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

It's not over until the fat lady sings....

Detailed Description:


Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

https://clinicaltrials.gov/ct2/show/NCT02345031?term=AUT022063&rank=1

 

They probably have given up trying to cure tinnitus directly. They know that if this drug passes some sort of trial to market then tinnitus sufferers all over the world will be on it like flies on doodoo. Yes I realizeds trial failed but they have only triald on 25 people for some reason unknown to me. I know that to make itas trial you need about 1500 people because there are so many causes of tinnitut many will just not respond. Sure the USA trials can also fail most likely but I'm just saying it's not over until it's over.

 

I'm wondering what 'lack of efficacy' means for Autifony...
Did they expect a cure for tinnitus or a symptomatic treatment/relief?
Did they happen to mention this at any time?
Because for most of us, even a temporary relief would be welcome.

 

i was wondering that too @ undecided

 

Thought 58 people were trialled?

 

I think he meant the 50% that got the actual medicine.

 

The interim analysis carried out by the Independent Data Monitoring Committee looked at trial data on 58 subjects. I don't think we know whether that means that only 58 subjects completed the trial. It is possible that these were just the first 58 to complete. Of those 58, I don't think we know if they were all given AUT00063. Indeed, it seems more likely that this group of 58 would have included some from the AUT00063 group and some from the control group. We don't know whether the split between the AUT00063 group and the control group was even (29 from each group) or not. All we know is that the IDMC recommended that the trial should be terminated based on their interim findings from looking at that group of 58. Autifony have said that they will publish their key findings after all the data has analysed.

 

I've been corresponding with Dr. Large, and Autifony sounds like they're out of the T treatment business. I'm no scientist, but I think it's too bad they try again by increasing the dosage and time frame. I'm sure they have their reasons. If it helps age related hearing loss, and is FDA approved, I'll swallow some to see what happens. On to SF!

Dear Scott,

Yes, we have received a number of enquiries. You should receive a reply from our clinical group in the next day or so as they work their way through emails. In the meantime, I can confirm that the AUT00063 QUIET-1 study was stopped for futility (no hope of showing efficacy), so there are no immediate plans to conduct further tinnitus trials. However, analysis of the full dataset is ongoing and once complete we intend to publish the results so that they can be of use to the research community for this important disorder.

All the best and I’m sorry that the news has not been better for you and fellow tinnitus sufferers,

Charles

 

58 people were trialled according to Autifony - none of know how many got placebo or the real drug. Maybe 57 got placebo or 57 got the real drug.....extreme examples yes but possible as the staff at the clinics did not know either.........
If you mean 50 percent of 58 people got the real drug (you are guessing at that) then that comes to 29 people and not 25 as stated in his post (the 25 I am sure was just an unintended error in his post).

 

Agree, I was just assuming he thought 25 got the real med. (Close enough to 50/50)

 

The reason is because of their inclusion/exclusion criteria, which they didn't seem to follow towards the end. I think what was really going on is that they started cherry picking people, only to get the results we know today.

 

The data management committee that did the analysis used to conclude that the trial should stop certainly knew how many received treatment. Assuming Autifony follows through with their stated plan to publish a paper, we will eventually know as well.

 

Perhaps I shouldn't have written Autifony is out of the T treatment business, as that's jumping to a morbid conclusion. They just don't have a T trial planned at this time, which doesn't mean they won't plan one at some point in the future. Time will tell.

 

I think it's safe to say, we are a long way off, coming up with a successful treatment or cure, for Tinnitus.

 

Well. A licensed treatment...

 

All eyes on SF0034 me thinks !

 

I was just reading some articles on SF, and it seems interesting, and gives us a chance to hope again. It sounds as though human trials will begin fairly soon, and in the US this time, so I'll gladly volunteer my brain for it. Perhaps we should start a new thread for this med, if there isn't one already?

 

where did you find it ?

 

I just googled it, and a bunch of articles showed up. There were not trial dates anywhere, but it sounds like they're not too far off by the wording of the articles.

Here's a snippet from one article...

There are five different kinds of KCNQ potassium channels in the body, but only two are important in epilepsy and tinnitus: KCNQ2 and KCNQ3. The problem with retigabine is that it acts on other KCNQ potassium channels as well, and that’s why it has so many unwanted side effects.

Tzingounis and Tzounopoulos first tested SF0034 in neurons, and found that it was more selective than retigabine. It seemed to open only KCNQ2 and KCNQ3 potassium channels, not affecting KCNQ 4 or 5. It was more effective than retigabine at preventing seizures in animals, and it was also less toxic.The results are promising, both for research and for medicine. SciFluor now plans to start FDA trials with SF0034, to see whether it is safe and effective in people. Treating epilepsy is the primary goal, but tinnitus can be similarly debilitating, and sufferers would welcome a decent treatment.

Tzingounis is pleased as well. “This [SF0034] gives me another tool, and a better tool, to dissect the function of these channels,” he says. “We need to find solutions for kids – and adults – with this problem.”

 

Honestly, would you think the company would have given up on the drug based on skewed test sample?

 

What makes you think it was a skewed test sample?

 

"maybe 57 got the placebo"

 

If that were the case, they wouldn't have stopped the trial.

 

which is exactly what I was saying.... I was quoting the post above.

 

Now we're going to put all our eggs in the SF00034 basket. Oh, I just can't wait to read in 3-5 years, a similar statement to Autifony's latest release. If targeting specific potassium channels, is the real deal, how and why did AUT00063 fail? Weren't they basically trying to hit the same target?

 

Ah, sorry - I completely misunderstood.

 

It's not just the target, but what it is intended to achieve on the target. I may be mistaken on this, but I thought Trobalt (SF as well) open the channel, where Aut closed the channel? I can't find it, but I seem to remember people talking about this in a Trobalt versus Aut discussion somewhere on TT?

You may very well be correct though. Time will tell, so it's back to Keppra for me I think.

 

Just one more thought, I thought it was questioned why was Aut closing the channel, while Trobalt opened, since it was the use of Trobalt that accidently discovered relief for epilepsy sufferers with T? Please someone correct if I'm way off on this?

 

It looks like both drugs open potassium channels. For some reason Trobalt has some effect in some people (Aut drug too if we read two success stories in this forum), so their MoA must be similar.

Anyway, I was so hyped with this drug and now so despaired that will not comment anything on the new fluorinated retigabine SF0034. Only time will tell.

 

@swc5150,

Since Trobalt is not the ideal solution and isn't a certified treatment for T, it kinda doesn't matter if one opens or closes the channels. Neither seem to work.

We are betting that as Hippocrates thought, Tinnitus is the little brother of epilepsy. (Paraphrasing.) What if it isn't? We are still awaiting a Tinnitus treatment, from an epilepsy drug.

Again, I think we know very little on how Tinnitus works and are still scratching the surface.