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

When do you know if you took placebo or the real drug?

 

As per Poonam Chowdhary (autifony)..

Results will likely be available at the end of this year..

 

I dont understand if the drug is so safe, why trial is only 1 month!!?? probably will need 3 months or more to see some noticiable effect as happens with troabalt, i think it will depend a lot of the onset time

 

I agree. Even most antidepressants take at least a month before they start to have any effect. For a drug that has no history in being used in humans for treatment of a medical condition, one month is a very short trial period.

I am also a little surprised in the few respondents who have come on this forum and are on the trial and expressing their findings.

 

I dont know what feedback participants need to give, but it may be and A-B-A test
A = baseline ie no autifony
B = with autifony

ie test the baseline ie no drug then the drug, then back to baseline again.

A-B-A test is often an improved way of testing compared to A-B .

Particitipants may be able to enlighten us on the feeback they have to give and when, we may then judge whether its ABA.

 

This actually scares me a lot.
They should really test people for different time frames to see what gives the best results.

It would be devastating if they just say it doesn't work while it only needed more time to kick in.

4 weeks is possibly nowhere near enough time!
Let's hope for the best!

 

They might need to up the dosage too.

 

I'm not a researcher or a scientist but this is bit silly to have a set dose and a set time frame.
More variability would certainly give better picture as to what may be more beneficial.

 

They might change stuff in Phase 3...I believe they did a dosage change in AM-101, so could do the same thing.

 

I think we should let the people conducting the research conduct their research. Ultimately they are conducting it in a way that they feel is the most beneficial for learning about the results of the study and are not conducting it to give its users a cure or relief from tinnitus, although if users experience any, that has to be a bonus.

 

I received an email from one of the researchers this week to say that the results probably wont be available till the end of this year.....just so you know......until then...lets just sit tight and wait......

 

Then more trials and by the time the drug comes to market, it will 2999! Lets wait for cure till then, suffering this dreaded curse!!

 

All these treatment protocols are based on either acoustic trauma or salicylate induced tinnitus in rats
I am not sure human tinnitus is similar what's the evidence

 

Who are the Doctors/Researchers running this Trial Study ? What exactly are they doing...try drugs or a device on subjects? Would you be able to provide that info. to curious ones here? Thx

 

maybe it is a good idea if you google the name of this thread AUTIFONY ... or read the start of it.

 

So what exactly is the purpose of this research/trial if not to find a cure???

 

If I recall correctly, the phase-I trial enlisted healthy volunteers for a 3-week course of the drug (possibly at a lower dose, 600mg, if I recall correctly). The treatment course for the phase-II trial is 4 weeks (for sure). I have been in contact with a researcher involved with trial several times. While the person did not explicitly mention the following when I spoke with him/her, the researcher did leave me with the impression that they are merely trying to establish whether the active compound of AUT-63 has some kind of efficacy (in humans). For instance, the person was unwilling to even attempt to answer as to whether AUT-63 would be curative or require life-long treatment to maintain suppression of symptoms of tinnitus. The person said - if I recall correctly: "It's early days still..."

Autifony Therapeutics did offer a little bit of insight themselves as to how soon the effects of the drug could be expected to be observed in humans:

The above is actually quite relevant/unique insight into the drug (as well as Autifony's own expectations).

My take on the whole matter (based on my collective information from the researcher) and knowledge in general is that the "real work" starts in phase-III. If phase-II is successful, that is...

attheedgeofscience
09/APR/2015.

 

As always, a cool-headed impartial logical thinking.

 

by the way what do you think of the low laser therapy ... by Dr Wilden ... They have removed our posts

 

Well - I did, as the Trial's peculiar name was "Autifony" (True term "Autophony", ironically is a classification under their long exclusions criteria list). Anyway, the clinical trial is based only in UK and as usual, the Trial evaluates a very specific, small criteria of subjects ingesting 800 mg of drug AUT00063 vs. placebo for 28 days of short-term testing: 150 subjects among twelve hospitals in UK = only 12 to 13 subjects!

The question is WHY they will NOT test any other subjects under their long "Exclusions" criteria list, which most T sufferers have. Why not?
I would say 3/4 of the population (& Veterans) have been diagnosed with "Depression" &/or "Anxiety", especially those who have T. Correct? And, "Otological conditions (including but not limited to....."
Obviously, the "researchers" already know the short-term results from animal lab studies. Million dollar gov. grants require the use of human subjects to pull in investors to get this out on the market asap, for all those baby-boomers/seniors in UK & N. America. $$$$$ Regardless of side-effects.
WOW- very short criteria and short-term testing (28 days). No disclosure of what occurs when patients under their long-exclusion criteria use it?...Obviously later, GP/ENT Drs will prescribe it regardless, to ALL desperate T sufferers.
Long-term Outcome? Again, no-one will know, till it affects the public on a much larger scale. Seems AUT00063's ingredients are very much alike of analgesic neurontin medication. Nothing new - just a fancier name & more money.

 

Because they do not want a highly heterogeneous mass of test subjects with various sub-types of tinnitus. That's why...

Yes. And...?

To my knowledge Autifony Therapeutics is a privately funded company with 3 main non-government investors. To the extent that funding has indeed been obtained from the UK government, perhaps that is simply because there is an unmet need for a tinnitus treatment and the science is promising (i.e. a first-in-class potassium channel modulator).

This is a phase-II trial. There is no need to do more thorough testing at this point. Simple as that.

Perhaps that group will be studied in a - yes, you guessed it - phase-III trial. Or perhaps the medication will end up not being prescribed for patients with maladies as per the exclusion list.

I didn't know that doctors could prescribe a drug that hasn't entered the market yet. And that was not a question, but a leading question (and without a question mark). All studies go on to a phase-III and a phase-IV post-market release evaluation. There is a reason why the average bench-to-bedside time period is about 10-years for drug candidates: it's because the stuff needs to evaluated properly and to make sure it is safe...


Finally, consider cutting down on your use of conspiracy theory material - I think it is having an unfortunate effect on you and your well-being. That would include staying away from websites and material such as:

1. www.darkgovernment.com/news/area-51/
   
2. http://rationalwiki.org/wiki/Moon_landing_hoax
3. Mel Gibson's Conspiracy Theory movie (1997)

In addition, I might suggest that you unplug your Internet connection permanently, because... "they" could be watching you...

 

I think they won`t test people with depression because they can not give an objective opinion about the results of the drug ... their emotions will play too much in there observations ... offcourse we all know anyone with decent T has some kind of down mood or depression about it ... but it takes an emotional stable person not to call his state a depression but take it as it comes ... with clarity. And so they will be a better judge to the effects of a drug and to give their opinion about it for scientific purposes ...

 

Does not require a "highly heterogeneous mass of test subjects" which you GREATLY exaggerated, but at least include those with more common forms of T from subjects in the general population. The only subjects accepted are ones who only had consistent "buzzing" of up to "6mos and no more than 18 mos." with NO other sinister or health issues. Realistic? Transparent? You believe in the testosterone pills on TV too?...they swore by clinical trials!
Many of the anti-epileptic drugs (AEDs) have side-effects that exacerbates or triggers suicidal thoughts and depression, therefore this may be the reason in not accepting any subjects with any level of "mental illness". However- this is not disclosed. Quote:"Nearly all anticonvulsants cause some degree of cognitive, behavioral, or psychiatric adverse reactions."

FYI: I confirmed this through FDA, did you? You are NOT educated in research nor comprehend how they process their work. You state they have 3 unknown "MAIN non-government investors". Who are they? Anything else? Are you saying one cannot question the validity of this trial, of those who will not disclose long-term outcomes or even say why they WON'T try it with a larger group of subjects from the general population, rather than just 13 specific subjects at 12 hospitals in 28 days. You state: "All studies go on to a phase-III and a phase-IV post-market release evaluation." Please provide this evidence of this for every drug and device on the market. Even FDA does not provide this data or information, only from "pre-clinical trials". Can you provide the published -valid- data of long-term trial requirements for every drugs/devices on the market? Pretty defensive of this Autifony" ClinicalTrial - Reason?

 

They are looking to prove efficacy in a certain type of patients with tinnitus. If they "cast the net too wide", they will get too many sub-types of tinnitus enrolled in the study. By having too many sub-types, that could lead to efficacy going unproven. Which would mean that the trial would fail already at the phase-II stage (despite being effective in a certain segment of patients). And that would be very unfortunate for the tinnitus community.

Yes. I have earlier on described them here:

If you read what I wrote earlier on in this thread you would have seen that the trial will progress on to a phase-III trial (with more test subjects). This is standard for any trial (not just this one).

Get help. And I am not even being sarcastic.

 

I rest my case.
You INVEST in SHARES in Corporate Conglomerate Pharmaceutical companies, including Pfizer. Therefore, your information is biased. Pfizer: A company with a history of Fraud, had one of the LARGEST Criminal fines in US history and Civil Penalties for providing false information to the public. Including "pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration (FDA) had never approved." etc. etc.

Thank you for sharing this critical piece of information about YOURSELF to the forum. Do you EVEN have T?

 

Why don't you take it from an unbiased source, then:

www.autifony.com/autifony-investors.asp

www.news-medical.net/news/20140604/Autifony-Therapeutics-awarded-c2a322-million-to-progress-first-in-class-drug-for-tinnitus-into-Phase-IIa-study.aspx

Happy???

 

@attheedgeofscience thank you for the info as always your such an asset to this forum
Thank you

 

There's more profit to be made in a life long treatment course, than a cure in one month.

 

Right on, Dan. I'm beginning to suspect that ATEOS is really a Vulcan!...

 

Since there obviously - and for good reason - continues to be an interest in the study (which is still in its early phases, overall, and post pre-clinical), I will release the info I have obtained from a researcher behind the trial:

Obtained: 24/DEC/2014.

Obtained: 21/AUG/2014.


Besides that, I have had a phone call with the same researcher during Fall, 2014 (which lasted about 5 to 7 minutes and which is where I gained most of my insight about the trial). In addition, I have also had two e-mail correspondences with the CEO of Autifony Therapeutics.

I do not believe that Autifony Therapeutics are in a "conspiracy" to maximize profits by specifically developing a drug that will require life-long suppressive treatment (as opposed to a one-off course) - which is what some members are insinuating. All they are aiming to achieve right now is to verify if what has been shown in animal studies also holds true in humans. If it works, Autifony Therapeutics are more than happy either way...

I will not disclose the source of the above information, but @Team Trobalt knows who the source is.

attheedgeofscience
10/APR/2015.

P.S. The links mentioned in the above sources may no longer be active (since the e-mails are at least ½-year old at this point...).