AM-101 TACTT1 Results Released

But I'm not gonna lie to them as ANY doubt in their data can set them back, and these people want to help.

 

@Hudson, excellent post and I know EXACTLY where you are coming from. I guess I am fortunate that I have an understanding girlfriend and family that is supportive, even though I don't really like discussing tinnitus with them as I spend enough of the day thinking about/try to think away from it. T is exhausting. I am now quite used to wearing earplugs when I go to the cinema and restaurants and simply mind my own business - the vast majority of people do the same. I have a well paid job and am in a happy relationship with my girlfriend who I am hoping to marry next year. Despite all of the cr*p that T throws at us, we must try and look at the positives and to try and shrink tinnitus to what it really is - an auditory compensating mechanism that is not trying to hurt us, even though we think it is. Believe me I have bad days and am working hard on overcoming anxiety and related dizziness which adds to the burden!

If you are reading this, think about the chair that you are sitting in. You probably weren't thinking about it until I just wrote this and this is the state I am aiming to get too. (Sourced from a TRT site!)

I am praying this company produces something that can at least alleviate the symptoms of T. I wonder how differently we would all feel right now if we knew we could go to the doctors next week and take a magic pill to remove T forever! I would bet fairly good! This could be the start of effective treatment and I am staying positive for this. Good set of phase 3 trials and big investment WILL flow in from financial institutions and this company would be an extremely attractive takeover target from one of the major pharma players.

Very noble to be going into the Tinnitus research field and I wish you the very best of luck if you do decide to go down this route!

Cheers,
Mission

 

Yes it`s true, it would mess with the data.. but it also could provide some miracle information that even chronic sufferers could benefit ... ah well ... just dreaming and hoping for an end to this..

 

Seeing the positive results and that reddit story Hudson posted I feel now really stupid having panicked and quit in the middle of therapy... Now that I am aware of relief this drug (probably) gave me, I'd gladly join phase 3 and have my ear stabbed again. In the name of science!

P.S. Still don't know if I got the real thing or placebo. Perhaps I should call my doctor

 

Why did you panic? What were you told were the risks? I want to do this treatment/trial.

 

Man did you say it right brother. You made me tear. God do we need that medicine and now.

 

What i derived from AM-101 is that the drug solves the problem at the early stages when T is only an inner ear and auditory issue before becoming a brain issue. This time period is determined as 3 months after onset, but the drug is considered to be also effective after 3 months. I think the term of brain plasticity can change from person to person when it comes to T is acute or not, but of course they should put exact limitations in order to conduct a right clinical trial.
I hope the Auris Medical becomes so successful, sells its products in the market, gains lots of money and invests for further researches. I like the way that they are targeting directly inner ear and find it promising.

 

Hello Erlend,


Thank you for your inquiry. I sincerely wish I could help you. Unfortunately, we do not have any trial open at this time, and we also have no plans to start one in Norway.


I can only wish that your tinnitus will become more manageable and that you will find relief through other means (masking… ).


I am sorry that I don’t have better news for you.


Kind regards,


Thomas Meyer


Me: I am willing to travel to where ever the trials will be





Erlend, yes, I understand, but even if there was an open trial, it would enroll only residents / native speakers.


TM

Oh well..

 

I panicked because my tinnitus became much, much worse few hours after second injection. This effect was only temporary however and few days later I felt a lot better.

Risks, pretty much everything bad that can happen with ears. Hearing loss, louder tinnitus, middle ear infections, I think there was even death included

In case anybody is interested, my experience with AM-101 is here -> https://www.tinnitustalk.com/threads/696/ and yes, I know what I did was pretty stupid...

 

So: It appears that University of Miami, where I am getting several different treatments, will be recruiting for an AM101 trial. I had been pretty psyched. But my doctor today told me it will be a three-month max from onset protocol. So I wont qualify.

I told him I had heard there might be some trials where you could be a far away from onset as 12 months, but he had not heard of any yet.

In the meantime, if you live in the U.S. Southeast and are interested, you may want to give UM a call.
http://otolaryngology.med.miami.edu/

 

That sucks when you're so close..
There is another AM101 trial for 12 months or something yes. I'll try to find the link.

 

Thanks Erlend. Won't lie; I was bummed. As someone else said on this thread, guess they want to concentrate on cases where the brain hasn't had time to build new neuropathways.

Interesting; asked my research doc on the visit before this one if he thought tinnitus was a brain or ear disorder. He said: In your case, at five months, I consider it an ear disorder. But eventually, if it doesn't go away, it's a brain disorder. I hope research looks at the chronic Bain path as well as the early onset ear path.

 

Why don't they use people who've had it for 5 months-3 years or something too? That way they would know when it's "too late"...

Is it the goo or whatever they spray into the ear that's super expensive?

 

They already have. Not very effective.

 

where did you have that from ?

 

Hey t-man: So they already tried AM101 on folks who have had T beyond three months? Also, while I obviously am biased, it doesn't seem like there should be a huge difference between three months and five months. But I guess for data gathering sake, they have to cut it off somewhere.

 

I thought I had read it here that they have done a twelve and six month trial with varying results. Of course, my memory is pretty defunct, so it would be best if someone else could reply with some verification.

 

didn`t see this info anywhere, it`s quit a long read so interesting.

Auris Medical Gets $51M for Hearing Disorder Drugs


By Cormac Sheridan
Staff Writer

In one of Switzerland's – and Europe's – largest biotech private equity deals for some time, Auris Medical AG landed CHF47.1 million (US$50.8 million) in a Series C funding from the two Sofinnovas, Sofinnova Ventures and Sofinnova Partners, to take forward its two lead drug candidates, AM-101 and AM-111, in acute tinnitus and acute inner ear hearing loss, respectively.

The Basel, Switzerland-based firm plans to start recruiting 600 patients with acute peripheral tinnitus into two placebo-controlled Phase III trials, one each on either side of the Atlantic, later this year. "We're currently in an SPA [special protocol assessment] process with the FDA," Thomas Meyer, founder and managing director of Auris Medical, told BioWorld Today. "We expect to have the data in 2015."

The company will consult further with regulators before finalizing plans for AM-111, a dextrorotatory peptide that blocks c-Jun N-terminal kinase (JNK) signaling, in acute hearing loss, but a Phase II/III trial could also get under way before year-end, he said. Auris in-licensed the drug from Xigen SA, of Epalinges, Switzerland, which is developing the compound in several other indications.

AMI-101 is an N-Methyl-D-aspartate receptor antagonist intended to dampen the excessive signaling to the brain that occurs with tinnitus. "It's a problem of aberrant excitation of the auditory nerve," Meyer said. The drug is delivered locally, via intratympanic injection, a repeatable outpatient procedure routinely performed under local anesthetic by ear, nose and throat (ENT) specialists, he added.

Meyer has a drug delivery background – he was previously CEO of insulin pump specialist Disetronic Group, which Basel, Switzerland-based Roche Holding AG acquired in 2003 – and he established Auris in the same year after acquiring an inner-ear catheter device for drug delivery to the cochlea, the snail-like structure that contains the sensory hearing organ. "I was intrigued by the complete lack of licensed drugs for ear disorders," he said.

Meyer invested CHF8 million of his own cash in the company, with the intention of focusing on disorders for which animal models were available. Both acute tinnitus and acute hearing loss can be induced in experimental settings, which enables preclinical proof of concept to be established. Moreover, they can also be more easily assessed clinically than can progressive hearing disorders, in which hearing loss is gradual.

"We picked conditions where patients are acutely aware that they have a problem; they can tell when it happened," he said. Given the underdeveloped state of the field, however, historical data and published guidelines were not available. "We had to develop a lot of things from scratch," Meyer said.

Tinnitus is a subjective experience, which makes objective measurements of improvement – in terms of reduction in loudness – difficult to attain. "We're relying on patient-reported outcomes," Meyer said. "In tinnitus, what we are aiming for – and what we could show in the Phase IIb trial – is patients experiencing a reduction in the subjective loudness of the tinnitus." The upcoming trial also will assess the effect of AM-101 on secondary endpoints, such as sleep disturbance, a significant problem for tinnitus sufferers.

Acute hearing loss is more straightforward, in terms of measurement, but assessing any drug-associated improvement can be complicated by spontaneous recovery. In a Phase IIb trial, AM-111 did demonstrate a clinically meaningful benefit – a 10 decibel recovery – in patients with severe to profound hearing loss but not in those with less severe problems. "We were unable to show it in mild to moderate cases, because the spontaneous recovery was too strong," Meyer said.

Auris has not yet decided on a commercialization strategy, should its drug candidates gain regulatory approval. In the U.S., its potential audience comprises about 9,000 ENT specialists. The figure is about half that in Germany, another major market. "It doesn't really take huge armadas of sales and marketing people out in the field to work that market," Meyer said.

Otology is largely virgin territory. There are no licensed drugs for tinnitus in the U.S., while in Europe drugs with a thin evidence base are licensed in a limited number of regional markets. Both Auris and its new investors take the view that the field could take off, in much the same way that ophthalmology has during the past decade.

"We found this a very attractive investment opportunity as a result of it being the most advanced and leading company in the world with drugs to treat hearing disorders," Jim Healy, managing partner at Sofinnova Ventures, of Menlo Park, Calif., told BioWorld Today. "We believe, with some conviction, there will be a new focus and emphasis on developing drugs for otology and hearing disorders."

Several other firms operating in that area have raised funding in recent years, including London-based Autifony Therapeutics Ltd., a spinout of London-based GlaxoSmithKline plc, which raised $16.4 million to develop ion channel modulators for treating hearing loss and tinnitus.

Otonomy Inc., of San Diego, raised $48.5 million in two funding rounds in 2010. Its lead compound, OTO-104, a sustained-release formulation of the steroid dexamethasone, has completed a Phase Ib trial in Ménière's disease, a condition associated with hearing loss, vertigo and tinnitus. Sound Pharmaceuticals Inc., of Seattle, is in the clinic with SPI-1005 with ebselen, a mimic of glutathione peroxidase, which protects the inner ear from sound-associated damage.

Basel-based Novartis AG twice extended a hearing loss research collaboration and license agreement with vaccine developer GenVec Inc., of Gaithersburg, Md. MedGenesis Therapeutix Inc., of Victoria, British Columbia, is developing a treatment for sensorineural hearing loss based on local delivery of glial cell line-derived neurotrophic factor.

Having raised about CHF75 million since its formation, Auris Medical is now the best funded firm on the otology block.

 

Great. Not very comforting for us long term chronics.

 

Do they explain why it won't work for chronic sufferers? I can't see it. And I had silence only 2 weeks ago so obviously my brain is still capable of it after 5 months

 

I got started having ringing in my ear about a month ago. Are there any trials in the northeast that i can sign up for?

 

http://clinicaltrials.gov/ct2/show/NCT01934010?term=tinnitus&recr=Open&rank=22

This is the next trial. They only take people who also participated in the previous trial.

 

So there's no hope for me to get this treatment then?

 

Actually, Rai, yes. Auris is starting another trial in December (it was supposed to start in July, but it was postponed until December, I'm not sure why).

http://clinicaltrials.gov/ct2/show/NCT01803646?term=tinnitus&recr=Open&rank=21

That trial is for patients in the "acute" stage. If your time table is true, you may well fit the criteria for this study. I can't say I know the locations that will be participating in this trial though. I do know that it will definitely be taking place in the US, and I would imagine they will have some location in the northeast but I can't guarantee that.

Assuming you meet the other criteria of the study, you could always give it a shot. I have heard positive things from people who receive the experimental drug. There is always a chance you'll receive the placebo, though.

 

open label follow on study ? what does that mean ?

Good news by the way

 

Genuin question: Is it possible to invest money in Auris Medical? This feels like a Lester mission on GTA lol

 

Is it still possible to apply to phase III trails.
Are the locations known?

Or do I misread the letter?

 

Open label basically means that the experiment administrators and the patients know whether they are getting the experimental or placebo drug up front. It can also mean that everyone is receiving the experimental drug.

Perhaps they feel very strongly that efficacy has already been shown in earlier trials. I don't know, I'm not an expert on this stuff. haha