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

Well i want it to work for everyone obviously, but those of you that it really really effects your life i just hope its at least able to bring yours down to like mild or ofcorse just cure this damn thing for good cause they said it did for rats so it could come real closeeee

 

Another question i have is are they tweaking this drug as they go? Or is it already made set in stone sittin at a labaratory waitin to be given out at clinical trials? Like can they find mistakes in it if so add a lil more of whatever they need? Or then would that mean that they would have to start the whole clinical trial process from the beginning.

 

From reading their summary of the results of Phase I, a big thing they were testing there was how the drug could be administered. As in, they gave different doses to people and tested blood/urine/whatever for evidence that it was getting into their system, how fast and at what dosages.

So it does exist, they can make more, and they have found a delivery method that meets their criteria. I'd assume part of that was testing various compounds with which it could be combined to allow it to cross the blood-brain barrier.

 

Does anyone know if AUT00063 is something you take once, or a few times, or something you'd have to take for the rest of your life?

 

You are indeed a beautiful person Grace!

 

nice points Grace. We all want the answers.

I've often wondered if it would need to be built up in your system or if it would act straight away like a pain-killer. ADs take up to 2 weeks whilst anti-convulsants can work immediately.My guess is that, at the correct dosage, it would work fairly immediately for acute cases and might need a little more reinforced dosing for entrenched cases but should work equally well for both, as the mechanism aims to restore over-active neurons to their resting state.

Even if these neurons somehow re-activate to a degree, AUT00063 promises to break the cycle and re-plasticize/change their bad habits.

Yes, we'd also have a pill that prevents and protects from further damage!
And a pill that even restores hearing quality to some degree.
Awesome indeed.
If Autifony delivers, few will care about cost (mass market size indicates it will hopefully be quite affordable),
dosing schedules or color of the packet.

Please let this be it.

 

Yeah i have a good feeling about it!!!! Its definally gonna do miracles the way im thinkin right now tryin to be optimistic! Just need a damn drug out there for all the people that have suffered years and years its time they get actual relief!

 

Susan shore from university of michigan is creating a device to
Target the overactive neurons ( which they say causes noisy tinnitus) making them less or hopefully returning them to a resting state. Now is autifony doing the same thing except drug form? The susan shore article mentions
Nothing about potassium channels though. Was just wondering if anyone knew the difference between the two treatment plans to calm T or of them two are real similar.

 

Trileptal costs about $3/pill.
So if Autifony would be similar in cost and we would need to take it once a day; using a patient pool of
3 million people-

$3 x 30days x 12 x 3,000,000 people = $3.24 billion dollars in 1 year. Am I correct ? lol

 

I wonder how long this will take to come on the market. Hopefully within the next 5-10 years. With my recent increase I don't know how much longer I can wait.

 

I spoke with Dr.Shore. She does not seem very optimistic about her device at the moment.
Autifony aims to treat the root of the problem.
Dr.Shore targets somatosensory nerves which happen to innervate the DCN hopefully indirectly modulate tinnitus producing nerve cells.

 

If phase 2 is successful - 3 years tops. Our suffering fates will be decided in the next 8 months or so.
I know, if Autifony fails, there will be nothing else on the horizon.

 

Kind of off topic, but heres an article that mentions Autifony as well as other companies from the UK who are really making progress in their respective fields. We're really fortunate to live in a time with so much technological advancement. If there's a generation to cure tinnitus, this is it.

http://www.thepharmaletter.com/arti...om-100-million-in-biomedical-catalyst-funding

 

Thanks for that info, yeah i have hope in autifony, and nerve stimulation so far.

 

So this is a therapy that has to be taken daily?

 

If I interpret safe for "daily dosaging", then I would have to assume that yes, daily.

 

Why do people keep asking if it will have to be taken daily? I don't see the point in that question???

 

I think people are uncertain about whether AUT00063 will be a course of treatment over a finite period or whether it will need to be taken indefinitely. No-one is sure how much this drug is going to cost and I'd imagine that some people would be worried about the expense if the drug needs to be taken every day for the rest of our lives.

But perhaps we are getting ahead of ourselves. I feel cautiously optimistic about this drug but if AUT00063 represents a significant breakthrough in alleviating or curing T, then it will become very big news indeed.

 

because in the trials people have to take it daily for several months. you can find that in the papers.

 

As Dan says, 3 years tops, which is LIGHT-SPEED as far as snail-pace drugs are concerned.
Thank goodness for the new fast-access programs that have been introduced.
Even so its a shame they cant speed up the phases (come on, just a bit, fellas)
In the meantime, get well Eric.

 

That's interesting, isn't it, as this can only be speculative suggestion until the first humans try it.
What if AUT00063 starts working after a couple of days?
They may have to scale-down their dosing schedule (and scale-up the cost of each pill).

So did the cured rats require continued dosing or were they iced before they could squeal?

 

I dont think they released that information yet. Some one on here said we should know efficiency by december hopefully? If its a fast acting pill and does "wonders" then it would be like compared to an anti anxiety med that you gotta take daily and have quick acting results so doesnt mean the cost will be high. If this drug works they will be rich regardless. I was lookin at lidocaine and how it effected rats and they said it made the rats T have a big reduction where autifony says it "abolished" all evidence of T. So maybe autifony will have better results who knows.

 

According to my ENT, the time to market is not really relevant for most of us, it's more about when will the drug be tested at a larger scale (phase 3).

It's relatively common for specialists, to offer motivated patients (for some not curable pathologies such as tinnitus) the opportunity to try a new drug before it goes to market. Of course you have to sign a discharge,report on the evolution of your symptoms, and see your doctor more than your mom.

I actually did that more than a decade ago for drug helping for a rare condition, I had it almost 3 years before the market launch and I was cured by the time it was available for the average joe.

So to answer your question, if and ONLY if the phase 2 is sucessful, and depending on the time they take to do the phase 2 & publish results, I would say 2 to 3 years.

My ENT did not have much time to discuss, but I have another appointment in a few weeks, so I will try to get his feeling about this drug.

 

wow, this is great Benryu, thanks for sharing. More hope.

You know, I would sign any discharge report or disclaimer form TOMORROW MORNING
if i could try AUT00063 out prior to market release.

I really would be prepared to take almost any reasonable risk to swallow a pill tomorrow.
It's a potassium channel modulator, not cyanide.

 

Thanks, I am from Montreal, QC too I am surprised that you actually met an ENT that is following on the research, the four that I have seen have not mentioned anything thing to me.

 

He was not particularly following tinnitus research, he was actually surprised when I mentioned what was going on for this problem in terms of research, but he could easily relate to other cases with similar new drugs becoming available through trials.

He told me he was curious about the drug and would do some research if he has time before my next appointment

Not sure if a was being honest about that, actually the only information I cared about was the early access lol

 

i get the subtlety of your point Rhea
if you're about to blow your head off with a shotgun the only thing that matters is will it cure/alleviate
everything else becomes valuable but, for some amongst us, peripheral detail.

if you're truly dying of thirst in the desert and running out of time to live you just want the water.
Is it perrier or walmart value? Will you have to drink some more later?
I don't flucking care, just give me the flucking water.

Really, I don't know if i can even wait 2 years.
And I wouldn't care if I had to eat the stuff all day, even if it tasted of dog waste.
Wish I could be indifferent ("I only hear my T when I listen for it in a sound-proof chamber under the sea-bed")
The intensity of our T decides our perspective.

Wishing you and everybody here wellness

 

It is definitely a possibility to pursue that option - or at least to attempt it. I know of instances - in my own circle of friends - where a person chose to use himself as a "guinea pig" with a new drug treatment because of being terminally ill with brain cancer.

As a counter example, however, I was in my own case not able to get the AM101 drug administered off-label (Auris Medical would not release the drug for off label purposes). And that was despite:

1) Finding a doctor who was directly involved in the AM101 trial already (and who was willing to perform the procedure).
2) Paying for the treatment myself - needless to say (but, clinical trial patients get it free-of-charge).
3) Signing documents to release the doctor of responsibility.
4) Letting the doctor know that my next step would be brain surgery (if not allowed to get the drug off-label; normally when the stakes are high, getting a decision overturned is easier).
5) Having subsequent direct contact with the CEO of Auris Medical to convince them of overturning their decision (I have family members living in Switzerland where Auris Medical is based).
6) Subsequent follow-up with my own GP (who is obviously clueless in such matters - but is nonetheless my GP) who contacted a senior physician at the University Hospital Of Leipzig (where I was treated in the very early stages of my tinnitus) for his opinion.
7) Follow-up and opinion of Professor Strauss of the advanced ENT surgery clinic in Leipzig, Acquaklinik (which has been handling certain parts of my "experimental medicine journey").

So I would say that I have tried pretty hard, but did not succeed.

I would therefore not agree entirely with your observations. The short answer is: it depends...

(And I have documented the above with Markku in case anyone questions the accurarcy of the information I have provided).

 

Considering the extraordinary lengths you went to get help, these people must be pretty damn heartless.

I wonder if the CEO would have been as obstructive if the patient in question was his own child. Probably not.
I wonder if a million pound donation would have swayed it to get another person on the trial. Probably.

They knew that you were on the verge of death. You don't have to be a practising Christian to
feel empathy for a fellow human being, especially if he is offering to PAY for help!

This is no nasty indictment on mankind, merely bad karma for the unfeeling greedy paranoid cyborgs at Auris.

Any of us would have helped you FOR FREE.
This sort of thing would make for a powerful article.
May none of them profit from our misery.
If you ever bump into the CEO one day, kick his ass - for all of us.

 

Thanks for sharing, I agree it's not automatic, but isn't the AM101 still in phase 2?

My comment is for drugs in phase 3.