Frequency Therapeutics — Hearing Loss Regeneration

In an interview they stated after Phase 2a it will be the pivotal phase meaning it will be the last one before they release FX-322.

 

I think the FREQ stock is pretty much a binary outcome. Pretty much a 0 or loads of money. Expect it will be a wild ride for everyone with skin in the game.

Probably went deaf, and the steroids brought it back from the dead but his hearing is still fudged, he just doesn't know it. I cant tell there is anything wrong with my hearing, yet I have tinnitus.

 

It still says they are recruiting on the clinical trial website. They are proceeding with the trial but I assume we won't get the results on the expected date.

 

If Frequency will not FULLY regenerate hearing 0-20 kHz, I don't see tinnitus going away...

It has to be a big shock to the system, the brain has to go WHOAAAAA that feels good...

 

Without frequency matching this is especially hard to interpret, though.

Almost any insult is more likely to affect the highest frequency ranges so if you had severe loss at say 16000 Hz you might not notice a change in your hearing but if the more mild damage "downstream" resolved and your hearing normalized on audiogram but you still had ultra high frequency changes that did not improve with steroids (again because they were worse), it would be hard to draw any kind of a meaningful conclusion from that.

Can you also ask your friend to tone match his tinnitus?

 

Yeah it's quite rare to test up to 16 kHz, so there might be damage there, especially if his tinnitus is very high pitched.

 

Maybe, depending on the results of 2a and if the FDA agrees.

 

I hope this happens.

 

Absolutely.

 

Reminds me of what happened to @attheedgeofscience, he did Low level laser therapy and restored some of his hearing, though his tinnitus remained, he mentioned LLLT restored 25dB of his hearing but his tinnitus was still there. So it was only after he did the stem cell IV infusion that his tinnitus got better. The stem cell was delivered into his system I think and not injected through the cochlear. Makes me wonder if tinnitus is just haircell damage simply or also inflammation, injury...What do you guys think of fx322 wrt LLLT/stem cells introduced systemically? Which method would be better? I would think that PCA approach would be more specific since it’s injected into the cochlear. But will it help with inflammation or injury? @Diesel mentioned we probably have a mix of injuries and I think need a mix of drugs(Fx322, Hough pill, RL81), LLLT, stem cell infusion and ear protection. So tired of this thing!!

 

It’s my friend’s audiologist in this case, and my friend intends to ask him many questions upon next visit. I think it’s very likely that there could be undetected damage to upper frequencies that didn’t resolve itself.

From what I’ve read and explored, it really doesn’t make logical sense to me that tinnitus would be “stuck in the brain.” I can’t get behind that notion. If the underlying damage is resolved, the tinnitus should dissipate (i.e. cochlear implants, hearing aids, TMJ treatment, earwax buildup, etc.). Plus, why I do have unilateral tinnitus if it’s stuck in the brain?

 

In the case of Noise-Induced or Sensorineural hearing loss, tinnitus is not stuck in the brain, it is a symptom occurring at the site of damage in the peripheral auditory system. Dr. Thanos specifically reinforced this in a recent interview re: tinnitus.

Let's consider what we know in the cases of folks with SNHL or NIHL (what FX-322 is designed to treat):

Where tinnitus is "reduced" through prosthetic or healing:
1. Hearing aids in some cases help reduce tinnitus experienced by people on this forum.
2. Cochlear implants reduce tinnitus in some cases.
3. Some people's damage heals, their audiogram improves, tinnitus is reduced to an extent.

Where tinnitus is "increased" through certain means:
1. A new insult occurs to the cochlea, increasing tinnitus, reducing hearing ability (acoustic trauma, etc).
2. Earplugs reduce input to the cochlea by blocking sound, making tinnitus seem louder.
3. Earwax cause a blockage, reducing input to the cochlea, making tinnitus seem louder.
4. Other ear-related issue cause blockages, or restrict sound from transmitting to the cochlea, making tinnitus seem louder.

In the cases where tinnitus is "reduced" , the input is always increased. Where tinnitus "increases", input is reduced.

So, FX-322 clearly shows that it increases input into the auditory system by regrowing hair cells. They have provided evidence in their most recent presentation: Increased word score in two measures, and audiogram improvement at 8 kHz and above.

In conclusion:
Given what we know about FX-322 in the Phase 1/2, where a single dose is applied. It stands to reason that the drug will restore hair cells above 8 kHz, and INCREASE input into the auditory system. As a result, tinnitus should DECREASE if it is experienced above 8 kHz.

So, in my humble opinion, anyone with NIHL/SNHL experiencing a tone-matched tinnitus at 8 kHz and higher should expect to see some level of improvement in their tinnitus after receiving FX-322. May not be a cure, per say, but there will be more input from fresh new hair cells providing some level of relief.

 

Studies have indicated that when hearing is restored there is a correlated reduction in tinnitus. For example:
82.6% of patients had improvement or elimination of tinnitus after tympanoplasty.

https://www.scielo.br/pdf/rboto/v73n3/en_a14v73n3.pdf

Also, cases where the auditory nerve is severed have shown a majority of patients reporting tinnitus as the same or worse.

Below is a paper describing the theory of stochastic resonance which is believed to be the mechanism responsible for tinnitus:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6110899/

The evidence overwhelmingly points to tinnitus as a maladaptive manifestation occuring within the audio processing areas of the brain due to reduced or corrupted audio input.

The question here is what degree of hearing restoration is necessary to reverse this process and will FX-322 provide that.

 

A bit off topic but not really: Can taking Prednisone be dangerous for those of us with ototoxic induced tinnitus? I think I read somewhere that ototoxic medication can deplete our support cells thus negate the effects of FX-322.

 

I believe FX-322 is intended to treat hearing loss due to ototoxic medication.

 

Prednisone isn't typically considered ototoxic. In fact, it's often given acutely after ototoxicity to help mitigate some of the effects.

 

Is it? That would be the first time hearing this and a very welcome good news.

However I wanted to take some more prednisone for a recent sound exposure and I am concerned that because my tinnitus is ototoxic induced, using it might cause a further damage.

 

I'd be interested in a more informed answer than what I'm about to share, but during the first four months or so when I experienced hearing loss and tinnitus, I practically lived at my ENT's office and eventually got sent to a super-duper specialist in the area. ENT put me on prednisone two or three times and super-duper guy gave me a steroid injection through my eardrum. I doubt they would do this if it were an ototoxic risk.

 

...and noise induced as well.

 

I'd say to the same hearing level you had about 1 year before tinnitus should do the trick.

Second part, I don't know, @FGG knows.

 

I have a feeling from the research that while this treatment may hopefully help with some tinnitus it isn't going to be the total killer and also synapse repair will be needed.

Note also that there are some I know who have lost hearing e.g., above 16 kHz and also actually do not have tinnitus. Therefore I question whether any form of lost hearing shall result in tinnitus.

 

I think any significant increase in input should at least improve tinnitus.

Evidence of this: cochlear implant studies, treatable forms of hearing loss, well controlled vs poorly controlled Meniere's (before end stage).

The results of Frequency's Phase 2A will of course provide us with better data than has previously been available.

 

This may seem like a left field analogy but it's the best I could come up with: Hearing loss is associated with tinnitus just like HIV is associated with AIDS. There are a certain amount of people with HIV who will never develop AIDS because of their T cell receptor genes. Genes and intrinsic factors play a role in tinnitus, too, in terms of the "predictive brain" and neurotransmitter systems (e.g. Glutamate/GABA).

Most people will get tinnitus with bad enough hearing loss, but some people will get it with mild loss just like some people will develop full blown AIDS early without HIV treatment and others never will. It doesn't mean HIV doesn't cause AIDS just because some people have better genes than others.

 

I have a feeling today being July 4th, a few more people will join Tinnitus Talk over the next week. At least today, we're the closest we've ever been to a cure. And yet, so far away. I'm more than a year and a half with tinnitus so far, it's been one hell of a struggle... but I won't give up. I want to know who discovered the cure. Hopefully FX-322 helps at least a tiny bit over the next few years.

 

With the prospect of a reformulation to reach lower frequencies and zero depletion of progenitor cells (numerous dosage potential) FX-322 may exceed your expectations.

 

Is there a way to get emergency access going the FDA channel vs the compassionate use channel? My hyperacusis is ototoxic induced.

 

So do I. I also wonder whether the Hough pill will help with this as well. We may have a cure. I hope the initial data is good going by what is seen and that the reliance is on delivery and isn't about how to mend any longer.

 

That will be the best news in my life so far.

 

I think expanded compassionate use is for cases where there’s life/death involved... I really am not sure though.

 

But it's only a question of delivery right? I mean this drug regenerates to almost 100% in vitro?