Auris Medical AG Secures $50.6 Million Series C Financing

erik

erik

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May 8, 2012
1,601
Washington State, USA
Tinnitus Since
04/15/2012 or earlier?
Cause of Tinnitus
Most likely hearing loss
#1
April 16, 2013 – Auris Medical secures CHF 47.1 mn Series C financing from Sofinnova Ventures and Sofinnova Partners to advance ground-breaking inner ear therapies through Phase III clinical development.

Auris Medical, a company dedicated to the development of novel therapeutics for the treatment of inner ear disorders, announced today the completion of a CHF 47.1 million1 Series C financing. Two leading venture capital firms, Sofinnova Ventures (Menlo Park, CA USA) and Sofinnova Partners (Paris, France), participated in the financing. The funding will enable Auris Medical to advance its two clinical projects, AM-101 for the treatment of acute tinnitus and AM-111 for the treatment of acute inner ear hearing loss, through Phase III studies and ultimately to market launch. In connection with the fund raising, Jim Healy, MD, PhD, General Partner at Sofinnova Ventures, and Antoine Papiernik, MBA, Managing Partner at Sofinnova Partners, joined Auris Medical's Board of Directors.

"The Series C financing represents an important milestone on our way to bring safe and effective therapies to the many patients suffering world-wide from tinnitus or hearing loss for whom today no proven drug-based treatment options exist", said Thomas Meyer, Auris Medical's founder and Managing Director. "Having established proof of concept in Phase IIb studies, we are now ready to move forward with our clinical development plans. Thanks to this latest financing round our leadership position in the emerging market for inner ear therapeutics will be further strengthened."

"We are impressed with the significant clinical progress that Auris Medical has made towards developing first-in-class therapeutics for two inner ear disorders," commented Jim Healy. "We are pleased to bring our expertise and network to back Auris Medical's team and help them build a successful and global business." Antoine Papiernik stated: "We are thrilled to support Auris Medical's development at this important time in its life. The company has developed a unique set of compounds that could ultimately address an important unmet medical need."

About Auris Medical
Auris Medical is a Swiss biotechnology company developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. AM-101 contains a small molecule NMDA receptor antagonist. In a Phase IIb clinical trial the treatment showed a statistically significant reduction in tinnitus loudness and several other outcomes in patients suffering from acute tinnitus with established cochlear origin. AM-111 contains a cell-permeable peptide that selectively blocks JNK signalling involved in apoptosis and inflammation. A recent Phase IIb clinical trial demonstrated a statistically significant improvement in the hearing and speech discrimination of patients with severe to profound hearing loss. In addition, Auris Medical is pursuing some early-stage research and development projects.

About Sofinnova Ventures
Sofinnova Ventures has over 40 years of experience building healthcare companies into market leaders. With USD 1.4 bn in committed capital, the firm applies capital and expertise to take companies from inception to exit. Sofinnova closed its life science-focused USD 440 mn fund, SVP VIII, in late 2011. The firm's investment team of MDs and PhDs has significant scientific, operational and strategic experience, and specializes in financing later stage clinical products and growth companies. Our team partners with entrepreneurs to address patients' unmet medical needs. Sofinnova Ventures has offices in Menlo Park and La Jolla, California.
For more information, please visit www.sofinnova.com.

About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For 40 years, the firm has backed nearly 500 companies at different stages of their development – pure creations, spin-offs, as well as turnaround situations – and worked alongside Europe's key entrepreneurs in the Life Sciences industry. With EUR 1.3 bn of funds under management, Sofinnova Partners has created market leaders with its experienced team and hands-on approach in building portfolio companies through to exit.


For more information, please visit www.sofinnova.fr.
Contact for Auris Medical
Thomas Meyer, +41 61 201 13 50, tm@aurismedical.com
Contact for Sofinnova Ventures
Jennifer James, +1 650 681 8429, jennifer@sofinnova.com
Contact for Sofinnova Partners
Anne Rein, +33 6 03 35 92 05, anne.rein@strategiesimage.com
 
#3
I don't think it's yet been established whether AM-101 works for chronic tinnitus.

There's a possibility it might work. Maybe not as effectively as for acute tinnitus, but could still provide some alleviation.
 
#4
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.
 
#5
I agree... but I'm really hopeful this AM-101 would turn out to be a viable treatment for chronic sufferers, too...

Well, this is a start anyway, and what with the HIFU and some other trials going on, things are looking brighter than ever before for taming tinnitus.
 
#6
I was skeptical about how squirting some goop into your ear could make it all better but they have been doing this for a number of years and if they secured that much funding then there must be something positive that they are doing.
 
#7
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.
 
#8
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.
 
#9
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...
 
#10
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.
 
#11
Fish said:
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...
Click to expand...

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.
 
#12
Microtransponder is another company to keep an eye on www.willrosellini.com and microtransponder.com. They have secured over $15 million in funding in the last year and supposedly their method does help those with chronic tinnitus. They are not going the drug route....their method uses Neurostimutlation.
 
#13
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.
 
#14
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.
 
#15
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.
 
#17
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?
 
#19
#20
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.
 
#23
Thomas Meyer of Auris Medical contacted me with the following message and asked to share it.


Statement about AM-101 trial in forum

Hello,
I have been reading some of the most recent posts about our company and the AM-101 project. I appreciate your member's interest and comments. There is however one piece of information that is not correct: in all of our clinical trials so far we had a 3 month time window corresponding to the definition of acute tinnitus - it was never 6 months, and hence never narrowed down to 3 months. Since we did not see a decrease in therapeutic effect towards the end of the 3 month time window (which is based on a somewhat arbitrary cut-off... but the line has to be drawn somewhere), we are planning to test AM-101 in one of our forthcoming phase III trials in the post-acute stage up to 12 months.
I would appreciate if you could share this information with your members.

Kind regards,

Thomas Meyer
Founder and Managing Director
Auris Medical
 
#24
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
 
#27
Markku said:
Thomas Meyer of Auris Medical contacted me with the following message and asked to share it.


Statement about AM-101 trial in forum

Hello,
I have been reading some of the most recent posts about our company and the AM-101 project. I appreciate your member's interest and comments. There is however one piece of information that is not correct: in all of our clinical trials so far we had a 3 month time window corresponding to the definition of acute tinnitus - it was never 6 months, and hence never narrowed down to 3 months. Since we did not see a decrease in therapeutic effect towards the end of the 3 month time window (which is based on a somewhat arbitrary cut-off... but the line has to be drawn somewhere), we are planning to test AM-101 in one of our forthcoming phase III trials in the post-acute stage up to 12 months.
I would appreciate if you could share this information with your members.

Kind regards,

Thomas Meyer
Founder and Managing Director
Auris Medical
Click to expand...



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
 
#29
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.
 
#30
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!
 

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