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

Absolutely, what do you say to someone with motor neuron disease, for them there is no waiting.
https://www.facebook.com/PatientsForStemCells?fref=ts
https://www.facebook.com/RightToTryNationwide?fref=ts

 

Again, I strongly disagree with that sentiment. The technology to design drugs has exploded in the past 25-30 years, and we're barely starting to scratch the surface of what molecular modeling can reveal. Beyond that, the technology to fabricate drugs from the ground up continues to get simpler, and then along side that we have biotech efforts like making synthetic yeasts which can produce specific drug molecules.

I don't think the future of pharma has ever looked brighter.

 

Excessively priced medication can cover for even the worst performing pharma companies. We shall agree to disagree so. Although I do appreciate the responses, much better than conversation on the facebook groups, also they can be seen by the pharma voyeurs who come here to view them.

 

Autifony has published a new FAQ concerning some of the questions people may have now that the QUIET-1 study has been terminated.

FAQ: http://www.autifony.com/autifony-tinnitus-quiet-study.asp


Q. Why has the trial been stopped?
A. Autifony Therapeutics has just completed the interim analysis on the QUIET-1 tinnitus clinical trial with AUT00063, and has received a recommendation from the Independent Data Monitoring Committee to terminate recruitment, based on the 58 subjects analysed, due to lack of efficacy. The Committee compared the outcome of the AUT00063-treated subjects with those that received placebo, and concluded that on a statistical basis it would not be possible to reach the magnitude of positive outcome needed to show improvement over the control.


Q. Why do you think the trial failed to show any benefit to tinnitus sufferers?
A. We don’t yet know that. At present, we only know that the aggregated, group data did not show any beneficial effect of AUT00063 on Tinnitus compared to placebo. We will analyse all the data in detail over the next weeks and months, to explore if any subgroups may have benefited from treatment and to see what can be learned from the study.


Q. Will you publish your findings?
A. We are committed to ensuring that our research can help inform future studies and committed to publishing our data , particularly as we are likely to learn things that could add to the understanding of tinnitus, as well as about future clinical trial design. These are all things may help further research in the area.


Q. Were there any safety issues? Does this mean that AUT00063 development will be discontinued now?
A. Importantly, there were no safety or tolerability issues identified with AUT00063 in this study. The Age Related Hearing Loss trial, “CLARITY” with AUT00063 that we are conducting in the US will continue as planned. The scientific rationale and the clinical endpoints for the CLARITY trial are completely different to the tinnitus study, and the absence of efficacy of AUT00063 in the QUIET-1 tinnitus trial does not alter our belief that we have the potential to provide benefit in other hearing indications.


Q. What about the people who have taken AUT00063 as part of this trial? Should they have any reason for concern?
A. No, as mentioned before, there were no safety or tolerability issues identified with AUT00063. We have only seen aggregate data to date and do not know if AUT00063 is having an effect at the individual level. We are very grateful to everyone who volunteered to take part in the study.


Q. Will subjects from the Tinnitus study be told if they were on drug or placebo?
A. Yes, eventually, but first we need to continue to analyse the data in a so-called blinded manner i.e. without knowing who took what, so that we are not biased in evaluating effects. When the analysis is fully complete, Autifony will be sharing a code-break with each site to let subjects know what they took as well as any outcomes.


Q. What does this mean for Autifony?
A. This is extremely disappointing news for us as well as for patients, as we had invested a huge amount of resources and effort, together with support from Innovate UK, in the hope that AUT00063 would prove to be a breakthrough in tinnitus treatment. However, unfortunately failure to show efficacy is not an unusual event in drug discovery and development, where as few as one in ten drug candidates that enter clinical trials result in a new medicine on the market. In parallel to the detailed evaluation of the tinnitus data to see where this will lead for tinnitus sufferers, Autifony will continue its other programmes, which include the evaluation of AUT00063 in age-related hearing loss, and the development of a new molecule for the treatment of schizophrenia.


Q. Do you think the short duration of the QUIET-1 trial was to blame for the observed lack of efficacy?
A. We acknowledge that the length of the treatment period in the QUIET-1 study (28 days) was not as long as in some past tinnitus trials, and we are aware that some drugs may take longer than 1 month to produce a significant effect. The 28 day limit was partly set by the limit of the safety data that we have from AUT00063, but in addition, we have routinely seen rapid, acute effects of the drug in preclinical models of hearing loss and tinnitus, so it was a reasonable to think that an effect might be seen in patients within 1 month.


Q. Does Autifony plan to continue research and drug development for tinnitus sufferers?
A. We will first ensure that we have understood all of the data from the QUIET-1 study, and we will consider whether there is reason to believe that Kv3 modulation still has potential to treat tinnitus (or perhaps a subgroup of tinnitus). Autifony is also looking at other targets that could be considered for this disorder since we know there is such a high unmet need.


Q. Can you explain why you were so sure to stop the trial after only half of the subjects have been evaluated?
A. Demonstration of efficacy in a placebo-controlled clinical trial such as QUIET-1 requires that there is a clear and statistically significant difference in treatment response between active drug (AUT00063) and placebo on the “primary outcome measure”. In QUIET-1, the primary outcome measure was the Tinnitus Functional Index, which is a well validated scale for assessing the severity of a person's tinnitus. We intended to recruit up to 152 subjects to be sure to have enough to test our hypothesis that AUT00063 improved tinnitus, but we planned the interim analysis after 50-60 subjects in order to check that the trial was going in the right direction, and to ensure there were no safety issues. There were no safety issues, but the TFI data from 58 subjects completed showed no indication of any effect of AUT00063 compared to placebo, and using statistical models we can be sure that even if we were to continue through to 152 subjects, this result would be highly unlikely to change.


Q. Now the study has closed, will Autifony suggest possible treatment or therapy?
A. Companies such as Autifony are not allowed to offer specific personal advice on healthcare to the general public; this is a matter for discussion with your GP or specialist. The British Tinnitus Association website www.tinnitus.org.uk has information on various forms of management.

 

I believe the drug was functional but it was sold to the highest bidder. We will see if this happens in the USA and will they hide the composition of the medicine.

All of it is totally strange... so now we have to hope and see what happens in the USA...

This is terrible!

 

Well, if CLARITY-1 proves to effective, it'll be on the market and we can get it off-label.

 

well daniel you spoke same about autifony... who knows when clarity will be available...

please you should not speak about it because you will jinx it. : ((((

 

Lol, ok I won't.

 

58 subjects, 28 days. Should be more days and more people.
Anyway, it is only logical to assume that clarity will continue only until it is also found ineffective...
After all, it is the same drug, why work for the elders?

Perhaps potassium channels may not be the way to go. Stem cells or hair cell regeneration may be the way. Thankfully, there is much going on in that area. Unfortunately, until they find something concrete, there won't be any temp solution we can take.
Personally, having tried various anticonvulsants (apart from trobalt), I can say they do not work for me as praised by other members, so I do not really believe in such a (brain drug) treatment.

 

Seems to me they had doubts about the trial length. What were the "preclinical models"? laboratory rodents?

My specifications for any future tinnitus drug trial:

1. Anyone with tinnitus for more than 6 months can be admitted
2. Anyone with any level of hearing
3. Trial number of at least 150 individuals, yes, 150
4. Trial duration 3 months, yes 3 months, and no mid term pull outs.....for any reason, except that if the drug showed severe adverse effects

 

You should give trobalt a try before you completely give out on brain drugs!!!

 

If I could I would already have. I cannot get my doc to right a prescription and I would have to buy from abroad. But I really doubt it would do anything since I have tried everything. I mean it would really surprise me, you know...

 

I'm currently vacationing in Spain and it's readily available here without prescription. Do you live in the EU? I could send you some for face value. I don't know if I have courage to try it myself.

 

Something just does not seem right with this trial. Several users who took Trobalt did not experience a reduction in T until they tapered up to a certain high enough dosage. How could Autifony keep their dosage the same and conclude that AUT00063 is ineffective? This dosage could be low enough where no one would benefit. What if the dosage just needed to be higher? How could Autifony just quit the trial without altering the dosage? It doesn't make sense.

Also, Autifony did not sound confident in their 28 day trial length by stating it was "reasonable to think that an effect might be seen in patients within 1 month."

 

There is definitely something fishy going on behind the scenes here. I am sure of it.

 

Hanlon's razor.

 

yes i agree, something just isnt right about it..... but why?????

 

I think there was too much money involved to credit Autifony's "failure" to stupidity.

 

Why? $$$$$$$$

 

Autifony, we suffer from tinnitus not common sense so cut the.....

 

well i think what u wrote is to be for some next future trial that will happen in some 8 years or more...
and again it is just your opinion, they needed to show drug has effect to sell it for more money

 

I fear that the hearing aids lobby will stop Trobalt long as it works for T

 

I agree!!!!!!!

*hearing aids lobby

*dr Neglers who was one of chairmans in ATA was strongly against Trobalt

*then we have those nice companies who sell sleeping machines and,

*those who produce sleeping pillows and headphones that you can wear while u sleep

*other tinnitus medication that has no interest to have competitors, but they should not care for chronic
tinnitus they are only for acute and i wish they do function and help at least someone

*medical schools who are teaching KBT and TRT psychologist

*entire kbt-trt psychologist doctors unions who would stay without job

*ENTs and audiologists

*ordinary psychiatrist and psychologist

*produce of other antidepressive medication that is being prescribed today as "help" against tinnitus

*then we have to be aware that China or any other competitor country has no interest that USA/UK make medicine that is effective againsT, because USA pais 2 billion for their war veterans for tinnitus and huse sum pay also UK, there is no interest enemy cut loses but interest is they have sick people they have to care for. That was always was logic of war wounded person is much bigger burden and therefore one should not kill enemy buw wound him so other side has to take care of him and deplete resources? (what do you think about this)

to cut is short, who has to profit from tinnitus medicine, maybe a company who makes it and they should get too much money so other companies will sabotage them. no one has interest to make it except us who have tinnitus

 

Not only was the Autifony trial "fishy" in the way it was concluded, I also "smell a large laboratory rat" with the whole affair.

 

Totally agree. Most trials up the dose within a few weeks. Autifony messed the trial right up.

 

A "preclinical model" involving results for rodents being alleviated of tinnitus compared to that in the human model - a few minutes or hours for rats and in a human, 3 months, 6 months or more?

AUT63 possibly does something to help tinnitus in some patients. It is unlikely we shall ever find out.

 

I'd like to hear their explanation as to why it worked on Corrine, just as it was expected to? And I'd be interested in seeing the data on 2 out if 10 success at that one trial site. IF it was in fact 50/50, I'll say again that's a 40% success rate. So, if it's safe like they say, let us of have crack at trying it!

 

We will if it comes out for other conditions...We'll get it off label or go to Spain.

 

I'm not saying I disagree but I don't think it is possible to hold development back, at least not in the long run. The oil industry tried by buying patents of solutions for f.i. electrical cars and ways to use solar power and then just sat on them not doing anything and yet we are seeing more and more electrical cars. And the oil industry has A LOT more money than the hearing aids industry.

As for ENTs they wouldn't be out of a job if there was a cure for tinnitus. They don't do anything for as as it is now except from the 5 magical words: "learn to live with it"!

 

Can anyone agree, that if something doesn't work, it doesn't work? The next step, is go back to the drawing board and find out why? Then modify the original idea and see if the new version works? You try again and again, until you've exhausted all the possibilities. Then you stop and move on to the next plausible solution to your problem.

Conspiracy theories exist all around us and many are usually based on misinformation, conjecture and gossip, just for the sake of gossip.

If there are mistruths out there, they will eventually surface or just die on the vine. As for me, I'll await the next, great brainstorm to evolve and let this one RIP.