It is incredibly likely the reason that Frequency Therapeutics refused to recognise the positive reports regarding tinnitus improvement is due to it being an unqualified fact from a research/trial perspective.
Very true. I would think that no additional clinical trials would be forthcoming for the "new and improved" FX-322 that reaches 4 kHz and beyond, at least I hope not.
I thought I read somewhere that reformulations require abbreviated trials that generally take up to a year.
Frequency Therapeutics cannot currently even market that FX-322 treats above 8 kHz because to date, they do not have any actual data or approved information which can support this claim. To do so would be a breach of the FDA regulations relating to making unfounded and also false claims about a treatment.
While I agree with your points overall, one thing that would need to be done by Frequency Therapeutics - if they determined that they could get better results with a reformulated medicine - is to at least take this new reformulation through the safety trials. As a result there would be a delay prior to its release, albeit brief.
I suspect it will vary from person to person how well it works in the first commercial version.
I believe FX-322 will help us if our tinnitus is in the high frequencies.
It is interesting that in their updated August corporate presentation on their website they have decreased the frequency of action down to around 6500 Hz from 8000 Hz according to the graphic on page 17. They may have updated that number based on reviewing the still blinded results from phase 2a.
My expectations have lowered by quite a lot. I was hoping for full restoration of my hearing, now expect some improvement in comprehension in conjunction with hearing aids. I'm just going by what's been reported. Even out of the four in phase 1b that showed significant improvements in word recognition scores, I'd say (without going back and checking) that three out of those four would still need hearing aids. If multiple dosing improves significantly on the results we've seen so far, then party time.
When, not if, Frequency Therapeutics can eventually one day deliver FX-322 (assuming clinical trials phase 2 and 3 provides proof of regeneration of hair cells) throughout the cochlea that includes all frequencies with success then it is reasonable to believe that the sound waves we all have come to know as tinnitus will be eliminated and potentially cured. I understand that statement is very optimistic but it is within reason in my opinion.
I'm not so sure August had an update to that graphic [1]. Slide 17 looks the same in this document and it's dated for May of this year:
They updated that cochlea graphic right around the same time as releasing the perilymph study. I would imagine their compliance reviewed that graphic and suggested making the graphic reflect what is actually known from actual data. So, before when it was deeper was probably just inaccurate.
FX-322 is essentially a curative therapy so I think it could significantly improve hearing loss for many people. Since this is the first generation of regenerative treatments, I wouldn't necessarily expect a 0-100 difference whereby someone with very severe loss has their hearing restored to that of a teenager's. But I do think it will be of benefit to many people. If you look at the way Frequency have spoken about their drug and even the wording on their website, I think their ultimate aim is to supplant hearing aids and not simply be an adjunct therapy. They seem like a very ambitious and driven company and I can imagine that they will want to perfect their drug. Even if the first version is better suited to tackling high frequency hearing loss, they'll find a way to improve their delivery method to address the entire cochlea. Perhaps I am an optimist but the technology will just keep on improving year on year so even if FX-322 1.0 is imperfect, there's no reason they wouldn't improve future formulations of it.
I think that there is a high likelihood of Frequency Therapeutics getting FX-322 working below 8000 Hz. However, I also question whether this has been done based off of results in the trials to date. While this is entirely possible, I don't think this is likely as Frequency Therapeutics would have not been able to use those trial results officially considering they are not verified and incomplete.
I would simply say your prediction is accurate although I assume that if someone has tinnitus from TMJ for example that it would not be alleviated with FX-322 or similar treatments.
Regarding the normal audiograms and possible high frequency hearing loss that may be causing tinnitus, FX-322 just regenerates hair cells, doesn't it, and wouldn't address cochlear synaptopathy - where the synapses are damaged but the hearing cells are intact? That's why it may not work for tinnitus if one of the proposed theories of tinnitus is correct, i.e. tinnitus originates from synaptic damage and not hearing cells that have been damaged or destroyed?
There are two definitions of "somatic tinnitus" and the confusion is from the fact that they get interchanged a lot.
Tinnitus arises from interference of input (that's why hydrops without synapse or hair cell damage can cause tinnitus from cochlear origin) and the brain reacting with "phantom cochlea". Either hair cell or synapse damage (or both) will reduce input.
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