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

Apparently the UK study is only going to be open to people who have had tinnitus for less than a year. This whole time I was under the impression that Autifony was going to target chronic T folks, and that just doesn't appear to be the case. The study in the US is going to focus on whether AUT00063 helps hearing impaired individuals hear slightly better (or at least if the compound provides some protective advantages to further degradation of the hearing system).

 

ugh dont tell me there gonna do that thing like am 101 is and only recruiting 1-3 monthes. If this drug is for chronic then it should start at 1 year!

 

Thanks for the update. Was that something you heard from Autifony directly, about the less than a year criteria?

 

If thats true, then they seem there gonna be doing this backwords.. I thought autifony was targetted for chronic T and its called chronic cause according to them T is then in the "brain" and acute is not. And isnt this drug targetting the brain to begin with?

 

Is there a link to the UK study? Are they recruiting?

 

They want the best results to show their investors. Much like am101

 

Some studies I read discuss plasticity as a two-way street. The brain adapts to the stimulation from your hyperactive nerves. Sometimes that means that the hyperactivity comes to be regarded as the normal state, and its absence will be met by the brain supplying the noise on its own.

So if AU00063 does indeed cause the hyperactive nerves to calm down, the brain may fill in the gaps from memory. Eventually, hopefully, it'll adapt to the lack of hyperstimulation. So if Autifony leaves their study open to everybody, they run the risk of exhausting the time they've set aside for the study before positive results are noticed.

Acupuncturists say the same thing, interestingly. They claim to have very good results from treating tinnitus that is less than a year old, and very poor results for cases that are four years old or older.

 

Btw, this goes for AM101 and AUT60001 or whatever the name is. I asked a doctor how long between a drug gets "accepted" to the drug being available to normal people in my country (scandinavia) and he said "very quickly"

So less than a year I'd imagine, if for example AM101 get approved in 2015, we'll have it available in 2016

 

i forget who said it but they said that treating T in acute stage is way different then treating it in chronic.. So if autifony is targetting the brain for chronic T..how would it work for acute stage. Im just not understanding it maybe? They shouldnt say targetting chronic if they only think there gonna get good results from acute stage. After all they said those rats had "chronic" T and when given 30 and 60 mg that it abolished "evidence" of t.

 

@Hudson, could you let us know where you got the info on the less than a year criteria please? Not asking you to name names but just in broad terms would be much appreciated. Many thanks

 

If Autifony fail to come up with a working treatment for chronic tinnitus then I'm going to gather as much media as i can and stage my suicide at wherever their head offices are maybe then people will understand just how serious this "condition" really is

 

perhaps they just try to create boundaries in order to get more accurate or better results. maybe later they will try it on a group who has had tinnitus for longer (like am101). after all they have to show good and fast results to investors...

 

No need to do that.. If they fail they will only learn from there mistakes.. It will take time but if not autifony then someone will find a way to treat chronic T.

 

I don't think Autifony is targeting any time-frame. They're targeting a specific phenomenon that they see in patients with tinnitus, namely the hyperactivity of specific sodium-gated potassium channels. My comment on plasticity was a theory as to why they may only want acute tinnitus sufferers in their test.

Because the brain adapts to whatever stimulus it is presented with, patients who have had tinnitus longer may have plasticity adaptations that work against stopping the noise. Think of your brain as an echo chamber. You shout into it and hear your own voice bounce back as an echo. Something like that happens several times between our ears and our brains. Sound waves get converted to physical vibrations by the hair cells, then electrical signals that travel to the brain where they are perceived as sounds (and I've left out several steps along the way). If the brain constantly hears a sound from this complex system, it grows accustomed to hearing it and adapts to better perceive it, in this theory, anyway. After awhile the brain can become so accustomed that it will continue hearing the sound even if the cause of that sound is removed. The longer a person hears phantom noises, the more likely it is that such an adaptation will occur.

But even if that is the case, it doesn't mean that AU000063 won't work for such a patient. It may simply take more time for the patient's brain to adapt to the lack of noise. That is my theory for why Autifony would want shorter-duration tinnitus sufferers to apply. If they get a lot of 10+ year sufferers, they may not respond in whatever small window of time Autifony has to gather results and report to their investors. But, if the acute duration sufferers do respond positively, they may invite longer duration patients for the next phase; even if that's not the case, the drug may prove effective for all ranges of cases. It's simply too early to tell.

 

A very insightful post, @rtwombly .

p.s. you addes an extra "0" in AUT00063 ;-)

 

Someone please link source or state where they heard this information regarding aut' being trialed on people with only 12 months old :|...pissed off is an understatement here :|

 

I received an email today from Action On Hearing Loss about Autifony who are researching a new tinnitus drug

Phase 1 testing (discussed elsewhere on this forum) has been sucessfully completed with 60 elderly and young volunteers.

Phase 2 will now commence later this year 2014


Funding awarded for tinnitus drug trial

Autifony Therapeutics awarded £2.2 million to progress first-in-class drug for tinnitus into Phase IIa study

Award follows successful completion of Phase I

London, UK – 4 June 2014 - Autifony Therapeutics Limited (“Autifony”), which is pioneering the development of novel pharmaceutical treatments for hearing disorders, today announced that it has been awarded funding of £2.2 million towards a Phase IIa clinical trial in tinnitus patients with its lead compound AUT00063, by the UK’s innovation agency, the Technology Strategy Board. Autifony will be sponsor of the clinical study, with Professor Deborah Hall at The University of Nottingham and National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit (BRU) as lead academic collaborator.

 

here is the link to the Autifony trial
http://www.autifony.com/publications/Autifony-TSB-tinnitus-Ph1-FINAL-4-Jun-2014.pdf

 

For anyone who doesn't know the conversion, this is equivelant to $3,733,499 USD.

That's pretty sick. Since its been demonstrated to be safe, lets hope it gets through Phase II and shows good results.

 

This is great!
more money for T research is always great news!

 

Maybe I read too quickly, I didn't catch anything that lead me to believe it has been successful in relieving sufferers of T, am I mistaken?

 

Phase 1 is for healthy patients in order to test side effect.s Phase 2 and 3 will show efficacy. The fact that it worked on rats should lead you to believe that it works though.

 

I have been approached by many tinnitus sufferers who want to erect a memorial for Autifony rats - if it cures tinnitus, and to all the other tinnitus rats that weren't cured - who have gone thru so much pain and suffering, so that we humans could enjoy some peace and quiet.

 

Mate, If this drug works I will erect an idol of an Autifony rat and praise it daily for the rest of my life!

 

If this works , i will find a rat and kiss the shit out of it lol

 

If this works and my T will be cured, i will sleep 7 days in row...

 

This is the key point.

A reliable inside source informs me that Autifony intends to treat both acute AND chronic tinnitus patients.

But it is vital to maximize phase2 success so that we all benefit from development.

More chronic cases may likely need a longer/stronger dosage regime but this is speculation not fact.

If they have located and can treat a tinnitus generator site it does look good. Awesome rats.

 

Agree, That is my understanding as well,

Theirs a few T suffers here that are freaking out a bit about them only calling for short term T sufferers for this next phase, and they have every right to as most of us will be pinning all our hopes on this drug from now on!

So I think we can all relax and fingers crossed for a successful phase IIa trial!

Rich

 

does anyone know if autifony would need to be taken for life or if is the sort of thing that would be taken for a few months, etc?