Same. At this stage with the current timeline, PIPE-505 may come out around the same time as FX-322 or later. I'm betting it's either FX-322 or PIPE-505 that will solve our issues.
Bro, FX-322 or any regenerative medicine for that matter is not coming out before Ebselen. Accept it.
Sad to say, I agree. It's hard but we have to face the music. It's going to be really, really hard for FREQ to save Phase 2a, if that is even possible if the full readout is positive.
PIPE-505 may show greater results provided it actually restores the synapses. Synapses are more vulnerable to damage than hair cells. This may explain why some people develop tinnitus after brief short noise exposures that shouldn't in theory be enough to damage their hair cells.
In new Phase 1bs or Phase 2a (final report), if there is an improvement of ≥ 20 dB at 8 kHz (or more), will it change to "OHC first" or "IHC and OHC at the same time"?
As a complete biological novice, I suspect the human systems are so complex and inter-related that to say any test absolutely measures only one type of cell has to be a gross over-simplification. I would think the different tests might lean towards indications of good or bad populations or health of certain cell types over others, though.
I disagree. While it doesn't meet the game changing requirements that you were looking for, doubling word scores for some people is absolutely life changing.
I agree, but there really is some degree of differential as well. PTA is almost entirely OHC, unless the person literally lost every IHC and synapse lol. It seems like WR could be both, but because the test normalizes for volume, it's a good measure of IHC. Then WIN is well-known to measure synaptopathy. Again, the "noise" volume is held constant and comfortable. The signal is gradually increased in 4 dB chunks so everything is a perfectly comfortable volume.
Everyone here said the same thing about FX-322 after Lenire flamed out. Seems to be a torch-passing game going on here as far as hope goes.
How many people go to the doctor and say they have perfect hearing and they just have trouble understanding a few words... It is a very small subset of people.
I mentioned this in a previous post that it is concerning the amount of hype and expectations a drug has when going through trials, only to find failure after failure.
Don't forget, though, @Aaron91 posted at least one interesting anecdote from a supposed participant.
I'm not sure what you're getting at? When someone knows they have a hearing problem, they're going to the doctor saying, "I can't understand my kids, wife, TV, radio, etc..." and typically what they are losing first is the ability to distinguish high frequency sounds, or hear them at all. This is actually really common as hearing wears / ages.
Pretty much covers it. I would add "lessons in new lawn care" for all new homeowners.Things I've learned learned from this thread lately:
- there is still reason to be hopeful
- being hopeful is a sin and you're a bad person
- the Phase 1b results are unprecedented, this drug could be life changing and usher in a new era of medicine
- the Phase 1b results aren't as good as one would hope from widely regenerating hair cells, and indicate a categorical failure
- 5 to 10 years for treatment is too long to wait for
- 7 days between doses is too short to wait for
- the less Frequency Therapeutics tells us the more we all have to say
By the time someone actually goes to the doctor, they are usually down 20 to 30 dB at the higher frequencies. It shows up in the audiogram and the word score tests. You need the word scores and the volume brought back up at those frequencies to really help someone. As of right now it is still iffy on how much FX-322 will help out with the audiogram portion of it.
So true. It feels like tinnitus history keeps repeating itself in a cycle: hope-trial-failure-next hope and again. I was randomly reading through old posts from 8-9 years ago where people were as hopeful as we are now about potential treatments coming up; thinking that no relief has happened in such a long time shatters my hope for a better future.
With all these current "delivery" methods and only guessing what goes on inside our cochlea and our brain because no one knows for sure where subjective tinnitus originates, in 40 years maybe something will work.
Not really, people improved their word scores and clarity but it barely did anything to the audiogram. Would you be making the same argument if the opposite were true?
I would have preferred the opposite to be honest, but it isn't about what I want. We are trying to cure deafness. We are trying to cure tinnitus. That is the whole point. Deaf people can't hear and it shows up on their audiogram. They just want to hear birds again. There are 466 million people worldwide with hearing loss. This is why they created FX-322 in hopes of helping people with hearing loss and it has been hypothesized that this could also help with tinnitus. It was never created to help them understand words better, even though we now know this is a great side effect...
I get this, absolutely. My take is that the drug isn't going very far into the cochlea so it's only hitting the highest frequencies. I believe it has grown functioning hair cells that are synaptically connecting to the auditory center, and that the delivery - thus the range of improvement - is so limited that they desperately wanted to get more in, and the method for getting more in was half-baked. Half the solution is missing, and hopefully being developed. But the step that has been taken towards that - getting *any* cells to regrow - has been revolutionary. I could be wrong and the whole thing could be a dud, but that's not the impression I have.
To me, it's not about focusing on the failures or using a past failure as a solid justification (IE: AM-101) to predict the future...
This is a good post and you are right! They are pioneering this stuff. I just find it really hard to believe that we have come this far and we are still learning things. They are a publicly traded company now, not a research firm. The expectations are a lot higher now.
Not trying to be negative. The results speak for themselves. As many scientists have come out and stated... It's a lot harder than we originally thought. We are where we are. We need to be realistic in what we are expecting from them.
There were also improvements in audiogram as well but in Phase 1b they only tested max 8 kHz and 3/6 showed improvements in the max frequency that was tested at 8 kHz. I imagine if there were improvements in 8 kHz that there were improvements between 8-20 kHz but that wasn't tested in Phase 1b.
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