Audion Therapeutics Trial

Wait isnt this about Regain?

 

You are resurrecting an old post of mine, but as far as I recall, this was about Trobalt's replacement.

 

No, the first post in this thread is about the use of gamma secretase inhibitors to regenerate hair cells, therefore this thread is about Regain.

 

Has anyone seen the papers related about gamma secrete inhibitor, like this:

https://www.ncbi.nlm.nih.gov/pubmed/23312516

From this paper I find the drug works much better at the apex area of the cochlear than the base. I am afraid Regain may not be efficient for high frequency hearing loss.

 

My only argument to that is that mice have a much much faster heart rate and metabolism. There is a circulation in the cochlear fluids, and maybe with mice as soon as the drug is injected it is quickly accumulated in the apex whereas humans, with larger cochleas and a slower metabolism, it may settle in the base more so. There are many variables.

 

If this found to be the case, it would be good to have drugs that affect the base better and drugs that affect the apex better. More people would be covered.

 

What is it?

 

Do we have patients here that participated in phase 1? What were the outcomes on tinnitus, hyperacusis and hearing loss?

 

If there are then they have signed NDA's. The only indication is a second hand anecdote, which I have no reason to doubt, that stated that their tinnitus and hyperacusis did in fact improve and they resumed their lives.

 

how many second hand anecdote do we have hear?

 

1

 

Remember that phase 1 tests the safety of the drug. Usually it is tested on healthy adults.

 

Yes, it tests safety, but still people can benefit. Phase 2 would be just adjusting doses to evaluate efficacy.

It's sad we don't have the participants from this trial or Frequency Thereupatics here...

 

Lol we might.

 

Phase 1 is tested on healthy individuals: https://en.wikipedia.org/wiki/Phases_of_clinical_research

Unless this trial was an exception, they don't even check efficacy.

 

They can test whatever they want but it's the FDA that won't accept efficacy data until phase 2, which in my opinion is a huge waste of time.

 

They can't test efficacy while they use the drug on healthy people. Again, unless this trial was an exception.

 

So you're saying that they tested phase 1 on people without hearing loss?

 

No. They tested on people with hearing loss.

http://www.isrctn.com/ISRCTN59733689

Who can participate?
Adults aged 18 to 80 who have hearing loss.

 

So then why can't they test the drug's efficacy and safety in phase 1 for any other reason than government rules?

 

This is taken from a cancer website but applies to tinnitus and hearing loss too.

Phase 1 is sometimes written as phase I. They are usually small trials, recruiting only a few patients. The trial may be open to people with any type of advanced cancer, usually those who have already had all other available treatments.

Phase 1 trials aim to find out:

• how much of the drug is safe to give
• what the side effects are
• how the body gets rid the of drug
• if the treatment helps shrink the cancer

Patients are recruited very slowly onto phase 1 trials. So even though they don't recruit many people, they can take a long time to complete.

They are often dose escalation studies. This means that the first few patients that take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the side effects people have and how they feel, until they find the best dose.

In a phase 1 trial you may have lots of blood tests because the researchers look at how your body copes with and gets rid of the drug. They carefully record any side effects you may have and when you have them.

The main aim of phase 1 trials is to find out about doses and side effects. They need to do this first, before testing the potential new treatment to see if it works. Some people taking part may benefit from the new treatment, but many won't.

 

So why can't they test the safety, and then take the exact same people and test their hearing?

 

Normally phase 1 is tested on people who don't have the condition that the drug aims to treat. Again, it tests for safety of the drug. But this does seem to be an exception to that rule.

 

So then they should be able to combine this study with phase 2 and shorten their trial review time.

 

Ask the FDA

 

@síocháin has replied to my message and she has let me know that she contacted the mutual friend to find out more. He basically did not state whether his tinnitus and hyperacusis had improved, only that he is doing better now and he can go on tour again. If it did not improve the likelihood of him going back on tour is quite low. Whether he was injected in one or both ears @síocháin does not know. I would assume it would have been in one ear.

I wonder if he experienced more improvement in either tinnitus or hyperacusis than the other.

But that’s all I got so far from @síocháin. Maybe when they are more relaxed on NDA he might be willing to talk more about it.

 

http://www.isrctn.com/ISRCTN59733689

When I scroll through to the very bottom to the editorial notes it states on 6/1/2020: Internal review.

@FGG

Do you know what they might mean for internal review?

 

Nope. No idea.

 

Just wanted to say thank you. Such evidence gives me (and probably others) hope that some day we can finally hear silence. Even this is not available yet, such hope gives strength to persist and keep living. Whoever is there I am happy to hear he is on tour again and doing better. Looking forward to further updates.

 

Does anyone know what's going on with Audion right now? I'd heard their results were initially going to be published Jan 30th, but they decided to delay things. According to this link:

http://www.isrctn.com/ISRCTN59733689

The publish date is now April 3rd, 2020 (my birthday, amusingly enough). Does anyone know why there was a delay in the first place? Was it due to the study, or them processing the results?