Frequency Therapeutics — Hearing Loss Regeneration

While that's true, the reason these new hair cells may be attacked is because this protein is specifically an anti-tumor oriented reaction to prevent the cells dividing and turning cancerous. It's this relationship that makes notch therapy ideal for cancer research. As the inactive nature of the gene(s) responsible for preventing cancerous cell division is what leads to tumors and cancer in the body.

 

I'm hopeful we will have something for hearing restoration soon! I'm also glad multiple companies are working on solutions because it gives me hope I'll be able to hear normally again without hearing aids.

Is anyone else hopeful for these drugs? Should we see treatment in the next few years? I sure hope so.

 

I am hopeful but I try to be overly cautious. As I worry it may be too good to be true at times.

 

They will work. In the beginning there won't be a permanent one-time solution, but as years go by, treatments will become more and more effective, as with everything.

 

People maintained hearing benefit a year after the FX-322 shot. I hope it can be permanent.

 

I am personally curious if this kind of treatment can be done multiple times. As in, multiple shots over a period of time activating more progenitor cells and turning them into new hair cells. Adult stem cells can turn into progenitor cells after all. This kind of regenerative therapy might be the cure for all hearing loss at some point.

 

I'm very interested if the potential for multiple doses is there as well. It seems like the scientists at Frequency Therapeutics sure thought so, but making the dosing schedule so compact was obviously a big mistake. We'll have to wait and see, but I'm sure at some point in the future after the single dose is more solidified and proven, they'll go back to the drawing board on the multi-dose route. Here's to hoping they crack this thing.

 

Based on what I get from Frequency Therapeutics' comments, scheduling is what they are also trying to figure out for future trials. Carl LeBel mentioned that they have identified what seems to be people having “their own unique timeframe” to respond.

What I am thinking is that if birds regenerate their hearing within 4-6 weeks after damage, then that is what may be the baseline for spacing. Depending on the size of the study, they may either go with 4-6 weeks (they perhaps learned something more during past trials and use that) or have different groups with mixed age/etc and space and see.

As far as FX-322 goes - if clarity/word recognition truly improves and stays the same for a year (that is what they state based on current/past results), then people with 10,000 Hz+ tinnitus may benefit with this drug alone. Single dose or not - a question, but just going off their studies and results, that is what we could see.

 

Does anyone know when to expect results for the FX-322 trial? And what about audiogram results?

 

Usable voice frequency band is 300 Hz - 3400 Hz. If word recognition is improved, then I would imagine tinnitus may benefit from these spectrums. Can’t see how 10,000 Hz would benefit other than it being exposed to the medication first. Most of speech energy is produced in the low-mid range of human hearing. This is all speculation of course; there might not be any benefit.

 

Lots of research in recent years is pointing to the ultra high frequencies helping with speech perception, especially in noise.

Extended high frequency hearing and speech perception implications in adults and children

Extended high-frequency hearing enhances speech perception in noise

 

ClinicalTrials.gov: FX-322 in Adults With Acquired Sensorineural Hearing Loss

The page estimates November for Study Completion.

 

It's way higher than 3400 Hz. Take a look at the speech banana:

Fricative sounds: F, TH, S, are highly used in English are produced north of 4000 Hz. Differentiating those fricative sounds from each other actually occurs in the ultra-high bands (per Chad's research), and differentiating them from affricates (ch, sh, etc) also requires capable hearing in those higher ranges. Therefore, it stands to reason that if FX-322 did cause some improvements right down to 8 kHz, and many English words on the two word tests contain fricatives AND affricates, then it seems reasonable that a patients ability to distinguish these different sounds from each other and recognize the right word can be associated with getting drug.

 

Maybe your avatar is the time to buy?

 

The trial ends in November. There will most likely be a quiet period to clean up the raw data and compile it into a report.

Expect early 2023.

It really seems like in 2025-27 there's going to be commercialized treatments in major cities around the world.

 

I thought a previous trial established no audiometric improvement of EHFs. I know we've seen some differences around 8 kHz, but I thought there was still some skepticism over what this actually was. Has there been an update?

 

Same, and with recent trials failing, it feels like my heart is being gutted.

 

I can literally hear everything on that chart. Birds chirping, leaves rustling, tap running. So this medicine may not help me but it can still help others.

 

Does anyone know what sort of audiogram you need to be a candidate for the FX-322 study?

 

Frequency Therapeutics haven't impressed me. Some sketchy results in Phase 1, barely significant against a backdrop of numerous trials failing to beat placebo.

 

You don't understand how hearing works. I am producer and hearing doesn't only improve by threshold, it's much more complicated and deep what hearing means, and that is why I trust them entirely. Just because something can't be seen on paper, doesn't mean it doesn't improve a person's life tremendously.

 

@Geatly, but they had no better results than OTO-413. As we saw in Phase 1 of OTO-313, such a small group often doesn't translate to larger groups. A small group gives a much higher 'chance' result that looks meaningful but isn't.

Unless Phase 1 results are more than moderately impressive, it really isn't a cause for great optimism.

 

A pure tone average at the Screening Visit of 35-85 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz in the ear to be injected.

While it may seem barely significant to you, I can guarantee you it is life changing for the subjects who were statistically significant. Subject 4 for example went from being a clear candidate for a hearing aid to being able to possibly get by without one.

How are the Phase 1/2 results sketchy? FREQ has had an inconsistent response rate in their trials because the FDA told them that they would need to explore all etiologies & all severities in order to get the broadest indication possible for their drug. This means probing all these different groups to find out who it does and doesn't work in but the market is punishing them for doing so because it doesn't understand their strategy.

For example, it appears to not work in age-related hearing loss which had no significant response and its a good thing that they know this now so that they could exclude those with age-related hearing loss in their currently ongoing Phase 2b. Where they do consistently see a response is in the moderate to moderately severe categories of SSNHL and noise induced hearing loss, between a 33% to 40% response rate which is quite remarkable when you consider how little of the cochlea they are actually treating and how much heterogeneity there is between any 2 cases of hearing loss.

Did you know that they included subjects with normal hearing in the Phase 1/2 trial? So of course those subjects weren't going to be able to respond and it diluted the numbers.

The hearing loss community has way too high of expectations for first generation hearing loss drugs in my opinion. We are seeing hearing restoration being done for the first time in history which is remarkable yet people are saying its barely significant. I fear there are many out there that won't be satisfied until they can be returned to perfect hearing.

 

FX-322 is hitting 8000-20000 Hz. Don't expect a lot from that on audiograms and various tests, since those frequencies are not as important to hearing as those below 8000 Hz.

 

But did we ever get evidence that extended high frequency thresholds actually improved via an EHF audiogram? Or is this just affecting synapses in that range and not actually thresholds? My understanding might be a bit off here.

 

The implication has been that inner hair cells are regenerating, but possibly not (or not enough) outer hair cells. This would explain the word score improvement and WIN improvements, but not audiogram improvements.

 

Do you think FX-345 will get more outer hair cells than FX-322?

 

From what I understood of the animal models, it was inner hair cells.

We all know this is going to fail, why do we get our hopes up every time?

 

I wouldn't sink them just yet. They've made corrections to their tests so the possibility still exists for success.

 

Brother, if you have a more positive outlook on the future, then you will have a better future.