Frequency Therapeutics — Hearing Loss Regeneration

Yes, synapses and nerves are more fragile then hair cells. That's the controversy. Hair cell regeneration might not help everyone because synapto-neuropathy plays a larger role in SHNL then scientist previously thought. Facts don't care about feelings, if nerve damage outweighs hair cell death the treatment will be ineffective. Someone correct me if I am wrong.

 

I've only found eveidence of the opposite. Their first trial was done only with people who had no more than a pure tone average of 70 dB (severe hearing loss).

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

I didn't find any indication of this drug being only for those with mild hearing loss at this time.

 

I don't think Frequency Therapeutics have put a definite limit on whom FX-322 may or may not be able to help. Stay optimistic.

 

Pretty sure they only tested it in those people because they were already receiving a cochlear implant so their ears were effectively already fucked and there was no real risk of causing further loss.

 

This is what I saw too. I believe the people in the trial were already scheduled for cochlear implants.

 

Of course that too, but the cochlear implant candidate appears to be their target consumer.

Check out this website:

https://www.frequencytx.com/our-approach/hearing-and-beyond.php

They appear to be setting themselves up to disrupt the cochlear implant market specifically. They keep targeting "chronic" and "disabling" hearing loss, and even direcelty compare their procedure to cochlear implantation.

 

Pretty sure you're right.

On the subject of what level of hearing loss FX-322 might help, there was a thread on Reddit where Will McLean's (it was supposed to be Will McLean anyway, according to people on this group) opinion was that people with profound hearing loss may not have the supporting cells to benefit from FX-322. He was talking about people with pretty much no hearing at all, and it was not stated as an absolute fact. People seem to think that the scientists have all the answers and the trials are to rubber-stamp what they already know. I really doubt that.

 

They're talking themselves up to investors, comparing themselves in the best light against the 'competition'. Of course they'll sell to sell to that market, assuming it works for people with that degree of hearing loss. It doesn't make it their target market. It's probably not big enough to justify the billions they seem to be expecting to make, and many people in that group probably will have more going on than just sudden sensorineural hearing loss. Last but not least, none of participants in the San Antonio trial were cochlear candidates as far as I know. So no, not their target market.

 

Well, this is disconcerting.

I'm trying to better understand the relationship between hyperacusis, tinnitus and just plain hearing loss.

Do people with hearing loss only, no tinnitus, suffer from hyperacusis?

 

Have you ever thought hyperacusis defined as "Pain from sound is not the same thing as "noises sounding abnormally loud?

These problems are not well understood and many times go unreported.

 

That's a pretty big "if". Some hypothetical treatment which would restore 30% of your lost hearing could be life-changing for someone with 50 dB loss thresholds, but more or less meaningless to someone with tinnitus despite ~10 dB loss thresholds.

 

I'm grateful for the existence of Frequency Therapeutics and all others out there researching into hearing loss, tinnitus, and hyperacusis. It is a shame, however, these conditions appear to be so far behind in research. Perhaps I'm naive though. I myself am going in circles with all of this. One minute it is a hair cell problem, next the nerves. One minute it's because of stress, the next because of noise. Maybe one day we'll have definitive answers.

Gonna take a break from the forums and do the best I can. Hopefully Frequency Therapeutics will offer more insight early next year.

P.S. Apologies for the self-pity and mopey attitude, just really down with my tinnitus and hyperacusis lately.

 

Why aren't heroes of basic logic like you involved in tinnitus research? Instead we have fashionistas like Derek Hoare stealing tax dollars to play games.

 

@Contrast, @Rb86,

There is no mention of tinnitus on the Frequency Therapeutics page. Where are you getting the idea that Frequency's main focus is to get rid of tinnitus?? There is no need to spread disinformation.

 

@Flamingo1
Frequency's main focus is to cure hearing loss and to restore hearing. That also automatically means curing tinnitus and hyperacusis, because they are the direct result of hearing loss, isn't it ? If your hearing is being restored, and the hair cells in the inner ear are being regenerated, tinnitus and hyperacusis automatically disappear. That's what I've understood. I don't know, we'll see. Fact is that Frequency has made a substantial partnership with Astellas, a Japanese pharma giant. They have paid Frequency 80 million dollars upfront for selling FX-322 outside of the US, and they will pay more than half a billion dollars to Frequency later in milestones. They do that for a reason. I assume it means that FX-322 could possibly be what will finally give us, tinnitus sufferers, back the heavenly silence we crave so much.

 

My mistake, as I already corrected. "Hearing loss". Being that it's a widely accepted theory that NIHL-based tinnitus is the brain making up for lack of sensory input from the nerves/hairs etc, it is very reasonable to speculate that curing or majorly improving hearing loss will then give new sensory input to the brain, allowing it to stop the tinnitus.

That's my logic anyway. The funny thing about all of this, AGAIN, it's all speculative. There's no misinformation spreading because there are no facts. There is no concrete knowledge of tinnitus. I don't think this therapy would be too much of interest on a tinnitus forum if the end goal here wasn't tinnitus reduction or removal.

 

I hope that is the case but there are definitely changes to the underlying nerves involved in tinnitus. Whether or not these changes are a result of hearing loss and will be corrected by restoring hearing or not is something that I want the answers to.

 

Frequency's main focus is to cure hearing loss and to restore hearing. That also automatically means curing tinnitus and hyperacusis, because they are the direct result of hearing loss, isn't it? If your hearing is being restored, and the hair cells in the inner ear are being regenerated, tinnitus and hyperacusis automatically disappear. That's what I've understood.

Just to be clear, there are people--including on this forum--who have tinnitus without hearing loss.

Tinnitus can disappear with the return of hearing, but not always. A friend had a rare condition whose name escapes me, but there were perforations on some inner bone structure, which when repaired restored his hearing. He still has tinnitus.

Similarly, lots of people who finally start using hearing aids after hearing loss report lower tinnitus. That includes me, who started using a hearing aid a couple days ago after two months of hearing loss. My tinnitus isn't gone but it's lower on average.

It stands to reason that restoring the original, natural structure of the hair cells could eliminate tinnitus but I doubt any specialist in the field guarantees that.

 

Perforations on an inner ear bone structure?

First off, the specialists in the tinnitus field are people like Pawel Jastreboff, so who cares what they think in the first place?

 

Was it semicircular canal dehiscence?

 

Sorry to randomly come into this thread, but what’s the current state of FX-322 currently? Is it starting a next phase? Is it still in its second phase? I’ve been trying to read places but it’s been a bit confusing for me haha.

 

I believe currently Frequency are at the end of a phase 1/2 in which there was positive results.

They are going to be reporting on September 18th or 19th on their findings and I'm assuming they'll enter phase 2a which will most likely be a few more months. This involves more participants in trials to do a wider test range.

If the FDA fast tracks FX-322 then they'll be in stage 3 by the middle - end of 2020.

By 2020-2021 (sometime) we should know if this is going to work or not.

If the FDA doesn't fast track, then most likely stage 3 will start in 2021 if not later.

I believe that we'll know if there's a cure for deafness within the next 1-5 years, which would help with a large majority of tinnitus (but perhaps not all tinnitus).

 

It will likely begin phase 2 very soon, probably within the next few months before the end of the year. They have just gotten a bunch of investors, mainly one really big pharmaceutical company, to pour in money and help them conduct trials worldwide along with a deal to sell the treatment once it is commercialized.

 

@lewis.D @ChrisBoyMonkey

Ahh. Alright. Reading all these articles was a bit confusing, so I needed some kind of explanation haha.

Thank you!

 

I don't think so. I'm pretty sure now his condition was otosclerosis.

The Web MD description of the disorder you mention sounds like what I recall him describing to me:
The canal that sits highest in your ear, the superior semicircular canal, is covered by bone. When you have SSCD, this bone has a hole or very thin place in it.

The key word being "hole." But I don't recall him saying anything about motion and other issues, and when I asked him via text what the name of his affliction was, he said otosclerosis. He's a busy guy so that'll be it for awhile. Other online sources say otosclerosis is the abnormal growth of bone of the middle ear. This bone prevents structures within the ear from working properly and causes hearing loss.

According to online resources, the treatment for semicircular canal dehiscense is to patch the hole. The treatment for otosclerosis is a staepdectomy, which builds another structure that replaces the function of the damaged stapes, which no longer moves, due either to a congenital issue or abnormal mineralization.

And here is where either he or I stumbled over language; Wikipedia says with otosclerosis, it is possible to improve hearing by removing the stapes bone and replacing it with a micro prosthesis - a stapedectomy, or creating a small hole in the fixed stapes footplate and inserting a tiny, piston-like prothesis. He talked about the surgery rebuilding stuff in there, so I think that's it.

 

Doctors who preform CI surgeries have first hand knowledge of the ear. So I wouldn't immediately discount their information, especially if it relates to the structure of inner ear.

 

OK thanks. I know a thing or two about otosclerosis since I have it myself and gone through the surgery.

 

Hello,

Last week, I went for a hearing test that went up to 12500 Hz, and the results showed that my audiogram was perfectly normal (just a "loss" of -10 dB at 12500 Hz).

My question is, as my tinnitus appeared the day after a concert, so because of an acoustic trauma, and that in December 2018, I still had hearing losses in the low range from -20 dB to -25 dB, but that I technically "recovered" all my hearing; I wonder if I still have hidden hearing loss, and if by regenerating it, my tinnitus could disappear or decrease? Or if hidden hearing loss is different from "visible" hearing loss with regard to the principle of hearing regeneration?


I would like an answer to these questions.
Simple speculation

And I'd like to know if you have a link, which shows that with this principle of regeneration, nerves grow back and eventually reattach themselves to the hairs cells? I've heard a lot about it, but I couldn't find any articles that talked about it.

 

When you expose yourself to loud sounds, your supporting cells generate a lot of glutamate, which in large quantities causes glutamate excitotoxicity in your auditory nerve synapse. This is called the "glutamate storm". That could be the root of many of our tinnitus cases. This would explain tinnitus in people like you and I that have very little measurable hearing loss.

If this is the case and our hair cells aren't dead, then I fail to see how FX-322 will help. There are other things like OTO-313 and OTO-413 that would be more likely to help.

 

Thank you for your answer !

Another thing bothers me, I feel like I don't have a speech-in-noise hearing difficulty. I have done several tests that have been found to be normal on this problem, but not perfect, hence my questioning. I hope that OTO-313 and OTO-413 can still help me with my tinnitus. I also know it appeared during a period of stress due to exams, but it mostly appeared the day after that damn concert.