Frequency Therapeutics — Hearing Loss Regeneration

On their website they’re even calling it Phase 2a. So no, highly unlikely. Tinnitus is listed as a secondary outcome measure in the trial design, so yes, they will most likely report on that. Hyperacusis isn’t mentioned I believe.

 

Eek, so 4 injections, one per week. They will basically know how effective it is after one month, but the study ends September next year... damn, that's unfair. (I know, they want to prove that the effects will last and also record more stuff.)

And does anyone know why on Earth would they test it against placebo? Why not open-label? It's not like hearing could improve with placebo. Some folks are gonna get useless intratympanic injections, which, if you ask me, is not completely ethical and has no real purpose for a study like this. Did I miss anything?...

PS: I still hope that Astellas will get involved and will try to get the drug approved in Europe/Asia. In the US the things are moving too damn sloooooowly.

 

A testicle or a significant part of female anatomy... actually we be able to afford it... by any means required... I am guessing ten grand with the surgery, and other deuce bag things we will need to pay for, such as coffee in the waiting room and disingenuous smiles, those cost a lot...
Not happy today... sorry.

 

Found an interesting study with regards to nanoparticle drug delivery and the apex of the cochlea (lower frequencies). Keep in mind phase 1/2 of FX-322 only established 4 patients with a 10 dB gain in the 8000 Hz frequency, which I think could be a problem going forward:

“Superparamagnetic nanoparticles can be driven inside the cochlea toward the apex with a preserved hearing up to 1 month in rats.”

https://www.ncbi.nlm.nih.gov/m/pubmed/31478462/

 

More like three months. But still. Too long for sure.

The only thing that would help speed things up would go something like this:

The American Tinnitus Association and Hearing Loss Association of America teamed up to raise awareness of these drugs and successfully lobbied Congress to pass a law to fund expanded and accelerated testing of them, or to get this to the attention of Trump and have him sign an executive order to do the same. This would be warranted because right to try laws were made for fatal illnesses, well what's worse, a disease that kills you, or a disease that compels you to kill yourself? Unless something like that happens then we are just going to have to wait. Unfortunately, organizations like the ATA and HLAA are staffed by normies that would probably never do something like that because they are hypnotized by authority and would side with the FDA's long process because they think that's just the way it has to be.

HLAA:
301.657.2248
ATA:
800-634-8978

 

The FDA has granted FX-322 Fast Track designation.

 

So with fast track status would they do Phase 2a then skip a Phase and go straight to Phase 3?

Did AM-101 ever achieve fast track status?

 

No. They’re even still calling it Phase 2a in their press release. My guy, unless this drug also happens to cure ebola, they’re not gonna be able to skip a trial. Fast Track means they’ll have more and quicker contact with the FDA. The FDA does not just come into play after Phase 3, but continuously monitors drug development. Even clinical trials have to be approved by the FDA.

And yes, AM-101 got it in 2016.

 

Surely it could get released earlier with the help of Astellas. Maybe they could conduct their own trials and release it in other markets where it’s less strict in terms of the FDA.

 

Sure the cash helps, but it’s not gonna save them years. If you really want this, participate in a trial.

 

WOOT! WOOT! Told you guys, the 2020s is our time. Tinnitus will be getting tons of working treatments soon.

 

We will never know if it helps tinnitus.

For people with hearing loss and tinnitus, they will be helped because better hearing = lower tinnitus.

But for those tinnitus sufferers who have no hearing loss, it's not yet known. Theoretically it should work.

 

lol what?
It seems like that if your tinnitus is not caused by hair cell damage then this wouldn't affect your tinnitus.

 

Me right now:

 

Did you guys know there’s a BBC News presenter - Lewis Vaughan Jones - who suffered sudden hearing loss and now has raging tinnitus in one ear? Might he be interested in hearing about news like this? The interview with him I read has him saying he was frustrated his ENT can’t do anything about it. This all happened two years ago or something.

 

I see. Well, he could be a big amplifier getting the message out that treatments might be arriving in a few years.

 

Some people with tinnitus have perfect hearing and their tinnitus is sound induced.
That said, a drug improving your hearing might not improve your tinnitus. My feeling is it should... but tinnitus can have a completely different mechanism from dead hair cells. No one knows.

The Hough Ear Institute are working on a pill for tinnitus and another pill for hearing loss, likely meaning that those 2 conditions are not originating from one source.

 

I think they do know that hair cell loss doesn't always cause tinnitus.

 

Yes, I have severe hearing loss in one ear, but most of the time just a light buzz in terms of tinnitus.

 

What can we do to make Frequency and others more known? I’m pretty sure we can make things move faster. Hundred of millions of people are suffering from hearing loss and tinnitus, the problem is that those sufferers have difficulties in claiming their rights.

Yes I think that today it’s our right to ask for a cure since we live with a scientific community that has started research to reverse aging! I got hearing loss and tinnitus just by going to a night club and I’m only 21. I was really shocked when I knew that there’s no medication for this and I’m obliged to pay the consequences for the rest of my life.

The Fast Track designation obtained by Frequency make things more serious for us as sufferers. We need to create more attention and consciousness around hearing loss and tinnitus in order to obtain a cure in the next few years.

 

I’m not even asking for a cure... If I can get in the mild-moderate hearing loss category, I’m good. I have a PTA of around 70 now. If it gets to 25-35, I’m cool.

 

Not without support from organizations like the ATA, the BTA etc. and I really don't think they are going to lift a damn finger to actually help us.

 

A nice first step would be to get Will McLean or someone like that on the Podcast. See where we stand with this drug. There’s not that much data to lobby with.

 

That link says they will be holding trials at 12 sites nationwide, so maybe it's not just in North Carolina.

 

A fabulous opportunity for all US citizens on Tinnitus Talk, with demonstratable hearing loss, to get themselves into the trial.

 

If anyone qualifies to be in the clinical trial hopefully they live near one of the 12 sites.

 

I really hope someone from Tinnitus Talk gets in the trial and they report hearing restoration, tinnitus and all other ear symptoms a thing of the past. And may they ride off to the sunset and finally get back on with their lives.

Oh and that they get to use headphones again.

 

Ain't happening.