Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

For those who might have missed this I'm going to just throw it into the "money mix" here, as it is staggering data. And for sure, one of the key reasons I have considered the T. cure ball will start rolling faster...Here's the summary, c/o the US Govt. Printing Office http://www.gpo.gov/fdsys/pkg/CRPT-113hrpt247/html/CRPT-113hrpt247.htm
Note the $$$$$$ involved!


SECTION 1. SHORT TITLE.

This Act may be cited as the ``Tinnitus Research and Treatment Act of
2013''.

SEC. 2. FINDINGS.

Congress makes the following findings:
(1) Since 2006, the most prevalent service-connected
disability for which veterans have received compensation under
the laws administered by the Secretary of Veterans Affairs has
been tinnitus.
(2) The number of veterans receiving such compensation for
tinnitus has risen each year since 2006, increasing the number
and cost of the compensation claims paid by the Secretary.
(3) A growing body of peer reviewed literature indicates a
direct connection between traumatic brain injury, post
traumatic stress disorder, and tinnitus.
(4) An analysis of data collected by the Department of
Veterans Affairs concluded that total amount of disability
compensation paid for tinnitus by the Department of Veterans
Affairs in 2012 was $1,500,000,000.
(5) Based on projected rates of growth, the amount of
disability compensation payable to veterans for tinnitus is
expected to exceed $3,000,000,000 in 2017.

 

Sounds like the AUT00063 is more for early onset tinnitus. Also, I think I read somewhere that stage two testing is only recruiting early onset patients (tinnitus for less than 6 months).

It sounds like this is more of a preventative measure taken in the early stages.

This is taken from a article I read on action on hearing loss web site....


By using AUT00063 to correct the activity of these neurons, the clinical researchers hope to reverse this early stage of tinnitus development and prevent longer term tinnitus-related changes in the brain.

 

Says its for "chronic", not accute. Maybe they should rephrase there wording then.

 

Tha

thats just ridculous. 3,000,000,000 a year by then in dissability there sayin?!!!

 

Can you link the article please?

 

http://www.actiononhearingloss.org....w-funding-boosts-tinnitus-research.aspx?jse=1

 

Source ?
This is not what's advertised from them on the public side nor in their investor presentations.
Please stop sharing non official information unless you back this up with tangible source.

Plus it would not make if you look at the latest publication from Professor Deborah Hall who's btw the lead on the project. She's basically demonstrating that there is no structural difference between a system afflicted by T. & a healthy system but a localized synaptic malfunction. - No matter how long the patient had T. -.

This is a study for Chronic T. for people who had it for a while and they will certainly target different group based on time, I expect the treatment to be shorter for accute T. for some brain plasticity reasons but this will be just be in the end a control variable and the drug is designed for chronic T. (long term)

So until we get the exact design or any official information, let's stop with the hearsay because it brings a lot of confusion and could misinform some potential candidates to the study.

 

What I read between lines confirm my initial statment, the drug is made for chronic T. but depending on the time it's been here the researcher expect I guess some inertia in the healing. In other words long term sufferers may need to take their drug longer than people with accute T.
From marketing / practical reasons they maybe want to show more impressive results on people with T. for a short time, but long term T. people should not worry. The worse case scenario would be that we will have to use the traitment for the rest of our lives. but who cares ?

 

Could people sue for false information if it does afterall only treat acute T.. Cause all this time it said " aims to treat subjective chronic t".

 

Read my previous post, we have nothing concrete to worry about and it all make sense. Even if they go for accute T. cohort for a proof of concept that is more sexy & quickly actionable than with long term sufferer.

 

And yes I just got tinnitus only three and a half weeks ago, and it might go away on its own (hopefly), but i would gladly take a pill every day of my life to be like my old self again.

 

Yeah fair enough.

 

@benryu

We already know one of Autifony's aims is to reduce chronic T. Check page 6 of the PDF linked in this thread from them:

http://www.anglonordicbiotech.com/img/File/Comp Pres 2014/Autifony-session 1.pdf

 

Producing the best possible results is always the goal of pharmaceutical and biotech companies when designing clinical trials. Acute tinnitus is easier to treat. Period. But that doesn't mean Autifony won't test its product on chronic sufferers. If, however, funding or treatment outcomes favor acute sufferers, it is possible the drug will be offered to chronic sufferers off label.

In drug development, it's all about generating and maintaining investor interest. That's reality.

 

Yeah this is what I say, thanks for sharing that, it totally disambiguate the accute madness going around haha

 

Im not trying to be annoying, and i
Know that they need to test on acute
to show better results, but can someone also give me some hope that this could work just as good for chronic, that it could for acute? I know you dont know until you know but is there a good reason to believe that it will?

 

Can these small companies not go public to raise capital?

 

Read my last 3 or 4 posts i made it clear lol no worry to have for the long term chronic, the drug is also for us.

 

Yep, they're specifically *not* targetting acute cases - they believe their solution will work for anyone whose Kv5 receptors aren't working up to snuff.

 

Does anyone know if this medication is being targeted towards ototoxic induced tinnitus? Or is it just for noise induced and age related tinnitus?

Sorry if this topic has already been covered.

 

Just a thought here but IF Aut' is only going to work to control newly damaged nerve over activity...then even if it wouldn't work on long term tinnitus...shouldn't it technically still work to prevent/treat any new tinnitus increases one might have?
So say you had t for ten years at a constant level and the aut' wouldn't treat or change that t because it is to ingrained in the brain...surely if you had another increase caused by futher damaged to the nerves then that new part of your t would then be acute and aut would work to rectify it?....

I hope that makes sense...just thinking out loud really.

Rhea x

 

I guess it should yeah if it works.

But i was just having a look at treatments for epilepsy. You have a bunch of treatments for all different kinds of epilepsies. Maybe it will be the same for tinnitus... the thing is we only have a few compounds being researched at the moment. Epilepsy already has around 20 different chemicals.

 

"Autifony have developed a novel drug, AUT00063, that may help to treat people with some types of tinnitus, in particular tinnitus associated with hearing loss following noise exposure or ageing"

From their website.

 

In my opinion, there isn't big difference between noise induced, ototoxic drugs induced and age induced T. All of them are based on damaged hair cells.

 

thats what i thought too.

 

Interesting point.
Epilepsy is often compared to tinnitus because its an expression of brain cells misfiring.
However, for up to 70% of epileptics, the cause of seizures is completely unknown.
With tinnitus, despite all the etiologies (causes), we can at least see many causal links.
And it does make sense that a tinnitus generator site in the brain is specifically auditory neurons.
Unlike an auditory cortex, there is no similarly clearly mapped 'epilepsy cortex'.
Epilepsy could be a truly brain-wide phenomenon (as in generalized seizures) without any clear-cut central site.

Our optimism can at least take strength from knowing that we're in the right neighborhood.

Yes, epilepsy does have more treatment chemicals available, but this need not dishearten us.
Epilepsy, let's hope they cure it, may simply be a more complicated hunt. A different animal.
I lived with an epileptic girl who died at 32. It could strike with immense force suddenly while she walked down the road and habituation was never a word in her vocabulary.

Some may say that tinnitus is brain-wide too.
Sure non-auditory brain areas do light up in tinnitus, but many such illuminations may simply be
the neuronal correlates of accompanying stress, anxiety, fear, depression, etc.
ie. the consequences of experiencing tinnitus, rather than the causes.

If luck is on our side and the key tinnitus generator site has been identified to be corrected by Autifony,
we can expect both acute and chronic cases to benefit. Remember that the science is quite simple.
It is all about allowing neurons to return to resting state.

And after researching this quite a bit, I don't buy that tinnitus can return from memory.
I'd put my money on there being a correctable physical anomaly.

It does seem amazing that a cure could simply happen like this but it's not unfeasible.

I must re-stress what others have pointed out. $12,000,000,000 on tinnitus compensation by DVA
since 2004 with minimal research is scandalous pressure for fast-tracking AUT00063 after phase 2.
About time we saw some articles in the main press about this issue to politicize the issue in advance.

Thanks to James for opening this line of discussion.
May we all get better.

 

Speaking of epilepsy. have you guys seen this thread?

https://www.tinnitustalk.com/threads/retigabine.5074/

 

Totally agree with you, I am really confident that we are on the good track, and when reading most of the latest scientific publications available, T. is not as complex as we thought, it's clearly not. It was just ignored by research for financial reasons and also because there wasn't enough T. sufferers.

Things have changed, investments are being made, and AUT00063 if successful in phase 2 is very likely to relieve a lot of us and open the way for other treatments.

 

it's refreshing and inspiring to read your words benryu
Amongst (many) others, I'd like to thank you and Dan for keeping
my hopes up with well-argued and researched points.
The Autifony thread has become quite a special place.

 

I just hope we can get it quick.