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

#3,091
Tinnitus Talk said:
Important Update on Autifony QUIET-1 Study

Statement from Autifony

Please find attached statement following the interim review of our QUIET clinical trial. We are all really disappointed, particularly on behalf of all the people with tinnitus for whom we hoped this could be an effective treatment. However, we are very grateful for all the support that we have received from everyone, and especially the volunteers who participated in our trial.

We can't say anything more until we have done the analysis of all the data generated by the trial, which will take a while. We hope that what we learn from the data will be of use to the tinnitus research community.
Click to expand...

Hope is lost..

I really, really hope someone else picks up on this, considering the succes some tinnitus sufferes have had with trobalt and other potassium channel modulators
 
#3,093
Tinnitus Talk said:
Important Update on Autifony QUIET-1 Study

Statement from Autifony

Please find attached statement following the interim review of our QUIET clinical trial. We are all really disappointed, particularly on behalf of all the people with tinnitus for whom we hoped this could be an effective treatment. However, we are very grateful for all the support that we have received from everyone, and especially the volunteers who participated in our trial.

We can't say anything more until we have done the analysis of all the data generated by the trial, which will take a while. We hope that what we learn from the data will be of use to the tinnitus research community.
Click to expand...
And this is exactly why I tried to calm people down and for some people I even said that stop bashing about Autifony being the saviour...
 
#3,095
Thorbamse said:
I don't have the insight nor the experience to tell, but you might be right. Anyway, I feel very down.. The worst thing a person in a difficult situation can loose is hope, and I just lost it.
Click to expand...

Well, trobalt works and SF is basically a more potent and safer version of trobalt.
 
#3,100
Is not my intention to give hope to anyone. These are sad news. But, the trial for hearing loss is still going on, and it's the same compound. If we are lucky and works for HL, the drug, the same drug, might still hit the market and maybe someome will benefit from it.

The statement clearly says that they're further analyzing the data to check if there is any subgroup thay might have been benefited by the drug. It's not a magic bullet, but it might be useful.
 
#3,102
For me, it wouldn't have worked, as I had a TIA, the blood clot damaging the auditory parts, but I'm so sorry for everybody who pinned hope on this . Don't give up, if I can live with my horrendous T, KNOWING I'll not ever be cured, then everybody, eventually, could possibly get used to it. They say 'embrace' it, but. I wouldn't go that far. Hang on, just because this failed, doesn't mean they aren't working on something else!
 
#3,103
This are very strange news. What do you think about external pressures to end this drug?

Because in the statement, they could change the drug dosage? The drug treatmenet time. Or saying that they will try another drug. It seems like they are abandoning tinnitus
 
#3,105
For anyone who wishes to know more about the role of Data Monitoring Committees in clinical trials, this document may be of interest:
http://www.hra.nhs.uk/documents/2013/10/data-monitoring-committees-in-clinical-trials.pdf

"A Data Monitoring Committee (DMC) is a group of people that reviews accumulating
data in a clinical trial and advises the sponsor (directly or indirectly) on the future
management of the trial. It mainly reviews safety and efficacy data but may also see quality and compliance data."

Autifony state that "there were no safety or tolerability issues identified with AUT00063" so there would be no question of the DMC advising the termination of the trial on safety grounds. The only possible conclusion is that there was no evidence of efficacy - in other words, there was no evidence to support the idea that AUT00063 helps reduce tinnitus. Autifony's announced intention to "explore if any subgroups may have benefited from treatment" sounds like an attempt to salvage some sort of positive outcome from the study when the available evidence (from what we currently understand) does not give any cause for optimism. This was not the news that anybody wanted to hear but questions remain about the methodology of the AUT63 study (dosage, trial duration, sample size etc) based upon what we know about Trobalt. Maybe, we should not abandon all hope for AUT00063 just yet.
 
#3,106
@PhilB

Providing the issue with dosage, trial duration and the rest, is there any chance they may consider another trial or that's all out of question now?

Do they have to publish final results?

After having two positive reviews here it's hard to believe it didn't work for more people.

Call me crazy but there's something fishy going on here:(
 
#3,111
amandine said:
Yes valeri we are not allowed to say this but someone just made big bucks on the back of this.
Click to expand...
Well that's how pharmaceutical companies work. Their main goal is to make money not to cure people. In fact finding a cure means killing their own business model.

What I find strange is the 4 weeks trial period, that's not enough time to determine the drug is safe or even effective.
 
#3,112
In the statement it said that it tested the results from 58 participants - thought there were supposed to be 150 participants?
Aso I recall that @tomm who tried am 101 and trobalt (powder from china) said that the autifony had helped him the most!
 
#3,113
valeri said:
FB post could have had 10.000 likes but we would still be where we are now.
Click to expand...
What we wanted to achieve with [USERGROUP=11]@Team Trobalt[/USERGROUP] was get results published in a peer reviewed journal of science (as this would create awareness within academic circles). I tried many times to get participants of the informal study to report their data in a timely manner (= standardized points of assessment) both by public pleas and personal follow-up PMs. Would you believe it, but, half of the participants (= 10-12) that I contacted did not even respond to my mail. The others responded with words to the effect of "I will see if I have time" (and this despite the exercise being just a one minute daily data form to submit, and, from folks who spend 4-5 hours surfing the forum in any event...!).

That's why Team Trobalt decided to shift to another strategy: create attention for the researchers in the USA who would have the competency to possibly undertake a clinical study of Trobalt (in other words: instead of us collecting the data via the Internet, they would carry out the whole operation on-site in the USA, physically). In addition, they are researchers with phamacological backgrounds, and, have the competency to do further research into potassium channel openers. But of course, research costs money, and since donations are very limited when it comes to collect them from communities such as this one, and since the ATA was not willing to step in (fully), we thought the best way to possibly help the researchers help us, would be via the social media. And indeed the Team Trobalt update we published was extremely successful...

www.tinnitustalk.com/threads/team-trobalt-update-%E2%80%94-april-9-2015.9064

...but spreading awareness was not!

The reason spreading awareness is important is because many, many people (incl. physicians) are not aware of Kv-channel research and they are also not aware of Trobalt (it's a last line drug in the treatment of epilepsy, after all). So as you can imagine, if you are at that level of knowledge (or lack thereof within the mass patient/physician population), then awareness really is the starting point. This was the rationale.

valeri said:
Is there hope for us beyond autifony?
Click to expand...
Listen... I cannot even begin to express my dissatisfaction with the incredible amount of clinical misinformation that floats around on a forum such as TinnitusTalk. Lots of arm-chair critics, wannabe experts, and self-proclaimed heroes who want to share their infinite wisdom of tinnitus. Among that misinformation, you will find statements as to "tinnitus is a brain-thing" - well, that's an accurate description isn't it? When was the last time you went to the doctor for check-up and heard him/her say: "I think you have a brain thing..."?

Tinnitus is not necessarily a "brain thing" - there is plenty of literature such as this which indicates other possibilities and involvements - namely that of the cochlea and auditory nerve (as you might expect):

http://link.springer.com/chapter/10.1007/978-1-4614-3728-4_4

Auris Medical AG is a very serious and very dedicated enterprise. They make decisions based on the very best science possible. They are also the first pharma company ever to enter the otology market for inner ear diseases, and, as it happens they are the first sponsor of TinnitusTalk:

www.tinnitustalk.com/threads/auris-medical-the-first-corporate-sponsor-of-tinnitus-talk.11325/#post-139169

It is known that they have a 2nd generation compound in their pipeline, AM-102. This is another intratympanic therapy, and, I can only assume that it is either more potent than AM-101 and/or that it has efficacy beyond the acute stage (otherwise why would a company develop a drug when they already have an existing one, right?).

So we will have to see what developments take place. What I can say is that I am very glad that there are serious and dedicated people such as Mr. Meyer around (CEO of Auris Medical). In addition, we have to weigh in on political agendas such as that which took place by the investor firm Kerrisdale Capital recently:

www.tinnitustalk.com/threads/scifluor-receives-us-patent-for-kcnq2-3-activator-to-treat-epilepsy-and-neurological-disorders.7743/page-3#post-140664

I specifically wrote the above post to "protect" the interests of the tinnitus community, and, had the update spread on the social media (here) and on another Facebook group. If you read the post, you will understand why.

I don't have faith in the tinnitus community in being able to help itself (for reasons I have stated many many times re: poor lethargic commitment). I do a bit of behind the scenes work (with a focused goal), and besides that, things will just have to go the way they go I guess. I don't believe it is possible to revive the cause of Team Trobalt. The tinnitus community has failed itself so many times before that I have no confidence in the members ability to do, well, anything really! I will not start to engage my old contacts from the USA again. No way. Not happening. Sorry.

attheedgeofscience
13/OCT/2015.
 
#3,114
Back to accepting, habituating, masking, praying, meditating, not listening to it, experimenting with other drugs....
Hope for AUT00063 is gone. Let's put our hope on something else, maybe SF0034:

"Heterologous expression of KCNQ2/3 channels in HEK293T cells showed that SF0034 was five times more potent than retigabine at shifting the voltage dependence of KCNQ2/3 channels to more negative voltages. Moreover, unlike retigabine, SF0034 did not shift the voltage dependence of either KCNQ4 or KCNQ5 homomeric channels."

Retigabine activates 4 of them (Kv7.2-7.5.)
AUT00063 was working on KV 3.1 voltage-gated potassium channels.
SF0034 only activates Kv7.2 and Kv7.3.

Since we know Retigabine is working (at least partly), SF0034 has better chances to help (even if it was only tested for preventing T). Maybe we will see very soon a drug from Autifony targetting KV7.2 and KV7.3.

Nevertheless it is a sad day, but let's not give up hope. (y)

Thanks ATEOS for your invaluable work, even if you emphasize we have failed as a community.
I do understand and accept this.
 
#3,116
Martin69 said:
Thanks ATEOS for your invaluable work, even if you emphasize we have failed as a community.
I do understand and accept this.
Click to expand...
I should in addition, mention that there are several doctors on this board - both known ones and unknown ones (i.e. members who have not declared themselves as doctors but where we know that they are from other sources) and I contacted a number of these, and, had my message spread all across the forum in this post:

www.tinnitustalk.com/threads/retigabine-trobalt-potiga-%E2%80%94-petition-to-the-ata.6896/page-4#post-81060

Despite my request for doctors to step forward, not a single one did. The only who actually did do so (since the beginning), was Dr. Nagler.

So it isn't just the "regular" members who have failed to step up, it is also the "support" elements. Trust me, I have written several personal e-mails to doctors on this forum asking them to participate.
 
#3,119
So, where can I get the remaining pills before they land in the dumpster? :dohanimation:
 
#3,120
attheedgeofscience said:
What we wanted to achieve with [USERGROUP=11]@Team Trobalt[/USERGROUP] was get results published in a peer reviewed journal of science (as this would create awareness within academic circles). I tried many times to get participants of the informal study to report their data in a timely manner (= standardized points of assessment) both by public pleas and personal follow-up PMs. Would you believe it, but, half of the participants (= 10-12) that I contacted did not even respond to my mail. The others responded with words to the effect of "I will see if I have time" (and this despite the exercise being just a one minute daily data form to submit, and, from folks who spend 4-5 hours surfing the forum in any event...!).

That's why Team Trobalt decided to shift to another strategy: create attention for the researchers in the USA who would have the competency to possibly undertake a clinical study of Trobalt (in other words: instead of us collecting the data via the Internet, they would carry out the whole operation on-site in the USA, physically). In addition, they are researchers with phamacological backgrounds, and, have the competency to do further research into potassium channel openers. But of course, research costs money, and since donations are very limited when it comes to collect them from communities such as this one, and since the ATA was not willing to step in (fully), we thought the best way to possibly help the researchers help us, would be via the social media. And indeed the Team Trobalt update we published was extremely successful...

www.tinnitustalk.com/threads/team-trobalt-update-%E2%80%94-april-9-2015.9064

...but spreading awareness was not!

The reason spreading awareness is important is because many, many people (incl. physicians) are not aware of Kv-channel research and they are also not aware of Trobalt (it's a last line drug in the treatment of epilepsy, after all). So as you can imagine, if you are at that level of knowledge (or lack thereof within the mass patient/physician population), then awareness really is the starting point. This was the rationale.


Listen... I cannot even begin to express my dissatisfaction with the incredible amount of clinical misinformation that floats around on a forum such as TinnitusTalk. Lots of arm-chair critics, wannabe experts, and self-proclaimed heroes who want to share their infinite wisdom of tinnitus. Among that misinformation, you will find statements as to "tinnitus is a brain-thing" - well, that's an accurate description isn't it? When was the last time you went to the doctor for check-up and heard him/her say: "I think you have a brain thing..."?

Tinnitus is not necessarily a "brain thing" - there is plenty of literature such as this which indicates other possibilities and involvements - namely that of the cochlea and auditory nerve (as you might expect):

http://link.springer.com/chapter/10.1007/978-1-4614-3728-4_4

Auris Medical AG is a very serious and very dedicated enterprise. They make decisions based on the very best science possible. They are also the first pharma company ever to enter the otology market for inner ear diseases, and, as it happens they are the first sponsor of TinnitusTalk:

www.tinnitustalk.com/threads/auris-medical-the-first-corporate-sponsor-of-tinnitus-talk.11325/#post-139169

It is known that they have a 2nd generation compound in their pipeline, AM-102. This is another intratympanic therapy, and, I can only assume that it is either more potent than AM-101 and/or that it has efficacy beyond the acute stage (otherwise why would a company develop a drug when they already have an existing one, right?).

So we will have to see what developments take place. What I can say is that I am very glad that there are serious and dedicated people such as Mr. Meyer around (CEO of Auris Medical). In addition, we have to weigh in on political agendas such as that which took place by the investor firm Kerrisdale Capital recently:

www.tinnitustalk.com/threads/scifluor-receives-us-patent-for-kcnq2-3-activator-to-treat-epilepsy-and-neurological-disorders.7743/page-3#post-140664

I specifically wrote the above post to "protect" the interests of the tinnitus community, and, had the update spread on the social media (here) and on another Facebook group. If you read the post, you will understand why.

I don't have faith in the tinnitus community in being able to help itself (for reasons I have stated many many times re: poor lethargic commitment). I do a bit of behind the scenes work (with a focused goal), and besides that, things will just have to go the way they go I guess. I don't believe it is possible to revive the cause of Team Trobalt. The tinnitus community has failed itself so many times before that I have no confidence in the members ability to do, well, anything really! I will not start to engage my old contacts from the USA again. No way. Not happening. Sorry.

attheedgeofscience
13/OCT/2015.
Click to expand...
I understand what you are saying and it seems as if you want to get thins done you have to do it your self. I abandoned the research field years ago (around 2010 when I finished my degree in Molecular Biology) but the more I think of it the more I want to get involved and specifically with tinnitus research. But I really don't know where to begin. I don't have the contacts or anything really. But as I said I'm thinking of re entering the field again.

I am also very disappointed with the community based on the facts you have presented.

When it comes to Autifony I'm a bit curious as to what they will write. I want to see that report that they are going to present based on the trial. I can't shake the feeling that they might have something but did things wrong from the start. I hope that they will find some kind of subgroup in their data that actually were helped by the drug but I am also a bit surprised that they could draw these kind of conclusions based on 58 people, which is only about one third of what they planed on. Would another 100 have changed the outcome? Is it possible that they are on the right track regarding what to target but their drug just didn't work well enough?

I'm curious about that report, needless to say.
 

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