I think it was @Danad who said it but I could be wrong. It was a while back & don't know the exact words but I think the argument was that while just about everyone has some degree of hearing loss, not everyone has tinnitus.
Not sure what the story is here. It seems like the Department of Defense alone would be interested enough to get it through trials. It was originally named 'the bomb blast pill', after all.
Well the early history of the Hough Pill is a bit muddy to me. They did have a partner, Otologic Pharmaceuticals (local to Oklahoma) but it seems like the partner didn't prioritize the pill for some reason or didn't have the experience Oblato has. I wonder if it has to do with the pill being tried (unsuccessfully) on stroke victims first. It's very unclear what happened but Oblato seems to be working towards more clear goals with the drug at least.
I agree that there is a certain amount of (especially sudden) damage that tends to cause tinnitus in everyone but it appears to still be specific to the damaged frequencies.
The ability to diffuse through the round window isn't all that groundbreaking (biotech has done this for a while now) but imo what is is when you add a surfactant to the vehicle to ensure that your substance continues to move forward without resistance to the apex of the cochlea.Yes, I made that confusing... I think the technology to diffuse through the round window is groundbreaking...
Great explanation, thanks
I don't believe that's quite how it works.
More likely, because being for-profit.
When an improved delivery method becomes available, would it be possible to receive FX-322 a second time?
I'm just hoping there's some sort of way for them to reformulate without going through a year-long trial. Like maybe if they use ingredients that are already proven safe?The ability to diffuse through the round window isn't all that groundbreaking (biotech has done this for a while now) but imo what is is when you add a surfactant to the vehicle to ensure that your substance continues to move forward without resistance to the apex of the cochlea.
Penetrance after round window diffusion has unfortunately been the sticking point for many a compound. The good news is that both Otonomy and Pipeline have done this, and confirmed that can reach sub 100 Hz - so it is indeed very possible to achieve.
Here's hoping that when Frequency reformulates they add something similar. Most of my damage is sub 4000 Hz with stuff as low as 50 Hz
They are doing multiple dosing in their trials so it's obvious it can be given more than once.
I essentially asked this yesterday. It seems like over-regeneration isn't a problem so there isn't any reason you couldn't.
A question was asked about whether FX-322 would reduce tinnitus and this was my reply:
We're speculating on something that doesn't yet exist. That said, sure, why not.
I hope Frequency pushes to reformulate to get maximum penetration and results for their drug.The ability to diffuse through the round window isn't all that groundbreaking (biotech has done this for a while now) but imo what is is when you add a surfactant to the vehicle to ensure that your substance continues to move forward without resistance to the apex of the cochlea.
Penetrance after round window diffusion has unfortunately been the sticking point for many a compound. The good news is that both Otonomy and Pipeline have done this, and confirmed that can reach sub 100 Hz - so it is indeed very possible to achieve.
Here's hoping that when Frequency reformulates they add something similar. Most of my damage is sub 4000 Hz with stuff as low as 50 Hz
Good question.
It would be nice if the drug worked straight away. I would assume the best time to get the shot is just before bed so it has time to regrow during sleep but we would all have appointments at different times so it's not possible.
I have no idea about what times and protocols to maximize the effects of the injection are recommended. Does it work right away? How long is it active for?
Those are some very good questions. I know for a fact in the Phase 2a clinical trials they are basically doing 1 shot per week. With Phase 1b it was just 1 shot but they basically recorded the progression from Day 0, Day 30, Day 60 and Day 90 and what they found out was it was still working its magic in Day 90 so it seems like its effects last a long time.
Based on the phase 1/2 info, improvement continues over the course of months. Are you asking this because intestines regenerate while you sleep? Since the chemical signals are being injected into you vs excreted by your own body I wouldn't think so, but it doesn't really matter. Don't get hung up on tiny details.
@FGG knows more about this than myself. From what I understand they cannot change their current formulation without starting over from scratch (ie: go back to phase 1) because of the FDA's IND Protocol. Right now their IND filing is for this formulation and this formulation alone, and all clinical trials through phase 3 have to be completed using it.
Exactly. You can't change your formation once you start the trial process but, once approved, there is a short process (about a year or so) to get a subsequent reformulation approved where you prove the reformulation "does what it says."
Seems crazy that it's automatically another year of trials regardless of the nature of the reformulation... I mean if the drug itself is the same what gives? Sigh.
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