It does treat synaptic damage in the area of restored hair cells. Dr. Loose talked about that in Frequency Therapeutics' JP Morgan presentation's Q and A.
How does Frequency Therapeutics know that synapses won't regrow with FX-322 unless hair cells are damaged? It may be possible that it regrows synapses even if hair cells are intact. What are they using to conclude this theory about synapses only being able to regrow if hair cells have been damaged?
They have looked at tissue samples after their drug is given (cochlear explants) so they probably have a good idea what it does and doesn't do.
With bilateral tinnitus cases comprising 39% and patients reporting poor localization at approximately 8%, TFI scores in the aggregate will not reflect the drug's full potential from treating only one ear.
This would be pointless for someone with unilateral hearing loss. I agree with you.
50.30% had unilateral tinnitus,
This is really useful.
It's complicated but I trust the company to report very detailed results and not just a mean on this.
I went back to review the Tinnitus Talk Podcast with Carl LeBel, and mrbrightside614 had actually asked a question along this line. For those interested, this topic is mentioned on page 15 of the transcript.
I think you might be overreacting a bit. There's the whole hidden hearing loss argument. Too many factors to count. They also talk about giving numerous doses to people so there's a greater chance it'll reach wherever it's needed. We know we'll probably need multiple treatments for this. It's just important not to prematurely give up.
In the 2020 JPMorgan Fireside Chat, Chris Loose was asked if in the Phase 1/2 about the response of the drug... he quickly said, "All patients that received FX-322 in the Phase 1/2 saw a benefit." They went on to explain that due to a ceiling effect with hearing (human hearing can only get so good), the mild group saw improvement but it wasn't significant enough to show a measurable benefit.
If the damage is intermittent or mild, then wouldn't FX-322 work? We would see damaged hair cells within areas and as a result FX-322 would treat these then.
Possibly. I am certainly not trying to spread doubt or anything. I'm very curious about the science behind all of this. A thought had just came to me regarding how it didn't seem like you can regrow hair cells that are already grown, separate from dead or destroyed hair cells, so I was wondering if there was any clear answer regarding how they plan to address those hair cells.
Their pre-clinical work was on severe hearing loss but their trials (up till now) excluded severe hearing loss sufferers and only included mild to moderate hearing loss groups.
This is actually really normal on these regeneration/restoration threads to have cycles where newcomers present doubts, and then pages of discussion go by... until the next "big" news comes around... then new doubts are raised, new anxieties are expressed, pages of discussions go by... and so on...
I'm relying on memory here but I think it was up to moderately severe. There's a big difference. For instance, the new category of over-the-counter hearing aids will only be for up to moderate hearing loss. Hearing loss greater than that is deemed (by the FDA) to require in-person intervention.
We are in agreement. They included everyone previously up to severe hearing loss (including moderately severe).
This was more or less what I was trying to get at in my post. As I view FX-322 as a tool designed to regrow hair cells that are either dead or devastated, I wasn't exactly sure how it goes about repairing those hair cells which might still be intact but have lost function due to wear or structural changes. I would believe this case is much more frequent in those with mild or moderate hearing loss.
FX-322 doesn't treat the hair cell directly. It is a novel treatment that utilizes a method they have invented and call, "Progenitor Cell Activation." The drug uses a set of molecules to 'activate' the creation of a new hair cell by causing an adjacent support cell to divide. Here's a video:
It makes new hair cells - no mechanism of action has been delineated via which it would rejuvenate existing hair cells, even if the company spokespeople have used diction, perhaps inadvertently, to that effect.
Right. There isn't a mechanism in which Frequency Therapeutics rejuvenates hair cells. It doesn't do that. It replaces dead hair cells and, I believe it has been suggested, damaged hair cells. There is a mechanism for this in the following:
The science is really amazing behind hearing and regenerative medicine but takes a few weeks of reading minimum imo.
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