MemberMy tinnitus is all over the place. It fluctuates daily, and sometimes within the same day.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
A quick reality check for this candidate...
What we know:
-It works well on mice.
-It has passed small safety trials and preliminary efficacy trials (it's not acutely poisonous and warrants further study).
-Patients who received the treatment had meaningful improvement to their word recognition scores, some had meaningful improvement to words in noise score. Some had a 10 dB threshold improvement at 8 kHz.
-There is currently NO data on impact on tinnitus at this time, though I personally choose to be optimistic.
-The results of phase 2a will be released in the second half of 2020 with no new info coming before then, as per NDAs.
-These results will let us know how effective the candidate is with variable dosage and a more meaningful sample size, as well as look at higher frequency audiometry, and tinnitus (this will be the money shot for many of us, but we've got to be patient).
Hard to swallow pills:
-The FDA is slow and annoying but truly necessary to stop actual poison from being administered to the masses. Even recently approved medications can be risky, until it's out to the masses the data is relatively limited.
-We have no inherent right to access this candidate while in development.
I really hope that this product works, I know many people with worse tinnitus than I who could strongly benefit. At the same time, expectations of a miracle cure set us up for disappointment. We won't know if it works until we have data, and we won't be able to use it freely until it's approved. The cries for immediate access will not be answered and are really not productive in maintaining our collective sanity as we wait for the good word from Frequency Therapeutics in 2020 and beyond as trials (hopefully) continue.
What we know:
-It works well on mice.
-It has passed small safety trials and preliminary efficacy trials (it's not acutely poisonous and warrants further study).
-Patients who received the treatment had meaningful improvement to their word recognition scores, some had meaningful improvement to words in noise score. Some had a 10 dB threshold improvement at 8 kHz.
-There is currently NO data on impact on tinnitus at this time, though I personally choose to be optimistic.
-The results of phase 2a will be released in the second half of 2020 with no new info coming before then, as per NDAs.
-These results will let us know how effective the candidate is with variable dosage and a more meaningful sample size, as well as look at higher frequency audiometry, and tinnitus (this will be the money shot for many of us, but we've got to be patient).
Hard to swallow pills:
-The FDA is slow and annoying but truly necessary to stop actual poison from being administered to the masses. Even recently approved medications can be risky, until it's out to the masses the data is relatively limited.
-We have no inherent right to access this candidate while in development.
I really hope that this product works, I know many people with worse tinnitus than I who could strongly benefit. At the same time, expectations of a miracle cure set us up for disappointment. We won't know if it works until we have data, and we won't be able to use it freely until it's approved. The cries for immediate access will not be answered and are really not productive in maintaining our collective sanity as we wait for the good word from Frequency Therapeutics in 2020 and beyond as trials (hopefully) continue.
I think it's a combination of supplements, acupuncture, and time. I have definitely healed since its onset.
From what I've gathered, LY3056480 is similar to FX-322 except that FX-322 doesn't deplete the supporting cells. Assuming both drugs are shown to be effective next year, what will be the fate of LY3056480? Will people not use it knowing that FX-322 is going to come out soon after? And has LY3056480 shown the same promise as FX-322? I haven't heard much about it.
I can tell you that if I could get my hands on FX-322 I'd get it shot into my ear today. I have no material concerns that it would harm me given where it is in the approval process. People are literally killing themselves over tinnitus - the risks are worth the potential reward.
Everyone's situation is different but for me, I'd go for it, and chase it with two scoops of Hough Ear pills.
Everyone's situation is different but for me, I'd go for it, and chase it with two scoops of Hough Ear pills.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
@LostOutWest I definitely swing between the "I got this" and "dear lord please cure me now, I can't take it" headspace. I just think that trying to be patient is the best way to get through the long wait for results. Maybe we'll get expanded access during the next phase? Maybe the worst of us could qualify for future trials?
IDK I guess patience is just the way I try to maintain my facade of acceptance to get by and others make it through by raging against the system. To each their own.
IDK I guess patience is just the way I try to maintain my facade of acceptance to get by and others make it through by raging against the system. To each their own.
"The Japanese want to be the regenerative medicine center of the world" -- that sounds good. Long live the emperor!
Also, a highlight from the article:
The "regen" boom in Japan is based on a series of reforms and new laws for pharmaceuticals, but especially the landmark Pharmaceuticals and Medical Devices Act (PMD Act) and the Act on the Safety of Regenerative Medicine. The result is the ability to offer conditional marketing approval for a regen so it can move more quickly to commercialization – an approval process widely seen as the fastest in the world.
Fingers crossed, they have that collaboration with Astellas, and there are chances that it will be approved sooner in Japan than in the rest of the world.
Let's hope they find that this actually helps with tinnitus first. If they do, I've always wanted to go to Tokyo.
Dudebro. There is a, what I consider to be a legitimate, second-hand anecdote about the Regain trial, in which a participant claimed that it improved his tinnitus and hyperacusis enough to rejoin his band. Regain and Frequency Therapeutics are both regrowing hair cells. It is speculated, rationally, that restoring hearing will treat tinnitus. Don't be a hater. Get off the Hater-aid.
Just go for it man, if you can muster the strength. I sat in a quiet room for 3 months straight in Ohio with nothing to do but feel like shit about tinnitus (and it was bad). Then I said screw it and bought a one way ticket to Hong Kong and my life changed about tinnitus and hyperacusis. It actually got better, despite the crazy city noise. Hope the best for your situation.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
@JohnAdams I see it more as a caution cocktail, but I hope you get to rub it in our faces that you were right all along.
What we're talking about is if FX-322 gets approved and works for tinnitus, it would be probably in Tokyo first. That's when I would go, if my ears are still ringing bad.
Yeah, I know, just shining light on your desire to go to Tokyo besides the tinnitus and drug approval stuff. I want to encourage you because I feel for your situation.
Thank you for the concern. Well I'm actually flying to Dublin next month, so that's where my resources are going towards.
I don't think that is true. They said a few had a marginal improvement, but apparently on any given day retesting someone they will vary + or - the amount they said there was an improvement. The number was not all the patients, rather a few showed the small % of improvement. I think these vague but promising statements are to gain share values.
Dude, there were 4 patients with +100% (yeah, doubled) word recognition scores. That result simply cannot be due to blind chance. Most of the other treated patients had only mild hearing loss and there was little room for improvement, as someone from Frequency reported. (Moreover, researchers explained that most of the drug concentrates in the high-frequency region of the cochlea.)
With regard to tinnitus, I guess it could work where hearing loss is also part of the problem. And I'm curious about OTO-413 (that one should repair damaged synapses) and PIPE-505... my intuition tells me they might have an effect for those of you who have tinnitus but no hearing loss.
- Dec 21, 2019
- 319
- Tinnitus Since
- 2014, 10/2019
- Cause of Tinnitus
- School Band, Noxious Car Radio
I think that FX-322 could also benefit those with undetected hearing loss. By which I mean those with tinnitus and hearing loss outside a standard speech range audiogram.
I asked an audiologist if they have ever seen a word score double due to variations in the test/chance etc. She said absolutely never, it would be unheard of.
I think it is safe to say at this point that there is more than enough evidence to presume that the drug can regrow hair cells in humans, and the nerves do in fact reconnect, and that there is some level of hearing function restored. The only question we should ask ourselves now is if reversing hearing loss/damage treats tinnitus.
That's a question for us but not a showstopper for the company. If they've improved your hearing and that improvement remains then you've got better hearing for your lifetime or until new noise damage. That's the definition of a value added drug.
RingingBrother
Member
- Oct 27, 2019
- 96
- Tinnitus Since
- 2018
- Cause of Tinnitus
- Noise induced hearing loss
Alright so I think I'm about to apply to the FX-322 trials but I'm still kinda nervous about it being a risk.
Hater aid? Haven't heard that in a while.
I heard about that Regain guy, but that's just one anecdote, not trial results or multiple anecdotes, and a different trial, although similar. It looks promising but all I'm saying I'm not going too crazy until I see them come out with the results and say that it helps tinnitus officially, and by how much. There's been no official word on that yet. That's when I'll make plans to get it myself. Other than that I can't do anything about it since I have normal hearing.
MRItechssuck
Member
I don't see any travel restrictions, like Dr. Shore... I might give this a shot (no pun intended).
Other than the drug itself... are there any complications to worry about with the injections? I'm probably not as spry and resilient as some. ;-)
Other than the drug itself... are there any complications to worry about with the injections? I'm probably not as spry and resilient as some. ;-)
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