Frequency Therapeutics — Hearing Loss Regeneration

[rid0871]

They already had a phase 1.

Why have another?

It's all crap.

The FDA can be bought like any other government department.

The only reason they want FDA to be on board is so the insurance companies can pay for the drug they release if there is ever any released.

I'm sorry, I know I'm mad, but I'm so damn tired of this noise. I would have rather got something else than this. Anything else. It's nothing but cruel suffering to all that have it

There are millions of stuff out there that says not FDA approved.

I think they're just stalling because it does not work.

I'm sorry for being so upset. I'm just tired of waiting.

 

[Margus]

Let's look at the positive side. All remaining participants are enrolled in the trial as of today, need to wait just 2-3 months to collect results and see if there are any adverse effects. All is going as planned.

 

[lymebite]

This paper has an interesting discussion on progenitor cells for hearing restoration.

See this section starting on page 69:

Chapter Five: Stem cells to repair against Noise-induced Hearing Loss.

https://lra.le.ac.uk/bitstream/2381/40043/1/2017SahotaRS_MD.pdf

 

[Leoglobe]

I hope that the results will be good. The positive thing is that I have been following this company for a while and they are ahead of their schedule. That is good.

The thing that worries me is that if there is a cure, I hope that they will care about people in my case: I have hidden hearing loss. My hearing until 8 kHz is fine but my tinnitus is around 12 kHz. They seem to care only about audiograms up to 8 kHz and quite severe hearing loss.

 

[streeter1985]

The thing that worries me is that if there is a cure, I hope that they will care about people in my case: I have hidden hearing loss. My hearing until 8 kHz is fine but my tinnitus is around 12 kHz. They seem to care only about audiograms up to 8 kHz and quite severe hearing loss.

In my opinion that's the only way they can go ahead to measure something that is actually measurable. They would not get the huge investments or interest with focusing hidden hearing loss. They need clear results that you can see in an (from the medicine/insurances accepted) audiogram.

I also hope it will work but lets say if I get my hearing back from 4 kHz to 8 kHz I still might have tinnitus because everything over 8 kHz is also gone/damaged and what bothers me the most is the tinnitus, not the hearing loss, but I sometimes have to say "ehhh? pardon me?"

So in my case, as a hearing loss patient, I can tell you we sit in the same boat. I don't differentiate that much, I think that would be too early.

 

[JohnAdams]

In my opinion that's the only way they can go ahead to measure something that is actually measurable. They would not get the huge investments or interest with focusing hidden hearing loss. They need clear results that you can see in an (from the medicine/insurances accepted) audiogram.

I also hope it will work but lets say if I get my hearing back from 4 kHz to 8 kHz I still might have tinnitus because everything over 8 kHz is also gone/damaged and what bothers me the most is the tinnitus, not the hearing loss, but I sometimes have to say "ehhh? pardon me?"

So in my case, as a hearing loss patient, I can tell you we sit in the same boat. I don't differentiate that much, I think that would be too early.

I have good reason to believe that FX-322 will actually work better on higher frequencies.

 

[Flamingo1]

I have good reason to believe that FX-322 will actually work better on higher frequencies.

What's your reason?

 

[JohnAdams]

What's your reason?

"The mice were then tested again and were actually able to hear, and were especially good at hearing high frequencies."

http://www.illustratedcuriosity.com/health/health-medicine/ly411575-a-drug-that-restores-hearing/

The first part of the cochlea that the drug will reach after entering the round window is the high frequency part.

 

[Contrast]

What's your reason?

higher frequencies are earlier in the cochlear spiral

 

[streeter1985]

Do you have an opinion regarding 70+ dB and/or dead regions at higher frequencies concerning this treatment? That would be really interesting to me. Do you see limitations?

I think they said in one email that they even assume that the nerve connects to the regrown hair cells. I am afraid of that Reddit post saying that it might not work for severe to profound hearing loss but wasn't able to find any information about a lack of supporting cells or maybe scars from an other source.

 

[Samir]

Do you have an opinion regarding 70+ dB and/or dead regions at higher frequencies concerning this treatment? That would be really interesting to me. Do you see limitations?

I think they said in one email that they even assume that the nerve connects to the regrown hair cells. I am afraid of that Reddit post saying that it might not work for severe to profound hearing loss but wasn't able to find any information about a lack of supporting cells or maybe scars from an other source.

As I recall, if the loss is 40 dB or more, it's indicative of inner hair cell (cochlear amplifier) loss. Unless there are progenitor cells in that tonotpic region of the cochlea, PCA treatment is not going to be very effective I'm afraid. But like you said, there was no mention of whether or not the progenitors are intact and for how long after the injury/damage. The optimal time window for treatment is a question that Frequency is trying to find the answer to during the trials.

 

[Striveon]

As I recall, if the loss is 40 dB or more, it's indicative of inner hair cell (cochlear amplifier) loss. Unless there are progenitor cells in that tonotpic region of the cochlea, PCA treatment is not going to be very effective I'm afraid. But like you said, there was no mention of whether or not the progenitors are intact and for how long after the injury/damage. The optimal time window for treatment is a question that Frequency is trying to find the answer to during the trials.

Would moderate hearing loss be excluded?

 

[Leodavinci]

I emailed them twice, sent them my audiograms and insisting they could learn a lot from my specific case. NO ANSWER!!!

They probably can't enroll requests because it is non random selection. It creates a bias in the sample to be studied.

 

[Gorbeh3]

Would moderate hearing loss be excluded?

If we can be honest, everything here is speculation. FT has spent millions in this idea that is worth billions and is competing with many different other companies trying to reach the same result.

No one here on this forum actually knows anything, and nothing will be known for certain until FT releases official statements.

Take everything said here with a grain a salt.

 

[Striveon]

If we can be honest, everything here is speculation. FT has spent millions in this idea that is worth billions and is competing with many different other companies trying to reach the same result.

No one here on this forum actually knows anything, and nothing will be known for certain until FT releases official statements.

Take everything said here with a grain a salt.

Thank you, you're right, I shouldn't be losing hopes and just saying that's it for me. I appreciate your comment, I'll take things as a grain of salt

 

[bell]

As I recall, if the loss is 40 dB or more, it's indicative of inner hair cell (cochlear amplifier) loss. Unless there are progenitor cells in that tonotpic region of the cochlea, PCA treatment is not going to be very effective I'm afraid. But like you said, there was no mention of whether or not the progenitors are intact and for how long after the injury/damage. The optimal time window for treatment is a question that Frequency is trying to find the answer to during the trials.

I think (and hope) it is not correct as excluding criteria of the trial only excludes this:

1. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected. https://clinicaltrials.gov/ct2/show/NCT03616223

 

[Samir]

Would moderate hearing loss be excluded?

For the clinical trial? I don't recall the inclusion criteria to be honest. That doesn't have to mean that the treatment would not be available to people with moderate hearing loss, assuming it is shown to be effective in the mild hearing loss group.

 

[Striveon]

For the clinical trial? I don't recall the inclusion criteria to be honest. That doesn't have to mean that the treatment would not be available to people with moderate hearing loss, assuming it is shown to be effective in the mild hearing loss group.

You're right, thank you, I just hope it works for everyone it would be a bummer to hear it will not work for the rest of us, I don't know how I would take it since I had my hopes up

 

[Gorbeh3]

For the clinical trial? I don't recall the inclusion criteria to be honest. That doesn't have to mean that the treatment would not be available to people with moderate hearing loss, assuming it is shown to be effective in the mild hearing loss group.

The trial was looking specifically for people who had significant dips at 4K to 8K on their audiogram. They did not say if a specific baseline was required for frequencies below that.

 

[katri]

We know when they complete the trials but do we know when they'll publish the results?

https://clinicaltrials.gov/ct2/help/how-find/find-study-results

 

[katri]

https://clinicaltrials.gov/ct2/manage-recs/faq#upload
These are the guidelines for the trials.

Can someone help me find the data for the previous hunan trial that proved it was safe? We can use that to estimate the amount of time it will take.

 

[katri]

They made an announcement fairly quickly at the symposium about how safe the study was.

So they got the results/ completed it around the target date and they announced its relative success. I'll try to comb for the results on their database because it isn't clearly stated in their clinical gov account. At the latest we'll know the actual validity of their claims from last year. Let me know if I mixed up something.

https://www.businesswire.com/news/h...s’-First-in-Human-Safety-Study-FX-322-Hearing

 

[JohnAdams]

They made an announcement fairly quickly at the symposium about how safe the study was.

So they got the results/ completed it around the target date and they announced its relative success. I'll try to comb for the results on their database because it isn't clearly stated in their clinical gov account. At the latest we'll know the actual validity of their claims from last year. Let me know if I mixed up something.

https://www.businesswire.com/news/h...s’-First-in-Human-Safety-Study-FX-322-Hearing

I think they said December. I don't think they're going to tell us if it helps with tinnitus though.

 

[Spiral]

I know it's way too early to think about this but... So provided there is a benefit of getting treatment with this... Ballpark range, how much would it cost to get treatment in both ears? I'd give my left nut to be able to afford this.

 

[JohnAdams]

I know it's way too early to think about this but... So provided there is a benefit of getting treatment with this... Ballpark range, how much would it cost to get treatment in both ears? I'd give my left nut to be able to afford this.

Probably comparable with cochlear implants.

 

[katri]

I'd give my left nut to be able to afford this.

Same. LMAO $200 for the injection (including numbing gel), $500 per ear?

 

[Enclave]

I know it's way too early to think about this but... So provided there is a benefit of getting treatment with this... Ballpark range, how much would it cost to get treatment in both ears? I'd give my left nut to be able to afford this.

Frequency has stated on multiple occasions that FX-322 is comprised of inexpensive materials that are readily available and easy to manufacture. All this points toward an inexpensive product. However, a set of very top of the line hearing aids can run you approximately $6k (American). Given that a small molecule therapy to restore hearing is clearly a superior technology to hearing aids, I would argue they price their drug just below the price of $6k to beat out the market of hearing aids.

I have no sources to support this, I'm just taking a guess based on markets and simple economics.

Aside from the inexpensive materials and inexpensive manufacturing of their product, the good news is that 1/6 of the world is estimated to have some degree of hearing loss. The more people that share your ailment the cheaper it becomes per unit.

 

[PolishSoldier87]

If It works, the price doesn't matter.

Health care is refunding cochlear implants so it would be nice to get cured for free.

 

[JohnAdams]

Same. LMAO $200 for the injection (including numbing gel), $500 per ear?

I seriously doubt it will be that price when released. If it is then that would be great!

I was thinking $20,000 per ear. One of the ingredients listed is LY411575 which is about $30,000 per gram.

 

[PolishSoldier87]

Will this help my ultra high frequency hearing loss?