Frequency Therapeutics — Hearing Loss Regeneration

[SouthKorean]

The FDA has granted FX-322 Fast Track designation.

Thank you, Lord.

Me right now:

View attachment 32203

What does this picture mean?

 

[Rb86]

That link says they will be holding trials at 12 sites nationwide, so maybe it's not just in North Carolina.

I live in North Carolina. Where does it say it's doing it and when?

 

[Bob90]

If what I'm remembering is true, even if this solves your hearing loss completely, one's tinnitus could still theoretically stick around since it's "wired in" if you've had it chronically. But I guess we wouldn't know that for sure until Frequency has finished all of their testing.

I do have hearing loss, but it is very mild across both normal and high frequency ranges, and I feel nerve damage is just as much a culprit as hair cell damage. Still, even if it would ultimately not help me very much, I am hopeful it will help many others and hopefully soon!

 

[jeff W]

Count on a second phase 2 trial first with more severe types of hearing loss.

I can't stress this enough: these are hearing loss drugs, not tinnitus or balance drugs. It's not gonna be like "Aha, this cures tinnitus/balance issues per our Phase 0! Screw hearing loss, let's get this on the market now!!"

Please elaborate.

 

[Lucifer]

I live in North Carolina. Where does it say it's doing it and when?

Durham, North Carolina, United States, 27713
Contact: Jaime Cheng, MD

No date when they are doing it but you could ask. Do you live close by to this place?

 

[FGG]

I live in North Carolina. Where does it say it's doing it and when?

Me too. Jamie Cheng was listed as researcher and in Durham. Duke?

Oops I see this was already answered. I live really close but don't think I qualify .

 

[Rb86]

Durham, North Carolina, United States, 27713
Contact: Jaime Cheng, MD

No date when they are doing it but you could ask. Do you live close by to this place?

About 3 hours. I am excited by this news but at the same time cautious. Not sure I'd jump in. Yes, phase 1 shows safety, but I don't think I'd survive my tinnitus or hearing getting potentially worse.

I believe their requirements are hearing loss for at least 6 months. I'm 4 months in and same hearing loss, no improvement. So it's likely I'd be a candidate.

 

[Rb86]

If what I'm remembering is true, even if this solves your hearing loss completely, one's tinnitus could still theoretically stick around since it's "wired in" if you've had it chronically. But I guess we wouldn't know that for sure until Frequency has finished all of their testing.

I do have hearing loss, but it is very mild across both normal and high frequency ranges, and I feel nerve damage is just as much a culprit as hair cell damage. Still, even if it would ultimately not help me very much, I am hopeful it will help many others and hopefully soon!

Aren't hair cells and nerves one and the same?

 

[Josdela]

If what I'm remembering is true, even if this solves your hearing loss completely, one's tinnitus could still theoretically stick around since it's "wired in" if you've had it chronically. But I guess we wouldn't know that for sure until Frequency has finished all of their testing.

I do have hearing loss, but it is very mild across both normal and high frequency ranges, and I feel nerve damage is just as much a culprit as hair cell damage. Still, even if it would ultimately not help me very much, I am hopeful it will help many others and hopefully soon!

It is one of the assumptions, that if the hearing of certain frequencies is recovered, tinnitus can be cured.

What happens if it does not eliminate tinnitus? I believe that only the OTO-313 would be a candidate to cure tinnitus.

We just have to wait for the results next year or, as you say, some member of Tinnitus Talk can sign up to the trial and share their experience/progress with all of us.

 

[Lucifer]

About 3 hours. I am excited by this news but at the same time cautious. Not sure I'd jump in. Yes, phase 1 shows safety, but I don't think I'd survive my tinnitus or hearing getting potentially worse.

I believe their requirements are hearing loss for at least 6 months. I'm 4 months in and same hearing loss, no improvement. So it's likely I'd be a candidate.

Let us know if you do sign up and get accepted for the trials.

 

[Rb86]

Let us know if you do sign up and get accepted for the trials.

Absolutely. Assuming there's no major confidentiality contracts (which is quite possible), I'd be letting everyone here know what's up every step of the way.

 

[Auron]

What happens if it does not eliminate tinnitus?

University of Michigan Device. One Two Punch.

 

[ChrisBoyMonkey]

About 3 hours. I am excited by this news but at the same time cautious. Not sure I'd jump in. Yes, phase 1 shows safety, but I don't think I'd survive my tinnitus or hearing getting potentially worse.

I believe their requirements are hearing loss for at least 6 months. I'm 4 months in and same hearing loss, no improvement. So it's likely I'd be a candidate.

If you have courage and do friend, you will be doing a lot of people suffering on this site a good service. I don't think anyone would think any less of you if you don't either, nobody wants to make this thing any worse.

 

[Jurger]

Ain't happening.

Why not? Have they asked since they went public?

 

[F-u-T]

Durham, North Carolina, United States, 27713
Contact: Jaime Cheng, MD

No date when they are doing it but you could ask. Do you live close by to this place?

Their Twitter announcement says they have already started dosing patients in the phase 2A study.

 

[Lucifer]

Their Twitter announcement says they have already started dosing patients in the phase 2A study.

Wow that was quick. Have some people already been given the drug in Phase 2a?

 

[Daniel Lion]

Wow that was quick. Have some people already been given the drug in Phase 2a?

This is one of the many things I don't get.

I follow ClinicalTrials.gov religiously... waiting to get a shot at participating.

Am I understanding correctly that the participants for the trial have already been selected? Or is that process underway now? Clarification please, thanks.

 

[Jurger]

Am I understanding correctly that the participants for the trial have already been selected? Or is that process underway now? Clarification please, thanks.

No, you can e-mail them for participation.

 

[WickedCarnival]

I wonder how long it will take for FX-322 to be available in Canada?

 

[JohnAdams]

I believe that only the OTO-313

Hell naw. OTO-413 will probably lower tinnitus with several doses. FX-322 will treat tinnitus, just watch.

 

[JohnAdams]

Aren't hair cells and nerves one and the same?

Not really. They are both considered to be nerves but the hair cell is a highly specialized type.

I'd survive my tinnitus or hearing getting potentially worse.

It won't.

 

[JohnAdams]

it's "wired in" if you've had it chronically.

That's bullshit. Nobody knows that.

 

[Jurger]

Aren't hair cells and nerves one and the same?

There's hair cells, the nerve endings of hair cells and the auditory nerve. All three are needed for natural hearing, all three can be damaged. New hair cells induced by regenerative medicine do seem to have nerve endings, from what we've seen in pre-clinical work from these drugs.

 

[JohnAdams]

What does this picture mean?

I'm focused on the track.

 

[Heinrich_S7]

I'm focused on the track.

@JohnAdams Do you think our sentence is almost up?

Life is going to be so beautiful in silence.

 

[Auron]

Life is going to be so beautiful in silence.

Music is going to sound so beautiful again!

 

[JohnAdams]

@JohnAdams Do you think our sentence is almost up?

Life is going to be so beautiful in silence.

Hope so. We may not get total silence out of this. Who knows?
The Frequency Therapeutics people will have some knowledge here in a few months about it. I wish they would do a separate study on people with very little hearing loss but tinnitus. Why wouldn't they? I don't understand their decision making process.

 

[tarmaced]

https://www.forbes.com/sites/aroy/2...-after-phase-ii-a-response-to-matthew-herper/

See the above link for the description of the 'conditional approval process'. This does happen.

This might also be referred to as rolling review.

Also see the link below to confirm that this has also happened 30 times in the EU:
https://www.bmj.com/content/357/bmj.j2062

Again people, some drugs are released on phase 2 data. See my previous post

 

[Heinrich_S7]

Hope so. We may not get total silence out of this. Who knows?
The Frequency Therapeutics people will have some knowledge here in a few months about it. I wish they would do a separate study on people with very little hearing loss but tinnitus. Why wouldn't they? I don't understand their decision making process.

Almost every other drug or treatment on the market is applicable to treating multiple several conditions, I see no reason why FX-322 can't be designated for both hearing loss and tinnitus.

 

[JohnAdams]

Almost every other drug or treatment on the market is applicable to treating multiple several conditions, I see no reason why FX-322 can't be designated for both hearing loss and tinnitus.

It's all about money.