Frequency Therapeutics — Hearing Loss Regeneration

[Remjii79]

Sorry if this has been answered before, this is quite a large thread, but has anything been said about this being effective for congenital sensorineural hearing loss?

 

[Hania]

I'm not going to say anything, in December we will talk again.

 

[katri]

Sorry if this has been answered before, this is quite a large thread, but has anything been said about this being effective for congenital sensorineural hearing loss?

Do you mean like genetic? Or progressive?

 

[Tim19941994]

What about genetic causes? Would FX-322 work for that? Alport syndrome for example.

 

[Don Tinny]

I wish the timeline were like this:

2019 - Phase 2
2020 - Phase 3
2021 - Available

 

[katri]

What about genetic causes? Would FX-322 work for that? Alport syndrome for example.

Possibly not. The trials are for people that don't have the genetic condition. It would work to regrow them but you might just lose them again because of it.

 

[JohnAdams]

I wish the timeline were like this:

2019 - Phase 2
2020 - Phase 3
2021 - Available

Or this:
2018 phase 1/2, it works! Skip to an open phase 3 in 2019 and allow people to have it.

 

[Remjii79]

Do you mean like genetic? Or progressive?

Yeah genetic stable sensorineural hearing loss.

 

[katri]

If it is stable then you should be fine.

 

[Don Tinny]

Or this:
2018 phase 1/2, it works! Skip to an open phase 3 in 2019 and allow people to have it.

Is there any chance that they will do it so fast? I'm afraid they'll choose the slow way.

 

[JohnAdams]

Is there any chance that they will do it so fast? I'm afraid they'll choose the slow way.

Well they are a startup corporation and the economics of that dictate that they want to keep initial costs low and get to market ASAP.

My thinking is that if they have a working product, which they will probably know soon, then they would probably want to get it to us sooner than later. No company likes government regulations.

After this trial they may know they have a good thing and want people like us to demand it.

 

[d'Wooluf]

After this trial they may know they have a good thing and want people like us to demand it.

Sorry JohnAdams. I agree with @annV, although I'd put it a little less bluntly.

It's all just fantasy and wishful thinking. If it happens - and we all hope it does - it will happen in its own time.

 

[JohnAdams]

Sorry JohnAdams. I agree with @annV, although I'd put it a little less bluntly.

It's all just fantasy and wishful thinking. If it happens - and we all hope it does - it will happen in its own time.

yes, restoring hearing in rodents and replicating the process in vitro in human tissue is a fantasy. so glad you agree with annv, an old woman that goes to disease support forums and insults people that believe in God.
I never said I know it works ive just said this is the best hope we have and we should be focused on this and IF IF IF IF IF IF IF IF IF IF IF IF IT WORKS then we should be advocating that the FDA cut red tape on it. if you disagree then you're just something special.

 

[IAmCalifornia]

yes, restoring hearing in rodents and replicating the process in vitro in human tissue is a fantasy. so glad you agree with annv, an old woman that goes to disease support forums and insults people that believe in God.
I never said I know it works ive just said this is the best hope we have and we should be focused on this and IF IF IF IF IF IF IF IF IF IF IF IF IT WORKS then we should be advocating that the FDA cut red tape on it. if you disagree then you're just something special.

I swear sometimes you talk to people and realise they're in the stone age.

Frequency is a medical marvel and you'd think they don't want it to happen.

 

[d'Wooluf]

Ok. If the struggle gets you to focus on something else apart from your tinnitus, I say go for it.

 

[Gorbeh3]

https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio

Nothing big, Lucchino talking to Bloomberg.

I didn't get a chance to listen to it, I'll check it out when I get home after work.

 

[Enclave]

https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio

Nothing big, Lucchino talking to Bloomberg.

I didn't get a chance to listen to it, I'll check it out when I get home after work.

I was just about to post this link, but here are a few things Lucchino mentioned:

- Frequency Therapeutics won't be looking at the data from this current trial until early next calendar year

- Lucchino made a offhand statement that FX-322 might be able to help those with severe hearing loss, but backtracks by stating the focus is on individuals who have lesser degrees of hearing loss

- Based on the data reviewed early next year, Frequency Therapeutics will try to go for the designated breakthrough status with the FDA to fast track this drug if they are seeing the results they are looking for in the current study.

 

[grate_biff]

"We wanna help people!", said Lucchino.

 

[Jack Straw]

I'm not going to say anything, in December we will talk again.

What's in December?

 

[JohnAdams]

From the above interview with Lucchino:

"So far so good"

If phase 2 goes good...

"Then you go to the FDA and talk to them about breakthrough or fast track status"
"We want to help people"

This interview was from Monday. They've given the drug. He sounded very optimistic.
I'd also perhaps speculate that they may know if the test subjects are healing. It would seem strange if they weren't interested.

 

[Chad Lawton]

https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio

Nothing big, Lucchino talking to Bloomberg.

Starts at 47:20 mark.

They B.S. about baseball until 50:40, that is when the good stuff starts.

Lucchino does mention Fast Track status with the FDA if the data looks promising...

 

[katri]

What's in December?

Frequency Therapeutics finishes their trial.

 

[Gorbeh3]

What's in December?

Results of phase 1.5 will be reported.

 

[grate_biff]

What's in December?

Completion of trial, phase I/II.

 

[Don Tinny]

What's in December?

I think she refers to the results of phase 1/2.

 

[Johan_L]

What's in December?

The current trial finishes in December. If it works and say 15 out 16 show improvement then it's pretty much a done deal. (Yes, I have my hopes up...)

 

[SuntoryTime]

What's in December?

December is the conclusion of the current small scale Phase 1/2 clinical trial. Frequency have not yet announced when a Phase 3 clinical trial will begin. I am crossing my fingers for 2019.

https://clinicaltrials.gov/ct2/show/NCT03616223

 

[Jack Straw]

They will most likely not announce the results for a couple more months if at all.

 

[Soren]

I was just about to post this link, but here are a few things Lucchino mentioned:

- Frequency Therapeutics won't be looking at the data from this current trial until early next calendar year

- Lucchino made a offhand statement that FX-322 might be able to help those with severe hearing loss, but backtracks by stating the focus is on individuals who have lesser degrees of hearing loss

- Based on the data reviewed early next year, Frequency Therapeutics will try to go for the designated breakthrough status with the FDA to fast track this drug if they are seeing the results they are looking for in the current study.

 

[Striveon]

I was just about to post this link, but here are a few things Lucchino mentioned:

- Frequency Therapeutics won't be looking at the data from this current trial until early next calendar year

- Lucchino made a offhand statement that FX-322 might be able to help those with severe hearing loss, but backtracks by stating the focus is on individuals who have lesser degrees of hearing loss

- Based on the data reviewed early next year, Frequency Therapeutics will try to go for the designated breakthrough status with the FDA to fast track this drug if they are seeing the results they are looking for in the current study.

Does this mean it'll only help those with mild and severe hearing loss? So any other type of hearing loss won't benefit? What about moderate hearing loss?