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

[attheedgeofscience]

ATEOS, neuropathic pain, epilepsy and tinnitus is neurology - it is exactly what Dr.Jeanomod is treating.

I don't hold a medical degree, but let me explain how I see it...

Tinnitus is a neurological condition (most probably) - agreed. But still, it most likely will fall under the category of otology - certainly, tinnitus is not considered a "hardcore" neurological condition such as epilepsy or ataxia. That's the point I am making.

Now when I look up my financial information, the companies I check out are listed in terms of their disease focus areas or "business category" as it is called - examples:

Autifony: "Other"
Otonomy: "Other, drug delivery, infectious"
Auris Medical: "Other"
Knopp Biosciences: "Neurology"

Do you see the distinction?

The above categorization tells me that otology therapy is not Knopp's primary focus. Perhaps tinnitus is something they are looking into as a by-product of their primary focus area ie. neurology. If Knopp was a "tinnitus company", they would have been assigned a business category of "Other". They weren't. That's the point I am making.

Take care.

 

[dan]

Ok I don't want to nitpick with you, we're on the same side here.
But all these drug companies should be under "neurology".
When you see Dr.Jeanmonod, he will explain it to you.

p.s. severe tinnitus is a hardcore neurological condition, imho.

 

[111]

I understand but, I don't believe they are looking into tinnitus specifically (that was the underlying message I was suggesting in my post). They are into neurology.

Do you think it really matters that much that it is a neurology company, at least they are completing research into different targets. Maybe companies are now realising that these Kv channels can help out on lots of conditions.

If you look at Autifony they say the below on their site.

Autifony are also using their pioneering approach to develop novel treatments for other serious disorders of the central nervous system.

Schizophrenia
Given Autifony's focus on modulation of Kv3 channels, which have also been implicated in other neurological and psychiatric disorders, there are opportunities for Autifony to investigate these other indications with compounds with different profiles.

 

[attheedgeofscience]

Do you think it really matters that much that it is a neurology company, at least they are completing research into different targets. Maybe companies are now realising that these Kv channels can help out on lots of conditions.

A "business category" is just a listing - agreed. But it provides an indication of what interests these companies are pursuing. As such, I don't care if it ends up being an anti-fungal drugs company which finds the cure for tinnitus.

The fact that they are pursuing Kv7 modulator subtypes, tells me that they are looking into diseases of the CNS (probably). Most likely, the tinnitus cases they are able to treat will have a limited focus. That's my guess. Their product seems to be in the pre-clinical stage. I doubt that they are a direct competitor to eg. Autifony or Auris Medical. My "financial nose" tells me they are pursuing "something else". If my financial nose had picked up a tinnitus scent, I would be more than happy to track down further information (and get in contact with them - one way or another). But my financial nose - which I trust a great deal - tells me that is not worth the time in this case (from a tinnitus perspective).

But I could be wrong, and I freely admit it. Please no further questions on this subject (= Knopp Biosciences) - for me, at least. Thanks!

 

[bluebrain]

So this kv7 modulator "thing" main idé is not primaly to treat t?

Are tinnitus treatment just a "maybe sidekick" effect of this research that were hoping for?

Sorry for my english and may my understanding with it.

 

[Juan Carlos]

IMHO, KNOPP is looking to create a med with same efficiency as Retigabine (kv7), wich i think is not bad at all in high doses, but without its bad side effect so it could be taken up to 800mg safely. Kv7 has 4 subchannels as I understood, and only some (2?) of them affect to tinnitus

 

[Stina]

IMHO, KNOPP is looking to create a med with same efficiency as Retigabine (kv7), wich i think is not bad at all in high doses, but without its bad side effect so it could be taken up to 800mg safely. Kv7 has 4 subchannels as I understood, and only some (2?) of them affect to tinnitus

Is that 800 mg a day, a week? Would you take it for some months, after regular intervals or for years?

 

[Juan Carlos]

Is that 800 mg a day, a week? Would you take it for some months, after regular intervals or for years?

that's per day, some people experienced benefits in few days. The recommanded treatment is 3 months if im not wrong (Autifony is 1 month), maximum dose 900mg per day. Check the Retigabine thread for details

 

[Eric Fridley]

im so hoping this stuff works cause idk how much longer i can take this i just want my relaxed quiet life back even if it takes 5-10-15 years to find a cure im hoping they do so we dont have to live life miserably

 

[dan]

15 years is a long time to wait

 

[Juan Carlos]

So this kv7 modulator "thing" main idé is not primaly to treat t?

Are tinnitus treatment just a "maybe sidekick" effect of this research that were hoping for?

Sorry for my english and may my understanding with it.

KV7 (retigabine) is meant to treat epylepsy, effect on T is like a 'secondary effect', but Autofony focus on KV3 wich is meant to be specific for T. Retigabine have some side effects that could be serious in some cases , but Autifony is meant to have very little side effects so it can ba taken full dose from the beginning while Retigabine must start slowly with low dosages

 

[Eric Fridley]

15 years is a long time to wait

thats why i said 5 years first im hoping they can get the cure after they have a treatment cause after they have a treatment a cure will be here faster cause they know what there doing and how tinnitus works

 

[Lisa88]

Just an add to some of the posts above:

Yes, I do believe t is a neurological condition - the brain, the central nervous system. But I also believe that it is where the brain interacts with the auditory system - i.e. the Central Auditory Cortex (with neuron overfiring) and the Central Auditory Nervous System. Why do some people get t and others do not? Maybe it could be because somewhere along this auditory nervous system, there is vulnerability, and the brain responds. Read up on the Central Auditory Cortex, and you will see this holds the crossroads to so many other nervous systems.

On the Autifony note, I don't think they have posted locations yet.
Please Please someone enroll in the trial, and keep us posted!!!

 

[t-man]

Please Please someone enroll in the trial, and keep us posted!!!

We would if we could. It's just their requirements are rare to this community.

 

[Danny Boy]

How long do you reckon this will be in trials, till when we can get it on prescription? And the requirements to enter the trial make me weep...You have to have hearing loss? Tinnitus is in the brain and this drug aims at the hyperactivity in the brain, so why would you need hearing loss?

 

[Lisa88]

How long do you reckon this will be in trials, till when we can get it on prescription? And the requirements to enter the trial make me weep...You have to have hearing loss? Tinnitus is in the brain and this drug aims at the hyperactivity in the brain, so why would you need hearing loss?

Just this phase appears to have the hearing loss requirements. This drug will be for t, not just t and hearing loss. They have intimated that they will open it up in future phases.

 

[Danny Boy]

I hope they do...Issue is, the requirements are for people with t for under 18 months...By the time phase 3 comes I won't be able to have it...And another issue is, does this only for people who've had it for under 18 months?

Just this phase appears to have the hearing loss requirements. This drug will be for t, not just t and hearing loss. They have intimated that they will open it up in future phases.

 

[rtwombly]

I hope they do...Issue is, the requirements are for people with t for under 18 months...By the time phase 3 comes I won't be able to have it...And another issue is, does this only for people who've had it for under 18 months?

It's likely that if AUT-00063 is successful, it will help people regardless of how long they've had tinnitus. There are really two effects they're hoping for: shutting of the noises and keeping them off without the drug. Even if only #1 works, the aim is that the drug will be so free of side effects that you can safely take it every day for life.

 

[jazz]

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?

Hearing loss--even hidden hearing loss--is associated with nearly all tinnitus cases. That said, for many hearing loss is a necessary, but not a sufficient condition for tinnitus emergence. Something else must also happen, and there are a variety of factors that must combine with hearing impairment, such as a deficiency in BDNF or some type of recent emotional trauma.

Tinnitus literature nearly always focuses on hearing loss as a tinnitus generator. For example, researchers like to analyze the relationship between the degree of hearing loss and tinnitus severity, or they like to examine how the psychoacoustical qualities of tinnitus correlate with hearing loss or maximum hearing loss.

Given these research areas, it makes sense that Autifony would focus on people with mild-to-moderate hearing loss. This group is the most well documented and best understood of the various tinnitus subtypes. People with no measurable hearing loss (or hidden hearing loss) or people with profound hearing loss, therefore, would not be as satisfactory as candidates for their study. And, of course, the mild-to-moderate hearing loss group will also be quite large so there's no reason to recruit from other tinnitus subgroups.

About the 18 month criteria, that number is sometimes used in medical literature to describe when the tinnitus precept becomes less likely to respond positively to therapeutic intervention. Of course, one year is the most common number used, but you do sometimes see 18 months. But 18 months is better for us chronic sufferers anyway.

Just remember it's all about Autifony creating the best possible climate for their trial to succeed. And this is not a bad thing. We want them to succeed. If they succeed with this trial, they may expand the time period beyond 18 months for their follow up study.

 

[Lisa88]

Hearing loss--even hidden hearing loss--is associated with nearly all tinnitus cases. That said, for many hearing loss is a necessary, but not a sufficient condition for tinnitus emergence. Something else must also happen, and there are a variety of factors that must combine with hearing impairment, such as a deficiency in BDNF or some type of recent emotional trauma.

Tinnitus literature nearly always focuses on hearing loss as a tinnitus generator. For example, researchers like to analyze the relationship between the degree of hearing loss and tinnitus severity, or they like to examine how the psychoacoustical qualities of tinnitus correlate with hearing loss or maximum hearing loss.

Given these research areas, it makes sense that Autifony would focus on people with mild-to-moderate hearing loss. This group is the most well documented and best understood of the various tinnitus subtypes. People with no measurable hearing loss (or hidden hearing loss) or people with profound hearing loss, therefore, would not be as satisfactory as candidates for their study. And, of course, the mild-to-moderate hearing loss group will also be quite large so there's no reason to recruit from other tinnitus subgroups.

About the 18 month criteria, that number is sometimes used in medical literature to describe when the tinnitus precept becomes less likely to respond positively to therapeutic intervention. Of course, one year is the most common number used, but you do sometimes see 18 months. But 18 months is better for us chronic sufferers anyway.

Just remember it's all about Autifony creating the best possible climate for their trial to succeed. And this is not a bad thing. We want them to succeed. If they succeed with this trial, they may expand the time period beyond 18 months for their follow up study.

Yes, thanks, Jazz. Always so interested in what you have to contribute.
A couple of us emailed, and they responded intimating that it will open up eventually. So yes, the drug will be available to us all in time, no matter how chronic and no matter what hearing loss or not shows up on our audiograms/OAEs.
Also, I have known of 3 people so far with t who also had Candida. They all 3 went on the Candida diet, and all 3 had t completely go away. They each had had t for about 25-30 years. Although these cases are specific to Candida, it also shows that t may be able to respond in chronic cases. Benryu's posts suggest that this KV3 opener may be able to do just that.

 

[Katarina]

http://www.actiononhearingloss.org....log/new-funding-boosts-tinnitus-research.aspx

fingers crossed.

 

[dboy]

Thanks Katarina. I was a little surprised when I read this:

"By using AUT00063 to correct the activity of these neurons, the clinical researchers hope to reverse this early stage of tinnitus development and prevent longer term tinnitus-related changes in the brain."

That sounds less like it will be suitable for chronic cases. I don't understand the supposed mechanism by which the drug works as well as several other TT members do - perhaps someone can comment on this?

 

[hoper]

sorry - is the drug only for people they have T 6-18 months? or is that just for the study?

 

[Stina]

sorry - is the drug only for people they have T 6-18 months? or is that just for the study?

Its for chronic sufferers and the 6-18 is for the study

 

[hoper]

okay thank you.
any informations when it comes to the market?

sorry if one of you wrote this already. my english is not good and i dont unterstand all

 

[Stina]

okay thank you.
any informations when it comes to the market?

sorry if one of you wrote this already. my english is not good and i dont unterstand all

They finished Phase I (side effect trial) successfully. Now they will start with phase 2 estimates to end sometime in 2016. After that they will know if it had a positive outcome and then they can see if they continue with the trials or not. Normally the 3rd trial takes around 1,5-2 years + time until it goes commercial. my guess is it will be on the market around 2019 unless it gets a special allowance to go on the market earlier (although there are no good grounds for that.)

 

[hoper]

does it comes to the european market too? for example austria?

 

[Stina]

does it comes to the european market too? for example austria?

Im sure its in Autifony's interest to get to as many countries as possible but as it depends on the country as well it can't be said before the drug is about to go commercial.
The trials take place in the UK.

 

[hoper]

and it had good results no? my name is hoper because i hope so much the drug (and oto311) will help me.

 

[Lisa88]

They finished Phase I (side effect trial) successfully. Now they will start with phase 2 estimates to end sometime in 2016. After that they will know if it had a positive outcome and then they can see if they continue with the trials or not. Normally the 3rd trial takes around 1,5-2 years + time until it goes commercial. my guess is it will be on the market around 2019 unless it gets a special allowance to go on the market earlier (although there are no good grounds for that.)

Are these timing estimates for Autifony listed anywhere?