Audion Therapeutics Trial

[Enclave]

"Although further development of the GSI inhibitor is required, the REGAIN project has helped shape the developmental and regulatory processes towards novel hearing loss treatments. 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."

I could be reading too much into this, but the quote above makes it sound like phase 2 is the end of the line here. Saying your drug candidate needs further development and the assistance of other research entities is a sign to me that they're waiving the white flag on the drug they have in its current form. This would account for the 7-year figure they quoted because if they have to reformulate and work with other groups that's essentially starting from scratch, which would be consistent with a 7-year timespan. Also, Audion hasn't made any funding announcements on additional investments in order for them to proceed. Frequency Therapeutics has way more money in investments than this project.

 

[Lucifer]

"Although further development of the GSI inhibitor is required, the REGAIN project has helped shape the developmental and regulatory processes towards novel hearing loss treatments. 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."

I could be reading too much into this, but the quote above makes it sound like phase 2 is the end of the line here. Saying your drug candidate needs further development and the assistance of other research entities is a sign to me that they're waiving the white flag on the drug they have in its current form. This would account for the 7-year figure they quoted because if they have to reformulate and work with other groups that's essentially starting from scratch, which would be consistent with a 7-year timespan. Also, Audion hasn't made any funding announcements on additional investments in order for them to proceed. Frequency Therapeutics has way more money in investments than this project.

When I saw that I wasn't too sure whether they will still go ahead with Phase 3 or ditch the current formula and start from scratch.

 

[FGG]

"Although further development of the GSI inhibitor is required, the REGAIN project has helped shape the developmental and regulatory processes towards novel hearing loss treatments. 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."

I could be reading too much into this, but the quote above makes it sound like phase 2 is the end of the line here. Saying your drug candidate needs further development and the assistance of other research entities is a sign to me that they're waiving the white flag on the drug they have in its current form. This would account for the 7-year figure they quoted because if they have to reformulate and work with other groups that's essentially starting from scratch, which would be consistent with a 7-year timespan. Also, Audion hasn't made any funding announcements on additional investments in order for them to proceed. Frequency Therapeutics has way more money in investments than this project.

That makes a lot of sense. Can they not show us the actual data though? I would love to know what a "hair cell like" cell is potentially capable of. Though I'm glad Frequency uses an entirely different approach.

Thinking about this more, man it would have been so valuable if they tested tinnitus. Because if their "hair cell like" hair cells produced any kind if a signal (even substandard) it might still have reduced tinnitus. Even if that same signal wasn't of a quality enough for hearing clarity.

That would be extremely valuable information. Then again, that question will get answered eventually with Frequency, who is also producing phenotypic hair cells

Been saying this for a while but...

 

[Daniel Lion]

"Although further development of the GSI inhibitor is required, the REGAIN project has helped shape the developmental and regulatory processes towards novel hearing loss treatments. 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."

I could be reading too much into this, but the quote above makes it sound like phase 2 is the end of the line here. Saying your drug candidate needs further development and the assistance of other research entities is a sign to me that they're waiving the white flag on the drug they have in its current form. This would account for the 7-year figure they quoted because if they have to reformulate and work with other groups that's essentially starting from scratch, which would be consistent with a 7-year timespan. Also, Audion hasn't made any funding announcements on additional investments in order for them to proceed. Frequency Therapeutics has way more money in investments than this project.

I read the news same as you.

It hurts, but the same for FX-322 would hurt more.

 

[ThomasC]

I feel kinda sad about the results. I wouldn't accept to take this drug, but it saddens me that a potential drug for tinnitus relief appears to have (somehow) failed...
I really Hope that FX-322 won't fail.

 

[Coleoptere]

It looks like the end of the road for Regain as we can see the status in the top of the page: closed project. The bottom of the page shows "Last update: 5 May 2020". Actually this is bad news for us.

 

[Lucifer]

It looks like the end of the road for Regain as we can see the status in the top of the page: closed project. The bottom of the page shows "Last update: 5 May 2020".

Omg I am a complete idiot, I didn't realise there were different tabs. I only looked at the results tab.

After going through it again I believe Audion Therapeutics' drug is done. They don't believe in it even though there was an improvement in 35% of the patients.

The closest drug next to be released into the market is FX-322. Please don't let us down. I hope they somehow skip trials so they can release it asap. I just want my fucking life back.

 

[all to gain]

This is such demoralising news... even though I was expecting bad news!

The nail in the coffin will come if FX-322 goes the same way.

Let's hope for the best.

 

[Coleoptere]

I really Hope that FX-322 won't fail.

This is why it is also bad news. Although I fully agree that FX is a better solution and more forecoming etc, etc, there are also similarities between the two; from a distance they have more or less the same success rate (27%/35%), the same method of delivery, the same support cells, neurons etc. But please let us hope that I'm pessimistic and totally wrong and that there is no relation between the two.

 

[Lucifer]

This is why it is also bad news. Although I fully agree that FX is a better solution and more forecoming etc, etc, there are also similarities between the two; from a distance they have more or less the same success rate (27%/35%), the same method of delivery, the same support cells, neurons etc. But please let us hope that I'm pessimistic and totally wrong and that there is no relation between the two.

I really hope FX-322 doesn't fail. I still think even if there is little improvement it's better than nothing and they should still release the drug. It might help with majority of tinnitus cases and could be the first drug to be able to restore hair cells.

 

[Daniel Lion]

Perhaps somebody could write to Dr. Albert Edge, I thought he was one of the principal scientific contributors and co-founders of the project.

What went wrong? I am sure Mr. Edge and Rolf Jan Rutten have down time with the Coronavirus situation and may be able to comment more extensively.

 

[d'Wooluf]

I could be reading too much into this, but the quote above makes it sound like phase 2 is the end of the line here.

Regain I think was a two year project. The two years is up. That doesn't say that the drug works or that it doesn't. They are claiming some improvement in hearing in some subjects. Take that at face value. Yes, Audion will need to find new partners because Regain is over. I don't see that as a reason to write them off.

 

[Joly]

@Coleoptere what do you mean "by same success rate"? According to @FGG, it's not the same treatment. FX-322 is better.

 

[Daniel Lion]

This is why it is also bad news. Although I fully agree that FX is a better solution and more forecoming etc, etc, there are also similarities between the two; from a distance they have more or less the same success rate (27%/35%), the same method of delivery, the same support cells, neurons etc. But please let us hope that I'm pessimistic and totally wrong and that there is no relation between the two.

Albert Edge also came from Mass Eye and Ear and Harvard and has co-written papers with McLean at Frequency and certainly knows most of the top people there very well.

I always found it strange or interesting that he went to Europe and tried his hand at hearing regeneration with a different approach than Frequency's. I do hope that Frequency can pull this off. It's a Herculean task. In retrospect what I thought to be a huge amount of money for Frequency really wasn't that much.

 

[Lucifer]

Albert Edge also came from Mass Eye and Ear and Harvard and has co-written papers with McLean at Frequency and certainly knows most of the top people there very well.

I always found it strange or interesting that he went to Europe and tried his hand at hearing regeneration with a different approach than Frequency's. I do hope that Frequency can pull this off. It's a Herculean task. In retrospect what I thought to be a huge amount of money for Frequency really wasn't that much.

I just hope FX-322 ends up working and does not become one of the biggest scams in pharmaceutical history. Man that would break my heart if it ended up being a scam.

 

[xyz]

What hearing tests? Any more info than that?

Unfortunately not much info. But 1/3 had a hearing improvement. Is this a placebo result and total failure? I would also be interested to know how this treatment affected tinnitus. @Daniel Lion Do you have an email address of some other researcher other than Mr. Rutten? Maybe someone else is willing to share a bit more info.

 

[FGG]

@Coleoptere what do you mean "by same success rate"? According to @FGG, it's not the same treatment. FX-322 is better.

It's not the same success rate.

All of Frequency's subject with word score deficits improved at least some and the majority improved a lot (mild hearing loss does not result in word score deficits).

Also, you can't compare therapeutic dose to safety dose.

It's not the same treatment, one creates hair cells (Frequency) and one converts already established support cells to "hair cell like" cells which may be closer to vestibular cells (I posted this study a while ago on the Frequency thread). Frequency has refered to this difference a number of times as to why the CEO feels their drug is vastly superior.

 

[FGG]

Regain I think was a two year project. The two years is up. That doesn't say that the drug works or that it doesn't. They are claiming some improvement in hearing in some subjects. Take that at face value. Yes, Audion will need to find new partners because Regain is over. I don't see that as a reason to write them off.

Are you saying Regain wasn't a formal trial but a data gathering project?

 

[Rubenslash]

Quite a disappointment, have been following them for years and the hope for hair cell regeneration helps in keeping my mental health under control.

At least we still have Frequency and Otonomy who both arguably have a better product.

 

[Coleoptere]

@Coleoptere what do you mean "by same success rate"? According to @FGG, it's not the same treatment. FX-322 is better.

Success rate I define as the percentage improved patients in the trials so far as posted in this threat. This is a weak comparison as we do not have details from the Audion trail and the results are from different phases etc. I fully agree with @FGC and I hope the current trial of FX-322 (multiple injections) will give much better results.

 

[MrCrybaby]

This drug has nothing to do with FX-322. Don't speculate on what this might mean for Frequency, because the answer is it means nothing. It's like saying the Justice League movie was bad and you're worried what that means about the quality of the next Avengers film.

Even a failed trial brings us closer to the truth.

 

[FGG]

This drug has nothing to do with FX-322. Don't speculate on what this might mean for Frequency, because the answer is it means nothing. It's like saying the Justice League movie was bad and you're worried what that means about the quality of the next Avengers film.

Even a failed trial brings us closer to the truth.

Perfect analogy.

 

[briano]

Does anyone know if FX-322 or OTO-413 will help with the "X" and "O"s on an audiogram?

 

[FGG]

Does anyone know if FX-322 or OTO-413 will help with the "X" and "O"s on an audiogram?

X's and O's just mean left and right ear. We will know the range of audiogram effects after phase 2a.

 

[vermillion]

Another bust! Why am I not surprised?
I'm a Tzounopoulos fan here. He's on the right track.
Trobalt was the only drug that objectively alleviated tinnitus. We saw that on the forum few years ago, therefore that direction seems as the one closer towards a real treatment. Not a cure. An actual treatment. Something that will take the edge off and make us feel like humans again.

A doctor that I consulted happened to coordinate the REGAIN's part at University of Athens. I took part in one of her studies back then. They were gathering data from musicians and performers in regards to ear issues. She put me in the study as a dancer. I'm gonna throw an e-mail to her and see if I can learn something more. Will let you know guys.

 

[Lucifer]

Are we sure that Audion Therapeutics' drug is a done deal. I know they only mentioned about 35% of patients that had improvement but even if there some improvement shouldn't they still continue and see this through the end? They could go to Phase 3 if they wanted to.

 

[Daniel Lion]

Unfortunately not much info. But 1/3 had a hearing improvement. Is this a placebo result and total failure? I would also be interested to know how this treatment affected tinnitus. @Daniel Lion Do you have an email address of some other researcher other than Mr. Rutten? Maybe someone else is willing to share a bit more info.

No, sorry I don't have any names besides those.
I will write this morning and keep everyone posted if I get a reply.

 

[d'Wooluf]

Are you saying Regain wasn't a formal trial but a data gathering project?

I'm saying that Regain was a two year EU funded project involving a consortium of companies and universities. That consortium ran two formal trials. The project has ended, Audion presumably still holds the licence for the drug, and more than that there's not enough information to speculate.

 

[Lucifer]

I'm saying that Regain was a two year EU funded project involving a consortium of companies and universities. That consortium ran two formal trials. The project has ended, Audion presumably still holds the licence for the drug, and more than that there's not enough information to speculate.

I really hope Audion Therapeutics still continue with their current drug. I think they also have a partnership with Eli Lilly so maybe those two companies can work it out or find more investors to help them continue their trials and move onto Phase 3.

 

[FGG]

I'm saying that Regain was a two year EU funded project involving a consortium of companies and universities. That consortium ran two formal trials. The project has ended, Audion presumably still holds the licence for the drug, and more than that there's not enough information to speculate.

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?