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

[Eric Fridley]

so i went to ENT yesterday and i have a 20% hearing loss in my left ear where my tinnitus is how much db is that? is that why i have tinnitus or is the tinnitus making me have hearing loss? can i be in the trial when is comes to US since my tinnitus is related to hearing loss? im due to a MRI scan of my ear brain and my jaw cause he wants to know why i have ringing in my ear for no reason

 

[dan]

so i went to ENT yesterday and i have a 20% hearing loss in my left ear where my tinnitus is how much db is that? is that why i have tinnitus or is the tinnitus making me have hearing loss? can i be in the trial when is comes to US since my tinnitus is related to hearing loss? im due to a MRI scan of my ear brain and my jaw cause he wants to know why i have ringing in my ear for no reason

You gotta ask for a copy of your audiogram and that will tell you how many dB loss at each frequency. I would assume they would do a US trial if the UK trial is successful.
Yes, the tinnitus is most likely due to the hearing loss in your case.

 

[Larry OT]

so i went to ENT yesterday and i have a 20% hearing loss in my left ear where my tinnitus is how much db is that? is that why i have tinnitus or is the tinnitus making me have hearing loss? can i be in the trial when is comes to US since my tinnitus is related to hearing loss? im due to a MRI scan of my ear brain and my jaw cause he wants to know why i have ringing in my ear for no reason

Tinnitus doesnt make hearing loss or worsen it. The sound of tinnitus is a brain function caused by many possible things. you have some hearing loss, and 20 %. from normal hearing range is not that bad. You do need to see the audiogram for db as Dan stated and your tinnitus is probably from the loss, but other factors may be involved.
You do need to be careful about loud music and other sounds that are loud and keep protecting your ears.
The MRI is important at this point. Ask for an open MRI as they are not as loud or clostrophobic. They may be able to determine what's going on but may never give you the reason other than hearing loss.
Some people get T for no apparent reason they know of.
It's a mystery in some cases. The important part is protecting your ears now and staying aware of ototoxic meds. Ask your doctors when they prescribe you meds.

 

[Eric Fridley]

i just hoping that in the near future we can get a good treatment for this cause i really dont wanna live my life with this like some of you already have been with it for 30-40 years i woul dhave already killed myself by then i am really hoping this AUT00063 really does work and it still can be even a cure cause they dont know how it works yet with people that have tinnitus but if its a good treatment then they are closer then ever to find a cure for this thing we mite have to live with is for another decade but i would say a cure will come in the next 10 years so ill be 35 so ill still have a good silence life to live after that

 

[FERNANDO GIL]

You should make your earing tests all the way to the 16 MHz. Other wise you will never know we're is your problem.
Tinnitus is always caused due earing loss.

 

[rtwombly]

In order to ensure a neurological cause and not a psychological issue.

Agree, that's the main reason, but hey are also hoping 063 helps with processing-based hearing loss issues. Two birds, one stone.

Any updates from our UK friends?

 

[dan]

I can't believe the Autifony trials have been going on since October and nobody has yet to come forward on any forum saying they were cured or improved...this is concerning to me.

 

[xanaxvictim]

I can't believe the Autifony trials have been going on since October and nobody has yet to come forward on any forum saying they were cured or improved...this is concerning to me.

I don't know. It's a good point. My feeling is they will be full by Feb anyway.

All i asked was if the person starting tomorrow would be willing to give me feedback. At this point, I know nothing about the person other than they are starting tomorrow. Which is a good thing, otherwise patient confidentiality would be broken. So only if the person starting tomorrow consents to talk to me, will I hear anything.

Sorry, no other info at this point. I thought i was pushing it as is, asking even that.

So it only began on Nov. 28 when the first test subject supposedly took his/her first AUT 00063 pill, not October, result too early to tell

 

[dan]

So it only began on Nov. 28 when the first test subject supposedly took his/her first AUT 00063 pill, not October, result too early to tell

When @amandine called one of the hospitals, the lady in charge said they already started in October, if I recall correctly.

 

[nills]

I can't believe the Autifony trials have been going on since October and nobody has yet to come forward on any forum saying they were cured or improved...this is concerning to me.

They will have had to sign papers not to speak about it, obviously ...

 

[mcgregor]

They will have had to sign papers not to speak about it, obviously ...

I didn't have to sign anything not speak about it, just a consent form to participate, don't know about starting in October, could have just been selection process that they where talking about. Medication has to be taken no longer than 28 days after been selected, so still early days from getting any more info.

 

[Cloaks]

Since there are claims that they have started in October, let's hope they're willing to disclose at least some (official) information concerning the preliminary results.

@nills ; Would there be that much to lose? Since they've got everything covered with patents. I can understand that it's not in their best interest if negative news would start to spread. On the other hand, I'd like to think that positive news would be very beneficial for their own (and others') cause.

If I would be in the position to get some (positive?) news out, I'd do it anonymously either way.. Since the community is starving for more information.

 

[SteveToHeal]

One of the requirements you get on is you are not on AD's. They are killing us here man. We have depression because we have t. Not the other way around. You get t. You get on AD's to cope. But then you can't get on a trial because you're on AD's. You can't win. I'm so frustrated with the criteria. It's almost as if it is not worth the suffering. Maybe just wait for other people to report. And before anybody tries to explain why trials need you off AD's, I know, I know, I know. Just hacked off with all this pushing to get well. F&*k!!!

 

[amandine]

Everyone the lady told me that the trial had been running since October not just registration

 

[Hudson]

I didn't have to sign anything not speak about it, just a consent form to participate, don't know about starting in October, could have just been selection process that they where talking about. Medication has to be taken no longer than 28 days after been selected, so still early days from getting any more info.

@mcgregor does that mean you're participating in the trial in the UK then?

 

[Martin69]

One of the requirements you get on is you are not on AD's. They are killing us here man. We have depression because we have t. Not the other way around. You get t. You get on AD's to cope. But then you can't get on a trial because you're on AD's. You can't win. I'm so frustrated with the criteria. It's almost as if it is not worth the suffering. Maybe just wait for other people to report. And before anybody tries to explain why trials need you off AD's, I know, I know, I know. Just hacked off with all this pushing to get well. F&*k!!!

Absolutely agree. We are on ADs, benzos and anti-anxiety meds.
And they want us being drug free.
Also they want have hearing loss in the low frequencies.
I do not have that, but hearing loss in the very high frequencies - where my T is.
But for me it doesn't matter at all since I do not live in the UK anyway.

I sometimes even don't know if I want to know at all if this drug helps or not.
I live in hope that something will help us. If the first message comes out, AUT00063 does not help, the disappointment would be hard to accept. The question is if no news is good or bad news.
For the moment, I think it is just too early.

 

[mcgregor]

@mcgregor does that mean you're participating in the trial in the UK then?

No unfortunately not , I got as far as signing the consent form then answering three pages of questions on my response to tinnitus ( passed on that )then a hearing test, failed on that ( 80 db loss ) to much of a loss for them,
so out of trial.

 

[RaZaH]

Do they require you to have low frequency hearing loss ? That is kind of strange as that is in no way classic acoustic trauma hearing loss @ 4-6khz.

 

[amandine]

@RaZaH

I was told that they are testing in some places up to 10 or even 12hz for hearing.
And what they were going to do is take an average hearing loss across the whole range.
The whole thing seems utterly confusing to me....

 

[Martin69]

@RaZaH

I was told that they are testing in some places up to 10 or even 12hz for hearing.
And what they were going to do is take an average hearing loss across the whole range.
The whole thing seems utterly confusing to me....

The drug is also for hearing loss. So they want to see if it helps against hearing loss, even if it does not do anything on T. But I am wondering how a drug can help against damaged hear cells. But I am no doctor, so I am only guessing here.

 

[valeri]

It's hard to believe that out of all tinnitus forums and Facebook groups we don't hear anyone got selected!!!!

 

[just1morething]

It's hard to believe that out of all tinnitus forums and Facebook groups we don't hear anyone got selected!!!!

They may have to take a "oath of silence", who knows?

 

[dan]

They may have to take a "oath of silence", who knows?

@mcgregor said that if he wanted to he could share his experience with Aut,but he wasn't accepted. So no, no oath of silence.

 

[just1morething]

@mcgregor said that if he wanted to he could share his experience with Aut,but he wasn't accepted. So no, no oath of silence.

I was referring to the one's that were accepted.

 

[dan]

I was referring to the one's that were accepted.

I am saying that Autifony did not object to it, were he to be accepted.
That's my understanding from Mcgregor.

 

[PhilB]

At this stage, I think it would be a mistake to assume that people who have been accepted on to the trial have been made to sign a confidentiality agreement which prevents them from discussing the trial on forums such as this one. I have been in frequent contact with one of the participating hospitals over the last 3 weeks or so. I am led to believe that this hospital has assembled a list of "trialees" but at present, the list consists entirely of people who were already ENT patients at the hospital.

At this particular hospital, there have been only a small number of inquiries from people (such as myself) who were not already known to the hospital but have contacted them as a result of seeing their number listed on the Autifony web site. More than once, it has been necessary for me to explain to them that the trial is actually open to anyone who meets the inclusion criteria and it is not restricted to their own pre-existing ENT patients.

As I've said before, the application process involves obtaining a referral from ones own GP. In my case, the referral initially got lost and it was necessary for the hospital to contact my GP in order to get it resent. The point I am making is that the NHS is a very large and sometimes cumbersome organization. It generally takes a long time to get anything done and my attempt to get recruited on to this trial is proving to be a slow and frustrating process. If my experience is at all typical, then I suspect not many people have yet been accepted. I don't know if those who are accepted will be sworn to secrecy but I think it is still too early to assume that this is the reason why we have not yet had any feedback from AUT00063 trialees.

 

[Martin69]

So quiet here.

 

[Hudson]

Well, the good thing about this trial is that it's slated to be completed by June of 2015. We'll probably get results a few months after that. If they start ramping up for a phase IIb trial right before the end of the trial or immediately after, that will be a good indictation that preliminary efficacy data was good.

 

[Viking]

I don't understand the exclusion criteria for patients who use ADs. probably because ADs affect potassium channel?
Prozac is also knowed like a ototoxic AD and with tinnitus activities but on pubmed i have found this:
J Pharmacol Sci. 2008 Jan;106(1):38-45. Epub 2008 Jan 11.

Open channel block of Kv3.1 currents by fluoxetine.

Sung MJ1, Ahn HS, Hahn SJ, Choi BH.

Author information

Abstract

The action of fluoxetine, a serotonin reuptake inhibitor, on the cloned neuronal rat Kv3.1 channels stably expressed in Chinese hamster ovary cells was investigated using the whole-cell patch-clamp technique. Fluoxetine reduced Kv3.1 whole-cell currents in a reversible, concentration-dependent manner, with an IC(50) value and a Hill coefficient of 13.4 muM and 1.4, respectively. Fluoxetine accelerated the decay rate of inactivation of Kv3.1 currents without modifying the kinetics of current activation. The inhibition increased steeply between 0 and +30 mV, which corresponded with the voltage range for channel opening. In the voltage range positive to +30 mV, inhibition displayed a weak voltage dependence, consistent with an electrical distance delta of 0.38. The binding (k(+1)) and dissociation (k(-1)) rate constants for fluoxetine-induced block of Kv3.1 were 5.7 microM(-1)s(-1) and 53.5 s(-1), respectively. The theoretical K(D) value derived by k(-1)/k(+1) yielded 9.3 microM. Fluoxetine did not affect the ion selectivity of Kv3.1. Fluoxetine slowed the deactivation time course, resulting in a tail crossover phenomenon when the tail currents, recorded in the presence and absence of fluoxetine, were superimposed. Inhibition of Kv3.1 by fluoxetine was use-dependent. The present results suggest that fluoxetine acts on Kv3.1 currents as an open-channel blocker.

There are many papers online about people experienced the disappearing of tinnitus with a low dose of fluoxetine (10mg) in 1 week.
I haven't word about Autifony

 

[Lisa88]

I don't understand the exclusion criteria for patients who use ADs. probably because ADs affect potassium channel?
Prozac is also knowed like a ototoxic AD and with tinnitus activities but on pubmed i have found this:
J Pharmacol Sci. 2008 Jan;106(1):38-45. Epub 2008 Jan 11.

Open channel block of Kv3.1 currents by fluoxetine.

Sung MJ1, Ahn HS, Hahn SJ, Choi BH.

Author information

Abstract

The action of fluoxetine, a serotonin reuptake inhibitor, on the cloned neuronal rat Kv3.1 channels stably expressed in Chinese hamster ovary cells was investigated using the whole-cell patch-clamp technique. Fluoxetine reduced Kv3.1 whole-cell currents in a reversible, concentration-dependent manner, with an IC(50) value and a Hill coefficient of 13.4 muM and 1.4, respectively. Fluoxetine accelerated the decay rate of inactivation of Kv3.1 currents without modifying the kinetics of current activation. The inhibition increased steeply between 0 and +30 mV, which corresponded with the voltage range for channel opening. In the voltage range positive to +30 mV, inhibition displayed a weak voltage dependence, consistent with an electrical distance delta of 0.38. The binding (k(+1)) and dissociation (k(-1)) rate constants for fluoxetine-induced block of Kv3.1 were 5.7 microM(-1)s(-1) and 53.5 s(-1), respectively. The theoretical K(D) value derived by k(-1)/k(+1) yielded 9.3 microM. Fluoxetine did not affect the ion selectivity of Kv3.1. Fluoxetine slowed the deactivation time course, resulting in a tail crossover phenomenon when the tail currents, recorded in the presence and absence of fluoxetine, were superimposed. Inhibition of Kv3.1 by fluoxetine was use-dependent. The present results suggest that fluoxetine acts on Kv3.1 currents as an open-channel blocker.

There are many papers online about people experienced the disappearing of tinnitus with a low dose of fluoxetine (10mg) in 1 week.
I haven't word about Autifony

As I understand it, any drug altering brain chemistry may adversely effect the trial. As I recall, the vagus nerve trial also showed unsuccessful outcomes for those on ADs and similar drugs.