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

[Markku]

BUT can anyone offer me a place to stay in England?

Your request deserves its own thread (more eyes will see it too), please start a new one in here:
https://www.tinnitustalk.com/forums/support.2/

 

[Rube]

@SteveToHeal

Out of interest, please say which site you called?
How will you get over the fact that you are not registered with a GP? Your T is not registered in UK. Or you can register and say that it is new maybe but that would not be fair. Or you can say that you have it since july but never sought medical help. Where will you have your hearing tests to show them....unless they remove this criteria then maybe ....they will probably do one wont they? to check?

By the time that is done will the 10 for each hospital already be filled from their ENT depts?
After all you have to get to UK, register with a doctor (which is quite easy and possible to do once you get past the long line of eastern europeans) and then apply afresh with your gp's request.
By the time you get a docs appt it may already be too late....unless you are flying over now?
I for sure would like to get onto it but is it possible?

@Danny Boy
They said that they will take people up to 12 months and only if they dont have enough people they will look at taking people 12 to 18 months.
Seems to me that this is already tied up...?

To everyone: by the way, it appears that Birmingham hospital did not know that their phone etc....is up on autifony site now.
Does not sound like it is really organised properly after all the faffing around for ages now....

Just phoned wigan.
1. 6 - 12 months and up to 18 months - no cut off at 12 months
2. Must be referred by GP or show have had appts at ENT in the area of hospital.
3. If referral only by GP but no ENT diagnosis then must attend an appt at ENT clinic first within the hospital
4. after ENT if it was necessary and successfully passed then follows
only 3 visits
first one is screening incl blood test and hearing test. This hearing test consists of checking db loss across whole range of Khz including from lowest up to 10 or 12 Khz. Then they take an average db loss from all that data - so if you have hearing loss at different kHz then this is averaged out to see if you fit the criteria for hearing loss. Blood tests results after 2 or 3 days.
2nd visit is first tablet and stay for one and a half hours then go home
fill in diary every day
3rd visit is to return on day 28 to take the last pill and hand in diary.
that is it
they confirmed that no side effects.
they said that even if they surpass the alloted number of people , if the person fits the criteria then they will take them as that is a good thing and the more the merrier. They said that they are open for these trials till May 2015 and that it has already been running for about a month. Cannot apply until you have had T for at least six months So it seems that the trials have already started and are currently ongoing.....and started already whilst we were waiting for info on the autifony site. So they did start in October and enrolment did start back in August 2014....guess from the patients already at the ENT depts at the hospitals.
Maybe they were looking to see if they had sufficient from the ENT depts OR they now want a much larger number of people to take part.
The impression I got was that certainly for Wigan there is no cut off number

@SteveToHeal

Out of curiosity as we are in the same boat - UK citizens but not curently in the UK

Did you tell them that you are outside UK at the moment and was this then not a problem as you are UK citizen
OR did you not mention that you are not in UK?
Cos you said that they are posting to your sister the info so it sounded like you told them that you are in USA currently.
In that case, what did they say to you re being with a GP for a referral?
thanks for letting me know

@amandine can you elaborate on where you said they confirmed no side effects? What did they base that statement on?

 

[SteveToHeal]

@amandine can you elaborate on where you said they confirmed no side effects? What did they base that statement on?

The guy I spoke to in Newcastle also said phase 1 had no side affects. So safety is ruled out. Brave people stepping in for that phase!!

 

[Rube]

The guy I spoke to in Newcastle also said phase 1 had no side affects. So safety is ruled out. Brave people stepping in for that phase!!

That's great news. Thanks Steve!
This drug is sounding better and better.

 

[Zimichael]

4. after ENT if it was necessary and successfully passed then follows
only 3 visits
first one is screening incl blood test and hearing test. This hearing test consists of checking db loss across whole range of Khz including from lowest up to 10 or 12 Khz. Then they take an average db loss from all that data - so if you have hearing loss at different kHz then this is averaged out to see if you fit the criteria for hearing loss. Blood tests results after 2 or 3 days.
2nd visit is first tablet and stay for one and a half hours then go home
fill in diary every day
3rd visit is to return on day 28 to take the last pill and hand in diary.
that is it
they confirmed that no side effects.

CLARIFICATION PLEASE! From anyone... Am I missing something super basic here??? Amandine, a possible implication from what you wrote is that there is a total of two pills of AUT00063!!!??? Or are you saying that they send you home after the first pill with 26 more, then you complete the last pill in front of them??? [Atavistic ceremonial tendencies perhaps?!]. Or indeed, you take the total of two pills in front of them?

You can see why I am asking...Two pills v. 28 pills is a galactic leap!...And has major ramifications for our ongoing "Kv" and Retigabine discussion.

Thanks, Zimichael

 

[Rube]

CLARIFICATION PLEASE! From anyone... Am I missing something super basic here??? Amandine, a possible implication from what you wrote is that there is a total of two pills of AUT00063!!!??? Or are you saying that they send you home after the first pill with 26 more, then you complete the last pill in front of them??? [Atavistic ceremonial tendencies perhaps?!]. Or indeed, you take the total of two pills in front of them?

You can see why I am asking...Two pills v. 28 pills is a galactic leap!...And has major ramifications for our ongoing "Kv" and Retigabine discussion.

Thanks, Zimichael

From the autifony website:
AUT00063 is an orally active preparation that will be taken as 4 capsules once daily with food, for a period of 4 weeks

 

[attheedgeofscience]

So safety is ruled out.

...Or "ruled in".

 

[amandine]

@Zimichael
Yes you are correct and I wrote that badly.
Just to clarify and apologise for my clumsily written post.
Yes indeed it is one pill a day for 28 days @ 800mg per pill daily.

First pill is taken at the hospital. Then a stay of an hour and half to make sure you are ok and then you leave.
So, as @attheedgeofscience said above, there may indeed be safety issues which is why you stay an hour and a half after the first pill. Who knows. Probably just precautioinary. If there were real bad side effects then I doubt very much that they would let you go home with the pills. However with the state of the underfunded NHS these days well who knows. However I doubt that they are in the business of handing out pills with bad side effects and then let you go home with them. Again who knows but conjecture and common sense tells me that this wouldnt happen. I feel from what I have read and asked and after today that the drug is safe to take.

On the contrary though, I would like to remind people of trials that have gone horribly wrong even though it was stated that the drug was safe. I remember an incident quite a while back now...2 chaps healthy went in to test a drug (cant remember for which ailment now). The drug was presumed harmless and they were trialling healthy individuals and paying them to do the trial. One of the men I believe was a student and needed extra cash.
Anyhow, to bring the story short, they both ended up in a terrible state, paralysed and had to have amputations etc....dont want to scare people but just bring us back to the reality that these are trials and things can and do sometimes sadly go wrong.
However yes the drugs which are said to be ok and thoroughly tested can still have devastating effects on our minds and / or our bodies too.

Anyhow to resume, after you take your first pill in the hospital , you then go home with 26 pills and a diary. You need to take the one pill daily and to complete the diary.

On day 28 you return to the hospital and take the 28th pill in hospital with hospital staff.
A further wait of one and a half hours apparantly and then you can go.

50 per cent chance placebo.
Safety issues were studied in phase 1 and at wigan yoday they told me that it is utterly safe to take according to phase 1 - who knows?

However, there is something that i did not mention in my previous posts.
I asked at wigan whether their data shows that this autifony drug eliminates T or reduces T. And what about the 4 week trial and no follow up drug?
I was told that they dont believe it will eliminate the T - this is an important point I think - but they believe that it will reduce T volume / loudness / intrusiveness.

So in effect it appears less effective than trobalt/potiga/retigabene or whatever it may be called in your country.

But equal to am-101 expectancies - reduce up to 50 per cent the T.

And will do so with 4 weeks of drugs regardless of their being no follow up drug to take unlike in am-101 where everyone gets a chance to get the real drug x 3 times too. But sadly yes injections. So far not really brilliant reports coming out of am-101 plus chance of 10 per cent hearing loss, worsening condition...

So there is the choice on offer at the moment....
not exactly great is it but at least it is something
and if something is all we have, then i guess we need to embrace it with both hands....gratefully.

 

[OnceUponaTime]

This is all new to me and very exciting. I never hear about Autifony Phase 1 before. What was the result of Phase 1? I rather wait a year praying and hoping than knowing/thinking no one is doing anything about it. I can only hope it will also help people that have been suffering for many years. Best wishes.

 

[RCP1]

@amandine

Hi Amandine. Do you have to be UK resident to take part?

Cheers

R

 

[lapidus]

I asked at wigan whether their data shows that this autifony drug eliminates T or reduces T. And what about the 4 week trial and no follow up drug?
I was told that they dont believe it will eliminate the T - this is an important point I think - but they believe that it will reduce T volume / loudness / intrusiveness.

Why would the people at the medical center in Wigan have "data" or any type of insight at all about the drug's efficacy?

 

[rtwombly]

Why would the people at the medical center in Wigan have "data" or any type of insight at all about the drug's efficacy?

lapidus is right. They don't have any data. That's the point of a phase II trial. Phase one safety, phase two efficacy. They're reasonably sure the drug is safe. That's all they know. If it is effective, it should be comparable to retigabine, hopefully better.

And just for accuracy, it's four 200mg pills a day, taken at the same time. Not just one pill.

 

[amandine]

@RCP1

Do you have to be UK resident to take part?

As far as I know yes. Well maybe the criteria is this - you must be registered with a GP. You must have an NI number. You must speak english. Of course maybe you can be egyptian living in china and still qualify. I think it is cos you need to be registered at a GP (who provides the referral) giving you residency and have an NI number which gives you the residency again so maybe this is more important than the citizen aspect of it - so maybe England resident. By the way I am not sure if they will have study sites outside of England....another few sites to be posted yet...

@lapidus

Why would the people at the medical center in Wigan have "data" or any type of insight at all about the drug's efficacy?

All I know is that I spoke with the woman at Wigan Hospital currently involved with the trials. She is in charge of them there. What I have written is what she said to me. The conclusions I leave up to you....

 

[amandine]

@rtwombly

And just for accuracy, it's four 200mg pills a day, taken at the same time. Not just one pill.

There you go!! See - you must be right. I dont know. She told me one pill a day x 28.
Thats what she said to me in english.
So i understood her fine.
So she doesnt know what she is talking about then?
ok...fair enough

 

[attheedgeofscience]

Yes indeed it is one pill a day

I have previously been in contact with a source from the clinical trial (twice) and shared the feedback from that. I did not enquire about dosage protocols as those were already posted on the informationally limited Autifony homepage:

"A. AUT00063 is an orally active preparation that will be taken as 4 capsules once daily with food, for a period of 4 weeks."

The homepage mentions 4 capsules per day. This conflicts with your own statement.

I briefly looked at a couple of other posts above, and also in one instance there seems to be a discrepancy between inclusion criteria for onset of tinnitus vs. that which is mentioned on the NHS-homepage (ie. 6-12-18 months criteria).

At the end of the day, it does not really matter to myself, I am just slightly surprised to see the discrepancies. Not to mention the delay of the clinical trial itself. Running a small clinical trial involving an oral preparation should be a "piece of cake". Compare this to clinical trials that are double blind and involving surgery such as AM101 or more advanced studies - also double blind - involving stem cells. Now there's a challenge in terms of preparations!

I would have contacted Autifony in a more "strict" manner than I did earlier on this Summer, but since they are a non-publicly listed company, they are not really under any obligation to meet anyone's demands.

I wish Autifony, and anyone who participates in the trial, all the best.

 

[attheedgeofscience]

And just for accuracy, it's four 200mg pills a day, taken at the same time. Not just one pill.

The homepage mentions 4 capsules per day. This conflicts with your own statement.

I see my question (in my own post above) has already been asked while I was typing my response.

Sorry about that.

 

[amandine]

@rtwombly

just thinking about this. She said take the pill and then she said take 26 pills home with you and return on the 28th day to take the final pill at the hospital.
Maybe she was just speaking in quick terms - meaning the four pills but just saying take the pill and 26 pills going home meaning 26 doses equalling 114 pills.
She has been working with the trial a month already. Would have thought she would know something.....?
I dont know - I am reporting what she said. Firstly it is not good if the staff dont know what they are talking about. Secondly how do we know then that we can trust the info that we get from other sites then like Manchester already called today along with Newcastle and Wigan.....?

 

[valeri]

Lot of grey area with this trial, and it shouldn't be like that at all

 

[dan]

Lot of grey area with this trial, and it shouldn't be like that at all

I agree, I also see it suspicious that a trial center would make any statement regarding the drug's efficacy- is it not against trial rules to disclose expected results for the drug?
Am I missing something here?
I mean this might affect the placebo effect or whatever.

 

[Rube]

I agree, I also see it suspicious that a trial center would make any statement regarding the drug's efficacy- is it not against trial rules to disclose expected results for the drug?
Am I missing something here?
I mean this might affect the placebo effect or whatever.

Same grey area when I was considering am101. The woman conducting the trial at one test center told me it works great, another ENT at a different test center said it wasn't showing promising results. One test center was strict with less than 3 months since onset another wasn't. So this doesn't surprise me at all.

 

[dan]

Same grey area when I was considering am101. The woman conducting the trial at one test center told me it works great, another ENT at a different test center said it wasn't showing promising results. One test center was strict with less than 3 months since onset another wasn't. So this doesn't surprise me at all.

aha , I understanad.....sort of

 

[amandine]

@attheedgeofscience

Sorry i saw your post after i posted.
Not much more to add though on this.......but thank you for pointing out the four pills a day thing.
Yes it does look like it has taken ages to bring this to trial.
The wigan centre told me that they have been running the trial for over a month now. So they did start in October. and must have recruited back in august from the ent dept.

 

[Rube]

@attheedgeofscience

Sorry i saw your post after i posted.
Not much more to add though on this.......but thank you for pointing out the four pills a day thing.
Yes it does look like it has taken ages to bring this to trial.
The wigan centre told me that they have been running the trial for over a month now. So they did start in October. and must have recruited back in august from the ent dept.

If they started in October then they were right on time as that's when autifony was expecting to start. That's good in my opinion, shows they are committed to moving this forward.
Additionally I don't believe the test centers talk to each other so we're hearing each centers different opinions. I'm waiting for actual results if some members manage to get in the trials.

 

[attheedgeofscience]

The wigan centre told me that they have been running the trial for over a month now. So they did start in October. and must have recruited back in august from the ent dept.

Possibly.

But I am still confused/surprised that the Autifony homepage has only very recently been updated with the clinical trial sites - if indeed the clinical trial itself has been in progress for a month (which I know is not the case - at least not for all sites, 100% guaranteed).

And if they have already been at it for a month now (at Wigan) they should be pretty much done with recruitment at this point with just 10 spots to fill (give or take).

Anyway... Enough about all that.

 

[amandine]

@attheedgeofscience

at Wigan) they should be pretty much done with recruitment at this point with just 10 spots to fill (give or take).

At Wigan she told me that they were definitely not stopping at 10 places.

That was Manchester I think who said 10 places and maybe Birmingham as well...

 

[Danny Boy]

@Zimichael
Yes you are correct and I wrote that badly.
Just to clarify and apologise for my clumsily written post.
Yes indeed it is one pill a day for 28 days @ 800mg per pill daily.

First pill is taken at the hospital. Then a stay of an hour and half to make sure you are ok and then you leave.
So, as @attheedgeofscience said above, there may indeed be safety issues which is why you stay an hour and a half after the first pill. Who knows. Probably just precautioinary. If there were real bad side effects then I doubt very much that they would let you go home with the pills. However with the state of the underfunded NHS these days well who knows. However I doubt that they are in the business of handing out pills with bad side effects and then let you go home with them. Again who knows but conjecture and common sense tells me that this wouldnt happen. I feel from what I have read and asked and after today that the drug is safe to take.

On the contrary though, I would like to remind people of trials that have gone horribly wrong even though it was stated that the drug was safe. I remember an incident quite a while back now...2 chaps healthy went in to test a drug (cant remember for which ailment now). The drug was presumed harmless and they were trialling healthy individuals and paying them to do the trial. One of the men I believe was a student and needed extra cash.
Anyhow, to bring the story short, they both ended up in a terrible state, paralysed and had to have amputations etc....dont want to scare people but just bring us back to the reality that these are trials and things can and do sometimes sadly go wrong.
However yes the drugs which are said to be ok and thoroughly tested can still have devastating effects on our minds and / or our bodies too.

Anyhow to resume, after you take your first pill in the hospital , you then go home with 26 pills and a diary. You need to take the one pill daily and to complete the diary.

On day 28 you return to the hospital and take the 28th pill in hospital with hospital staff.
A further wait of one and a half hours apparantly and then you can go.

50 per cent chance placebo.
Safety issues were studied in phase 1 and at wigan yoday they told me that it is utterly safe to take according to phase 1 - who knows?

However, there is something that i did not mention in my previous posts.
I asked at wigan whether their data shows that this autifony drug eliminates T or reduces T. And what about the 4 week trial and no follow up drug?
I was told that they dont believe it will eliminate the T - this is an important point I think - but they believe that it will reduce T volume / loudness / intrusiveness.

So in effect it appears less effective than trobalt/potiga/retigabene or whatever it may be called in your country.

But equal to am-101 expectancies - reduce up to 50 per cent the T.

And will do so with 4 weeks of drugs regardless of their being no follow up drug to take unlike in am-101 where everyone gets a chance to get the real drug x 3 times too. But sadly yes injections. So far not really brilliant reports coming out of am-101 plus chance of 10 per cent hearing loss, worsening condition...

So there is the choice on offer at the moment....
not exactly great is it but at least it is something
and if something is all we have, then i guess we need to embrace it with both hands....gratefully.

I can believe that it wouldn't be as effective as trobalt, as Autifony will want people to be on their drug for life as there's more money in it...If that is true, trobalt may be the actual cure as opposed to this.

 

[rtwombly]

I can believe that it wouldn't be as effective as trobalt, as Autifony will want people to be on their drug for life as there's more money in it...If that is true, trobalt may be the actual cure as opposed to this.

That doesn't make economic sense. If people hear there is a cure for tinnitus, they will flock to the pharmacy for this pill. If people hear that there is a new treatment, but you have to stay on it for life, lots of people will decide to keep "living with it". Plus, people aren't going to stop developing new cases because there is a cure, if anything they'll get sloppier about noise protection and there will be more new cases than ever. There are plenty of new and recurrent cases every year to keep Autifony in the black for decades.

 

[valeri]

I agree, I also see it suspicious that a trial center would make any statement regarding the drug's efficacy- is it not against trial rules to disclose expected results for the drug?
Am I missing something here?
I mean this might affect the placebo effect or whatever.

Agree, very unusual that they would disclose results to a random person over the phone.
But.... on the other hand it's promising if it has been found that this drug reduces the volume, that's brilliant in my opinion!
So they have either started the trial and have some promising results or they don't know what they're talking about at all.
Anything is possible!

It would be good if another TT member from UK can ring the same hospital and see what answers we get this time!

 

[dan]

Apparently they have begun the trial a month ago.

 

[SteveToHeal]

Then why only 28 days if you have to stay on it for life? I am hoping it is a once-off reducer/cure and that it is permanent. Similar to Mpt's experience of Retgabine without the side effects.

Would they have a trial that showed a reduction in t volume and annoyance, just for it to come back once the participant stopped the drug? Perhaps. It would be recurring revenue but as rtwombly says above, unless hearing protection starts gaining the same public awareness as having safe sex, there will be enough t cases to treat with once off pills. So either way they win. Maybe just not as much on the recurring plan.

I'd take a pill a day to get rid of t or at least lower it to a point where i could function again. With no side affects. Without question.

Re the trial: It would be torture for any participant if recurring was the case but i guess Autifony can do what they like to prove the drugs efficacy. It would really suck though i you did get the real pill, get a t reduction, have it come back after the trial and then have to wait for phase 3 and pray you got on that one to get your t down for another month and then wait some more for it to hit market.

Yes ateos, safety ruled out/in , get the picture --> No safety concerns in phase 1 is what i meant.