Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
Member
"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.
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
No problem. I'm probably gonna get a lot of marriage proposals after phase 2 haha
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).
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.
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.
- Jul 10, 2015
- 128
- Tinnitus Since
- 12/2014
- Cause of Tinnitus
- Ototoxicity from Electronic Cigarettes (Propylene Glycol)
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!
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
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ps. sorry for being off topic
. ps. sorry for being off topic
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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
ps. sorry for being off topic
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
ps. sorry for being off topic
Well, at least we have two drugs on the way. I do expect Autifony to have great results.
Don`t forget the underdog - Brivaracetam ... you never know but it might be a golden bullet without anyone knowing yet ... hope it will be released soon.
Dubbyaman
Member
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
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
Markoana, pure optimism! However, time will tell and I sure hope your estimate, is better than mine!
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
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
noisebox
Member
- Jul 4, 2015
- 319
- Tinnitus Since
- 04/2012
- Cause of Tinnitus
- West End show. Came back 2015 vitamin D overdose prescribed
Oh well the lead Professor says 2 years to market if all goes well. So my money is on 2018. I have to cope somehow.
noisebox
Member
- Jul 4, 2015
- 319
- Tinnitus Since
- 04/2012
- Cause of Tinnitus
- West End show. Came back 2015 vitamin D overdose prescribed
Well i cant participate, did anybody notice you need to able to take 2 forms of contraceptive?
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
AU = both ears
T = tinnitus
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.
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.
Saying that. I was reading an article and the ENT said the drug would work better for tinnitus then age related hearing loss.
Just a little correction. AUT00063 isn't meant to treat age related hearing loss.
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