Audion Therapeutics Trial

[Paulmanlike]

30 per cent showing improvements?

I don't know why people think that's bad. I would be more weary however if it was a tinnitus drug that said 30% showed improvement because of how hard it is to get accurate measures of improvement for tinnitus.

But hearing loss is a different game.

The part that got me though, is that it hopes to 'partially' restore hearing. Partially?? We want perfect hearing, but that's a move in the right direction.

Anyway, if anybody comes across more information and correspondence please share!!!

I have no detectable hearing loss myself on a normal audiogram, but my ears ring 24/7. As far as I know, my tinnitus is caused by synaptic damage in the cochlear, and I think the hidden hearing loss drugs is my hope that restores synapses rather than focusing on regenerating hair cells from Audion and Frequency. So I should be focused more on Otonomy and the Hough pill/injection that will more likely do something to cure or treat my own tinnitus?

 

[patorjk]

So I should be focused more on Otonomy and the Hough pill/injection that will more likely do something to cure or treat my own tinnitus?

Until there's data back from Frequency's Phase II study on tinnitus, I wouldn't be more focused on one solution over another. FX-322 could wind up be the solution for everyone, or it could wind up just being the solution for some (or in the worst case, none of us). We won't know until we get data back.

And even if it is only the solution for some, you could never really be sure which drug to take (unless they come up with some kind of testing mechanism to see if the drug would work for you). Just thinking out loud, if it turns out these drugs only work for certain types of tinnitus, fixing tinnitus could wind up being rather expensive. You might end up having to try several different drugs before something works (assuming all of the drugs currently in the pipeline make it to market).

 

[d'Wooluf]

I guess I should have worded it more clearly. What I meant to ask was were these "proof of concept" studies and not studies in which to directly seek drug approval with then?

They referred to them as phase 1 and phase 2 clinical trials, so I would guess the latter.

 

[Coleoptere]

It is a bad week for trials on hearing loss

https://www.tinnitustalk.com/thread...-is-again-continuing.12949/page-5#post-527019

 

[Jurger]

I don't understand why everyone is so gloomy about this drug. We've only seen some rudimentary results on the research website of the European Union. They even state there Audion wants to pursue further research and trials and aims to have it on the market within 7 years. Furthermore, the website says 35% of all patients showed hearing improvement. That's great news as far as I'm concerned considering there's still no treatment and they still have plenty of room for improving the drug. For example, unlike Frequency they haven't tried using a gel as a delivery method. Maybe this drug could even function as a supplemental drug to FX-322 with FX-322 inducing supporting cell growth and Audion's drug transdifferentiating those new supporting cells into hair cells. That would counter the biggest con of this drug, which is that it depletes supporting cells.

 

[Lucifer]

This is either good news or bad news but the Audion Therapeutics website is down.

https://www.audiontherapeutics.com/

This could mean two things. They could be updating the website to add Phase 2 clinical trial results or they shutting down the website after the EU Horizon 2020 posted about their results already.

 

[xyz]

This is either good news or bad news but the Audion Therapeutics website is down.

https://www.audiontherapeutics.com/

This could mean two things. They could be updating the website to add Phase 2 clinical trial results or they shutting down the website after the EU Horizon 2020 posted about their results already.

This is bad news. But this adds to our general impression that the trial was unfortunately a failure. Probably we don't hear anytime soon anything from them. Maybe in seven years.

 

[Turgy]

I can access their website as normal.

 

[xyz]

I can access their website as normal.

Ah yes, you have to tell your browser to access it via http and not https.

 

[Jurger]

I don't understand the information on the EU website if this drug is a total failure.

 

[FGG]

I don't understand the information on the EU website if this drug is a total failure.

My impression is the current drug did not meet their endpoints but they believe maybe a similar drug with a similar method (Gamma Secretase Inhibitor) may be usable with further research. It appears that this is the end for LY3056480, though, unless I'm vastly misinterpreting things.

 

[Jurger]

My impression is the current drug did not meet their endpoints but they believe maybe a similar drug with a similar method (Gamma Secretase Inhibitor) may be usable with further research. It appears that this is the end for LY3056480, though, unless I'm vastly misinterpreting things.

Which part of the website tells you that? I only read that the drugs needs further development, but that could also mean they want to finetune dosage, delivery method, etc. They would not have posted they hope to release in 7 years if this was a total failure. I also believe this drug could work quite nicely with FX-322 or any other drug that induces supporting cell growth.

 

[xyz]

Which part of the website tells you that? I only read that the drugs needs further development, but that could also mean they want to finetune dosage, delivery method, etc. They would not have posted they hope to release in 7 years if this was a total failure. I also believe this drug could work quite nicely with FX-322 or any other drug that induces supporting cell growth.

Why do they then not publish their complete results? Probably because they are not satisfied with it.

 

[FGG]

Which part of the website tells you that? I only read that the drugs needs further development, but that could also mean they want to finetune dosage, delivery method, etc. They would not have posted they hope to release in 7 years if this was a total failure. I also believe this drug could work quite nicely with FX-322 or any other drug that induces supporting cell growth.

https://cordis.europa.eu/article/id/415956-a-regenerative-therapy-for-hearing-loss

"Although further development of the GSI inhibitor is required" is the phrase that stuck out to me. It didn't say further testing or adjusting of dosage, it said development. But maybe I am reading too much into that.

 

[Jurger]

https://cordis.europa.eu/article/id/415956-a-regenerative-therapy-for-hearing-loss

"Although further development of the GSI inhibitor is required" is the phrase that stuck out to me. It didn't say further testing or adjusting of dosage, it said development. But maybe I am reading too much into that.

I think we're getting into semantics here, but I don't see why developing a drug couldn't include dosage or a different delivery method. These trials were done with public money. What I'm reading is that they want a private sector partner to get it onto the market within 7 years.

 

[FGG]

I think we're getting into semantics here, but I don't see why developing a drug couldn't include dosage or a different delivery method. These trials were done with public money. What I'm reading is that they want a private sector partner to get it onto the market within 7 years.

I suppose it is up to interpretation but taken in context with the lack of hard data and the CEO saying they hadn't had their Eureka moment yet, it's not the horse I would bet on.

 

[Jurger]

I suppose it is up to interpretation but taken in context with the lack of hard data and the CEO saying they hadn't had their Eureka moment yet, it's not the horse I would bet on.

Well, I wouldn't bet on any one drug that's in development right now. A much more likely scenario is where you need multiple treatments like with a lot of other complex diseases.

 

[Alex0o_o0]

Well, I wouldn't bet on any one drug that's in development right now. A much more likely scenario is where you need multiple treatments like with a lot of other complex diseases.

Get your synapse count up with Hough pill, grow some nice luscious locks with fx-322 ,reboot brain with some good ol' neuromodulation and you're good as new. And if that doesn't work you'll have the refined trobalt pill to make your brain shut up. Ah, I can't wait for 2030, just 10 more years of noise!

 

[Chinmoku]

Well, I wouldn't bet on any one drug that's in development right now. A much more likely scenario is where you need multiple treatments like with a lot of other complex diseases.

The fact that FX322 has regrown hair cells in explanted cochleas and the improvements seen already in phase 1 at low dosages cannot be denied. Audion had no such feats. I would not compare them at all in terms of promise.
Edit not to mention depletion of support cells where FX is superior.
I know you were not directly comparing them but I see some reasons to be much more optimistic about FX than Audion.

 

[Jurger]

The fact that FX322 has regrown hair cells in explanted cochleas and the improvements seen already in phase 1 at low dosages cannot be denied. Audion had no such feats. I would not compare them at all in terms of promise.
Edit not to mention depletion of support cells where FX is superior.
I know you were not directly comparing them but I see some reasons to be much more optimistic about FX than Audion.

On the EU website it says that they had hearing improvements in 35% of subjects. Not too shabby. Not denying the con of depleting supporting cells. That's why I'm saying they could be complimentary to each other of either one doesn't yield enough results. I don't understand the skepticism with regards to this drug. It's not like there are tons of drugs available or in human trials for hearing loss.

 

[serendipity1996]

The fact that FX322 has regrown hair cells in explanted cochleas and the improvements seen already in phase 1 at low dosages cannot be denied. Audion had no such feats. I would not compare them at all in terms of promise.
Edit not to mention depletion of support cells where FX is superior.
I know you were not directly comparing them but I see some reasons to be much more optimistic about FX than Audion.

Yes exactly and we have evidence from their recent study that a therapeutic dose successfully reached its destination in the cochlea.

 

[Jurger]

I just received an email from the lead researcher. She says that they're still analysing long term results and that COVID-19 caused some delay. I pointed out that the EU website already has some results, so I guess some EU civil servant snuck in her lab at night. She says she expects to publish the results at the end of this year.

 

[Lucifer]

I just received an email from the lead researcher. She says that they're still analysing long term results and that COVID-19 caused some delay. I pointed out that the EU website already has some results, so I guess some EU civil servant snuck in her lab at night. She says she expects to publish the results at the end of this year.

Which lead researcher is this? To be honest this trial finished in December last year and it's now June.

Does it really take that long to review their results. It's really pathetic that the CEO has been ignoring our emails and phone calls. You think with COVID-19 they would have more time to review their results and be able to release their results faster.

EU Horizon 2020 already hinted that Audion Therapeutics won't go to Phase 3 due to the drug not providing enough improvements to warrant a Phase 3 clinical trial.

 

[Jurger]

EU Horizon 2020 already hinted that Audion Therapeutics won't go to Phase 3 due to the drug not providing enough improvements to warrant a Phase 3 clinical trial.

I contacted Anne Schilder, Professor at UCL.

I don't think the EU website hints that. It says that 35% had their hearing improved and that more development is needed. We should keep in mind this is a government website, so I took "further development is needed" as: "public funding stops here, now the private sector needs to take over".

 

[d'Wooluf]

Does it really take that long to review their results. It's really pathetic that the CEO has been ignoring our emails and phone calls. You think with COVID-19 they would have more time to review their results and be able to release their results faster.

They don't actually answer to us unfortunately.

EU Horizon 2020 already hinted that Audion Therapeutics won't go to Phase 3 due to the drug not providing enough improvements to warrant a Phase 3 clinical trial.

Interesting. I haven't seen that. You got a link?

I just received an email from the lead researcher. She says that they're still analysing long term results and that COVID-19 caused some delay.

It would be really surprising to me if those academic institutions agreed to partner with Audion on this if they weren't going to publish the results. Publishing the results of studies is what academic institutions do. I don't really expect their compound to be 'the answer' but I'm interested in what they got. Any improvement would be encouraging in the long term.

 

[xyz]

I just received an email from the lead researcher. She says that they're still analysing long term results and that COVID-19 caused some delay. I pointed out that the EU website already has some results, so I guess some EU civil servant snuck in her lab at night. She says she expects to publish the results at the end of this year.

Hopefully it does not take Frequency one year to publish the study results.

 

[Jurger]

They don't actually answer to us unfortunately.

Interesting. I haven't seen that. You got a link?

It would be really surprising to me if those academic institutions agreed to partner with Audion on this if they weren't going to publish the results. Publishing the results of studies is what academic institutions do. I don't really expect their compound to be 'the answer' but I'm interested in what they got. Any improvement would be encouraging in the long term.

That's exactly how I think of it. Not 'the answer' but a step forward. Here's the EU link:
https://cordis.europa.eu/article/id/415956-a-regenerative-therapy-for-hearing-loss

 

[Lucifer]

I contacted Anne Schilder, Professor at UCL.

I don't think the EU website hints that. It says that 35% had their hearing improved and that more development is needed. We should keep in mind this is a government website, so I took "further development is needed" as: "public funding stops here, now the private sector needs to take over".

They also stated 7 years indicating they want to explore other options and try out a different drug.

 

[Jurger]

They also stated 7 years indicating they want to explore other options and try out a different drug.

Why should 7 years mean they want to try out another drug? It takes 10 years to develop a drug. REGAIN started in 2018. 2027 would be a pretty average speediness.

 

[DoNotGoGentle]

I contacted Anne Schilder, Professor at UCL.

I don't think the EU website hints that. It says that 35% had their hearing improved and that more development is needed. We should keep in mind this is a government website, so I took "further development is needed" as: "public funding stops here, now the private sector needs to take over".

Wow if pathway Atoh1 uses up your support cells to make cells then frequency should be at least 35% i suspect at least a double response 70%. Since they are all about keeping your support cells.