Intratympanic injections are nothing new to the medical field. Just imagine if this stuff does help with tinnitus? They weren't looking at it before, but maybe something in phase 1 made them want to look into it further. The whole medical community has pretty much all agreed on the idea that hearing regeneration would help.
No man. Tinnitus has been on their minds. There is an ancient Reddit thread where there is a person under the name of "The Leviathan" that was taking flak for expressing his opinion that hair cell regeneration could help with tinnitus. The flak was very similar to the kind of small minded nay-sayer stuff we see here on this site regarding potential treatments. "The Leviathan" claimed to have been a member of the lab that discovered this and is very likely to be William McLean. This was all well before phase 1.
Where can I find an article or link that the 'REGAIN' project has almost completed the phase 2 study?
Where can I find a link to the anecdote?
The thing about intratympanic injections is that, yes, they do it all the time, but not one intratympanic delivered drug is approved for any condition. It's all off-label use of dexamethasone used for acoustic trauma, Meniere's disease and sudden hearing loss because there isn't really anything else. And yes, concentrations of dexamethasone in inner ear perilymph is higher than if taken orally, but it's still a very tiny amount. I just don't know where Frequency Therapeutics gets the confidence from with regards to intratympanic injections.
It's here in the Audion thread:
The premise in the message of that guy is based on the statement that many patients with tinnitus improve when they have a hearing aid because "it increases the sound input".
There will be double blinded placebo control data available from the current FX-322 trial in about a year regarding whether or not this helps with tinnitus. This is all very new, so there is no direct data to support it yet.
Also you may want to look into residual inhibition and reconsider your assumptions.
Hough directly states it helps tinnitus greatly - how they know this, I don't know.
It's certainly interesting that we have 3 or 4 companies coming to the table, testing essentially the "same" therapy. There must be something to it, because among the 4 of them there's probably hundreds of millions being thrown at this.
The problem with hearing aids is that they don´t cover high frequencies, where tinnitus is usually located.
That's actually still considered in the range for "high frequency hearing loss." The diagram shows it tapering off distal to 4000 Hz but didn't imply these were the highest frequencies. It only makes sense that the higher the frequency, the more drug exposure because it's closer to the point of entry.
I think some drug will still penetrate those areas. I have hopes this drug will extend further than the zone of high concentration but may need additional rounds.
There aren't any other inner ear drug delivery methods that are approved (as far as I know). I think we'll get intracochlear injections first. That won't change much with regards to bioavailability in the apex of the cochlea, but you're at least certain that what you're injecting reaches the cochlea. Intratympanic injections are unpredictable in that regard. You never know how much permeates. With intracochlear injections you penetrate the round window membrane and then inject the drug.
That's straight from their slides:
So far, all of us that reported hearing back were rejected. I do believe the odds are *someone* on here will be part of the trial. There is a NDA, though, so I'm not sure how much they can tell us, though. Also no way to know if they are placebo or not.
Did any of these 15 people measure above 8 kHz? If not through Frequency Therapeutics, then independently on their own? If so what happened between 8-16 kHz???
Very interesting! Looks like they settled on this being only effective for 3500-16000 Hz. It even says FX-322 is "designed for higher frequencies". No it's not, it's a cope. That's a big chunk of hearing they are leaving out. That sucks...
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