Frequency Therapeutics — Hearing Loss Regeneration

Well... Let's see what they are presenting at the conference! The question now is if they started the Phase 2 trial ASAP and what results they so far have of that.

In their latest press release they wrote about improvements both in audiometry as well as in word scoring. What do you think that means in detail?

 

Not too sure.

I also wonder how this drug would work in terms of hearing regeneration because I was reading some previous posts and it said we have 15,000 hair cells in the ear. Is there a limit in terms of how much can be regenerated using this drug.

 

That’s exactly what they are trying to find out in their current trial.

If I remember correctly, the main difference between Audion and Frequency Therapeutics is that the latter multiplies the supporting cells before activating them, making the treatment repeatable... Can’t remember where I read this. Perhaps others here can confirm or deny my claim.

 

You are correct, but I wouldn´t disregard that Audion also could be repeatable as treatment. Time will tell.

 

Also how would they know after getting the treatment how many hair cells a person has. Each person is different and may require multiple doses.

 

Euthanise, dissect, count. Too time-consuming, so they'll probably just re-test your hearing.

 

I would say that after the treatment they test the hearing with an audiogram and word scoring. That's what they did in the first trial and found out improvements in hearing.

 

I know that they will be doing Phase 2a later this year. So if this ends up being successful how many phases are there before it comes into the market?

So after Phase 2a, would it be Phase 3, and then come into the market?

 

This depends on what they find in Phase 2a. The dose may need further tweaking before Phase 3. Hopefully, information in September will give us a better idea.

 

Hopefully in September they will mention whether the participants whose hearing improved also experienced a reduction in their tinnitus volume, or better yet their tinnitus went completely away.

I assume if their tinnitus did reduce in volume, it wouldn't have gone away fully in Phase 1.5. because Phase 2a is where they increase the dosage.

 

I agree with that. But it is impressing that the initial test with the drug seemed to be so successful that even with a low (safety) dosage they experienced improvements in hearing!

With regards to tinnitus, we will see, because people without hearing loss also have tinnitus... But maybe the tinnitus will reduce when the hearing is restored. However, it's a long time until September... I really hope that they will then start the Phase 2.

(REGAIN has, as far as I have seen, started their Phase 2 and they will finish it by December).

 

I didn't realise that REGAIN is way ahead compared to Frequency Therapeutics. Are they doing a similar thing with hair cell regeneration?

 

Well, the chances are that most of those who are said to not have hearing loss indeed do have some hearing loss. The problem is that hearing usually isn't measured over 8000 Hz and so someone could have hearing loss in the higher frequencies. Also there is hidden hearing loss where single tones can be heard but speech processing and hearing in background noise becomes a struggle.

I am one of those. I have done several hearing tests which all come out clean. But they have all been done up to 8000 Hz only. However if I use a sound generator on my computer and start by setting the volume so that I can hear a tone at, let's say 5000 Hz and then slide up over 13 000 Hz I don't hear it anymore until I significantly raise the volume. So over 13 000 Hz I probably do have hearing loss.

 

https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004544-10/GR

http://www.hearingreview.com/2019/0...eport-positive-phase-results-drug-treat-snhl/

 

Don't forget the number of people who potentially need this cure (young people who are heavy headphone users, who attend loud parties, go to loud concerts, etc. and also people who have had a sudden hearing loss).

 

Does FX-322 restore synapses too?

 

I think synapses do form with the new hair cells.

My guess on the implications of this are, if you have widespread synapse damage (as I do), since the new hair cells grown will make new connections, you will still regain some hearing.

For example, even if you are just growing back the 10% (or whatever) that you lost, for instance, with age this should improve the overall number of hair cells with functional synaptic connections and thus hearing.

Any other thoughts on this?

 

If they say "improvements in hearing", I'd say yes. But maybe I am wrong about that?

Now I've seen the post by "FGG" and I'd like to agree with him/her! The new hair cells may form new synapses. But they probably partially use the existing ones of the previous hair cells? If so, I think that the synapses will be restored.

 

My fear is synapses couldn't be restored enough to be useful if hair cells are intact.

 

How does fast tracking a drug work? If Phase 2 is successful, can it be fast tracked?

 

Yes, apparently.

 

Not all your hair cells are intact. Humans start to lose hair cells starting from a young age. IMO, if this works whatever amount you have lost will regenerate with new synapses adding to improved hearing in *those* regenerated hair cells. Overall, net increase either way.

My two cents.

 

For the record, nobody here truly knows the timeline here, this is uncharted territory for the FDA and medical world.

Assuming it works, best case scenario is this could be out by 2021, worst case scenario is the FDA wants to take a long time to wait and see if there might be delayed effects and it doesn't come out till 2025, 2026.

 

I see, thank you for your comment. That makes sense. I just saw somewhere someone mention auditory nerve degrading or something and I got nervous lol. This drug has all my hopes and dreams in it (bad idea I know).

 

In this case I hope that for minor hearing loss with heavy synapses damages, additional growth factor therapy provided by hidden hearing loss researchers could be available, so that sound clarity and dynamics become optimum, as long as mixed therapies (Frequency + NT3 neurotrophin for instance) could work together without risks.

 

If it came out in 2021 it would be so good. The only concern I have is how long would it take to release it to other countries .

Same lol. I think REGAIN should finish Phase 2 by the end of the year and release their results next year. So they are definitely more ahead than Frequency Therapeutics. There is now a lot of competition which is a good thing because the first company that releases it will gain a lot of revenue if it actually works, especially if it makes tinnitus and hyperacusis go away.

 

Do you reckon Frequency Therapeutics have started their Phase 2 trials yet?

 

Are REGAIN and Frequency Therapeutics the two companies leading the way to cure hearing loss or are there others to keep an eye on also?

 

Glad they may cure hearing loss. I'll keep my hearing loss, just cure my tinnitus

 

There are also some others as well such as Decibel Therapeutics and Otonomy but I think REGAIN and Frequency Therapeutics are further ahead in terms of their phases.

REGAIN would finish Phase 2 by the end of the year and publish results in January 2020. Not too sure if Frequency have started Phase 2