Frequency Therapeutics — Hearing Loss Regeneration

Amen to that, ready to get back to my normal life. Going on 23 years old

 

Wait, so Alamo ENT isn't administering the drug to everyone in the trial? Some are getting a placebo? Is that right?

 

we're in this together and I hope and pray you, as well as all of our fellow sufferes get rest from these dumbass torturous sounds. I have a great feeling that fx-322 is it. it's in phast 1.5 out of 3,

 

I thought this was 2?

 

I’m sorry brother. All these little issues have literally change everything about me. Am not the same man I was before. Desperate for anything that could possibly help. Really think this is the cure though.

 

no not yet unfortunately.

 

oh, they will get it when it comes out.

 

just follow the NDA, you don't want to get sued and possible push back the release of this drug.

 

Some are getting placebo.

 

Can someone please post a summary of what is currently going on? This might be helpful for others as well. Too many threads to go through...seems like some good news are on the way. Thanks in advance.

 

Going on with what?

 

yeah dude, I hope this works out so you can go back to your normal life. I hope we all can. you are very young.

 

Didn't want to start a new thread for this, but looks like they've got a new breakthrough.

https://decibeltx.com/wp-content/uploads/2018/08/Decibel-Press-Release-8.2.pdf

 

Change your profile mood to slyly give us the signal it's working.

 

We could already cure tinnitus on mice in 2005 when I was just like you, looking for a cure right after being affected and still a teenager. It was in Montpellier, France. Don't ask me for more details, I guess I would need to google for an hour, 2005 is like a century ago to me. After 13 years living with it, I learnt not to believe too hard in big announcements with no concrete results on humans.

I don't want to sound too pessimist, hope makes me live too, keeps me on tracks every morning, but keep in mind it's not that simple. This new study seems promising, right, at least for people to recover a part of their hear. In their announcements they don't state 100% recovery to start with, their target is lower. If your tinnitus sounds lower, you'll be happy for 3 days, then you'll be looking for a new way to make it even lower as your obsession with it can't be cured with fx 322.

I want to believe in fx 322 just as much as you and I'll be checking this topic regularly this year, but not every day like some of you... do not forget to live your life, even wounded!

 

Tell me please, the mechanism of regeneration of the inner ear (even theoretically) developed by the companies Frequency Therapeutics and Decibel Therapeutics is aimed only at the regeneration of the outer hair cells? Or does it include the regeneration of inner hair cells?

Will it help people with damage to the inner hair cells?

I just cannot find the information which cell division affects aminoglycosides (gentamicin) with ototoxicity, only the outer hair cells?

Who knows about this? Huge thanks in advance!

 

Both
Progenitor cells exist in both layers

 

So how does this gel work then?

 

I as understand it very basic the gel “wakes” the progenitor cells. The cells then do what they were programed by natur to do. That is make new IHC/OHC`s. Just like birds have the abillity to do. They restore there hearing in a few weeks.

 

More info about the San Antonio trial:
https://clinicaltrials.gov/ct2/show/NCT03616223

 

Some positive factors in my opinion:

- People up to 65 year old can participate => indicates that the drug will not only benefit young people as some feared (because in many hair cell regeneration papers "young" mammals are typically used as test subject). Also note that in the Audion Therapeutics trial, subjects up to 80 yo are eligible.
- People with noise induced OR sudden hearing loss can participate => will not only benefit people where noise is the cause of hearing loss but likely also people with sudden HL, ototoxic induced HL,...
- People above 70 DB HL in lower frequencies can not participate => it is likely that FX-322 will benefit all people with HL at 70 db or lower. Probably will also benefit people with more (severe) hearing loss but they obviously want to show the best clinical results, hence exclusion of these people who probably already lost a lot of supporting cells.

 

Like ive been saying. I think fx 322 will be our best bet.

 

3 groups.

High Dose: 8 participants
Low Dose: 8 participants
Placebo: 8 Participants

That’s a 67% chance of receiving the drug.

Also, I find it very interesting they’re utilizing a high dose this early in the study.

I’m very curious to see if FX-322 is believed to have therapeutic impact on frequency ranges 6000hz - 800ohz. In the inclusion criteria they only reference 500hz, 1000hz, 2000hz, and 4000hz. No mention of 6000hz-8000hz. These frequencies are still important for human speech and hearing as a whole. Hopefully these ranges can be restored with this drug, but this is ambiguous at best at this point.

 

Under 'Outcome Measures' it says nothing about hearing loss... ?

 

If support cells are there I think it will help. Frequency response is dependent on location in the cochlea. Basically it is sort of like a coiled up piano. A support cell is a support cell regardless of location.

 

From what ive read this is the purpose of phase 2 type trials, to work out dosage amounts. Phase 3 is all about scaling it up.

 

Good point, only endpoints mentioned are adverse effects and some type of compound blood concentration measure. Guess that's why it's a Phase I/II not a Phase II.
Although it is also interesting that they are having a control/placebo group as well. I wouldn't think that would be very necessary just for the above endpoints.
The again I don't really get why a placebo group would be necessary even if they're actually trying to measure potential improvements hearing loss. Just doesn't seem like the type of thing susceptible to the placebo effect. But who knows.

 

If there's no measure of efficacy, we're still at phase 1, aren't we?

I was wondering about the need for the control group too. It's not as if you believe that your hearing will improve, therefore it does. If only it were that easy. Hypnosis would do the job. Hearing tests are reliable and verifiable. I would have thought that 'before' and 'after' are all you need. Anyway, there's probably a reason they're paid the big bucks and I'm not.

 

If the outcome measures mentioned are the only ones, the trial will be over on day 15. Can they add more outcome measures as the trial progresses? Are there any clinical trial geeks listening? I'm wondering whether they might wait for the primary goal (adverse effects or lack of ) to be determined before they move on.

 

placebo? wtf? If your hearing improves, it can be determined using an audiogram. You can't mentally make it better. Why waste someone's time and hope on a placebo, especially when you are having a needle go through your eardrum?