MemberWhat I want is to travel to that planet near the Black Hole like they did in Interstellar. Every hour on that planet was 7 years on earth. You go there and spend a couple of hours and come back. Voila! Cure already created!
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
What I want is to travel to that planet near the Black Hole like they did in Interstellar. Every hour on that planet was 7 years on earth. You go there and spend a couple of hours and come back. Voila! Cure already created!
Dubbyaman
Member
I wrote to them recently and thought i'd share. They really didn't do a good job at answering my question but their response was informative nonetheless.
QUESTION
Hello my name is Jason. I've had tinnitus since last October. First off i'd like to applaud your efforts in trying to develop solutions to this horrible disorder. I am a member of tinnitus talk and they applaud your efforts as well along with other tinnitus sufferers all over the world.
My question to you is, does autooo63 tackle only constant pure tone tinnitus or do you think it can have an effect on cycling multi sound tinnitus as well?
Thank you very much for your time and god bless.
RESPONSE
Hi Jason,
Many thanks for your email. 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 this study. Quite possibly we shall do subset analysis of the current study's 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.
Our results will be most likely available by mid-2016 and will also update our website www.autifony.com accordingly.
Please feel free to contact us for any queries you may have.
QUESTION
Hello my name is Jason. I've had tinnitus since last October. First off i'd like to applaud your efforts in trying to develop solutions to this horrible disorder. I am a member of tinnitus talk and they applaud your efforts as well along with other tinnitus sufferers all over the world.
My question to you is, does autooo63 tackle only constant pure tone tinnitus or do you think it can have an effect on cycling multi sound tinnitus as well?
Thank you very much for your time and god bless.
RESPONSE
Hi Jason,
Many thanks for your email. 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 this study. Quite possibly we shall do subset analysis of the current study's 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.
Our results will be most likely available by mid-2016 and will also update our website www.autifony.com accordingly.
Please feel free to contact us for any queries you may have.
Thankyou Dubbyaman (Jason) for this. This is so informative and answers a lot of the questions raised on here. Not least of which is the timescale in respect of conclusion of trials and possible inclusion criteria for future trials. Well done for contacting them and posting their response. Xx
3 years at least to finish the study and may be 1 year for aproval so at all 4 years at least ,it's a long way guys.
So at the best end od 2019, or more realistic 2020... so far from now! And to be more sad, aut63 is our only hope until 2020. all eggs are there in next 4, 5 years :/
Well I guess we have to take heart that there is potentially a drug that may help us under development and hopefully on it's way. A few years ago sufferers didn't even have that glimmer of hope. I know 3+ years sounds a long time but if the results from each of the trials are positive then, hopefully, knowing we're getting closer to an effective treatment will ease the anxiety of the wait. Because wait is all we can do guys. And let's not forget SF0034 is also under development so who knows what the future holds . . . maybe a choice of treatments !!!
- May 7, 2015
- 1,008
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
I don´t like the sound of this statement as it makes me think that the numbers for treating long term T is a bust!
Dubbyaman
Member
Hi guys, it's not unusual for pharma companies to expand the types of patients they trial a drug on whilst it's being developed. If anything it's usually a good sign, if it's working in one set of patients it may well work in another set of patients, thereby, when the company applies for a licence to market a drug it can be indicated for more patients at various stages of the disorder/disease so more people can benefit from the drug (and of course this means more wonga for the company too).
The results of phase II next year will be the life or death for this drug. It will be crunch time.
Dubbyaman
Member
Gill Hayes I understand things take time and everything is a slow process especially in the medical field but suffering of any kind intrudes on the ability to just gracefully wait it out but thats what we have to do. I'm just saying it's hard for some including me. I can't imagine what people who got this condition pre 2010 or even 2000 felt because like you said, back then there was literally nothing.
We don't know what type of patients this drug is going to be licenced for yet. That is what the trials are for - to determine efficacy, tolerability, side effects, dosage, patient types, duration of treatment etc etc. It could well be that it is licenced for anyone with tinnitus no matter how long they've had it - we will just have to wait and see.
Yes Gill, that is why I and few member were saying how it sounds, not how it definitely is... I hope so much that firstly it is gonna work, and second that is gonna work for 5+ year t suffers.. Because it will be useless for all of us here if there is not that second condition...
Seeing as you got the exact same reply as I got from them, and mine was from Nov 2014, I wouldn't say they were that good at responding either, they are obviously using set templates to reply to questions.
I would suggest no one of any significance in the company would be looking at these questions now anyway and the receptionist is probably sending out the pre arranged replies.
Below is my post from the 18th Aug, which is quite funny as 2 people thought it was informative back then, and you post exactly the same reply and 6 people now think it is informative, maybe if we keep repeating this email every 2 weeks or so we might get 20 people rating it informative soon !
Yep, looks like they're sending out the same response to each person ! At least they're consistent haha !!!
I guess they must be inundated with queries about timescales etc and it's just easy to send out a 'template' response. It's not fair but there we are . . .
I suppose we can at least take away the message that it's likely to be 2018 - 2020 before AUT00063 gets to market ( assuming, of course, that it gets through the trials successfully).
I guess they must be inundated with queries about timescales etc and it's just easy to send out a 'template' response. It's not fair but there we are . . .
I suppose we can at least take away the message that it's likely to be 2018 - 2020 before AUT00063 gets to market ( assuming, of course, that it gets through the trials successfully).
Dubbyaman
Member
Strange but I had a different reply which I am not going to post here.
But it was not as far dated as your replies I can assure you.
So mid 2016 for results and then for UK people certainly they may be able to get some help.
That is all I am liberty to say and will do no good to discuss argue or pester me or autifony either......
hang on all .....thanks
But it was not as far dated as your replies I can assure you.
So mid 2016 for results and then for UK people certainly they may be able to get some help.
That is all I am liberty to say and will do no good to discuss argue or pester me or autifony either......
hang on all .....thanks
Dubbyaman
Member
Thats it. Im coming to get you and you and I are going to that planet for a good 12 hours. Then when we get back and we see that the world is still dragging their asses with this, F*ck it. Three day trip!!! Bring all your loved ones tho lol
I agree with amandine. Autifony isn't going to show their hand to random emails. They also won't over-promise... that's business 101. I would assume lots of us suffering would be able to get on the phase 3 trial as well, depending on location and hearing loss requirements. P3 trials are intended to study effects on large groups of people, and we definitely have a large group ready to be studied.
Dubbyaman
Member
Can you guys be any more vague, what is up with this ?
"I know things but if I tell you I will have to kill you."
Is autifony part of the freemasons operating from Area51 or something?
I sure hope that if this drug does have positive results it becomes widely available outside of the UK quickly. Waiting to see the results is hard enough, I sure wouldn't want to have to wait even longer, possibly worsening the efficacy, because it isn't available in certain places.
Hi all, having worked in the pharmaceutical industry for many years I can tell you they are very secretive about the drugs they are developing. They don't want competitor companies getting their hands on their info. This is especially true of a first in class drug which AUT00063 is. I don't know why amandine has had a different response to the other posters but I think we have to respect that she can't tell us more. But it's great to hear what she has divulged.
That's not what I meant at all. Anyone is free to ask Autifony questions, just don't expect them to divulge too much. If they happen to, that's great.
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