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

@benryu makes some sound scientific reasons why it would work for most (see Retigabine thread). Also, Phase I trial apparently passed all the safety tests.
Opening KV3 channels could be the key for most etiologies of t.
So, while it is good to err on the side of caution, let's also try to keep the hope alive. Sometimes, that is all we have.

 

It might work for the most but not everyone, esp. on the people who already take drugs or have health issues (esp. the elrderly). Doesn't mean that the ones it does't work on should gives up hope, it might just means giving it time.

 

This was posted in the Retigabine thread but I feel it would fit here too:
http://www.grunenthal.com/grt-web/G...ed_potassium_channels_(KCNQ2-3)/124700103.jsp

Seems like this potassium channel thing is the future.

 

since autifonys trial is 4 weeks for a patient, can we assume aut00063 would only need to be taken a short while to have effects ? i would be a bit concerned of long term side effects if this was required to be taken forever.

 

I think we don't know either way. Especially re the drug interactions. And who is to say potassium channels work differently for the elderly. It is possible this drug could reduce t. But everyone's t is different, and everyone responds differently. Let's wait and see what happens. I encourage you to read benryu's posts.

 

potassium channel openers work specifically to correct hyperactivity
at the neuronal source,
as indicated for epilepsy. hopefully this applies to tinnitus,
irrespective of age or condition chronicity, even possibly any etiology!

i love the fact that the 00063 trial is going to be short, just 4 weeks,
it reflects the confidence of Autifony that there's no need for
prolonged treatment, (or maybe even further treatment, wow, what if)

Come on Autifony, you can do it!!!

the govt early access schemes could apply here, once phase 2 is complete,
it only requires the company to submit its drug for consideration.

 

that is what i was wondering.....if the 4 week treatment is an indication that this is a once and done medication or will it need to be taken forever.

 

I do need to remind you that the phase 2 itself is not going to be for 4 weeks. We still don't know how many people they are planning to enroll or how many sites there's going to be. The patients will not be enrolled all at once in one place for 4 weeks and then be done with. My guess is that this will take several months at least. Just look at how long the AM-101 phases have been.

 

i would like to know if they continued to monitor their experimental rats.
if i were a scientist i would have done exactly that.
i'm betting those cured rats stayed cured and didn't need re-dosing.
it kind of makes intuitive sense that if you've had tinnitus for decades
you might need longer treatment time, but essentially tinnitus is what's been
called a channelopathy in need of correction.
autifony are confidently aiming for the chronic market and it may be an
individual thing how much you need and for how long but the working
model is probably built around correctional treatment.
like i said, we need to know how those rats are doing NOW.
if Dr.Large is reading this, boy we'd like to know.

 

thanks, i never understood this, let's see what happens

 

I realize that
I was merely focusing on the length of the treatment being 4 weeks. To me that kind of gives an indication that a long term dose may not be required. But i could be way off base, does anyone have any thoughts?

 

"taken as 4 capsules once daily with food, for a period of 4 weeks" - that's the drug. The monitor period could be 3 months after that.

 

Auris is monitoring this forum, I would imagine that Autifony has been or at least will be once the phase 2 trials start. But i doubt they will post up any info, it would be great if they did but I'm pretty certain they won't.

 

Ok, finally they have released some more info, ok so i have had t for 11 years BUT what if i got t 11 years ago and then it went..but now it has come back just 17 months ago?...eligible you think (please god I need to be in on this) :S

 

I would love to be in this trial also. I hope they expand to usa sooner rather than later.

 

from their website at / http://www.autifony.com/autifony-tinnitus-quiet-study.asp

Q. Will this drug adversely affect my hearing?
A. AUT00063 has completed initial “Phase I” safety studies in healthy volunteers. No adverse effects of the drug on measures of hearing were observed in any of the subjects.

Q. What are the side effects of AUT00063?
A. AUT00063 has completed initial “Phase I” safety studies in healthy volunteers. The drug was very well tolerated in young and older healthy volunteers. No serious adverse effects were noted during the Phase I trial.

 

I agree and I understand that hope is important for many and I not trying to bring anyway down . However, even if a drug works, that doesn''t mean that there are no side effects (which even for a short period can sometimes create serious issues as we see with antibiotics which for example can destroy your ears for life). Also, everyone's body is different so one drug might not fix everyone's problems.. If one has for example to choose between a possibly life saving heart medication or dealing with tinnitus its a very bad dilemma.
Im really speaking of my own personal experience. As a child I had to take many, many medications which had a lot of side effects. I still take one drug in a small amount but I don't really know what kind of effect it has on my body. Now I only take medications when I absolutely need them which is also why I would only take a new drug if there was a no other choice. Also, even nowadays when there are several drugs for arthritis there are still people who become crippled by it even when they receive the best care. It is not possible to habituate to deformed joints, but it is possible to habituate to tinnitus. And I do believe that after a longer period there might be some sort of one time operation to deal with the problem for the vast majority. Overall medications are not such a good solution, because it depends too much on the individual and have an effect of the body as a whole, not locally.
I am of course hoping that it will work but I think a lot of registered people read this board as well and I would not like them to think that a drug will work for them anyway and continue destroying their ears. Thats why I believe both sides are important here. Sorry if I seem too blunt.

 

17 months is more than a year I think? I would advise you to contact them and tell them honestly about your situation. Considering the importance of the drug I would not advise you to lie but couldn't hurt to ask.

 

17 months is still less than 18. I would give it a go.

 

Why lie to get on this trial, they have set a criteria for a reason, they have obviously worked out that up to 18 months the 4 week course of medications could work out, you tell lies to get on it and all of a sudden you are reporting different results to what they expect and this could ruin the trial, think of everyone else rather than just yourself please.
The results could be used to set time scales and dosages for people who have had this for longer than 18 months, i dont see anyway this could work for someone up to 18 months then if you have it for 19 months onwards it wont work, this will not be the case. they will be wanting to get results as quickly as possible to get this thing moving to get approved, then once approved it might be in longer cases you are told to take it for say 6 months, but for this trial they want a short time span, so please think of others before bending the truth to try to get on it.

 

The worst thing that can happen if you call or email them is that you'll get your name in early for the next phase.

The fact that they've said they want to target 6-18 months if HUGE. If they weren't confident in the drug but felt financially committed to the trial, they would have said 3 months or less. At < 3 months you're far more likely to get some spontaneous resolution of symptoms, meaning that they could claim more success than they actually got. The range they've picked says that they believe they can reverse entrenched maladaptive plasticity - change your brain - in under 4 weeks. I don't mean they're confident it will be a permanent change, but they've got to believe they can get people to say, "Wow! This stuff really works!" in 4 weeks.

Is there anybody on here who would turn down a slot if they said AUT00063 would only work for three weeks? I'd not trust myself with a credit card if somebody offered me three weeks of silence.

 

lol im with you @rtwombly .....where do i sign!
i dont know what to think about them targeting 6-18 month cases, they didnt pull it out of thin air they must have some analysis behind it......but yea its HUGE

 

You can guarantee that if you or I have thought of it then the scientists at Autifony have thought of it!
Remember they spend years and years doing the research and testing of any new drug like this so I wouldn't be too worried about trivial things like this.

Rich

 

She says she got t 11 years ago and then it went... So she had no more T. She then says" but now it has come back just 17 months ago" - imho, I still think she fits the criteria and deserves a chance.

 

I completely agree, now I am beginning to believe that with long enough reversal to the point in which the absence of tinnitus becomes ingrained through neuroplasticity, tinnitus can be cured. The only question I have is how long will that take? If I had the opportunity with AUT00063 or even Retigabine for that matter, I wouldn't taper off of it even if my tinnitus were to fully disappear, I would take my sweet time to make sure my brain adjusts to my new state without T. I would stay on Retigabine and the likes until 1 minute before my skin is expected to turn blue, but that's just me, what do I know? The science behind tinnitus is complex, I'm just beginning to wrap my head around the tip of the iceberg.

 

You misunderstood her (I think?). Her T didnt went away, that's the lie she would tell them to get into the trial. Im very much against people lying to get into the trial since it can screw up the results and put an end to this whole thing if we're unlucky.

 

Well I completely missed that part, in any case, I am quite confident with extended use of a drug like this tinnitus is hypothetically curable. Now for lying to get into a clinical trial...that stuff can ruin the chance for the rest of us.

 

"...BUT what if i got t 11 years ago and then it went..but now it has come back just 17 months ago?"
i.e. it went.
That is how i understood her. It only came back 17 months ago. However, instead of us arguing about interpretation of her phrase... let he respond by what she actually meant. @Rhea. If it went and only came back 17 months ago, I think she deserves a chance.

 

Exactly my point, to lie just to get in will be so wrong for everyone else, they have a criteria for a reason and it isnt so people can try to get round it. Just let them do the tests exactly how they need to, and go from there.

What would happen if everyone lied to get on this trial and they expect this to work on people who have had it for the time scale they say and it doesnt show results like they thought, could ruin it all.
The next phase might be for people from 18 mths say to 2 years, then the next from 2 years to 5 years, none of us know what they have planned for the next phases, just let them do it how they need to to get the best results for everyone.

 

Read the above how it is written, it is quite clear