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

They are doing phase 1 on tinnitus patients with significant hearing loss? Well that seems like a win win to me-- cause although not many of us have hearing loss or significant amount.. We will still know the efficiancy of the drug after phase 1-- if it decreases T with patients with hearingloss then those of us without should be good too. I understand alot owanna enroll in phase 1, but dont meet the criteria so thats deff disappointing... This has prob been asked before but if they enrol in october then does it start in october or do they enrol, make apt with doctors, get paperwork filled out all that crap that in reality they wont start the actual trial until january? Leavin us about a year until we hear of any efficiancy?! Even though its 4 week trials? So the efficiancy will know after the 4 weeks but they prob will wait a year take there time on even posting them.

 

Is this trial just going to be in the UK? Sounds interesting and more easy to get than the auris trial.

 

Response from Dr. Harris, CMO Autifony Therapeutics:

I had asked if they would consider relaxing the hearing loss restriction.

 

Who is their "expert" advisory? lol

 

Plus, even though I can notice my tinnitus in a lot of situations, its even more apparent if you have almost no hearing like my dad (although, bothers me way more than him... he never even mentioned it to me once in the 25 years he had it until I got it)

 

This selection criteria is rediculos!
Why not choose 1/3 with hearing loss, 1/3 with t and hearing loss and another 1/3 with t only?
This whole thing doesn't sound good at all!
There is no such a thing as killing two birds at once, too bloody complex when it comes to t!
This will not be a 4 week thing, this will take a looooot longer
What are those people thinking?????
Pissed!

 

As Dr. Harris mentioned, they expect to fill the trial slots quickly. If not, they'll consider changing the criteria. Remember that we are a small sampling of tinnitus patients. Statistically, most of the people with tinnitus have qualifying hearing loss.

 

@rtwombly
Regardless of hearing loss, don't you think that testing this drug against 3 different scenarios would give them a better picture regarding drug efficiency?
It just doesn't make sense but I hope to be proven wrong!

 

@valeri I think the sample size is too small to subdivide it further. The plan they mention on the website was to have two trials, one in the UK for tinnitus, one in the US for hearing loss. Evidently they couldn't do both trials at this time, so this hearing loss requirement allows them (hopefully) to go to their investors saying, "Our drug helps tinnitus sufferers and those with moderate hearing loss."

One of the things that has to be accounted for in a clinical trial is people dropping out for various reasons. If you start with a sample size of 50 people, and 15 drop out, you've only got 35 cases you can point at and say, "The drug works." And what if it doesn't work in all cases, because as you pointed out, tinnitus is a complex condition? Say it works in 25 cases. Is a major pharmaceutical company going to invest millions in a drug that helped 25 people? The best you could hope for in that scenario is that they'd fund another study.

With a sample size of 152 persons, even if half drop out and a third of those remaining don't get clinical benefit, you're still better off than the three way split you propose.

I think one of the points of contention here is that there doesn't seem to be a definite connection between tinnitus and hearing loss. But that objection misses the point. AUT-00063 was designed to help people with tinnitus and people with hearing loss from the same source. The tinnitus is coming from hypoactive neurons and the hearing loss is coming from hypoactive neurons. That's the theory and what the drug is meant to combat. So the best way to test that is to find people with tinnitus and hearing loss. If it helps those people you've proved all three points of your theory:

1) Tinnitus is generated when certain neurons in the auditory brain become hypoactive
2) When these neurons become hypoactive, hearing loss is often a symptom
3) AUT-00063 improves the functioning of these neurons, lessening or eliminating tinnitus and improving hearing comprehension

That last point contains a clarification worth making. AUT-00063 doesn't regrow cochlear hair cells, so there is a ceiling to what it can do for hearing improvement. However, part of Autifony's theory is that a good portion of hearing loss is actually a failure in signal processing, which is a function the drug can improve.

Understand that I'm not really arguing in favor of Autifony's decision so much as trying to understand it. It'd be much easier to find people to report back on their experiences if hearing loss were not a criterion. But I expect a good part of the reasoning came down to economic reality. There may well be concern at some levels that the market share for AUT-00063 may not meet expectations. This could be based on the belief that since many people "just live with" their tinnitus, they are not guaranteed to seek out the cure even when it is widely available. None of us think that. But the decision-makers at GSK who do not having personal experience of the condition may do.

 

Only open to UK residents signed with the NHS.

 

Perhaps ... but I doubt across the whole spectrum. Thus not qualifying. Most people have T in one or two frequencies. So an example is a high pitched whistle with a low pitched drone. From what I have read, associated hearing loss occurs in the corresponding T frequencies so perhaps one or two dips in hearing. High freq T = high freq hearing loss. Low freq T = low freq hearing loss. Both = both etc. The best explanation as was already mentioned, is that the broad spectrum hearing loss is catering for the trial they planned for the US but they ran out of cash.

It's just my guess and i doubt there are stats for all 700,000,000 of us, what type of T we all have. However, my guess is only 10-20% have the hearing loss associated with the T they want. However, it's such a small sample size 152 that they probably will fill slots. It's just how quickly they will find them....

Hopefully, they will battle to fill the slots quickly enough to minimise operational costs, that they will relax the criteria and some UK TT forum people can take part.

 

Clinical trials are set to start in October in the UK. Keep checking their website for updates. http://www.autifony.com/autifony-tinnitus-quiet-study.asp

 

So i guess.. start october and end november? a 4 week trial period correct?

 

No, they wont do all the patients at one time. Each and every patient will take the medication for 4 weeks. The phase itself could go on for a whole year for all we know.

 

The actual trial of the drug is 4 weeks. But probably will take longer. Have to set up sites , recruit, test, crunch data, write reports, meetings etc. I hope it moves fast I want the trial to come to usa.

 

Given that they are targeting hearing loss related tinnitus then it seems quite logical that they want people with measurable hearing loss. It could have to do with the fact that the concept of the causes of tinnitus is not clear and not all patients with tinnitus have hearing loss so it could due to a variety of factors. Obviously at the moment they are interested in getting fast results - treating the patients will be an interest once its on the market.
I would therefore strongly advise against lying - its better to wait instead of ruining the closest chance of getting a treatment for millions of people.

 

agreed. im also certain they know more than us and therefore know what they are doing. also lying to get in the trials is not advisable, it could skew the results and ruin it for the rest of us.

 

Of course people with a medical degree and loads of experience in the field know more than us! And they really seem interested in helping patients, not just getting money. The criteria is most likely for the patients own good - kind of like rules for children which they might not understand at the moment but will understand in the future.

 

Call me skeptical but I would say it's the other way around. However, i do understand that they are limited financially for whatever reason and thus the call to combine both trials into one. It just DQ's a large batch of us. We've waited long enough... Especially the old-T-timers. I would have hoped for maximum inclusion and in my mind, if they really wanted to help people, they would have found a way to have two separate trials --> One for T and one for hearing loss, as was outlined in their initial plan.

At the end of the day, it's about money. Maybe not them as individuals. Maybe they are all humanitarians at heart, maybe not? But the very nature of RnD relies on funding. So maybe not enough funding for both? Bean counters get hold of the figures and propose the best ROI. It's then up to the board to decide what is best for the company. Maybe they are doing their best with what they have. Again, just guessing.

I'm still not happy about it but it is what it is ....and there is nux i can do to change that. You'd have to be pretty good to cheat your audio. And b4 i get jumped on, i'm not suggesting it

 

Can anyone comment on the dosage schedule for aut00063. Quite different than retigabine, where the aut00063 is 4 pills in one dose per day for four weeks.

 

Yes of course they want money too but there are way easier ways to get tmoney instead of working a degree for a decade, then gaining years of experience and then working for a decade in order to make the drug. Its logical that helping people with science needs good marketing and scientists want to eat and rest too.
And nowadays I believe the criteria for allowing a drug on the market are very strict so they can't just do what they want - if they could then it would most likely on the market already. better be safe than sorry...

 

We are not talking rich here. We are talking MEGA SUPER WEALTHY. So yes, there are maybe better ways to make money but as far RnD goes, this is the holy grail for any medical research company. I think most doctors would agree that the person(s) that finds the cure for tinnitus (and hearing loss) will not only be nobel prize winners (instant fame status) and go down in the annals of history, along with the greats but will also profit monetarily in ways we can only imagine. So there is a lot riding on this for those involved both professionally and personally. No pain, no gain, so they say. So yes, these guys have done the hard hours but now they want the reward. And in my eyes, if they crack the T code, they are more than welcome to that and more! And I hope Autifony stocks outstrip Google

It's well beyond the realm of ordinary people and just making a living. It's big money/status, whatever you want to classify it as and the reason why the big driver when it comes to making decisions and getting results. It is also ironically the reason why the rules to bring it to market are so strict and well in place. Almost directly proportional to the potential billion yield. I'm glad the rules aren't relaxed by the FDA or country equivalent. I totally agree with them being in place in the case of T. Otherwise, we'd have pharmacies dispensing "Harry's Miracle T" cure every other day of the week!

 

The sad truth is that even if a person found the cure for T, he/she wouldnt win the nobel prize for it, cause no one cares about T. Maybe if they found a cure for hearing loss and deafness, but most definitely not for T.

And I agree with @Stina
No one who studies several years to become a medical professional do it solely for fame and glory. The main reason people become doctors or scientists is because they want to help people and make the world a better place.

 

I disagree. T is getting lots of attention now due to war veterans. Re the other point, we'll have to agree to disagree as it's getting off topic. Let's just hope it works.

 

yes T AND hearing loss are both certainly getting alot of attention as a result of the war veterans.....and trust me autifony knows it as they specifically referenced it in a response to an email i sent about extending the aut00063 trials to usa.

 

I would have to disagree with this as well, I have noticed, especially the later half of this year, that one of our more recognizable audiology clinics is advertising big time on the radio about Tinnitus as well as hearing loss, so T is becoming way more prevalent than ever before!

Agree x10, not one doctor, nurse or medical scientist that I know or heard of are in there chosen profession to make mega bucks!

Rich

 

does anyone have any thoughts on this or was it already discussed?

 

When first diagnosed 7 years ago, it took me 12 odd months to "habituate" to my tinitus, along with therapy, depression meds, and no finger nails or hair...however, I still don't understand that if I'm not focusing on it, but focusing on the masking, I still hear it over the masking, the weird thing is at 3 in the morning I am sound asleep in noddy land (with my white noise) my tinitus will wake me with the sound of a big mac truck stuck on full throttle crossed with a spin dryer thats got a broken off switch...deeming me partially deaf for most of the next day until it decides to subside to a level of tolerance. It also has no preferance of which ear, a lot of the time its in the middle.....or sounds like it's in the middle...as mine wasn't caused by anything environmental...I have always thought it's more to do with my brain than my ears....I've lead a very stressfull life due to family issues, and finding out stress is related to tinitus, just made life more gaga..!!.I don't hate much in my life, but I hate having tinits....I would swap it for just about anything, I would welcome any research to find a cause and make it stop.

 

Rube, I think it's probably to do with the low side effects they expect, in conjunction with the short time frame. They want to hit you with a massive dose all at once from day one, to give your brain a full month to adapt. Since the phase 1 trial showed it was safe, they're dropping da bomb.

 

@rtwombly thanks for the reply. I hope the trials show that a month dose is all thats required to rid tinnitus and/or repair some hearing loss. although that might limit their money making potential.......no repeat customers.