If the Phase 2B produces positive results, they'll most likely stick with the trial design in Phase 3. They're more focused on word score deficit, than high frequency audiograms. Most likely, it seems as though differentiation of certain syllables (fricatives) that exist well above 8 kHz improves with cell regrowth by FX-322. This is probably what translates to improved word scores.
In the first trial with FX-322, I think it was 3-4 patients that had improvements in their audiogram at the highest frequency that was tested, which was 8 kHz. Imagine if they tested up to 16-20 kHz. There would have been more patients with improvements in their audiogram.
That's something I want to know too. I only saw unapproved drugs via the FDA's official website for Compassionate Use/Extended Access which is annoying since my GP chuckled at me when he looked at my audiogram. If it hits the market, how would I even get access to it...
If this fails, I feel like this is not only for FX-322 but also for FX-345 as well. If FX-322 can't show any improvements in its current delivery method, I don't expect FX-345 to do anything either.
If the results were accurate in the earlier trials they had success in, then FX-322 Phase 2b trial shouldn't fail unless the more participants they have added in this trial easily shows the drug not being effective.
Yes, you will see improvement, but not to the extent of those with moderate, moderately-severe, severe, and profound hearing loss since they have more to gain. Even me, who doesn't have much hearing loss would gain much from the extended frequencies since that's what makes up a good chunk of my tinnitus in my left ear.
I'm like you @ColinUK. Maybe it's our no bullshit, conservative down to earth nature in Britain. Of course I hope FX-322 works but after seeing 40-45% of participants in Phase 1 trials experience clinically significant improvements for OTO-313 and OTO-413, and subsequently fail, I hold out no faith in FX-322.
It seems they care more about speech recognition but tinnitus is listed as a secondary outcome measure. They are only looking at 25 self-reported answers instead of asking the full 142 enrollees, I assume more than 25 in the trial have tinnitus though so I don't get that.
I wouldn't read to much into the stock price. It was over $50 at one point before the poor results. People always end up making money whether this stuff works or not, if they are smart (rules me out unfortunately). I got a few stocks when it was around the $1.40 mark so I really hope it works for my ears and wallet's sake, but I think the reality is next year my ears will still be hurting and ringing and my fortune won't be improved, but fingers crossed for a double win.
I hope so too, although I agree with your statement. Having too much faith in FX-322 (or any other potential treatment) just sets us up for major disappointment. The market is driven by profit, not necessarily by results. At the same time, one can't help but hope...
Mid-stage refers to the fact that it is Phase 2 which is considered the middle phase. It is referencing the readout we are waiting for in Q1 of 2023.
Let me fix that for you "This has progressed through trials set by the FDA that are designed for safety/determining cohorts." The only trial that was actually a failure is the current one. Like Chad has continuously reminded people, there is a fundamental difference between the purpose of the current study vs. the earlier trials
Could you please provide us with your reasoning to why you believe this is the case? Specifically in regards to the differences between the Phase 2a and 2b study as the number of participants is just one of the changes to the study design.
We all are not lmao. My tinnitus, for example, is purely neurological. Fixing hair cells won't fix a neurological condition.
For some time now I've been circling around the idea that all tinnitus is neurological; something like the lack of an expressed gene for example within the brain's filtering circuits upstream of the cochlear.
How about a gene therapy that regulates all hyper-excitable circuits?
Thanks for this, it's a very interesting announcement. I won't derail this thread but in brief, the thing I've found fascinating along the way is something called, Transmembrane Potential, i.e. the electrical voltage across every human cell.
This article specifically mentions gene therapy and potassium channels to modulate and calm over-active cells. There is already something that calms over-active cells using the potassium channel and it's called XEN1101.
Only thing that describes tinnitus is thalamocortical dysrhythmia and hyperexcitability of different brain areas. The best approach would be some brain implant/stimulation or targeted meds.
If we're lucky, it's about 1-3 years from what I heard until XEN1101 would become available.
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