Frequency Therapeutics — Hearing Loss Regeneration

[LostOutWest]

I don't think the healthy audiograms are telling the whole story with our ears. I think I wiped out what hair cells I had left above 15.5kHz.

I agree. I had my audiology done up to 16 kHz and the taper was apparent after 12 kHz. Sure at 38 years old there should be some taper, but I cannot help but like my high frequency head tinnitus to that spectrum of hearing loss.

If this drug helps restore the nerve / ear connection and hair cell growth, then I can't see why it can't help reduce the tinnitus signal regardless of hearing loss (or, lack of significant hearing loss).

I'm going to see if I can get a point of view on any of this from Frequency Therapeutics. Let me see who I can write to.

 

[JohnAdams]

What if the problem is in your auditory nerve?

It could be but as I've stated about 6 million times, they observed that when the hair cell is regenerated that the auditory nerve regrows and reconnects.

 

[MrCrybaby]

What if the problem is in your auditory nerve?

The new hair cells grow neurons that attach to the auditory nerve, like @JohnAdams said, and if the main body of the auditory nerve was badly damaged you would not be able to hear at all (think cutting a telephone line).

 

[HootOwl]

It could be but as I've stated about 6 million times, they observed that when the hair cell is regenerated that the auditory nerve regrows and reconnects.

If Caveman is referring to the actual SG bulb that creates the end of the auditory nerve, then yes, this might be a problem. FX-322 doesn't touch the actual spiral ganglion bodies as far as I'm aware. But Liberman believes it takes decades for these to degenerate after the peripheral axons have died.

I think the trouble here is people are using the words auditory nerve and SGN fibers interchangeably which is adding confusion. But this stuff is confusing, so I totally get it.

 

[JohnAdams]

If Caveman is referring to the actual SG bulb that creates the end of the auditory nerve, then yes, this might be a problem. FX-322 doesn't touch the actual spiral ganglion bodies as far as I'm aware. But Liberman believes it takes decades for these to degenerate after the peripheral axons have died.

I think the trouble here is people are using the words auditory nerve and SGN fibers interchangeably which is adding confusion. But this stuff is confusing, so I totally get it.

I'd think that if any link in the chain didnt regenerate that there would no effect but they reported hearing improvements so isn't that indicative of everything healing?

 

[MrCrybaby]

I'd think that if any link in the chain didnt regenerate that there would no effect but they reported hearing improvements so isn't that indicative of everything healing?

You only need to heal the link in the chain that breaks, which seems to fortunately be the neurons science is regrowing these days! Potentially other steps in the chain heal damage naturally, for example the myelin sheath on a nerve can reform in 3 months.

 

[HootOwl]

I'd think that if any link in the chain didnt regenerate that there would no effect but they reported hearing improvements so isn't that indicative of everything healing?

My understanding is most people don't actually have damage to the bulb or the auditory nerve itself. Maybe in truly severe hearing loss, but not usually in mild to moderate. I think Rinri Therapeutics is trying to regenerate the spiral ganglion bodies themselves.

 

[Piney]

I missed the trial entry by about 4 words, my word recognition was too poor, I believe it had to be about 20% and up.

The only thing I know is I joked around with them and said I don't know what this is but I don't want to grow two heads, and the lady said two people who have taken it are doing good so far. I don't know what that means. It was an 11 hour drive for me. I wish it was closer, I would've hung out in the front and ask someone who got the shot how it was going.

I don't know what else to say. Dr. Susan Shore's trial is so slow it's unbelievable, Lenire still isn't in the United States, the Hough Hearing Institute says they have a magic pill but no one can get to it.

It's beyond frustrating. Who's coming out first with any news, good or bad, besides Lenire? I've lost track.

 

[JohnAdams]

It's beyond frustrating.

What's worse are the people in this community that are just happy with the very slow process and would never even dare to try and get organized to push for it to speed up. Even worse they would probably fight it.

 

[MrCrybaby]

What's worse are the people in this community that are just happy with the very slow process and would never even dare to try and get organized to push for it to speed up. Even worse they would probably fight it.

I agree! Now that that curative research is coming to fruition it would be nice to at least have it specifically tested for our condition.

 

[Piney]

It's crazy. These companies make claims but where's the results, where's the product, what is this secret cloak the FDA wears?

I wrote my Congressman and they want me to do the work on some auditory panel or something but I can tell it will get nowhere. I could understand it if these entities said ya we tested it, we got nothing.

But when you say we've seen great results, been working on this for 20 years, why are the trials years long?

I need to target the FDA, this whole forum needs to knock on their door or the speed will never change. I'm going to find out where they are when I'm done writing this, I should have started with them.

It's the only path I can see, those who hold the marbles of the Scientists, Companies and Professors.

 

[LostOutWest]

In an effort to be proactive, I sent some emails to Frequency Therapeutics' leadership to see if they would share any light on the efficacy of FX322 for tinnitus patients with no detectable hearing loss. Let's see if I get a reply.

I believe @Hazel has already tried to get these guys on the Tinnitus Talk Podcast... they are close to my place in New England, I'd be more than happy to go interview them if they'd give me some time.

 

[JohnAdams]

I agree! Now that that curative research is coming to fruition it would be nice to at least have it specifically tested for our condition.

It is. Right now.

 

[FGG]

It is. Right now.

Exactly. For those who don't know: Frequency is including tinnitus testing as part of the current trial.

 

[RingingBrother]

What's worse are the people in this community that are just happy with the very slow process and would never even dare to try and get organized to push for it to speed up. Even worse they would probably fight it.

Would be nice if the drug could be available right now but I'm not sure if there's any way for us to speed things up. I wonder if anyone has tried writing to that FasterCures website about this?

 

[MrCrybaby]

Phase 3 (as far as I understand) tends to be quite international and has a large volume of patients. Maybe if we're lucky they'll expand to tinnitus patients with normal audiograms, or tinnitus patients with audiograms worse than what they currently accept?

It's understandable why they're doing it the way they are in phase 2a though. You need lots of success to get approved so they only want ideal candidates that they are confident will benefit.

 

[FGG]

Phase 3 (as far as I understand) tends to be quite international and has a large volume of patients. Maybe if we're lucky they'll expand to tinnitus patients with normal audiograms, or tinnitus patients with audiograms worse than what they currently accept?

It's understandable why they're doing it the way they are in phase 2a though. You need lots of success to get approved so they only want ideal candidates that they are confident will benefit.

They probably won't expand their trial for tinnitus patients with normal audiogram because they don't need to get approved specifically for tinnitus for it to be used off label.

That's part of why these trials seem so narrow. They need the FDA to approve it for a specific indication knowing full well people will pay for this off label out of pocket.

Insurance doesn't cover hearing aids, maskers etc. Getting it labeled for all the indications isn't as important as getting the drug approved for a single indication and going off label from there.

 

[JohnAdams]

They probably won't expand their trial for tinnitus patients with normal audiogram because they don't need to get approved specifically for tinnitus for it to be used off label.

That's part of why these trials seem so narrow. They need the FDA to approve it for a specific indication knowing full well people will pay for this off label out of pocket.

Insurance doesn't cover hearing aids, maskers etc. Getting it labeled for all the indications isn't as important as getting the drug approved for a single indication and going off label from there.

I wonder if insurance will fight covering this for tinnitus or lobbying against it getting approved for tinnitus.

 

[JohnAdams]

normal audiogram

Well, for most of us, a normal audiogram is only up to 8kHz. They are doing the extended audiogram this time. If we would get our extended audiograms that could change the game, right?

 

[KMc24]

I don't think the healthy audiograms are telling the whole story with our ears. I think I wiped out what hair cells I had left above 15.5kHz.

I think I took out my hair cells up to 15kHz. I can't hear a thing after that. Audiogram says "normal" but I have very high frequency tinnitus.

 

[JohnAdams]

I think I took out my hair cells up to 15kHz. I can't hear a thing after that. Audiogram says "normal" but I have very high frequency tinnitus.

Same. Do you get fluctuations?

 

[thinlay]

There is also the natural loss of hair cells as we age, presbycusis. I have read that we lose an average of 2 kHz per decade.

For example I hear perfectly up to 18000 Hz and then I hear nothing more after that which is normal according to my ENT.

 

[JohnAdams]

There is also the natural loss of hair cells as we age, presbycusis. I have read that we lose an average of 2 kHz per decade.

For example I hear perfectly up to 18000 Hz and then I hear nothing more after that which is normal according to my ENT.

But when they are violently destroyed more than just the hair cell is damaged.

 

[JohnAdams]

This has passed 2 safety trials.

It repairs things that are implicated in tinnitus.

We deserve the freedom to have an ENT shoot our ears up with it now.

 

[ajc]

This has passed 2 safety trials.

It repairs things that are implicated in tinnitus.

We deserve the freedom to have an ENT shoot our ears up with it now.

I DISAGREE. Frequency Therapeutics is the one to decide, NOT you, NOT the government. Frequency Therapeutics has made it abundantly clear they don't want this in any expanded access program just yet.

You are a broken record, how many times have you spammed this thread with your demands? It starts to get boring to read your tirades...

 

[JohnAdams]

I DISAGREE. Frequency Therapeutics is the one to decide, NOT you, NOT the government. Frequency Therapeutics has made it abundantly clear they don't want this in any expanded access program just yet.

You are a broken record, how many times have you spammed this thread with your demands? It starts to get boring to read your tirades...

You can easily place me on ignore but I know you won't because you feel the need to stalk me and police my thoughts.

 

[Bartoli]

This has passed 2 safety trials.

It repairs things that are implicated in tinnitus.

We deserve the freedom to have an ENT shoot our ears up with it now.

Even thoroughly researched drugs that were commercially available still hold a danger. We had Trobalt, Thalidomide (Softenon), and a host of others. I appreciate your willingness to take one for the team, but as for me, I rather would not replace one ailment with another. Or worse, not have it help for tinnitus and still get other problems.

 

[JohnAdams]

Even thoroughly researched drugs that were commercially available still hold a danger. We had Trobalt, Thalidomide (Softenon), and a host of others. I appreciate your willingness to take one for the team, but as for me, I rather would not replace one ailment with another. Or worse, not have it help for tinnitus and still get other problems.

SMH.

It has already passed safety tests. By your logic we should never get anything that could treat our tinnitus because it may have unforeseen side effects. Also, Thalidomide was obviously not thoroughly tested.

Here, you may need this:

http://www.free-iqtest.net/

 

[Bartoli]

It has already passed safety tests.

followed by

Also, Thalidomide was obviously not thoroughly tested.

..in the same post.

So what's it John? Are we going to believe in the tests or aren't we?

You are willing to try every drug there is that hasn't been tested yet but start bitchin' about ototoxicity and throw a tantrum because "researchers should test drugs more thoroughly"

 

[Bartoli]

By your logic we should never get anything that could treat our tinnitus because it may have unforeseen side effects.

No, by my logic having a drug tested according to the requirements needed to make it commercially available is the minimally acceptable liability. Even then it could still have unwanted side effects.