Frequency Therapeutics — Hearing Loss Regeneration

I think they are seeking their own paths so they can be the ones that get the glory and the patents and ultimately money and recognition while we slowly deteriorate.

 

https://www.cnbc.com/2018/05/30/trump-signs-right-to-try-legislation-on-experimental-medicines.html
Can this apply to FX-322?

 

I think it should but it probably won't. Tinnitus makes people suicidal, which is fatal, but this drug isn't being tested to treat tinnitus, it is for hearing loss. Moreover, not all tinnitus is from hearing loss. If we have tinnitus with hidden hearing loss, we may be ineligible even when this is released.

 

I don’t want to go offtopic by discussing how obsolete ENT tests are, but I do have a question:

Do ENTs consider high frequency hearing loss to be “hidden” hearing loss? Or are we talking about a different type of hearing loss?

 

I think hair cell regeneration could also help hearing loss not detected by tonal audiograms.

I can't imagine it doing nothing.

 

If not all tinnitus is from hearing loss then the damage can be to the nervous system itself... and not hair cells?

 

My audiogram shows hearing loss. The loudness of the tinnitus wouldn't let me hear the tones.

 

Unless the ENT can't detect hearing loss and won't refer you to the treatment.

 

Agree, just because ENTs don't test 8-20 kHz doesn't mean medicine will magically skip over that part of the cochlea

 

Yes, people with hyperthyroidism report tinnitus.

 

You also need to know hidden hearing loss isn't just over 8 kHz.

it also can mean trouble hearing speech in background noise within 250 Hz - 8 kHz because of damaged cochlear ribbon synapses or certain hair cells that work as amplifiers.

 

Judging by your audiogram and complaints of hearing damage, it's obvious your tinnitus was brought about by SNHL.

 

They're different.
Hidden hearing loss is hearing loss that doesn't show on a hearing test. High frequency hearing loss does show on a hearing test if the test covers those frequencies.

 

That's why the Otonomy drug for hidden hearing loss is BDNF, which doesn't regrow hair cells, but restores the synapses.

 

Could I get a rough date on when this will be coming to market?
2022? Later?

 

@Samir You mean that 2022 would be on the early side, right?

 

Very early.

Phase 2 starts in 2019. Let's say that takes 1-2 years.

Next is a phase 3 that can take anywhere from 1-4 years.

There will probably be a peer review, add 1 more year.

I would say anywhere between 2022-2026.

 

Star date 2233.04

 

Seriously though, seems far off to assume that tinnitus would be considered in the US as a terminal condition. If we got a slightly more loose definition then maybe.

 

Under normal circumstances I would agree with this time line, however, this is not normal circumstances.

If phase 2 shows positive results there is going to be immense pressure to get this out ASAP by the US government for veterans.

https://www.military.com/benefits/v...us-is-number-one-disability-for-veterans.html

 

That and they aren’t just set on curing hearing loss. They want to expand to other areas. They aren’t going to spend 10 years on ears alone. They made it their mission statement, they want to be the first ones figuring it out. If they fail with this then it’ll be harder for them to gain any more investors.

 

Does anyone know if FX-332 is going to be or has been planned to be “fast tracked” by the FDA/Frequency Therapeutics under one of these 4 conditions:

https://www.fda.gov/forpatients/approvals/fast/default.htm

 

Man, I don't think anyone knows anything.

 

Would make sense to "fast track" it. It certainly is an unmet market.

What I´m hoping for is an "Open phase III", which mean we could get the drug as fast as 2 years from now.
That would be the fast "fast track" option.

Anybody know any examples where an "Open phase III" was being conducted?

I just heard about this as an option from someone on this forum.

 

I doubt it. Why would they fast track it when they don’t know if it seriously works yet?

They’ll have to show sufficient evidence to prove that they should be allowed to fast track their drug.

 

Well they're testing it on humans now so they'll know soon enough.