Frequency Therapeutics — Hearing Loss Regeneration

[ChrisBoyMonkey]

Just to add some caution. All these these new therapeutics - whether it's FX-322, REGAIN, CGF166, Hough's siRNA etc. - operate under the assumption that human supporting cells can induce hair cell growth. Until one of these companies/institutes releases Phase 2 results, we don't know if that's the case. Yes, there's promising in vitro and in vivo work, but as someone very wise once said: if mouse results were fully indicative of human results, humanity would be disease free by now. Plenty of drugs that showed promising results in in vivo work, eventually failed in human trials.

The other thing is that even if these theories hold up, there will still be a patient population that won't be helped, either because their hearing loss is too great (too few supporting cells), or the cause of their hearing loss is not hair cell related (neuropathy, Vestibular Schwannoma, brain damage etc.).

Another obstacle in treating hearing loss is the lack of diagnostic tools. There is no imaging technology or way to test perilymph of the inner ear to see what's going on in a patients inner ear. All we have are hearing tests, which are far from perfect. That makes screening patients for therapies a lot harder.

And then there's of course the problem of inner ear drug delivery, which I won't nag about again.

Just to add some clarification, the FX-322 phase 1 was showing early positive results in live humans. Agreed that we want to see more that with this ongoing Phase 2 trial.

 

[vttbx]

Just to add some clarification, the FX-322 phase 1 was showing early positive results in live humans. Agreed that we want to see more that with this ongoing Phase 2 trial.

I'd say you are correct.

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

 

[JohnAdams]

that human supporting cells can induce hair cell growth.

They already did that with human tissue from a donated cochlea. It's fact.

 

[jeff W]

After a few of us hounded them for nearly 2 weeks, Degiro have finally added Frequency Therapeutics to their trading platform, ASIN US35803L1089. If anyone (in Europe) is looking for a cheap way to purchase them.

 

[Jurger]

They already did that with human tissue from a donated cochlea. It's fact.

That's true, I stand corrected. But it's also a fact that it's a lot easier to get enough of a drug in a donated cochlea than in real life patients. We don't know if human supporting cells are too refractory to respond to FX-322 in the concentration you can get into the inner ear intratympanically.

 

[JohnAdams]

That's true, I stand corrected. But it's also a fact that it's a lot easier to get enough of a drug in a donated cochlea than in real life patients. We don't know if a human supporting cells are too refractory to respond to FX-322 in the concentration you can get into the inner ear intratympanically.

That is indeed the question. Hopefully multiple doses can do the job. If all fails, I read somewhere on this forum that they are developing a needle that can worm its way into the round window, which seems like a neat trick if they can pull it off.

 

[Caveman]

That is indeed the question. Hopefully multiple doses can do the job. If all fails, I read somewhere on this forum that they are developing a needle that can worm its way into the round window, which seems like a neat trick if they can pull it off.

Do you mean the microneedle that's being developed at Columbia University? BTW, does anybody know when they're going to test it in a clinical trial? Is there a schedule?

 

[Jurger]

Do you mean the microneedle that's being developed at Columbia University? BTW, does anybody know when they're going to test it in a clinical trial? Is there a schedule?

https://news.columbia.edu/news/surgeon-tries-reach-behind-eardrum-treat-hearing-disorders

Don't know when they will do a trial. I think they're finishing their research first soon. Then I suppose a company has to put resources in it.

 

[Caveman]

https://news.columbia.edu/news/surgeon-tries-reach-behind-eardrum-treat-hearing-disorders

Don't know when they will do a trial. I think they're finishing their research first soon. Then I suppose a company has to put resources in it.

That's such a long way to go... We'd better cross our fingers and hope the FX-322 treatment works as it is

 

[FGG]

I don't qualify. Gutted .

 

[Gorbeh3]

I don't qualify. Gutted .

Do you know why?

Did they reject you because of something you said? Or because of your audiogram?

 

[Coleoptere]

https://news.columbia.edu/news/surgeon-tries-reach-behind-eardrum-treat-hearing-disorders

Don't know when they will do a trial. I think they're finishing their research first soon. Then I suppose a company has to put resources in it.

Does it need all the 1-2-3 phases? And again 1-2-3 once used together with FX-322?

 

[Jurger]

Does it need all the 1-2-3 phases? And again 1-2-3 once used together with FX-322?

Don't think so. Let's say in 10 years time there are 5 injectable drugs that are used to treat hearing loss or tinnitus. That would mean every new delivery method would have to go through trials for each of those individual drugs.

Needles and other delivery methods have their own approval process for 'medical devices'. Once it's approved, it can be used with any drug so as long that drug's also approved.

Remember: Frequency is using a hydrogel right now. Hydrogels have never been approved specifically for FX-322. They were probably just approved a long time ago as a medical device to deliver drugs into the inner ear. And now FX-322 benefits.

 

[Jurger]

I don't qualify. Gutted .

Keep your chin up. Your audiogram is fine up until 8000 Hz so it's no wonder. Should they find out after Phase 2a the drug restores ultra-high frequencies you can still benefit in a Phase 2b. Should they decide they don't want to market it for that purpose despite its efficacy (because of small patient population), you could still get it off-label from your ENT once it's released.

By the way, I wouldn't be surprised if this drug became very popular off-label. Right now it's not being tested for age-related hearing loss (presbycusis), just for noise-related hearing loss and sudden idiopathic hearing loss. If this gets approved, a lot of ENTs will want to offer this to old people, particularly if they are at a higher risk for dementia.

 

[FGG]

Do you know why?

Did they reject you because of something you said? Or because of your audiogram?

My audiogram.

 

[FGG]

Keep your chin up. Your audiogram is fine up until 8000 Hz so it's no wonder. Should they find out after Phase 2a the drug restores ultra-high frequencies you can still benefit in a Phase 2b. Should they decide they don't want to market it for that purpose despite its efficacy (because of small patient population), you could still get it off-label from your ENT once it's released.

By the way, I wouldn't be surprised if this drug became very popular off-label. Right now it's not being tested for age-related hearing loss (presbycusis), just for noise-related hearing loss and sudden idiopathic hearing loss. If this gets approved, a lot of ENTs will want to offer this to old people, particularly if they are at a higher risk for dementia.

One of the nurses also commented that they were surprised I couldn't listen to music at all or watch TV without captions with my audiogram. There is clearly more to my sudden hearing loss than just hair cell loss (though I definitely have that at higher frequencies, too). I think maybe I should try for a synatopathy drug trial, if I can get in one.

 

[Caveman]

One of the nurses also commented that they were surprised I couldn't listen to music at all or watch TV without captions with my audiogram. There is clearly more to my sudden hearing loss than just hair cell loss (though I definitely have that at higher frequencies, too). I think maybe I should try for a synatopathy drug trial, if I can get in one.

What do you feel when you listen to music? How long have you been feeling this way?

 

[Lotus72]

Hi everyone. Rick from Norway here.

I've got classic NIHL, attached is my audiogram. I am thinking that it is better to wait until they have done extensive research in order to get the most out of the treatment from Frequency Therapeutics. I should be a perfect test candidate though, since my audiogram has been steady for at least 14 months.

 

[FGG]

What do you feel when you listen to music? How long have you been feeling this way?

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

 

[hopeful4future]

So if any of you were to get approved for the phase 2 trial, would you not do it for some reason? For example, it potentially making things worse or the possibility of long term damage?

I guess I'm just curious if there are any risks with this procedure or drug they stick in your ear.

 

[ChrisBoyMonkey]

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

So strange... it's things like these that makes me angry that science hasn't got these diseases figured out yet. I originally wanted to be a neuroscientist, but I knew I didn't have the money to go for it so I did marketing instead...

If I get better (my tinnitus is pretty damn severe now and I am nowhere near close to habituating the way my sleep is going), I'm going to keep pursuing my dream of neuroscience. There's so much work that needs to be done, so many life-changing diseases people have to just live with. Chronic diseases without any treatment need to be a thing of the past.

 

[JohnAdams]

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

I am in the same boat but only to a small fraction of that. My tinnitus fluctuates and at its worse, I need subtitles on when my child is running around playing and screaming. My clarity is diminished and I'm sure it is from high frequency hearing loss.

 

[Rb86]

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

FGG I'd like to offer you hope. I've read a success story on here where the person had similar "broken speaker" sounds and it went away after around 2 years.

Please look up my thread noise induced success stories that give you hope. The 4th one down I posted I think is the one where a broken speaker sound is mentioned.

 

[jeff W]

One of the nurses also commented that they were surprised I couldn't listen to music at all or watch TV without captions with my audiogram. There is clearly more to my sudden hearing loss than just hair cell loss (though I definitely have that at higher frequencies, too). I think maybe I should try for a synatopathy drug trial, if I can get in one.

Forgive me if I am mistaken, but did you not list your cause of tinnitus as Ménière's?

 

[Jurger]

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

That sounds more like neuropathy, but it's strange your audiogram is fine. What did your otologist say? Might it be a somatic issue?

 

[John Queen]

I feel sad, crushed. All music sounds muffled and distorted to me regardless of the frequency. Some parts of every song sound far away and other parts are just missing. It definitely had a quality like a blown out speaker. Oddly, I can pick out most lyrics just fine but when watching TV if it has any background noise (i.e. anything but news), I need captions to understand about 30% of what is spoken.

This all happened suddenly Feb 1st, though I had tinnitus that started a month earlier.

I'd hug you now if I could. I'm in a similar situation, but I have pretty bad hearing loss (worse than you, in any case), and when there's (loud) background noise I can't hear much. I think what we need is both hair cell regeneration and synapse repair for the surviving hair cells (I see Otonomy has started its trial for OTO-413, link here https://clinicaltrials.gov/ct2/show/NCT04129775?term=otonomy&draw=3, maybe you can get in if it's in your state).
And I thought, maybe it's also the number of hair cells in each cochlear region that matters. Maybe you can have enough hair cells to detect the sound, so you respond well to pure-tones, but not enough to create a signal that makes sense to the brain...

 

[John Queen]

I am in the same boat but only to a small fraction of that. My tinnitus fluctuates and at its worse, I need subtitles on when my child is running around playing and screaming. My clarity is diminished and I'm sure it is from high frequency hearing loss.

Hey, I see you went to South Korea to that doctor, Minbo Shim.

If he offers that PRP + stem cells treatment anyway, can't he offer sustained-exposure BDNF treatments as well (the drug Otonomy is currently testing)?

 

[Caveman]

Do you guys think low-level laser therapy (for example, Dr. Wilden's) could help in this kind of situation?

 

[Aleksa Uzunovic]

Ey guys, it's great that FX-322 got fast track status. Shouldn't we be optimistic now about it because it restored hearing in mice? That makes it a 99% chance that it will work in humans, right?

 

[ajc]

Shouldn't we be optimistic now about it because it restored hearing in mice? That makes it a 99% chance that it will work in humans, right?

LOL no.

Cancer, Alzheimer's, Parkinson's, MS, dental caries, everything has been cured in mice already.

Translating that to humans IS NOT straightforward. Most successful mice studies fail in humans.

It's just in mice! This scientist is calling out hype in science reporting

Twitter account: https://twitter.com/justsaysinmice