Audion Therapeutics Trial

[Mentos]

I tried to call the CEO like 10 times, left a message on a voicemail, texted him --- still no reply at all.

They do not seem to care about communication with patients at all.

 

[Paulmanlike]

I tried to call the CEO like 10 times, left a message on a voicemail, texted him --- still no reply at all.

They do not seem to care about communication with patients at all.

Bit creepy.

So we are expecting results to see the efficacy and confirm further safety?

 

[Lucifer]

Bit creepy.

So we are expecting results to see the efficacy and confirm further safety?

Yes Phase 2 tested for both safety and efficacy. The results should have released end of last month.

We don't know if the delay of results releasing is due to COVID-19 or the results were negative.

It shouldn't take 4 months to review the results.

 

[FGG]

Yes Phase 2 tested for both safety and efficacy. The results should have released end of last month.

We don't know if the delay of results releasing is due to COVID-19 or the results were negative.

It shouldn't take 4 months to review the results.

The date on the clinically trials page is just an estimate, don't forget. It wasn't a confirmed release date that they missed.

 

[Lucifer]

The date on the clinically trials page is just an estimate, don't forget. It wasn't a confirmed release date that they missed.

I know but you have to remember the original release date was the end of January, then they changed it to end of April.

They should at least be more outgoing like Frequency Therapeutics and keeping us up to date.

It's a shame the CEO of Audion Therapeutics couldn't give a small reply saying when they will release the clinical trial results for Phase 2.

A few of us have emailed weeks ago and still no reply. Even @Mentos called and texted and still no reply.

Why is the CEO ghosting our emails, calls and texts. Did something go wrong in the clinical trials that he is too afraid to say.

 

[Joly]

So the person who was cured thanks to this treatment, it's a fake legend? No real results?

I hope FX-322 will be different. It's difficult to keep the faith.

 

[serendipity1996]

So the person who was cured thanks to this treatment, it's a fake legend? No real results?

I hope FX-322 will be different. It's difficult to keep the faith.

We just don't know yet so we can't really draw meaningful conclusions from it.

 

[FGG]

So the person who was cured thanks to this treatment, it's a fake legend? No real results?

I hope FX-322 will be different. It's difficult to keep the faith.

FX-332 produces hair cells, Audion produces "hair cell like" cells. Their methods are completely different and Frequency has released way more data. Not to mention, Frequency's CEO is excited about their drug and Audion's literally said "well, we haven't reached our Eureka moment."

I don't have a lot of faith in Audion at this point but I do have a lot in Frequency. Everything about their method is better.

 

[Lucifer]

So the person who was cured thanks to this treatment, it's a fake legend? No real results?

I hope FX-322 will be different. It's difficult to keep the faith.

I don't think it's a fake legend.

@síocháin even contacted the musician who was able to rejoin the band due to tinnitus and hyperacusis improvement.

I don't think @síocháin or the musician would make this story up because how the fuck would they even know about Audion Therapeutics.

You would have to know about this type of stuff by researching or through Tinnitus Talk. Almost all ENTs and Audiologists don't even have a clue about hearing regeneration treatments.

I think with FX-322 we can be more positive about the CEO and the company is actually outgoing and praising about the drug and what it can do. Not many companies will do this. They are even backed up by the funding they got from Astellas.

You don't get that type of funding unless you can prove the drug works hence why I believe FX-322 will be able to solve our issues unless you have a loss of synapses then OTO-413 or Hough pill should help restore those synapses.

 

[FGG]

I don't think it's a fake legend.

@síocháin even contacted the musician who was able to rejoin the band due to tinnitus and hyperacusis improvement.

I don't think @síocháin or the musician would make this story up because how the fuck would they even know about Audion Therapeutics.

You would have to know about this type of stuff by researching or through Tinnitus Talk. Almost all ENTs and Audiologists don't even have a clue about hearing regeneration treatments.

I think with FX-322 we can be more positive about the CEO and the company is actually outgoing and praising about the drug and what it can do. Not many companies will do this. They are even backed up by the funding they got from Astellas.

You don't get that type of funding unless you can prove the drug works hence why I believe FX-322 will be able to solve our issues unless you have a loss of synapses then OTO-413 or Hough pill should help restore those synapses.

That person deleted the anecdote from their messages (or at least it's not still there when I check their profile). From what I remember, they said a friend was in the trial and after was able to go back on tour. There wasn't any other info that I recall including any specifics (including time frame) about the case.

 

[Lucifer]

That person deleted the anecdote from their messages (or at least it's not still there when I check their profile). From what I remember, they said a friend was in the trial and after was able to go back on tour. There wasn't any other info that I recall including any specifics (including time frame) about the case.

I just checked now and it is still there. I'm not too sure how I can link the post to here.

 

[Lucifer]

The rumour in the music community here was this person was doing much better with his tinnitus and hyperacusis and could work with music again like before. I managed to get in contact with him and turns out he has been a part of the Regain Project trials.

He said he unfortunately wasn't allowed to tell me much about it, but that he had some gel-like medicine injected in his ears, and it had helped him a lot. He used those words!

And also I see he is touring again, which really is a good sign!

Just wanted to post it on the forum, cause it sure made me hopeful for some relief in the near future!

Here you go @FGG.

 

[Lucifer]

When should we start worrying about Audion Therapeutics Phase 2 clinical trial results?

If they don't release it by the time Frequency Therapeutics releases their Phase 2a clinical trial results, is that when we should be worried?

 

[xyz]

When should we start worrying about Audion Therapeutics Phase 2 clinical trial results?

If they don't release it by the time Frequency Therapeutics releases their Phase 2a clinical trial results, is that when we should be worried?

Check this:

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

...
The clinical study was conducted at University College London, University of Tubingen and the University of Athens. After showing safety and tolerability of the GSI, 44 patients were treated in a study looking at efficacy of the drug. Efficacy results demonstrated improvements in performance in several hearing tests in up to 35 % of patients, warranting further product evaluation.
...
Partners plan to conduct additional clinical studies in collaboration with other research groups active in the hearing loss field, hoping to have a product approved in clinical practice within 7 years. Furthermore, the project has opened the way for others in the field seeking to introduce treatment to the hearing loss patient community.

 

[FGG]

Check this:

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

...
The clinical study was conducted at University College London, University of Tubingen and the University of Athens. After showing safety and tolerability of the GSI, 44 patients were treated in a study looking at efficacy of the drug. Efficacy results demonstrated improvements in performance in several hearing tests in up to 35 % of patients, warranting further product evaluation.
...
Partners plan to conduct additional clinical studies in collaboration with other research groups active in the hearing loss field, hoping to have a product approved in clinical practice within 7 years. Furthermore, the project has opened the way for others in the field seeking to introduce treatment to the hearing loss patient community.

What hearing tests? Any more info than that?

 

[Lucifer]

Check this:

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

...
The clinical study was conducted at University College London, University of Tubingen and the University of Athens. After showing safety and tolerability of the GSI, 44 patients were treated in a study looking at efficacy of the drug. Efficacy results demonstrated improvements in performance in several hearing tests in up to 35 % of patients, warranting further product evaluation.
...
Partners plan to conduct additional clinical studies in collaboration with other research groups active in the hearing loss field, hoping to have a product approved in clinical practice within 7 years. Furthermore, the project has opened the way for others in the field seeking to introduce treatment to the hearing loss patient community.

I don't think those are Phase 2 results. I think what they are talking about is Phase 1.

 

[FGG]

I don't think those are Phase 2 results. I think what they are talking about is Phase 1.

It's pretty low information vs Frequency for phase 1 results. Where is the hard data?

 

[patorjk]

I don't think those are Phase 2 results. I think what they are talking about is Phase 1.

Actually, I think these are the Phase 2 results.

The clinical study was conducted at University College London, University of Tubingen and the University of Athens. After showing safety and tolerability of the GSI, 44 patients were treated in a study looking at efficacy of the drug. Efficacy results demonstrated improvements in performance in several hearing tests in up to 35 % of patients, warranting further product evaluation.

The Phase I study only had 15 people in it [1]. The study described in [2] says there was an enrollment number of 59 people. That's not too far off of 44, and maybe they're not counting people who dropped out?

Based on the percentages, 15 of the 44 people showed improvements in hearing. If this is the Phase II results, this is incredibly low fanfare for what is something that is really remarkable (and it's a better improvement rating than what Frequency showed in their Phase I study - 27% showed improvements - though I know dosage was an issue as well as testing the higher frequencies). I wonder why they're being so low key? Do even they think Frequency has a better product so they're demotivated to do more? Or maybe they really are just digging into the data more to find the best way to present things.

[1] http://www.audiontherapeutics.com/2...-in-patients-with-sensorineural-hearing-loss/
[1] http://www.isrctn.com/ISRCTN59733689

 

[FGG]

Actually, I think these are the Phase 2 results.

The Phase I study only had 15 people in it [1]. The study described in [2] says there was an enrollment number of 59 people. That's not too far off of 44, and maybe they're not counting people who dropped out?

Based on the percentages, 15 of the 44 people showed improvements in hearing. If this is the Phase II results, this is incredibly low fanfare for what is something that is really remarkable (and it's a better improvement rating than what Frequency showed in their Phase I study - 27% showed improvements - though I know dosage was an issue as well as testing the higher frequencies). I wonder why they're being so low key? Do even they think Frequency has a better product so they're demotivated to do more? Or maybe they really are just digging into the data more to find the best way to present things.

[1] http://www.audiontherapeutics.com/2...-in-patients-with-sensorineural-hearing-loss/
[1] http://www.isrctn.com/ISRCTN59733689

Really need the hard data to interpret this. If this was like a US Phase 2a, it means there were multiple dosings. If everyone in a higher dose category, saw improvement that's more meaningful than if it was random. Factor in noise vs age (age can have other degenerative changes such as strial atrophy) and can make it muddier.

 

[Lucifer]

It's pretty low information vs Frequency for phase 1 results. Where is the hard data?

Actually, I think these are the Phase 2 results.

The Phase I study only had 15 people in it [1]. The study described in [2] says there was an enrollment number of 59 people. That's not too far off of 44, and maybe they're not counting people who dropped out?

Based on the percentages, 15 of the 44 people showed improvements in hearing. If this is the Phase II results, this is incredibly low fanfare for what is something that is really remarkable (and it's a better improvement rating than what Frequency showed in their Phase I study - 27% showed improvements - though I know dosage was an issue as well as testing the higher frequencies). I wonder why they're being so low key? Do even they think Frequency has a better product so they're demotivated to do more? Or maybe they really are just digging into the data more to find the best way to present things.

[1] http://www.audiontherapeutics.com/2...-in-patients-with-sensorineural-hearing-loss/
[1] http://www.isrctn.com/ISRCTN59733689

My bad, you are right these are definitely Phase 2 results if Phase 1 was 15 patients and Phase 2 was 44 patients.

I thought it might be Phase 1 because they said the drug will likely take 7 years to come out which I didn't believe was accurate.

Too bad @Michael Leigh can't admit and front up when he is wrong. At least I own up to my mistakes.

 

[Lucifer]

Like @FGG said, I was hoping that they would provide more substantial data to back their claims like how Frequency Therapeutics did when they released their Phase 1B results and still continue to keep us up to date with Phase 2a clinical trials.

There's no hearing tests or diagrams in that website link. You would think if they were going to release the results they would have posted it on their own website and not on the European Horizon 2020 website.

 

[Croaker]

15 of 44 showed improvements in a phase II designed to demonstrate clinically significant effects... not very impressive to me. I wonder why hair regeneration, even the inferior fake hairs that Audion creates, wouldn't fix everybody at least a little? I hope fx-322 at therapeutic doses isn't so limited.

 

[FGG]

15 of 44 showed improvements in a phase II designed to demonstrate clinically significant effects... not very impressive to me. I wonder why hair regeneration, even the inferior fake hairs that Audion creates, wouldn't fix everybody at least a little? I hope fx-322 at therapeutic doses isn't so limited.

I will admit, that's actually better results than I expected considering that I read a paper showing that compounds using their method produced cells that were phenotypically closer to vestibular hair cells. But I'm kind of an Audion skeptic.

 

[Lucifer]

15 of 44 showed improvements in a phase II designed to demonstrate clinically significant effects... not very impressive to me. I wonder why hair regeneration, even the inferior fake hairs that Audion creates, wouldn't fix everybody at least a little? I hope fx-322 at therapeutic doses isn't so limited.

They even injected them with 4 doses spread out in 4 weeks and only 15 of 44 of those patients got improvements whereas FX-322 injected the patient with only 1 dose and there was 1 patient in the trial who doubled their word score.

Imagine if in the FX-322 Phase 2a clinical trials they will be injecting patients with 4 doses spread out over two weeks. It should be way better than Audion Therapeutics' drug.

Why is there no mention of Phase 3? Do they even still believe in their drug or are they going to ditch it and let FX-322 be the only competitor in the market.

 

[FGG]

They even injected them with 4 doses spread out in 4 weeks and only 15 of 44 of those patients got improvements whereas FX-322 injected the patient with only 1 dose and there was 1 patient in the trial who doubled their word score.

Imagine if in the FX-322 Phase 2a clinical trials they will be injecting patients with 4 doses spread out over two weeks. It should be way better than Audion Therapeutics' drug.

Why is there no mention of Phase 3? Do they even still believe in their drug or are they going to ditch it and let FX-322 be the only competitor in the market.

The number of doses is only one factor when you are diverging dosage studies. My comment/question was whether or not each dose was equivalent, because if not that would make it closer to an FDA Phase 2a type study. Is this information available?

 

[FGG]

My bad, you are right these are definitely Phase 2 results if Phase 1 was 15 patients and Phase 2 was 44 patients.

I thought it might be Phase 1 because they said the drug will likely take 7 years to come out which I didn't believe was accurate.

Too bad @Michael Leigh can't admit and front up when he is wrong. At least I own up to my mistakes.

Please don't summon him to the research threads. Otherwise, this might derail into yet another TRT debate.

 

[Lucifer]

The number of doses is only one factor when you are diverging dosage studies. My comment/question was whether or not each dose was equivalent, because if not that would make it closer to an FDA Phase 2a type study. Is this information available?

This is what I found on the clinical trials website:

"This injection takes approximately ten minutes. This is done in ascending dose cohort of 25μg, 125μg, 200μg, and 250μg applied in 500 μl. The maximum dose is determined by the maximum volume that can be administered in the inner ear and the maximum solubility in the formulation".

 

[d'Wooluf]

Ok, just a brief summary. Probably a minimum requirement of EU funding. As they're not chasing investors they may not even release the full results. I hope they do. Still, the project seems ongoing, and that's a good thing.

 

[Lucifer]

Ok, just a brief summary. Probably a minimum requirement of EU funding. As they're not chasing investors they may not even release the full results. I hope they do. Still, the project seems ongoing, and that's a good thing.

If those are actually Phase 2 results then I guess there were only a few negatives about it but from that article it seems they can move on to Phase 3.

They should see this through to the end. If they can be the first ones to release the drug that would be cool and life changing for all of us. I dream everyday I can get my old life back. I miss it.

 

[FGG]

This is what I found on the clinical trials website:

"This injection takes approximately ten minutes. This is done in ascending dose cohort of 25μg, 125μg, 200μg, and 250μg applied in 500 μl. The maximum dose is determined by the maximum volume that can be administered in the inner ear and the maximum solubility in the formulation".

So it was like phase 2a then. It would be difficult to interpret results then without the data from individual cohorts.