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

#2,401
@Gill Hayes - sorry to hear that you didn't get on the trial. I didn't get on either. In my case, it was high blood pressure which made me ineligible. That was back in January and my BP has lowered a bit since then but I am now just over the 18-month limit. I guess we just need to be patient in waiting for the time when this drug is available to all who might benefit from it, that's assuming it does what it is supposed to do.
 
#2,403
Nucleo said:
Is this for real real? They won't let you in if they deem you don't have it bad enough?
Click to expand...

Oh man, FINALLY !!!!! A company that takes tinnitus trials seriously! I am SO happy that people who dont suffer from their tinnitus or cope with it very well, are screened out!
People - if you dont SUFFER from your tinnitus - Please dont try out for this trial?!
First it increases chances of placebo effect, secondly, you are taking the place of a sufferer that is truly in need of this drug.

If you DONT SUFFER, be patient and wait for phase 3 or 4 (market release)!!!

I am so glad Autifony is doing this thing RIGHT. As previous companies trialling tinntius would let very mild T people and not severe sufferers, hence the placebo effect is HUGE.
We need ROBUST conclusions - not IFFY.
 
#2,404
Yes Nucleo that is correct !

I was a bit surprised myself. But then I thought, well because I'm doing so well with my T it would be difficult to monitor whether it was the drug ( if I got the active drug of course - because I might have got placebo) or if it was just the progression of the condition that was causing me not to hear it / it fading.
There has to be a level of loud, consistent T I suppose in order for them to be sure the improvement (if there is any) is due to the active drug working and not a natural improvement that would have happened anyway - so I kind of get it.

PhilB - sorry to hear you didn't get on the trial either. But it makes sense that someone with high blood pressure wouldn't get on, as unfair and frustrating as that is.
I passed all the 'tests' but my T wasn't bad enough, even though my T is there all the time and I would definitely know if there was any improvement ! They assessed it by asking me to answer loads of questions on a questionnaire and you have to score between 25 - 68. I got 14.6 so it was a no go for me. I said I would be happy to be included in the Phase 111 trial if the criteria was expanded to include any level of tinnitus etc and they said I would be contacted if this was the case. So who nows, we may get on the next phase trial ( if there is one!). Fingers crossed . . . x
 
#2,405
dan said:
Oh man, FINALLY !!!!! A company that takes tinnitus trials seriously! I am SO happy that people who dont suffer from their tinnitus or cope with it very well, are screened out!
People - if you dont SUFFER from your tinnitus - Please dont try out for this trial?!
First it increases chances of placebo effect, secondly, you are taking the place of a sufferer that is truly in need of this drug.
Click to expand...

Well I assume one must have some degree of suffering to actively seek out and sing up for clinical trials. These trials are no joke. We're talking about experimental drugs after all.
 
#2,406
dan, I agree with you entirely BUT if people don't go for the screening they don't know whether they fit the bill or not. I think it a credit to anyone who puts their neck on the line and their wellbeing at stake and subject themselves and their health to try a new, unproven drug that fucks with their brain for the greater good of everyone else. Show some respect sir.
 
#2,407
Gill Hayes said:
dan, I agree with you entirely BUT if people don't go for the screening they don't know whether they fit the bill or not. I think it a credit to anyone who puts their neck on the line and their wellbeing at stake and subject themselves and their health to try a new, unproven drug that fucks with their brain for the greater good of everyone else. Show some respect sir.
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You have a point too, but what I mean is just exactly what you said yourself

Gill Hayes said:
I was a bit surprised myself. But then I thought, well because I'm doing so well with my T it would be difficult to monitor whether it was the drug ( if I got the active drug of course - because I might have got placebo) or if it was just the progression of the condition that was causing me not to hear it / it fading.
Click to expand...

In my personal opinion, and its just mine opinion, a person with T ought to know if he is suffering or coping well...its pretty much a no brainer. If you need a screening questionnaire to tell you whether you are suffering - then ur not suffering lol.
 
#2,408
Nucleo said:
Is this for real real? They won't let you in if they deem you don't have it bad enough?

Here are the inclusion/exclusion criteria from the trials web page. It seems they have removed the hearing loss requirements of 20 db?

https://clinicaltrials.gov/ct2/show/NCT02315508

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
  • English-speaking, who are UK residents registered with a UK General Practitioner;
  • Experiencing stable tinnitus (consistent from day to day)
  • Tinnitus has existed for not less than 6 months, and not more than 18 months - Contraceptive methods must be used before and for at least 30 days after the stop of the study treatment.
Exclusion Criteria:
  • Severe hearing impairment such that verbal communication is unreliable;
  • History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the Investigator and which might be jeopardised by entering the study;
  • Moderate or severe depression or generalised anxiety
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of starting the investigational treatment
  • Participation in hearing study, involving an intervention, within 3 months from last study visit;
  • Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson's disease;
  • Tinnitus as a concomitant symptom of a known otological condition (including but not limited to otitis externa, otitis media, otosclerosis, cholesteatoma, Ménière's disease or other vestibular problems, acoustic neuroma, or temporo-mandibular joint disorder);
  • Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat);
  • Intermittent tinnitus (comes and goes from one day to the next);
  • Surgery or medical condition that might would be expected to significantly affect absorption of medicines;
Correct me if I'm wrong someone but it seems to me that doing well with your tinnitus is not an exclusion criteria. It seems quite the opposite really.
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They just need sane people that are able to objectively give answers and data ... if they let in emotionally unstable people it is really hard to trust what they say ... one day might be good another bad and you wouldn`t know what really was the reason.
 
#2,409
dan, this trial is to develop a drug for tinnitus not for suffering. I have tinnitus. The fact that you have to be suffering as a criteria for inclusion was a new one on me. Please think before you write your drivel.
 
#2,410
Gill Hayes said:
dan, this trial is to develop a drug for tinnitus not for suffering. I have tinnitus. The fact that you have to be suffering as a criteria for inclusion was a new one on me. Please think before you write your drivel.
Click to expand...
Well apparently it's not drivel since Autifony seems to agree with me, but we're on the same side here so I will honorably back out.
 
#2,411
I agree with Dan.

Alot is at stake with these trials so they have to do it right.

If you take people that are suffering and after the trials they are doing much better, not suffering, you can be sure the drug is effective, there can be no discussion or interpretation of the results afterwards. It either works or not.

With people that have T but are not suffering the results can be much more subjective.
 
#2,412
Bart said:
I agree with Dan.

Alot is at stake with these trials so they have to do it right.

If you take people that are suffering and after the trials they are doing much better, not suffering, you can be sure the drug is effective, there can be no discussion or interpretation of the results afterwards. It either works or not.

With people that have T but are not suffering the results can be much more subjective.
Click to expand...
Thank you Bart. It takes courage to stand up for the truth, however inconvenient or painful it may be.
 
#2,413
Dan, Bart whatever your standpoint on this the fact remains that nowhere has Autifony stated in their inclusion criteria that a person has to be 'suffering' with their T in order to be included in the trial. If they had maybe me and others would not have wasted an afternoon off work for no reason.
 
#2,414
Gill Hayes said:
Dan, Bart whatever your standpoint on this the fact remains that nowhere has Autifony stated in their inclusion criteria that a person has to be 'suffering' with their T in order to be included in the trial. If they had maybe me and others would not have wasted an afternoon off work for no reason.
Click to expand...

Idk, you tell, me do other companies for different drugs state in their inclusion criteria -

YOU MUST SUFFER FROM YOUR CONDITION!

Sounds kind of silly if you ask me lol.
You see Tinnitus is one of the most heterogeneous conditions out there. It has a dozen causes and it has a super wide spectrum of suffering - from NON ISSUE to SEVERE and DISBALING.
Imagine 90% of trialees were those in the Non-Issue category - it would be a very ineffective trial at best, as most trialees would have a very hard time telling the difference is their pre and post trial tinnitus.
So please give Autifony the benefit of the doubt in dealing with these obstacles.
As the drug passes more phases, criteria will be surely more lax.
Im sorry you wasted an afternoon going to Autifony, but I am glad you were refused (no personal offense).

Edit: There was actually a very good reason for your afternoon, now many people can make a more informed decision as to whether or not to apply for the trial.

Double Edit: Pardon me for my direct approach and uncensored style of posting.
I am not British.
 
#2,415
nills said:
They just need sane people that are able to objectively give answers and data ... if they let in emotionally unstable people it is really hard to trust what they say ... one day might be good another bad and you wouldn`t know what really was the reason.
Click to expand...

But then they also turn down people who are not ''suffering enough'' according to their standards. I could trust testimony from such patients. Who the hell can get in then? They won't take people who are are doing relatively well and they won't take complete trainwrecks either as people who have depression and/or anxiety as a result of T are excluded. It's no wonder they have a hard time getting their participant quota.

For all it's worth my opinion is that it is far easier to sucessfully treat mild conditions than severe ones. Tinnitus included.
 
#2,417
Sorry for small offtopic, I give all my hopes to Autofiny

But, Autifony is not so large company, compared to Bayer or La Roche... Potential market for T. drug (that works) is abt 60.000.000 of customers worldwide. Let's suppose that 1 month treatment is not gonna be less than 100 euros, it is 6.000.000.000 per month- income? Just one month. For example whole 1 year income of Bayer is 48.000.000.000

Do u folks think that big sharks as La Roche, and Bayer are gonna let that to Autifony?
 
#2,419
PhilB said:
I don't know anything about the specifics of the relationship between GSK and Autifony
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See below, they basically allowed Autifony the rights to patented compounds and data in exchange for shares in Autifony


GSK takes minority stake in new spin out Autifony Therapeutics
22 August 2011

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

Issued: Monday 22 August 2011, London UK

GlaxoSmithKline plc today announced that its wholly-owned subsidiary Glaxo Group Limited (GSK) will receive a 25.4% minority equity stake, representing a £1,250,000 investment, in Autifony Therapeutics Limited, a UK-based biotechnology start up created through a funding round of up to £10 million alongside investors Imperial Innovations and SV Life Sciences.

Under the terms of the agreement, Autifony will issue 850,000 A ordinary shares to GSK in exchange for a number of pre-candidate voltage-gated ion channel modulator compounds and associated patent applications and data for development in hearing loss, as well as 571,429 Series A preferred shares in recognition of £400,000 worth of development work funded by GSK on behalf of Autifony.

GSK will also be eligible to receive a further 550,000 A ordinary shares on achievement of a pre-determined milestone, at which time there will be a further investment by the existing consortium and GSK will then own 13.2% of Autifony on a fully diluted basis.
 
#2,420
Lots of speculation here. The fact remains that they know what they are doing as they have conducted many trials and have bought many drugs to market already. How many have all of us done? That answer is a big fat zero, zilch, nada.
 
#2,421
markoana said:
Sorry for small offtopic, I give all my hopes to Autofiny

But, Autifony is not so large company, compared to Bayer or La Roche... Potential market for T. drug (that works) is abt 60.000.000 of customers worldwide. Let's suppose that 1 month treatment is not gonna be less than 100 euros, it is 6.000.000.000 per month- income? Just one month. For example whole 1 year income of Bayer is 48.000.000.000

Do u folks think that big sharks as La Roche, and Bayer are gonna let that to Autifony?
Click to expand...
Autifony is a daughter company of GSK .. .and has big shot investors behind them ... they are small fish with big brothers and sisters and moma shark behind them ...

Autifony Therapeutics is an independent UK based biotechnology company formed in 2011 as a spin-out from GSK, which retains equity in the company. The company is focused on the development of high value, novel medicines to treat hearing disorders and serious disorders of the central nervous system, such as schizophrenia. Autifony Therapeutics is funded by SV Life Sciences, Imperial Innovations, Pfizer Venture Investments, International Biotechnology Trust PLC and UCL Business.
 
#2,422
Rube said:
Lots of speculation here. The fact remains that they know what they are doing as they have conducted many trials and have bought many drugs to market already. How many have all of us done? That answer is a big fat zero, zilch, nada.
Click to expand...

It is Autifony's very first trial as an independant entity from GSK. They have not brought any other drugs to the market.
 
#2,423
nills said:
Autifony is a daughter company of GSK .. .and has big shot investors behind them ... they are small fish with big brothers and sisters and moma shark behind them ...
Click to expand...



I hope so Nills...But as far as I am thinking about autifony, I have kind of fear that they are not strong enough to produce drug for 70 billions USD income per year... This is big game, that drug will not have any other alternative, everyone, millions worldwide will buying this.... I think that we are not aware of how big money is in the game if any drug for T made success...
 
#2,427
Nucleo said:
To assume Autifony will be a sucess just because some former GSK authority figures are involved is a fallacy.

Only results will matter.
Click to expand...
Maybe you should check your reading comprehension skills. Nowhere did I say they were going to be a success. I stated they know what they are doing, they have plenty of experience
 
#2,428
Rube said:
Maybe you should check your reading comprehension skills. Nowhere did I say they were going to be a success. I stated they know what they are doing, they have plenty of experience
Click to expand...

Ad hominem attacks. Stay classy Tinnitus talk.

My argument still holds. Having plenty of experience does not automatically mean they know what they are doing.

Autifony doesn't seem to follow their own inclusion/criteria. They've refused entry for a participant here and gave her an excuse that is clearly not an exclusion criteria here based on the clinical trial info site. They also seem to have removed the hearing loss criteria? Not sure.

https://clinicaltrials.gov/ct2/show/NCT02315508
 
#2,430
Nucleo said:
Ad hominem attacks. Stay classy Tinnitus talk.

My argument still holds. Having plenty of experience does not automatically mean they know what they are doing.

Autifony doesn't seem to follow their own inclusion/criteria. They've refused entry for a participant here and gave her an excuse that is clearly not an exclusion criteria here based on the clinical trial info site. They also seem to have removed the hearing loss criteria? Not sure.

https://clinicaltrials.gov/ct2/show/NCT02315508
Click to expand...
Nice try. You misinterpreted what i wrote , tried to put words in my mouth and now youre hurt that you were corrected.
I guess they keep securing funds because they don't have a clue as to what they are doing....yes that makes perfect sense.
 

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