Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
A new drug that could help reduce the horrific symptoms of tinnitus is set to run further trials at two Greater Manchester hospitals.
Salford Royal Hospital and Wrightington Hospital in Wigan will be running the QUIET-1 study, comparing the effect of the new AUT00063 drug to a placebo (dummy drug) after four weeks of treatment.
Tinnitus is the perception of a noise being heard in the head and/or ears and is commonly explained as a ringing sound, but can be all sorts of noises at different levels.
Manchester resident Campbell Robertson, 73, has suffered from the condition for six years and only found out he had the condition, which he was unaware existed, after being diagnosed by a doctor.
"Some sufferers still don't know what it is and assume it is normal," he said.
"GP's don't like it because there's nothing at the moment that can be done in terms of prescriptions or consultations – there's no cure."
"I know people who have got it much worse than mine – people who have noises like using an electric drill that goes on and on.
"The ones with the louder noises suffer most, it is certainly something that has driven people to suicide in the past."
Approximately 10% of the UK adult population have or experience tinnitus – equating to around 6.3 million people in the UK – which is commonly caused by working in noisy working environments.
AUT00063 has completed an initial "Phase I" safety trial and was well tolerated in young and older healthy volunteers with no serious adverse effects being noted.
The drug is an orally active preparation that will be taken as 4 capsules once daily with food, for a period of 4 weeks.
Both hospitals are now calling for people under 18 years old who have had continual tinnitus for more than 6 months but less than 18 months to take part in the clinical study.
Earlier this week, the British Tinnitus Association told MM that people should change their 'flippant' attitudes towards the incurable condition, which can lead to sleeplessness, distress and even suicide.
"Tinnitus is perhaps not taken seriously by those who haven't experienced it, but that may be because they don't know what it is and what it's like to have it," said projects manager Emily Broomhead.
"Sometimes people are quite flippant with health issues until they actually go through it – thinking it won't happen to them – but tinnitus is so common in all age ranges.
"It's vital that more people are made aware of the damage that can be caused by just listening to music too loudly or by not protecting their ears when they are using noisy equipment."
The QUIET-1 study will be conducted at a number of sites in the UK and more information on the study can be found by clicking here.
http://www.mancunianmatters.co.uk/c...-reduce-horrific-symptoms-tinnitus-drug-trial
Salford Royal Hospital and Wrightington Hospital in Wigan will be running the QUIET-1 study, comparing the effect of the new AUT00063 drug to a placebo (dummy drug) after four weeks of treatment.
Tinnitus is the perception of a noise being heard in the head and/or ears and is commonly explained as a ringing sound, but can be all sorts of noises at different levels.
Manchester resident Campbell Robertson, 73, has suffered from the condition for six years and only found out he had the condition, which he was unaware existed, after being diagnosed by a doctor.
"Some sufferers still don't know what it is and assume it is normal," he said.
"GP's don't like it because there's nothing at the moment that can be done in terms of prescriptions or consultations – there's no cure."
"I know people who have got it much worse than mine – people who have noises like using an electric drill that goes on and on.
"The ones with the louder noises suffer most, it is certainly something that has driven people to suicide in the past."
Approximately 10% of the UK adult population have or experience tinnitus – equating to around 6.3 million people in the UK – which is commonly caused by working in noisy working environments.
AUT00063 has completed an initial "Phase I" safety trial and was well tolerated in young and older healthy volunteers with no serious adverse effects being noted.
The drug is an orally active preparation that will be taken as 4 capsules once daily with food, for a period of 4 weeks.
Both hospitals are now calling for people under 18 years old who have had continual tinnitus for more than 6 months but less than 18 months to take part in the clinical study.
Earlier this week, the British Tinnitus Association told MM that people should change their 'flippant' attitudes towards the incurable condition, which can lead to sleeplessness, distress and even suicide.
"Tinnitus is perhaps not taken seriously by those who haven't experienced it, but that may be because they don't know what it is and what it's like to have it," said projects manager Emily Broomhead.
"Sometimes people are quite flippant with health issues until they actually go through it – thinking it won't happen to them – but tinnitus is so common in all age ranges.
"It's vital that more people are made aware of the damage that can be caused by just listening to music too loudly or by not protecting their ears when they are using noisy equipment."
The QUIET-1 study will be conducted at a number of sites in the UK and more information on the study can be found by clicking here.
http://www.mancunianmatters.co.uk/c...-reduce-horrific-symptoms-tinnitus-drug-trial
Member"AUT00063 has completed an initial "Phase I" safety trial and was well tolerated in young and older healthy volunteers with no serious adverse effects being noted." This is all well and good, although, from Phase 1 and Phase 2 we have heard absolutely no one quoting any success. I find this very strange, as I'm sure that someone somehow that trialled this drug would have leaked out their success. Sorry to sound negative, sincerely hope I'm wrong.
Hello all, I'm very new to this web site. From everything I've read, you guys all seem to be very helpful, supportive and knowledgeable.
I have had tinnitus (stress induced) in a very mild and unobtrusive form for the past 7 years, and have never had any trouble with loud music/noises. However, a few months ago I went to a very loud gig (for those of you that live in London, don't go to Oval Space without earplugs!), which increased my tinnitus to a level which is no longer manageable for me. Sleeping is difficult, and life is not a pleasant experience when I am in a quiet room or can still hear it while watching TV.
Reading about trials like this has given me some degree of hope that there could be a possible solution to lessening the intensity of tinnitus. Please forgive my relative ignorance in this area, but my question to you guys is – do you believe this trial is likely to work? Or is this trial just one of many which have come and gone, in which every time one like it comes around people cling onto with a hope that it could be the cure for them?
I certainly do not want to put any sort of downer on the trial (I think it looks really groundbreaking and promising), I just merely want to view this with the best realism I can, and not get my hopes up for something that could just end up being one of many fallen hopes.
Many thanks all and have a nice weekend!
R
I have had tinnitus (stress induced) in a very mild and unobtrusive form for the past 7 years, and have never had any trouble with loud music/noises. However, a few months ago I went to a very loud gig (for those of you that live in London, don't go to Oval Space without earplugs!), which increased my tinnitus to a level which is no longer manageable for me. Sleeping is difficult, and life is not a pleasant experience when I am in a quiet room or can still hear it while watching TV.
Reading about trials like this has given me some degree of hope that there could be a possible solution to lessening the intensity of tinnitus. Please forgive my relative ignorance in this area, but my question to you guys is – do you believe this trial is likely to work? Or is this trial just one of many which have come and gone, in which every time one like it comes around people cling onto with a hope that it could be the cure for them?
I certainly do not want to put any sort of downer on the trial (I think it looks really groundbreaking and promising), I just merely want to view this with the best realism I can, and not get my hopes up for something that could just end up being one of many fallen hopes.
Many thanks all and have a nice weekend!
R
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Phase I = healthy volunteers (in most cases, and in this case, also). Success is therefore not measured in terms of efficacy, but in terms of safety.
Phase II = small scale clinical trial for patients with a pathological condition (in this case, tinnitus). I have spoken and corresponded several times with a researcher from the trial (that information has already been released, and so I will not begin quoting it again). The trial is on-going and did not start until around x'mas time (despite apparent incorrect information to the contrary i.e. that it started in October, for instance). Researchers as well as the folks behind Autifony are (very) unlikely to start releasing efficacy data prematurely. I have just checked my financial sources on the clinical trial, and this is the most up-to-date information I have:
"Phase IIa data (year end 2015); Complete enrollment Phase IIa (mid-2015); Phase IIa final data (1Q16)"
I fully understand that members on this board are interested in the results, but if you (and others) really want to get somewhere with this (i.e. get info before end of 2015), then I suggest you become part of Team Awareness and start following up on "leads" with the clinical trial centres, directly. This is the only way to get information, reliably. This is how I have developed contacts with researchers which has - since - proven very beneficial.
You can get leads with clinical trial folks (i.e. the ones who actually carry out the trial). Sometimes they are helpful, other times they may not be - it's a bit of trial and error (that's why this kind of investigative work takes some perseverance, but it is very rewarding when you succeed).
attheedgeofscience
27/MAR/2015.
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
On the end as said before it will take them into next year to publish weak results
why those inventor invent some implants.
it makes me sad
and same in english? HOW CAN YOU KNOW IF THE RESULTS WILL BE WEAK. ARE YOU AN ALL KNOWING GOD?On the end as said before it will take them into next year to publish weak results
why those inventor invent some implants.
it makes me sad
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
Not at all, but is fi you monitor their progress you might understand they never fulfill there is promises except take money grants. I wish I am very in mistake but you dont need to yell. I know it probably hurt you to think something will be of Aut063. Well I spoke with dr Charles Large and he told me it may take long time for twitching medicine. That saying can be now or never or in 20 years effective 30%...
I spoke with dr Large and if you know they said last year results will be 1Q2013, and start of phase 2 end of summer, what happen result came out and of summer and start was in december, and we will find about results maybe this year....
Before screening start being realistic that you have crippling disease that has high possibility to stay with you until end of your life or some minim 10-15 years. Accept that as possibility. I relly hope they ficx it now and we fasttrack it and i pray that miracle happen but me who have really severe tinnitus, that from start has progressively got worsen 2 ties, once was lyrica/iboprufen other time simple injection of corticosteroids. I know and accept i have progressive severe reactive tinnitus and I may be living my last days because if i get sick or get accident and have to have surgery or some infection it will worsen to up the limit of tolerance.
I accept that life as it was ended, my university lost, i live like mouse rat in a hole...
MY progressive reactive tinnitus is terrible and i had to accept it is the way it is even if i get little help reduce it 30% next medicine poisoning can make it 50% more as it does every few months so I accepted my cripling condition that is permanent and it took my life and I made peace with it, I live as i can.
MAYBE YOU SHOULD UNDERSTAND THAT MIRACLES DON'T EXIST AND PREPARE YOURSELF BY ACCEPTING WHAT YOU HAVE AND WHAT YOU LOST FOREVER AND LIVE YOUR LIFE IN REALITY. IF MIRACLE COMES GOOD.
I wish tomorrow they come out and say autifony fixed people with tinnitus, chances are slim, i am realistic, company is smelly and well ... nothing... be realistic only... false hope can me more hurting.
Dubbyaman
Member
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
How can the results be available the year before you spoke with him? Makes no sense.
For God's sake, this is a trial.
Definition of TRIAL!
.a formal examination of evidence by a judge, typically before a jury, in order to decide guilt in a case of criminal or civil proceedings.
.a test of the performance, qualities, or suitability of someone or something.
.test (something, especially a new product) to assess its suitability or performance.
The last definition is the one that is relevant in this case.
For a start, they have calculated the dosage and time for the medication to have affect, that is why this is called a trial, they might find after the trial has concluded, that the dosage and length of time medicated isn't working like it should.
If this is the case, they will recalculate the dosage and, or, time on said dosage and then have another trial which could very well take another year to run.
Their are so much variables to trials, this is the very reason it can take up to 5 odd years to get it right, so I implore members to be patient and stop clogging the thread with pointless whinging and fact less opinions that are not justified and are born of ignorance!
Definition of TRIAL!
.a formal examination of evidence by a judge, typically before a jury, in order to decide guilt in a case of criminal or civil proceedings.
.a test of the performance, qualities, or suitability of someone or something.
.test (something, especially a new product) to assess its suitability or performance.
The last definition is the one that is relevant in this case.
For a start, they have calculated the dosage and time for the medication to have affect, that is why this is called a trial, they might find after the trial has concluded, that the dosage and length of time medicated isn't working like it should.
If this is the case, they will recalculate the dosage and, or, time on said dosage and then have another trial which could very well take another year to run.
Their are so much variables to trials, this is the very reason it can take up to 5 odd years to get it right, so I implore members to be patient and stop clogging the thread with pointless whinging and fact less opinions that are not justified and are born of ignorance!
Its a good working assumption that Autifony drug will not work. If it does work its a bonus.
Endless speculation as to who what why mechanisms , there is no one here who appears to have beyond a superficial knowledge and forgive me for saying this but most are simply ignorant when it comes to discussing experimental science. It seems that TT forums are full of endless speculation.
Rather than putting all our eggs in one basket TT should be lobbying govts for increased funding for research. I have said this before and will repeat it ad nauseum.
Endless speculation as to who what why mechanisms , there is no one here who appears to have beyond a superficial knowledge and forgive me for saying this but most are simply ignorant when it comes to discussing experimental science. It seems that TT forums are full of endless speculation.
Rather than putting all our eggs in one basket TT should be lobbying govts for increased funding for research. I have said this before and will repeat it ad nauseum.
I agree that it is but, there is also a good few here that do understand the mechanisms and the science, hence the reason I for one, am imploring certain members from cluttering up the thread by paranoid speculation and unfounded opinions!
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
well use brain it was about phase one and they lied, they gave in 3Q, phase 1
Autifony drug has potential
http://www.autifonytherapeutics.com/publications/Turneretal2013-TRI_final.pdf
If, by year end results are not up to the expected goals, adjustments in dose and duration will be made. Until they get it right. That's it.
The rest is speculation and has no real value at the moment.
http://www.autifonytherapeutics.com/publications/Turneretal2013-TRI_final.pdf
If, by year end results are not up to the expected goals, adjustments in dose and duration will be made. Until they get it right. That's it.
The rest is speculation and has no real value at the moment.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
True. But also rather self-evident at this point in time: a drug would never make it past the preclinical stage if it hadn't shown promise in the animal-models.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Basically, you decide within yourself that:
A gentle reminder to everyone considering joining a team: don't join teams if you are not willing to make a commitment.
Calories
Member
- Mar 30, 2015
- 35
- Tinnitus Since
- March 2015
- Cause of Tinnitus
- B12 Difficiency, Possibly salycilic poising from fenugreek and ginger
No one knows for sure. It needs to work first. End of this year 1stQ of next year we will know if it works and what the next step is. It will take several years atleast.
About 50 M USD were invested into AM-101 and the results confirmed the drug failed.
Let's face it Am-101 is delivered in a intra-tympanic way, which is an uncalibrated way, and the drug wasn't specific enough to target the root cause of tinnitus.
Now they're talking about micro-pumps and the trials for those start within 3 years, with better drugs on the way.
This is a whole different ball game with Autifony. It bypasses the inner ear and goes straight into the central pathways. If they get it right, investment should flow in, fast I hope.
Let's face it Am-101 is delivered in a intra-tympanic way, which is an uncalibrated way, and the drug wasn't specific enough to target the root cause of tinnitus.
Now they're talking about micro-pumps and the trials for those start within 3 years, with better drugs on the way.
This is a whole different ball game with Autifony. It bypasses the inner ear and goes straight into the central pathways. If they get it right, investment should flow in, fast I hope.
What a damnass decided to invest this much money?
Doesn't he/she know it's the brain that needs to be treated?
What a waste of money!!!
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Could you quote a source of this information? That is a pretty bold statement to make (without a source ) - I trust you would agree.
Here is a some info I have (easily available):
Log in or register to get the full forum benefits!
Similar threads
