Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
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I received a reply from Dr Peter Harris who is the chief medical officer for autifony. This is what he said:
" Unfrotunately we cannot run the QUIET-1 study in the US. Our plans are to harvest the data from the study during 1Q16 and then to decide how to move forward internationally. As there is a placebo arm in the study, the results will not be clear until we break the code at the end of study. There is much interest in a tinntisu study in the USA and we do hope that the QUIET-1 data will be encouraging to expand our work."
Don't know why they would need to expand the trial to the US. I thought they were fast-tracking?
Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.
Serious Condition: Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
Unmet Medical Need: For a drug to address an unmet medical need, the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:
- Showing superior effectiveness
- Avoiding serious side effects of an available treatment
- Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
- Decreasing a clinically significant toxicity of an available treatment
- Addressing an expected public health need
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
- Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
I couldn't find it either. Can one of the mods post it up ? @marqualler @Markku
Mods is the autifony q&a available ?
Well, with all the respect to all who suffers badly from T, but I don't think you can compare cancer with T. Cancer is a lot more worse, and sometimes even deadly. T, on the other hand, is not - aside from suicide.
I agree with T being a bitch and all, and also the incurable being curable. I just think that you should not be saying that no one cares about T because cancer is more prioritized.
If you had hyperacusis, 10/10 tinnitus and reactive tinnitus you'll agree with what I'm saying...
Unless they do a 3b, that should be it for small trials. It would then be released into the market, but highly monitored. At least that's basically how the US FDA does it. The UK could be a little different?
I'll be happy to catch the first few rounds of drinks my friends
I'll be happy to catch the first few rounds of drinks my friends
I agree that T is not given the priority it deserves. But I still think cancer is to be taken more seriously. It's said that T is 10/10 for a very little per cent of everyone with T, but everyone with cancer is going through hell. But if you are one of those with very loud T I do not mean to offend you. I think I'm going a bit off topic though, let's just say that any drug that may reduce T should be given to those who during several years still have suicide thoughts and very loud T, but not to everyone with T, because drugs are not on the market for a reason. And the same goes for cancer, but in the case with cancer I think those who need to do it are a higher number. That's all.
I'm good with that. Just getting tired of wasting my time looking at this thread. Just think it'd be great to have a discussion thread and a news thread. Like how the participants are separated out. I couldn't even imagine trying to dig through 69 pages trying to find participant reactions.
Just want to separate the signal from the noise.
I don't have loud tinnitus or hyperacusis anymore. I took trobalt and keppra. And trust me, I risked my vision to get where I was. But let me tell you, if you had what I had you'd want to kill yourself right there and then.
Probably should ask mods about that, seems like very good idea.
@Markku can you think about that? Closed thread with short and related news. Right now its impossible to find info here about that us clarity-1 study for example.
Great quote. You have a gift for stating the truth sharply, eye openingly and to the point.
They are still recruiting people for aut63 in Notingham:
http://www.nuh.nhs.uk/communications-and-media/news/2015/july/do-you-suffer-with-tinnitus/
Think we need to wait another 6 months for the results
http://www.nuh.nhs.uk/communications-and-media/news/2015/july/do-you-suffer-with-tinnitus/
Think we need to wait another 6 months for the results
They are still recruiting people for aut63 in Notingham:
http://www.nuh.nhs.uk/communications-and-media/news/2015/july/do-you-suffer-with-tinnitus/
Think we need to wait another 6 months for the results
I would go on the trial, but my hearing is too good. Gosh, it's like they haven't heard of 'hidden hearing loss'.
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