Frequency Therapeutics — Hearing Loss Regeneration

[chinup]

Frequency Therapeutics suspects that FX-322 is restoring hearing at the highest frequencies first, and may be treating tinnitus. We'll know more in Q1 and Q2 when they release results of the active Phase 2A.

I wonder if this means that tinnitus tones in lower frequencies will be more difficult to treat. My lowest tone is around 4 kHz.

 

[scotty03874]

They said to wait until after my appointment on the 21st to give it three weeks and to call back. That it was a possibility they would offer it. I feel if more people would call and ask for it they may offer it.

I should call them.

I have severe/moderate hearing loss (-70 dB) at 3000 Hz, 4000 Hz, 6000 Hz.

I wonder if I would qualify for compassionate use?

 

[Pete88]

I should call them.

I have severe/moderate hearing loss (-70 dB) at 3000 Hz, 4000 Hz, 6000 Hz.

I wonder if I would qualify for compassionate use?

It cant hurt to try. The more people who contact them, the more attention it gets. The more attention it gets, the better.

Squeaky wheel gets the grease!

 

[Diesel]

I have severe/moderate hearing loss (-70 dB) at 3000 Hz, 4000 Hz, 6000 Hz.

I wonder if I would qualify for compassionate use?

You might qualify for the severe hearing loss Phase 1b currently going on.

 

[Keith Handy]

Squeaky wheel gets the grease!

Apropos metaphor, particularly in this group.

 

[Drachen]

I wonder if this means that tinnitus tones in lower frequencies will be more difficult to treat. My lowest tone is around 4 kHz.

I think it's all but certain that FX-322 actually functions as it is intended to in terms of restoring hair cells, but the critical issue to be addressed is delivery of the drug throughout the cochlea.

I am going to assume the above graphic is a satisfactory representation of the frequency ranges within the cochlea since I got it from Britannica.

In this case, if your issue is say within the 4 kHz range, you would need to get enough injections for the drug to work its way down there. It has been stated before in this thread that the drug doesn't act upon intact cells, so further injections could push unused portions of FX-322 further down to address areas that need regeneration.

I don't think any of us can say for sure yet how "difficult" it will be to manage the lower frequencies, but that is a key issue that Frequency Therapeutics is not only aware of but actively trying to address in research.

This is also assuming that if your tone is a certain frequency then that implies you have damage to that specific region. I'm not sure if this is conclusive but rather assumed.

 

[vttbx]

Does anybody know (or have some idea) how effective FX-322 may be for those with tinnitus like me; who have no real hearing loss or difficulty in hearing.

In fact I have been told by two audiologists my hearing is superb and very sensitive. My hearing test came out with both ears around the 5 dB from 250 Hz - 1 kHz, then with both ears near to 0 dB from 4 kHz to 8 kHz. My hearing test dips around the 2 kHz - 4 kHz mark in mainly the left ear (lowest to 10 dB). My buzz like tinnitus and sensitive ear is really all coming from the left ear. I have near perfect hearing tests up to 8 kHz. I think my tinnitus has come from damage to the higher frequencies.

Do we know if people like me are in the clinical trials and if FX-322 will help with those higher frequencies? Or have they just picked people with really poor hearing?

You should feel lucky to have great hearing. I would give the world to have your audiogram and only tinnitus to deal with.

 

[GBB]

You should feel lucky to have great hearing. I would give the world to have your audiogram and only tinnitus to deal with.

No offense but this is just someone in one circle of hell preaching at someone in another circle.

 

[vttbx]

No offense but this is just someone in one circle of hell preaching at someone in another circle.

Understood. We have all been there. I was just trying to offer some perspective and maybe something positive to think about.

 

[Philip83]

I think it's all but certain that FX-322 actually functions as it is intended to in terms of restoring hair cells, but the critical issue to be addressed is delivery of the drug throughout the cochlea.

View attachment 42828

I am going to assume the above graphic is a satisfactory representation of the frequency ranges within the cochlea since I got it from Britannica.

In this case, if your issue is say within the 4 kHz range, you would need to get enough injections for the drug to work its way down there. It has been stated before in this thread that the drug doesn't act upon intact cells, so further injections could push unused portions of FX-322 further down to address areas that need regeneration.

I don't think any of us can say for sure yet how "difficult" it will be to manage the lower frequencies, but that is a key issue that Frequency Therapeutics is not only aware of but actively trying to address in research.

This is also assuming that if your tone is a certain frequency then that implies you have damage to that specific region. I'm not sure if this is conclusive but rather assumed.

Like me and Diesel discussed earlier in this thread, there is somewhat of a chance that fixing higher frequencies might actually mitigate lower frequency tinnitus because it's giving the brain more input in total than what it had before, potentially keeping it busy enough to "mask" the other tinnitus frequencies. It's just a theory though.

 

[Diesel]

SERIOUSLY... Even Frequency Therapeutics is throwing shade at the "Normal Audiogram" = Normal Hearing fallacy.. they just shared this on Twitter:

Rethinking the Standard Approach to Audiometric Testing

BURN.

 

[Lucifer]

SERIOUSLY... Even Frequency Therapeutics is throwing shade at the "Normal Audiogram" = Normal Hearing fallacy.. they just shared this on Twitter:

Rethinking the Standard Approach to Audiometric Testing

BURN.

Can't wait for these specialists to get ahead at these new treatments coming out and realising that a normal audiogram does not mean there is no damage.

 

[FGG]

SERIOUSLY... Even Frequency Therapeutics is throwing shade at the "Normal Audiogram" = Normal Hearing fallacy.. they just shared this on Twitter:

Rethinking the Standard Approach to Audiometric Testing

BURN.

I wish they would do a PSA: If your tinnitus was caused by noise, you have hearing damage. Even if you don't notice it and even if your audiogram is normal.

 

[Diesel]

I wish they would do a PSA: If your tinnitus was caused by noise, you have hearing damage. Even if you don't notice it and even if your audiogram is normal.

I wish I could give this more than one rating.

 

[Greg Sacramento]

I wish they would do a PSA: If your tinnitus was caused by noise, you have hearing damage. Even if you don't notice it and even if your audiogram is normal.

Such a true statement. I have a notebook where I record the handicap percentage possibilities between your mention and other many conditions that can cause tinnitus, but far from all. For many, tinnitus/hearing loss is caused from noise or meds alone, but we have many that post with also having other conditions that need consideration input as well.

 

[FGG]

Such a true statement. I have a notebook where I record the handicap percentage possibilities between your mention and other many conditions that can cause tinnitus, but far from all. For many, tinnitus/hearing loss is caused from noise or meds alone, but we have many that post with also having other conditions that need consideration input as well.

That's a good point, too.

There is a tendency on this forum (and elsewhere) to want to simplify it all and say tinnitus is caused by damage to one structure. It's simply not true (if it was, hydrops, middle ear disease, ETD, ear drum rupture, ear wax, TMJ etc. wouldn't cause tinnitus). Anything that interferes with the auditory system will cause "phantom cochlea" aka tinnitus.

It can be multi factorial. You could have simple hearing loss or you could have noise induced hearing injury with additional cofactors such as TMJ, autoimmune disease, etc. Cofactors matter in terms of severity. The effects are additive.

An example I used for someone recently in how chronic conditions can have cofactors that *seem* unrelated is that an uncontrolled UTI can make it very hard to manage diabetes in a dog. Physiology is not simple and not easily reducible.

That being said, stress is definitely a factor too. Not because of some mind over matter/positive thinking BS but because chronic uncoping stress actually affects your neurochemisty/receptors (see photos below).

I should clarify my earlier post: even though if you get tinnitus from noise and it denotes hearing damage, it's not always permanent (acute inflammation can interfere with the auditory system).

 

[serendipity1996]

SERIOUSLY... Even Frequency Therapeutics is throwing shade at the "Normal Audiogram" = Normal Hearing fallacy.. they just shared this on Twitter:

Rethinking the Standard Approach to Audiometric Testing

BURN.

I am really liking the optimistic tone struck by this article - it pretty much firmly acknowledges that we're on the verge of a real transformation in the way that hearing loss is treated. Sometimes, when I'm feeling down I find myself doubting whether any of the drugs in the pipeline will *really* work - this helps dispel much of my pessimism and worry.

 

[Lucifer]

I am really liking the optimistic tone struck by this article - it pretty much firmly acknowledges that we're on the verge of a real transformation in the way that hearing loss is treated. Sometimes, when I'm feeling down I find myself doubting whether any of the drugs in the pipeline will *really* work - this helps dispel much of my pessimism and worry.

I have the same doubts as well but hearing these new treatments that could potentially come out has allowed me to remain optimistic for the future.

 

[Lucifer]

I can't believe it's the middle of January now and we have two and a half months before they release Phase 2a clinical trial results up to Day 90.

Praying that the results are positive and they can release FX-322 soon.

 

[Born To Slay]

I can't believe it's the middle of January now and we have two and a half months before they release Phase 2a clinical trial results up to Day 90.

Praying that the results are positive and they can release FX-322 soon.

Honestly, all of the behavior on their part indicates we are in the verge of seeing greatness, and it'd be a great follow up to Otonomy's fantastic results in December.

 

[Damien0000]

I would like to know if FX-322 might have a beneficial effect on my tinnitus, which is either stress-induced, or more likely caused by an auditory shock lasting 2 seconds from in-ear headphones.

My audiogram is normal but apparently my hair cells are damaged (not broken but damaged).

Thanks for your reply.

 

[Lucifer]

Honestly, all of the behavior on their part indicates we are in the verge of seeing greatness, and it'd be a great follow up to Otonomy's fantastic results in December.

Yeah, Frequency Therapeutics and the CEO tweeted recently about normal audiograms not meaning that there is no hearing damage which I would assume means the results of FX-322 are looking positive but we will have to wait and see.

 

[Lucifer]

I would like to know if FX-322 might have a beneficial effect on my tinnitus, which is either stress-induced, or more likely caused by an auditory shock lasting 2 seconds from in-ear headphones.

My audiogram is normal but apparently my hair cells are damaged (not broken but damaged).

Thanks for your reply.

I assume your tinnitus is caused from in-ear headphones. So far there have been a few candidates that have mentioned that their tinnitus was lowered but you may need a synapse drug such as OTO-413 as well to completely get rid of your tinnitus.

 

[Pete88]

I would like to know if FX-322 might have a beneficial effect on my tinnitus, which is either stress-induced, or more likely caused by an auditory shock lasting 2 seconds from in-ear headphones.

My audiogram is normal but apparently my hair cells are damaged (not broken but damaged).

Thanks for your reply.

From what I've read, shocks from headphones are just static shocks due to a variety of reasons. But just in case a shock did damage your hair cells, I'd assume that the hair cells affected would benefit. If the reason for auditory issues is related to the hair cells, this should help.

 

[Drachen]

I would like to know if FX-322 might have a beneficial effect on my tinnitus, which is either stress-induced, or more likely caused by an auditory shock lasting 2 seconds from in-ear headphones.

My audiogram is normal but apparently my hair cells are damaged (not broken but damaged).

Honestly, I'm a bit skeptical of any variant of this symptom being "stress-induced". I haven't been able to find anything conclusive about the science behind it actually causing the phantom noise, but if others here have any links, I'd be glad to read them. How I have hitherto understood it is that things like stress and anxiety simply exacerbate your perception of it.

Your auditory shock could have been the push off the edge of any accumulated damage up to that point. Regardless of however normal your audiogram may have been, there's still a chance it has missed pertinent damage in between the tested ranges or in ranges which were not tested, typically the higher frequencies. The extent of damage you must receive before you might acquire this symptom is not conclusive either, especially since many with hearing loss don't have to deal with this.

I'm still not sure on what is expected with regards to managing damaged but not destroyed hair cells. I asked this question a few pages back a bit nervously, and I'm still not sure I understand what the resolution may be. I think FGG said something to this extent where the hairs broken enough to cause issues will eventually die from apoptosis, which then makes them candidates for regeneration by FX-322.

Alternatively, there's also the potential issue that you may have synaptopathy on top of normal hairs. This is going to be addressed by another drug, OTO-413, which is also looking very promising in this field.

 

[Diesel]

Yeah, Frequency Therapeutics and the CEO tweeted recently about normal audiograms not meaning that there is no hearing damage which I would assume means the results of FX-322 are looking positive but we will have to wait and see.

It also points out that the audiogram is a terrible indicator of hearing improvement. For example, in the Phase 1/2, they indicated that a few patients saw improvements of 10 dB at 8 kHz on the audiogram.

Assuming a simple standard audiogram was used, the next lower tested frequency after 8 kHz is 4 kHz. There's a big gap in untested frequencies there.

So, of those few that showed improvements at 8 kHz; we really don't if maybe they might have gotten improvements down to 7 kHz, 6 kHz, or even 5 kHz because the audiogram doesn't test those frequencies. However, if it did, it might help explain some of the word score improvements and how deep FX-322 can really go.

This is actually a problem for Frequency Therapeutics in the Phase 2A as well. If they aren't using the more granular audiogram that adds more tones between 1 kHz and 8 kHz, understanding how deep each dosage goes is going to be a guessing game.

From a clinical standpoint, if at least a more detailed audiogram is used, it may be easier for doctors to determine the treatment schedule for patients with hearing loss. For example, a patient with only losses above 8 kHz may only need the single dose. But a patient with losses above 4 kHz may need 3. Or if they have a specific dip, like the classic noise "notch" between 3 kHz and 5 kHz may require 4 doses to get drug deep enough to hit that damaged zone.

 

[frpp]

It also points out that the audiogram is a terrible indicator of hearing improvement. For example, in the Phase 1/2, they indicated that a few patients saw improvements of 10 dB at 8 kHz on the audiogram.

Assuming a simple standard audiogram was used, the next lower tested frequency after 8 kHz is 4 kHz. There's a big gap in untested frequencies there.

So, of those few that showed improvements at 8 kHz; we really don't if maybe they might have gotten improvements down to 7 kHz, 6 kHz, or even 5 kHz because the audiogram doesn't test those frequencies. However, if it did, it might help explain some of the word score improvements and how deep FX-322 can really go.

This is actually a problem for Frequency Therapeutics in the Phase 2A as well. If they aren't using the more granular audiogram that adds more tones between 1 kHz and 8 kHz, understanding how deep each dosage goes is going to be a guessing game.

From a clinical standpoint, if at least a more detailed audiogram is used, it may be easier for doctors to determine the treatment schedule for patients with hearing loss. For example, a patient with only losses above 8 kHz may only need the single dose. But a patient with losses above 4 kHz may need 3. Or if they have a specific dip, like the classic noise "notch" between 3 kHz and 5 kHz may require 4 doses to get drug deep enough to hit that damaged zone.

100% facts.

And really, not testing more frequencies even on a standard audiogram is just a complete and total industry wide fail.

 

[Gb3]

Yeah, Frequency Therapeutics and the CEO tweeted recently about normal audiograms not meaning that there is no hearing damage which I would assume means the results of FX-322 are looking positive but we will have to wait and see.

I assume there are results that indicate effectiveness in the frequencies outside a normal audiogram.

 

[Lucifer]

100% facts.

And really, not testing more frequencies even on a standard audiogram is just a complete and total industry wide fail.

Agree. Only thing I'm worried about are those people that suffer from hyperacusis. I hope ENT specialists don't force hyperacusis sufferers to get their hearing tested if it's going to make hyperacusis worse.

They should be allowed to get FX-322 without having their hearing tested if their hyperacusis was caused by noise damage.

 

[frpp]

Agree. Only thing I'm worried about are those people that suffer from hyperacusis. I hope ENT specialists don't force hyperacusis sufferers to get their hearing tested if it's going to make hyperacusis worse.

They should be allowed to get FX-322 without having their hearing tested if their hyperacusis was caused by noise damage.

Agreed, it's a hearing regenerating drug, not Oxycontin, it should be available upon request. Personally I'll be paying out of pocket but, I'm afraid scamsurance if they do opt to cover treatment with FX-322, they will most likely want the audiograms done.