MemberHi, any source on that statement?
Generally speaking, I'm happy that they do the trialing properly by using current standards. Not with the people with "hidden hearing loss" or whatever that is if you know you have a hearing loss...
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
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Generally speaking, I'm happy that they do the trialing properly by using current standards. Not with the people with "hidden hearing loss" or whatever that is if you know you have a hearing loss...
Hi guys,
If you Google 'Autifony' the TT site Q&A is there. The fast track statement is part of that Q&A.
If you Google 'Autifony' the TT site Q&A is there. The fast track statement is part of that Q&A.
al
what I found was only this
Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The preclinical work looks very positive and exciting but, until we have done this first clinical study in people with tinnitus we have no idea of whether those models will be predictive of its activity in humans. So we shall have to wait until this study finishes before we know. Clinical research just takes a long time, certainly a number of years. However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account.
https://www.tinnitustalk.com/threads/autifony-q-a.8331/
Always good to add a link and a quote for the benefit of the other members
what I found was only this
Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The preclinical work looks very positive and exciting but, until we have done this first clinical study in people with tinnitus we have no idea of whether those models will be predictive of its activity in humans. So we shall have to wait until this study finishes before we know. Clinical research just takes a long time, certainly a number of years. However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account.
https://www.tinnitustalk.com/threads/autifony-q-a.8331/
control c and control v will copy and past anything on your computer ... very handy thing
or you push right mouse butten after selecting text and then do copy or paste.
I've read Q&A before and I've never seen them mentioning that they will fast-track it. Either way, please check your facts before spreading rumors.
There are mechanisms in place when a new drug meets an unmet urgent clinical need to get it licenced and to market quickly. Below is the direct quote from the Autifony Q&A and I think it clearly implies that this would be the case with AUT00063 should it successfully get through its trials. When asked about time to market the quote below was their response, whether you call this 'fast track' or anything else I think the meaning is clear.
"However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account".
That process however is out of Autifony's hands but I would like to think they will do all they can to ensure this 'fast tracking' (or whatever you want to call it) happens.
"However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account".
That process however is out of Autifony's hands but I would like to think they will do all they can to ensure this 'fast tracking' (or whatever you want to call it) happens.
It's clear there is an unmet need but is it urgent enough to warrant a fast track? Given these are the very first brain-targeting drugs indicated specifically for tinnitus It would be probably best to err on the side of caution.
But that's probably an unpopular opinion on here.
Well, there's 600,000 people with severe tinnitus and 10 million with moderate/mild tinnitus, in the uk, who I am sure will want the drug. Not enough? How about 65 million people worldwide with severe tinnitus, suppose they aren't important enough to get a drug fast-tracked to enable them to have a better life?
"Fast Tracked" to me just means making it a priority. It doesn't, or at least it shouldn't, imply pushing it for approval in an irresponsible manner.
Yeah,...I agree, @Danny Boy,..that there's sufficient human misery to warrant the fast tracking of drugs that may reduce the degree of suffering for people with T and H.
Yeah,...I agree, @Danny Boy,..that there's sufficient human misery to warrant the fast tracking of drugs that may reduce the degree of suffering for people with T and H.
Dubbyaman
Member
AUT - Autifony
00063 - maybe there were 62 compounds tried beforehand that did jot all?
This is often the case. I believe SciFluor'S SF0034 is also named after that convention.
Well this is what I'm talking about. What we like to think has nothing to do with reality.
Let's be realistic here. Fast tracking is usually used when there is a life threatening and/or serious condition with unmet medical needs (in case if you didn't know). Tinnitus isn't one for the most of the time. Fast tracking may or may not happen but we can't be sure. And that was my point - let's not spread inaccurate information by saying that "they will fast track it" when we don't have any certainty that it will happen.
Tbh, at the moment, we have no certainty that the drug will pass the phase 2 if though it looks promising.
Nucleo - Whilst I agree with your 'err on the side of caution' statement I would refer you back to the Autifony statement posted above = 'an effective drug for tinnitus is critically needed' - I think that says it all.
I work for, and have worked for some of the world's largest pharmaceutical companies for the last 14 years and I can assure you when it comes to a 1st in class drug for an unmet clinical need the pharmaceutical company involved will try to push it through MHRA and NICE as quickly as possible. Yes there is a lot of regulatory hurdles to get through, yes this takes time and negotiation by the pharmaceutical company involved (and it is not always successful) but they will give it their best shot.
So 'err to caution' - yes, that is the sensible thing to do. Will AUT00063 (if it gets through it's clinical trials successfully) be pushed through all the regulatory hurdles ASAP, I think so.
I work for, and have worked for some of the world's largest pharmaceutical companies for the last 14 years and I can assure you when it comes to a 1st in class drug for an unmet clinical need the pharmaceutical company involved will try to push it through MHRA and NICE as quickly as possible. Yes there is a lot of regulatory hurdles to get through, yes this takes time and negotiation by the pharmaceutical company involved (and it is not always successful) but they will give it their best shot.
So 'err to caution' - yes, that is the sensible thing to do. Will AUT00063 (if it gets through it's clinical trials successfully) be pushed through all the regulatory hurdles ASAP, I think so.
Well yes it is in the best interests of Autifony to get their drug to the market as soon as possible. I am sure they will do all they can to make sure it happens. Will it be granted though? I was thinking on the side of the FDA here. I would be curious to see what are the drugs and what kind of disease treatments were given the green light in the past. I've tried to find but to no avail.
This is of course assuming it passes phase II trials at all. Remember that on average, only 1 out of 6 products successfully passes trials and makes it to the market.
http://www.nature.com/news/2011/110928/full/477526a.html
I think we are putting too much faith into this Phase II trial. I just entered into AM-101 and before I did I contacted lots of people who said they were trial patients in AM-101 or AUT00063. I had one guy respond who completed AUT000063 and he said it did nothing for him. He also added that the staff told him eight others at his hospital had no success either. Keep in mind I don't know if his hospital had only 9 patients, or as the nature of the Internet I cannot verify the facts. However, it would be cruel of someone to lie about a trial. About half of Phase II trials fail so it would not be outside the realm that this fails.
A lot of drugs crash and burn at the trials stage that is true and this one may well do too. The point is that if it doesn't crash and burn chances are it will be pushed to get to market as soon as possible, given the need. But it may also crash and burn even at this stage too. Nothing should be taken for granted with drug R&D and the regulatory processes involved in getting a drug licenced and to market.
As for some people on the trial experiencing no affect from the 'drug' lets keep in mind (as far as I'm aware) this is a randomised, placebo controlled trial and those people may well have got placebo - who knows. The patients certainly won't and the trial nurses/doctors may not either.
Yes we have to be realistic about all the above but I see no harm in being cautiously optimistic either.
As for some people on the trial experiencing no affect from the 'drug' lets keep in mind (as far as I'm aware) this is a randomised, placebo controlled trial and those people may well have got placebo - who knows. The patients certainly won't and the trial nurses/doctors may not either.
Yes we have to be realistic about all the above but I see no harm in being cautiously optimistic either.
I guess it was a placebo hospital...There is no way this drug does nothing for 10 people...look at what Trobalt does and its not even aimed at tinnitus.
blasphemy!! 200 hundred years ago we would burn you at the stake!
no, seems really strange it does nothing for them ... I hope something like `placebo hospital` exists. I don`t know how they do these things but it seems the only plausible answer. We had one woman that had major improvement so that alone means it does something ..
If the phrase "placebo hospital" implies a belief that there are some hospitals who are giving out AUT00063 exclusively and other hospitals who are administering the placebo exclusively, then I think this is most unlikely. I tried unsuccessfully to get on the trial but during the course of my application, I learned enough about the methodology to know that this is not how it works. Autifony assign a number to each participant and then supply the hospital with a course of medication to be given to the patient with that number. The decision about who gets the real stuff and who gets the placebo is taken arbitrarily for each patient number. The doctors who hand over the pills do not know who is getting the real stuff and who is getting the placebo. As far as I understand it, all this is in line with best practice for double-bind randomised clinical trials.
Hi PhilB,
you are absolutely correct - that is exactly how it's done. This ensures there is no bias or skewing of the results and that the results are robust. This type of clinical trial is the 'gold standard' and is used most of the time. Neither the clinicians nor the patients know who got what - so anyone claiming that they know they got the active drug is telling porkies.
you are absolutely correct - that is exactly how it's done. This ensures there is no bias or skewing of the results and that the results are robust. This type of clinical trial is the 'gold standard' and is used most of the time. Neither the clinicians nor the patients know who got what - so anyone claiming that they know they got the active drug is telling porkies.
You have to take everything on the Internet with skepticism. There is no way of verifying what is being posted as being fact. Just the nature of the beast. Ethically, study staff should not be disclosing what other patients experienced. We also don't know how many people actually participated at this hospital. For all we know there could have been 20. It is also not beyond the possibility that someone looking to drive a stock price up could post faulty info.
To be fair, if I was administering the trial I would just say to every nosy patients that no one reported improvement to stop further inquiries. It must really annoy them when people do this.
I would not put much, if any, stake in the second-hand info you received. Afterall, we had a guy here on TT who posted supposed pics of AUT he was taking (claiming it didn't work), and it was nothing more than a generic bottle of vitamins. You could also have a quick conversation with Corrine on her experience...that should make you feel better and more optimistic
No Dan, Autifony is not a misfire at all in fact it's looking very promising so far ! We won't know for sure until the results are out, which is some time off yet, but don't lose heart hun ! x
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