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

#2,522
Sailboardman said:
DB. Am I correct in stating that, Autifony has not entered into phase III clinical testing as yet? And if so, wouldn't it be safe to say, we are still, at least, 7 years away from a marketable product? That's again if it shows significant results, after phase III testing.

I know everyone here has postulated that, 00063 is the magic drug, that may or may not cure/reduce T. My question was, what's being worked on now, if 00063 fails to miss the mark? Will we be thrown back into the dark ages again, hoping for yet another treatment, before we go insane or better yet die? Nobody on this forum, can answer this question, I know.
Click to expand...


"Companies can submit an initial application to the MHRA if they think their drug meets the requirements for the scheme, with evidence to support this from the early stages of their clinical trials (for example, from phase II trials). The MHRA will assess the application and decide if they agree that the drug may be eligible for the scheme. If so, the medicine will be given a PIM designation."

"The scheme does not replace the normal licencing process, but the early access scheme could allow access several years before the formal licence is granted. For example, the drug could be made available after phase II trials while phase III trials are still ongoing."

I hope that helps.
 
#2,525
I wonder if sf0034 would get fast tracked too if the aut drug doesn't work. I know that its main objective is to treat epilepsy but all the articles I've read still mention tinnitus in it. And I remember reading somewhere that theres a possibility that phase one could skip the safety protocol and go straight into testing the efficacy of it because it is based on a drug already in the market (retigabine).
 
#2,526
Bertman said:
I wonder if sf0034 would get fast tracked too if the aut drug doesn't work. I know that its main objective is to treat epilepsy but all the articles I've read still mention tinnitus in it. And I remember reading somewhere that theres a possibility that phase one could skip the safety protocol and go straight into testing the efficacy of it because it is based on a drug already in the market (retigabine).
Click to expand...

Well, they aren't even in phase 1 yet, let alone phase 2. Anyway, it does seem to work. We have already have one person say it reduced by 75% and she said other people on the trial were having the same results.
 
#2,527
Danny Boy said:
Well, they aren't even in phase 1 yet, let alone phase 2. Anyway, it does seem to work. We have already have one person say it reduced by 75% and she said other people on the trial were having the same results.
Click to expand...
That's good to hear. Personally I am just trying to find more possible treatments so that I still have hope for improvement if for some reason aut doesn't get to market or doesn't work on me.
 
#2,528
Danny Boy said:
Well, they aren't even in phase 1 yet, let alone phase 2. Anyway, it does seem to work. We have already have one person say it reduced by 75% and she said other people on the trial were having the same results.
Click to expand...

Are you talking about Mrs D here Danny? I hadn't seen where she said others at the same facility were having similar results.. Would be awesome if that's the case!
 
#2,529
This was taken from the Scifluor thread. phase 1 projected for 2016 and phase 2 for 2017. I know a lot could go wrong and make it take longer but best case scenario is that it's only 2 years behind aut. But heres to hoping Aut works like it's supposed to:beeranimation:.

ps. sorry for being off topic
 

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#2,531
Bertman said:
This was taken from the Scifluor thread. phase 1 projected for 2016 and phase 2 for 2017. I know a lot could go wrong and make it take longer but best case scenario is that it's only 2 years behind aut. But heres to hoping Aut works like it's supposed to:beeranimation:.

ps. sorry for being off topic
Click to expand...

Well, at least we have two drugs on the way. I do expect Autifony to have great results.
 
#2,537
Sailboardman said:
DB. Am I correct in stating that, Autifony has not entered into phase III clinical testing as yet? And if so, wouldn't it be safe to say, we are still, at least, 7 years away from a marketable product? That's again if it shows significant results, after phase III testing.

I know everyone here has postulated that, 00063 is the magic drug, that may or may not cure/reduce T. My question was, what's being worked on now, if 00063 fails to miss the mark? Will we be thrown back into the dark ages again, hoping for yet another treatment, before we go insane or better yet die? Nobody on this forum, can answer this question, I know.
Click to expand...

Why 7 years, phase III (if phase II shows good results) will be next yaer. So 2018 Q4 is realistic. Or 2019, but "at least 7 years" :S :S :S pure pessimism
 
#2,539
Lots of speculation and guessing going on here for sure about time scales, so here is a copy of correspondence I had directly with Autifony during Nov 2014, when I asked a question about time scales for testing.

Seeing as this is directly from Autifony I consider it to be useful information and not guess work


-----Original Message-----
From: xxxxxxx@autifony.com>
To: xxxxxx@xxxxxcom>
Cc: <xxxxxxxx@autifony.com>
Sent: Nov, 2014
Subject: Re: time scale testing question

Hi xxxxxxxx

Big question to answer, However…..
IF the Phase II study were to go well and to suggest that we might have a useful medication, at a minimum we would need to conduct two Phase III studies and possibly some other phase II dose-evaluating studies either in parallel or before starting the phase IIIs. One of these might be in the US and one might be multinational in the EU - but absolutely nothing even discussed about this yet as we try to take it one step at a time. Phase III studies tend to take around a couple of years, recruit lots of subjects and take a while to analyse and share the data with the regulatory authorities. So we are looking at 3+ years after finishing the QUIET-1 study. Quite possibly we shall do subset analysis of the QUIET-1 data to try to determine which subjects do well and which do not - and work that sort of information into our development programme; we would also wish to look at effects on more acute tinnitus as well as those with chronic long-term tinnitus. So much to explore.

Regards

xxxxxxx

Nov 2014, xxxxxxx@xxxxx.com wrote:

Hi xxxxx

Could you possibly answer a question for me please. Assuming all goes well, and you have very good results from this phase of testing, how many mores phases would be needed ?

regards
xxxxxx
 
#2,540
111 said:
So we are looking at 3+ years after finishing the QUIET-1 study. Quite possibly we shall do subset analysis of the QUIET-1 data to try to determine which subjects do well and which do not - and work that sort of information into our development programme; we would also wish to look at effects on more acute tinnitus as well as those with chronic long-term tinnitus. So much to explore.
Click to expand...

I feel this is a reasonable estimate. About 2 years for each of the phase III trials they have to conduct.

Now the question is where those phase 3 trials will be and who will be able to participate:

111 said:
Quite possibly we shall do subset analysis of the QUIET-1 data to try to determine which subjects do well and which do not
Click to expand...
 
#2,543
I was talking to a pharmacist friend of mine tonight about drug and he chuckled and thought the name was pretty neat. In medical terminology AU means ears and the T must stand for tinnitus. The 00063 probably signifies the 63rd compound they tried..... thus AUT00063

AU = both ears
T = tinnitus
 
#2,544
bellringer said:
I was talking to a pharmacist friend of mine tonight about drug and he chuckled and thought the name was pretty neat. In medical terminology AU means ears and the T must stand for tinnitus. The 00063 probably signifies the 63rd compound they tried..... thus AUT00063

AU = both ears
T = tinnitus
Click to expand...
If thats true it means they did a shitload of work since company is very "new" - though researchers are veterans. Looks like they are pretty set on fixing tinnitus since their name is AUTifony :)
2020 looks like closest reasonable date if all goes extremely well and positive for their tests imo. You still have to manufacture and transport drugs in massive ammounts, so business side will take time to figure out too.

On a side ote waitting for results or more info is killing me.
 
#2,545
bellringer said:
I was talking to a pharmacist friend of mine tonight about drug and he chuckled and thought the name was pretty neat. In medical terminology AU means ears and the T must stand for tinnitus. The 00063 probably signifies the 63rd compound they tried..... thus AUT00063

AU = both ears
T = tinnitus
Click to expand...

It might very well be the 63rd compound they tried and therefore went with that name. However AUT is probably an acronym for Autifony. This compound was developed for age related hearing loss first hand, not just T.
 
#2,547
lapidus said:
It might very well be the 63rd compound they tried and therefore went with that name. However AUT is probably an acronym for Autifony. This compound was developed for age related hearing loss first hand, not just T.
Click to expand...

Saying that. I was reading an article and the ENT said the drug would work better for tinnitus then age related hearing loss.
 

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