hey, I have been following AM-101 and Auris Medical since my onset of tinnitus in late 2009. Here is my take.

I unfortunately do not share the view that this drug will help chronic sufferers. In AM 101's first trial, subjects with tinnitus 6 months or fewer were eligible to participate. In the second phase, the qualifying window was narrowed down to 3 months.

Obviously, Auris Medical's goal is to produce the best data possible in order to keep their investors happy and keep alive the hope of bringing this drug to market. There is no doubt they carefully tracked success rates with the subjects' length of time since onset. Additionally, AM's own web site proposes a theory that tinnitus has an acute window or phase and a chronic phase, and that chronic tinnitus is harder to treat because, according to their theory, at some point (days, weeks, or months after onset) tinnitus sets in the brain (becomes centralized) and thus, becomes permanent. In effect, the window of treatment has closed.

Based on this data tracking, their numbers undoubtedly showed higher success rates with newer cases and thus, to show even better results in the next phase, their team decided to restrict subjects to a narrower window to improve the data. I am only speculating of course, but it did strike me that the window decreased from 6 months to 3 months between the 2 phases. There was a reason for this change.

I do not mean to be a Debbie Downer and I certainly hope it does work for chronic cases, too, but you cannot discount AM's theory outright, and they likely had initial data before they began their more extensive trials to support it.

Beyond whether AM-101 will work for chronic cases, my other concern is that this drug will be heavily marketed and become really successful as the go-to drug for ENTs, who will no doubt be happy to finally be able to offer something for patients with tinnitus walking through their doors. Most tinnitus sufferers see a doctor about their tinnitus around the time of onset (acute phase), so most would be a candidate for therapy. If AM-101 does prove to become really successful, I fear other companies and researchers will lose their incentive to investigate other treatment options that might benefit those of us left out of AM-101's reach, in much the same way AIDS research for a cure would instantly dry up if a successful vaccine were developed.

No, AM-101 will not be a vaccine per se, but it will be similar -- something like a morning after pill. Get tinnitus after damaging exposure at a loud concert, make an appt. with an ENT, get the shot, and the tinnitus is effectively treated. (I realize "effective" is relative, and still a question mark at this point). Developing a tinnitus treatment is a very expensive proposition. I just hope AM-101 does not corner the market and thereby dampen the chances of other treatments, ones that might benefit everyone, from being investigated and developed. Seeing as how they will be the only game in town if they win FDA approval, I believe this is what might happen.

 

I think I will reserve judgement on this one for now, an effective treatment for chronic tinnitus is whats needed, I dont know how they define success when success can be spontaneous in the case of acute tinnitus. In any case the clinical need is treatment for chronic tinnitus , hearing loss and hyperacusis.

 

While I am happy to see some progress obviously, AM-101 worries me a little. What somebody else said before - it could be that if AM-101 successfully enters the market and becomes somewhat a first-line treatment for acute tinnitus, I am afraid all other manufacturers, medical companies will jump on the AM-101 boat and just create similar drugs while giving up their other projects. Thus putting chronic tinnitus sufferers in a difficult situation...

 

If this is successful, this will prove that treatments ARE possible, though, which will prove to be a watershed event of sorts I think. It will give a lot of pharmaceutical companies an incentive to invest more time and money in the research.

 

Yes, Fish, exactly my thought. It's like any technology...once the initial "wheel" is invented, other companies will copy cat and piggy-back off of this initial prototype (known entity) because it's cheaper and easier and less risky to do so. Developing an entirely new strategy (unknown entity) is always a more time-consuming, risky, and expensive proposition.

 

True, Erik. I have followed their progress as well and am hoping this treatment modality will prove beneficial. In general, I am much more apt to root for the non-pharma route. Unfortunately, doctors tend to prefer to write scripts -- less labor intensive and no equipment to purchase, upkeep, and store.

An even worse scenario than AM-101 would be the development of a drug one had to take on an ongoing, permanent basis to gain relief. Fortunately, with the failure of Neramexane, nothing like this is currently in trials AFAIK. Such a drug would mean $$$ from our pockets directly into the coffers of big pharma, and long term side-effects naturally would be a concern. The huge advantage to neurostimulation appears to be the lack of side-effects.

Obviously, AM-101 has the advantage of a much easier, less time consuming, and less labor intensive delivery. A shot is far more practical and less costly than having a device implanted, and then undergoing a series of treatment sessions.

Despite these challenges, I am hopeful some type of neurostimulation, whether it be near infrared light or vagus nerve stimulation, will prove effective.

 

I think that the whole premise of this treatment, its mode of action and proof of efficacy will be scrutinsed top to bottom. There are many questions marks over each at present. The Auris theory of tinnitus is not by any means verified and full of assumptions and as such remains just a hypothesis, one of many. A treatment for chronic tinnitus is by far the more pressing need.

 

I agree Joejunior,

There has been some resistance to AM's theory among tinnitus experts, from what I understand. And even if their theory does happen to be valid in relation to the drug they have developed, this of course does not mean other treatments can't work with chronic cases. There are theoretically so many ways to approach tinnitus treatment, from disrupting its pathway, to retraining the brain, to stem cell therapies...the list goes on. The brain research initiative recently announced undoubtedly will spur investigators to gain a much deeper understanding of the brain, which will in turn lead tinnitus researchers towards better approaches in designing effective treatments.

 

How quickly could stage 3 be completed with this funding? Do we know anyone who had success on the American trials of this drug?

 

I would be interested in the trial results so far:
some initial questions
1. was it a double blind randomized trial and if so who conducted it and details?
2. what is the definition of success or effectiveness used for trial?
3. how did effectiveness of treatment compare versus duration of tinnitus?
ie did effectiveness depend on the duration of tinnitus, eg 1 week old tinnitus vs 3 or 6 month tinnitus?

 

HI R&B I havent heard about the brain research initiative - do you have info?

 

Encouraging that some companies are developing treatments other than the usual sound therapies. A pity that its effectiveness seems to decrease the longer the time since onset - but at least there might be hope for those affected by this horrible condition in the future.

 

Actually, I was referring to this, but happy to see Europe also moving forward on brain research.

http://news.cnet.com/8301-11386_3-57577499-76/obama-unveils-$100-million-brain-research-project/

 

Look like these are both very worthy projects.

 

Sounds Good and Nice Action from auris.

Makku could you ASK him if it's worth to make trials on chronic tinnitus patients as well?
Maybe it will help to some special forms and types of tinnitus?

Would be interesting to know , isn't it?

SISKO

 

That's good news!! Are they still recruiting for these trials?? And where are they?

 

Fingers crossed for those guys. It was silly of me to quit, I'd gladly have few more injections now if I had the chance

 

Very greatful to Mr. Thomas Meyer for taking time to speak on behalf of our groups discussion and his teams research. Thank you Markku for your refined and professional attitude towards this board and its member.s Victor

 

An anecdote is not a demonstration but you may want to google translate this: http://www.france-acouphenes.org/forum1/viewtopic.php?t=10658&start=0

In short, this is a testimony from a test subject who reported a clear diminishing of his tinnitus.

 

translation of one person's experience:

Section that everyone expects, lol ... Honestly, I did not feel anything the first day, no perceptible change. The last injection was a little weird, I felt it was poorly made, I did not have the usual problems (vertigo tinnitus +) and I was wondering if the injection was actually done correctly, all that I covered, the liquid flowed out of my ear ... The weekend was pretty awful, because tinnitus had changed a little: much more pregnant, more pervasive ... I'm just saying that the drug was indeed hoping to have actually taken the drug and not the placebo ...
A week later, the effects are still there, so I think I actually took the drug. Tinnitus in the ear is gone but there is still a kind of central tinnitus. Let me explain: whereas before and since the beginning, I "heard" tinnitus clearly on the side "in" ear after treatment and waiting time, it seems that tinnitus has migrated innermost of the head, with a much lower intensity. After a week, I'm here: tinnitus is more centralized, much more bearable, and much lower intensity. I sleep much better, given the rehab that I had done, but also to the fact that tinnitus does not prevent me from my sleep because I hear a lot less and it wakes me more. I found a quality near-optimal sleep, I sleep well (I insisted because it was my main annoyance before!) And am again able to fall asleep within 30 minutes (the average acceptable apparently) and wake up to the order (before, sometimes I do not even hear the alarm because I think I slept very badly and that the effects of drugs played too), I'm more tired the day (because I do not take more drugs)
This tinnitus is much more flexible in intensity than I had before. Some days I did not hear any more, over long periods (especially at work, where I work in a quiet office environment) and I had the "search" to hear again. Other times, especially near sharp enough noise (hiss of station master of flowing water safe, atmosphere pretty rough street), it is strong enough to the point of not even being covered by the surrounding noise ...
I've spent the first appointment control (Day 7 J) and now I wait for the next (D Day 30) but I must say that my "quality of life" has improved, and made my tinnitus not completely disappeared but perfectly bearable.

 

Mr. Meyer,

Thanks for your reply to this forum and for responding to statements I made.

When the drug was being researched in Germany back in 2009 (when my tinnitus onset began), AM-101 was looking for subjects under six months. I believe this to be true because when I first found out about AM-101, I had already had tinnitus for 2 months and remember thinking I still had a few months left to try to see about participating in an AM-101 study!

Granted, this might not have been a trial, but I do recall the window for subjects in the Germany study was SIX months. I contacted you directly about participation, and because I was not an EU citizen (even though I speak fluent German), you informed me that I was not eligible to participate.

I would really appreciate it if you could clarify this, because my memory usually serves me fairly well, and I do distinctly remember one of the inclusion criterion was to have had tinnitus for six months or fewer, not three months. Again, this was a study -- not necessarily a trial -- being conducted in Germany in 2009.

Since you admit this window of three months was arbitrary and is now being increased to 12 months, it does seem highly plausible that at least for a while, in an early study, the window was 6 months. However, I admit I might be wrong about the 6 months. It is certainly possible that the AM-101 website or your e-mail response stated tinnitus tends to become chronic or centralized or "memorized" by the brain by 6 months (note: other sources I have read state tinnitus becomes chronic after 1 year, just for the record), and hence my confusion.

Either way, I won't post any more (aside from questions...see below) because I realize now that doing so is likely to cause more harm than good due to the risk of being inaccurate and disseminating false information to readers on these forums. Also, I have no basis on which to be authoritative since I am not a tinnitus clinician or researcher.



Thanks!