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

[RoadToSilence]

Didn't the preliminary findings on the trials with the rats show that their tinnitus was gone the next day? I'm being pretty hopeful here, but that sounded like great news. Do we really know of anyone that has received the actual medicine and not the placebo?

Yes, the rat study is very encouraging (according to the authors, AUT63 "abolished evidence of tinnitus"). Strange that I am jealous of a rat…

Anyway, there are two TT members who are on the trial - @Hotspur & @chamferman, but no one knows whether they have received the drug or the placebo. They have been posting their progress here https://www.tinnitustalk.com/threads/autifony-phase-ii-trial-participants-experiences.8339/page-2, but there has not been much activity as of late. Any updates guys?

 

[RB2014]

Thanks. That's what I thought. I'm going to go out on a limb here and say that after reading the accounts of both participants that they both got the placebo. One of them was taking the pills at the wrong times and the doctor told him not to worry about it. I'm guessing its because he got the placebo and they knew that it didnt matter when he took the drug. Also it seems like neither of them had any side effects. Thats good news also and supports that they got a placebo. As far as we know the animal models are pretty accurate and if the rats got rid of their tinnitus then it should work for humans also.

 

[Dana]

@RoadToSilence ...."Strange that I'm jealous of a rat".....you lightened my evening with this, LOL

 

[DebInAustralia]

I thought this study was a double blinded study though?

 

[earsnothappy]

I'm kind of surprised that there aren't any other participants on this site. I hope a few more turn up and post about their experiences!

 

[James White]

I'm kind of surprised that there aren't any other participants on this site. I hope a few more turn up and post about their experiences!

Lots of people don't even know what an internet forum is

 

[preslys]

@James White
lots of people avoid searching on internet in order to forget their pain, they try to habituate it.

 

[Jokko]

Anyone know when aut00063 comes out on the market? How many years it takes 10, 100?

 

[Markku]

Anyone know when aut00063 comes out on the market? How many years it takes 10, 100?

Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The early preclinical work looks very positive and exciting but, until we have done this next study in T sufferers 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/

 

[RichL]

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 tells me if it's successful we may see this rushed through quicker than what would be the norm!

One would hope anyway!

 

[lapidus]

One of them was taking the pills at the wrong times and the doctor told him not to worry about it. I'm guessing its because he got the placebo and they knew that it didnt matter when he took the drug.

No, the doctor have no idea either if it's placebo or the real drug. That's what a double blinded study is.

 

[skoupidis]

I take it there will be a phase 3 after the current phase and then it will be released? It could take years. And we don't have a clue if it works at all in humans. Only 2 people posting here? What can I say, if any of them took the real thing it didn't go too well. Lets hope there will be someone else posting here with much better results or else...

 

[RB2014]

I take it there will be a phase 3 after the current phase and then it will be released? It could take years. And we don't have a clue if it works at all in humans. Only 2 people posting here? What can I say, if any of them took the real thing it didn't go too well. Lets hope there will be someone else posting here with much better results or else...

Maybe they could just market it as a vitamin pill and get around all the red tape and start selling it now. I think many of us are at the point where we dont really care what it does we just want to buy some. After spending money on Ginko, Niacin, B12, etc etc, I'll buy a bottle of whatever they have even if it only has a 10 percent chance of working. They could call it, May reduce tinnitus or maybe not. That would still be a lot more honest than some of the other stuff I've seen out there.

 

[Christian78]

No, the doctor have no idea either if it's placebo or the real drug. That's what a double blinded study is.

they could take pill and get sample analised

 

[SteveToHeal]

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.

Awesome!!!

 

[joejunior]

Can Tinnitus Talk write to Autifony, requesting on behalf of its members for an update on progress of the trials, including any preliminary results? The trials have been going on long enough

 

[Markku]

Can Tinnitus Talk write to Autifony, requesting on behalf of its members for an update on progress of the trials, including any preliminary results? The trials have been going on long enough

We are already in contact with them.

Read the Q&A from the below link and if your question is not covered, post it in the thread and we'll try and get it answered. The folks at Autifony are really, really busy but they've been very nice to us. They will answer what they can.

However, the trials haven't really been going on long enough for them to publish any results about it (yet). Some more patience is needed, clinical trials don't work that fast.

https://www.tinnitustalk.com/threads/autifony-q-a.8331/

 

[joejunior]

I think its time for an update then. I don't accept that they are too busy for our questions, on the contrary I think they would welcome them.

BTW I think other institutions and companies should also be asked for a progress report on behalf of TT members.

By sheer weight of numbers, TT has a mandate.
Use it.

 

[Christian78]

I think those activist from animal protection made it impossible to test on monkeys chimpanzee who is just 2% genetically different from us. they should test medicine on mouses and then monkeys to find cure, we are not same as rats and seems that autifony fork perfect on mouse but not on humans. We need to thank to animal activist that they cant test on moneys. Am I wrong?

 

[Stink]

I think those activist from animal protection made it impossible to test on monkeys chimpanzee who is just 2% genetically different from us. they should test medicine on mouses and then monkeys to find cure, we are not same as rats and seems that autifony fork perfect on mouse but not on humans. We need to thank to animal activist that they cant test on moneys. Am I wrong?

you are right animal activists should be blamed! http://en.wikipedia.org/wiki/Animal_testing_on_non-human_primates#Chimpanzees_in_the_U.S.

 

[nills]

I think those activist from animal protection made it impossible to test on monkeys chimpanzee who is just 2% genetically different from us. they should test medicine on mouses and then monkeys to find cure, we are not same as rats and seems that autifony fork perfect on mouse but not on humans. We need to thank to animal activist that they cant test on moneys. Am I wrong?

No one knows yet how it works, so none can say anything about how it seems or assumes or maybe or if it works ... people, please stop assuming things without having the scientific backup - it just gives the wrong message to everyone else and honestly is a waste of time to read these messages ... i`m not interested in what anyone thinks about this medicine, i`m interested if it really works or not. I read to many thoughts on things we don`t know on this forum ... stick to the facts please.

About waiting for the results - millions of people are waiting for results ... thank god these scientists are working on it ... sit back and wait like everyone else. We are not a special group to have first knowledge about these things... we are all tinnitus patients.

 

[joejunior]

Of course we are a special group, being the group that has tinnitus and is most affected by tinnitus.

Tinnitus Talk is missing a trick here - it has an opportunity to become more than a talking shop for tinnitus patients, to be more involved in advocacy and getting information from the various companies and organisations involved.

Sitting back and relaxing coupled with endless speculation is not a good option.

 

[attheedgeofscience]

Tinnitus Talk is missing a trick here - it has an opportunity to become more than a talking shop for tinnitus patients, to be more involved in advocacy and getting information from the various companies and organisations involved.

True. But someone has to actually do the work involved.

And as it happens, I - personally - was the one who "did it" for two companies already:

www.tinnitustalk.com/threads/auris-medical-q-a.8201

www.tinnitustalk.com/threads/otonomy-starting-phase-2-trial-in-2015-for-tinnitus-%E2%80%94-no-limit-on-your-onset.6365/page-3#post-93572

And the reason I did it was because no one else did!

 

[Markku]

Of course we are a special group, being the group that has tinnitus and is most affected by tinnitus.

Tinnitus Talk is missing a trick here - it has an opportunity to become more than a talking shop for tinnitus patients, to be more involved in advocacy and getting information from the various companies and organisations involved.

Sitting back and relaxing coupled with endless speculation is not a good option.

Tell that to @attheedgeofscience and @Zimichael and our other volunteers who have put dozens if not hundreds of hours into the Tinnitus Talk Teams.

What have you done...? Would you like to join one of the teams? There's a thread about it here:

https://www.tinnitustalk.com/threads/tinnitus-talk-teams-—-awareness-research-tech-trobalt.7694/

 

[attheedgeofscience]

Sitting back and relaxing coupled with endless speculation is not a good option.

...which is also why I have been in contact with a key researcher from the trial several times:

As promised, I have attempted to get some answers in relation to the clinical phase II trial of AUT00063. The person I spoke with is the same source as I have used earlier on (but whom I will not disclose the name of in public).

The URL* for the NHS study listing mentions that the first date of enrollment was 29/AUG/2014. This is incorrect. The study has not begun yet (which is also why the 10-12 different study sites have not been published on Autifony's own website). The error will be corrected, I am told.

The clinical trial committee has had to re-visit the option of allowing non-UK nationals to participate. This is no longer an option. The decision was apparently based on external consultant advice.

The person I spoke with does not believe that the real drug will be offered post clinical trial in the event that a participant receives the placebo. The reason is that there is not enough evidence - yet - to suggest if the drug works or not (no surprise there since this is a phase IIa trial evaluating efficacy).

The person I spoke with says it is not known if the drug will be curative or not (ie. whether a one-off course or continuous life-long therapy is required). That's what the whole clinical trial is there to answer - in part.


http://www.nhs.uk/Conditions/Tinnit...7-GB&Condition=Tinnitus~quiet&pn=1&Rec=0&CT=0

 

[attheedgeofscience]

The trials have been going on long enough

See this:

https://www.tinnitustalk.com/thread...ing-loss-and-tinnitus.6516/page-26#post-85104

 

[RichL]

No one knows yet how it works, so none can say anything about how it seems or assumes or maybe or if it works ... people, please stop assuming things without having the scientific backup - it just gives the wrong message to everyone else and honestly is a waste of time to read these messages ... i`m not interested in what anyone thinks about this medicine, i`m interested if it really works or not. I read to many thoughts on things we don`t know on this forum ... stick to the facts please.

Totally agree @nills , but unfortunately I think your wasting your time trying to stop members doing this as I have pleaded the same thing on previous pages and still members are putting unsubstantiated thoughts into posts and pushing reply!

Please stop this people!!

 

[Danny Boy]

So Autifony's new drug is useless? Why don't just improve on trobalt?

 

[Pilot]

My mother has an appointment in Tampa, FL in the next 2 weeks to enter the autifony study for age related hearing loss. This is probably a screening, but she seems to fit all there criteria so I hope she is entered into the program. She does seem to have difficulty hearing someone in a noisy environment, but more importantly she has had tinnitus for 30 years. Her tinnitus started when she was taking aspirin for 2 years straight for sciatica pain, but it could have another cause. She says it gets louder based on the weather, humid days it gets louder, she isn't hindered by it though. If she starts taking the drug/placebo then I will keep in touch with her and relay her thoughts.

 

[RichL]

So Autifony's new drug is useless? Why don't just improve on trobalt?

@Danny Boy , Please bro, their is no need for post's like this, we just have to be patient, it is far too early to say either way!