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

http://www.autifony.com/autifony-pipeline.asp

There isnt any more info right now but they will relase it on their website shortly.

EDIT: Some pages back in this thread dboy stated some criterias but they are only hearsay so far.

 

Yes, saw that. Thanks @lapidus
Emailed them with my interest.
Weird that no results of Phase I have been posted.
Makes me worry.
Will keep you guys posted if I hear anything.

 

Phase 1 was successful. It has been posted in this thread.

 

http://autifony.com/autifony-pipeline.asp

Phase 1 is for safety, so all it proved was the drug doesn't hurt healthy people. They didn't publish any findings on efficacy.

 

Right. Thanks, Guys. Did not think of checking page 1 of this thread. Instead went back the last 20 pages. Oi!
Well, feeling hopeful about this one.
@rtwombly @lapidus

 

I just got this email from Autifony five minutes ago...and my Reply, as it does not seem like Charles Large would mind or that it is not "public" information (or no way I would break confidence). Will post on the Retigabine thread too...

Dear Michael,
Thankyou for your email and your interest in Autifony's clinical trial of AUT00063 for tinnitus. We have received a number of contacts regarding this trial, and I want to ensure that I can respond personally to each one. Autifony's UK trial is planned to start in October this year and will involve a number of UK sites. More information about the trial will be made available via Autifony's web site in the next few weeks. Please do check back with the website at that time. We are not currently planning studies in the US, but if the first trial is successfull then I expect we will extend to the US for further studies.

My best regards,

Charles Large


Thank you... I will make this info known (as it does not seem private) on the tinnitus website I am heavily involved in so you don't get flooded with similar emails to mine asking just the same question I did. (Probably someone has already posted it though, as news travels fast).
Good luck with your trials, and indeed us tinnitus folks are SUPER excited about where this is all heading. I sure hope that somehow (if as successful as all hope) AUT00063 can be fast-tracked somehow. For one, the Veterans Administration here in the USA is "bleeding" huge amounts of $$$ for tinnitus injury. It is their BIGGEST single expense item, and forecast to grow to a staggering figure by 2017. (I'm sure you are aware of the report).
Best to you all...and "do hurry" if you can.
Michael M.

So there we have it folks...No USA trial in the works yet.

Best, Zimichael

 

@Zimichael
I just moreorless received the same email.
Love your response.
Sounds like things are moving.

 

As always those damn Europeans seem to get the coolest tinnitus treatments first.

I suppose I have love for them anyway.

 

https://en.wikipedia.org/wiki/Chronic_(medicine)

it says it all

 

@Valentin
Thanks. Hopefully, it is just labels with t, and not re the coding of t in the brain re plasticity. Grrrr.

 

Chronic just simply means the body is not healing itself naturally, so damage or malfunction persists in some way. Fix the damage, and most likely your chronic issues will be highly treatable.

 

@Zimichael Thank you for providing this information.

 

It has to do with brain plasticity and there have been numerous studies proving that. Have no references to give but Im sure if you search on medical databases you will find research about tinnitus indicating that changes take place in the brain after a while after getting tinnitus. Its not really about "coding" anythings, more about your brain being unable to change- the same goes for depression.

 

I have been searching for such studies for months, and none to be found. Coding is another term for tinnitus setting in the brain that audiologists and ENTs use - but still no research. They can't even image tinnitus, how are they going to observe its plasticity? T engages the central auditory cortex, the limbic system and other areas. I would think time frames vary, as tinnitus is varied.

 

Agreed. And in many cases now depression CAN be treated successfully with medication, treatments are so much more effective nowadays. So hopefully T treatment will have similar breakthrough

 

@Stina, why are you always so negative about curing tinnitus.

 

@Stina
Also, making a definitive statement like that does need some form of back up.Have you read any such studies before on the medical databases you refer to?
@jazz do you have any information on timeframe of brain plasticity setting in/coded in the brain with t? See a couple of posts above this one also. Thanks, Jazz.

 

Thanks for updating us, Zimichael. I've been waiting to hear just like you, and now know my course of action. I was hoping Autifony would start the trials in parallel, but since they are not going to be enrolling in the US, I'll be concentrating on getting a prescription for retigabine.

 

I have read about that but actually my information mostly comes from the psychiatrist who has explained it to me. yes of course depression can be treated but it wont go away on its own. Most likely tinnitus can also be treated with the right medication, but it rarely leaves on its own. So in conclusion brain plasticity means that the brain needs help in order to stop the reaction.
Im not being negative about the treatment, Im just saying that it might take some time and its better to wait for the company instead of rushing into marketing smth that they are not a 100% sure about.

 

hi everyone this is my first post! i received the same response, i sure hope they are able to fast track. definitely excited and hopeful they are successful, looking forward to a solution definitely helps.

Thank you for your email and your interest in Autifony's clinical trial of AUT00063 for tinnitus. We have received a number of contacts regarding this trial, and I want to ensure that I can respond personally to each one. Autifony's UK trial is planned to start in October this year and will involve a number of UK sites. More information about the trial will be made available via Autifony's web site in the next few weeks. Please do check back with the website at that time. We are not currently planning studies in the US, but if the first trial is successfull then I hope we will extend to the US for further studies.

 

Very familiar words! Seems everyone that sends an inquiring Email gets the same generated response, just hope it doesn't get put back again, they were looking at starting in either August or September now it's October.
Still, very exciting!

Rich

 

what's the MOST OPTIMISTIC timescale on AUT00063 becoming available?
Wild guesses gladly accepted.

Remaining in optimistic fantasy mode, if Autifony is the real deal,
would a $50,000 bribe get you a bottle of pills or is it only cops on the take.

 

I don't understand there is so much speculation when it will be available. This because it is not yet clear if 63 will help HUMAN T sufferers....

 

unlikely as it seems AUT00063 could actually be a cure, it does a very specific clever job
i'm really interested to know whats the earliest it could be fast-tracked ( in a perfect world)

...yes i know its not a perfect world, THOUSANDS OF MILLIONS of dollars
have been spent compensating our war veterans for tinnitus without serious
funding of research for a cure to bring us all real relief.

 

in all honesty we want this drug to go through 3 phases.. Idk who wouldnt want it too..

Well since reg is a potassium channel targeter... And aut00063 is supose to be more specific to T i would put my bets that autifonya drug is gonna do more treating/curing it more then reg

 

well at least we can help the rats , they have feelings too

 

I don't normally comment on these types of speculative/wishful questions, but I will this time...

Using the AM101 trial as an example, the clinical trial started in 2007. The very latest information I have tracked down via my financial sources, is that the clinical trial data for phase III will be postponed by a quarter (vs. the information I have previously provided to this site). That means it is now due for completion in early 2016. It is unclear to me how much longer after that - if data is proven adequate - the drug will be released to the market; but as you can see there is some time between start and finish of a clinical trial...!

Now in the case of AM101, "things" are a bit different in terms of pre-market release usage. The reason is: the components in AM101 (Esketamine and Hyaluronic acid) are already in use on the market for other medical purposes, and that means any doctor can already today use the drug legally even if it has not been approved by the FDA (provided Auris Medical will release the drug to the doctor, of course). Indeed, I am aware of two specific doctors (one in the US and one in Germany) who will perform the procedure as in the AM101 trial (provided the patient pays for the procedure, needless to say). However, Auris Medical will not release the drug for off-clinical trial purposes (so don't bother exploring this avenue - in this specific case). Now, in the case of AUT00063, we are talking about a new drug (with no similar components on the market) - it is a so-called "first-in-class drug". For this reason, I doubt that any doctor - anywhere - can prescribe the drug legally (even if Autifony is willing to release the drug). So bribing or off-clinical trial usage will not get you anywhere (I have already tried).

You can find the chemical formula for the AUT00063 drug(s) in the attachment. I believe you requested this in another post...

As for AUT00063, I believe that efficacy probably has been established even though phase I trials are for healthy volunteers only. I have reliable information that it has been tested on tinnitus patients already. The reason is that tinnitus (or hearing loss) is not a disease, and selecting patients with tinnitus or hearing loss would not constitute a violation of a phase I trial. Probably, that is how they got around the issue...

Probably, Autifony have indications that they are on the right path (so far) - but this is speculative (on my part), but nonetheless very likely.

So when (if at all) will AUT00063 be available? I don't know. 2018? 2019? Something like that... But more importantly is the chance to take part in the phase II or possibly phase III trial. It is still unclear to me if the treatment would require continuous medication or only for a limited period to cure/treat tinnitus.

 

Lmao

 

No ones neggative.. She may came out soundin neggative but she just means everyones jist gottta hold there horses and patience!!! This shit will be cureddd/treated even if its with a pill, its gonna happpen! this plasticty and potassium channels are just sky rocketing so we just wait!! I swear im havin dreams bout all these potassium channels and doctors and trials i think im on here too much lol

 

@attheedgeofscience It seems pretty clear that it will take some time. Just like with REG, you have to retrain the brain cells to fire at a healthy rate. You do that by forcing the behavior with a drug, then after a currently unknown period of time, the brain's plasticity adapts to make the modified behavior its new normal. I read somewhere that it takes 21 days to break a habit, that is, if you consciously forgo the habitual behavior for 21 days, your brain will adapt to the lack of the habitual stimulus. So our brains are addicted to rrrrrrrrrrrrrr or eeeeeeeeeeeee or whatever yours sounds like. We need a drug to switch that off long enough to kick the habit.

On another note, you posted previously about the three phases of a clinical trial. Phase three is comparison with existing drugs, i.e. what you also posted was the reason Trobalt was removed from the German market. Since AUT00063 is first in class, wouldn't that mean it has no need for a phase 3 trial? Mind you, their website calls the upcoming UK trial phase IIa, so presumably there could be a IIb/c/d...before they come to market.