MemberOn page 54 of the Frequency Therapeutics presentation it mentions about the colour of the circle representing the people that responded to FX-322 and you notice that with the severe trials it has a darker circle and says 100%. Does this mean everyone who was treated in the severe hearing loss trial experienced improvements?
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
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On page 54 of the Frequency Therapeutics presentation it mentions about the colour of the circle representing the people that responded to FX-322 and you notice that with the severe trials it has a darker circle and says 100%. Does this mean everyone who was treated in the severe hearing loss trial experienced improvements?
- Apr 28, 2021
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- Feb 14, 2020
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Yes. BUT. The circle is smaller indicating a small sample size. Which is why it isn't highlighted with the dotted orange circle. We won't know truly how well this drug does for severe loss until the readout.
I do think everyone experienced improvements. Severe hearing loss sufferers had great response because they have more inner ear hair cell death, so the hearing improvement can be easily seen unlike in other types of hearing loss.
Yea sample size is smaller because I think they only have 24-30 participants for the severe hearing loss trial.
But if it's true that 100% of patients experienced improvements for the severe hearing loss trial, I am really shocked. I was not expecting it to do so well.
- Feb 14, 2020
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No, I mean the sample of patients with Severe loss that HAPPENED to get FX-322 in one of the other trials is probably a handful of patients; making it too small to be meaningful for this chart.
The Severe Trial results have not been released.
The size of these two circles is too small because the number of patients with severe hearing loss and the number of patients with presbycusis are about the same.
Also, unlike the others, the numbers are white.
I think they're probably writing that they're close to this.
Because it has not been confirmed.
Yea I guess so but not sure what the 100% means for the severe hearing loss category if the official results haven't come out yet.
If the severe hearing loss trial results have not been released yet then it's bad they added the severe category in that diagram which says 100%.
Chad Lawton
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Some patients with Severe hearing loss were in the 201, 111 & 112 studies and those are the patients they are referring to in that chart. The Severe hearing loss trial is labeled 113 and is not included in those results so they have not yet disclosed the Severe trial results. We can infer that the trial will likely have at least some success seeing that Severe patients in the other trials saw improvement.
I thought 201, 111 and 112 trials went up to moderately severe. The only severe trials that have been done are those that are in 113 so when they stated 100% for the severe hearing loss trial, this must be for 113. What we don't know is if the 100% that experienced improvements in the severe hearing loss trial is true or false.
I understand. So it means that it will not be confirmed until the reading of 113 is completed.
The reason for the white letters.
111 contained severe.
Chad Lawton
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The 113 data isn't included and there are 3 reasons why I say that.
1. At the top of the image you provided, 113 is not listed. It only says 201, 111 & 112.
2. The Open label 111 study did include Severe patients. It says so on slide 10 of the current slide deck posted on their website. For all we know, that 100% bubble in the slide you shared could be 1 patient or it could be a few.
2. If you look at slide 15 of the current slide deck, it says the N count of patients dosed for the single dose studies combined thus far is 71.
Phase 1/2 had 15 patients dosed with FX-322
Open Label 1b had 32 patients dosed with FX-322
Age related trial had approx 23/24 patients dosed with FX-322
That adds up to 70/71 patients. If the Severe trial were included in that, that number would be in the mid 90s.
Current slide deck - https://investors.frequencytx.com/static-files/d0fdfc76-ef0f-426b-8b15-21f4d6ffd61b
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- Feb 14, 2020
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They're being transparent. A few patients has severe hearing losses in past trials, 100% saw improvements, but not enough to draw a final conclusion. How is that bad?
There is a graph on page 4 where VPA does not penetrate deeply.
https://www.tinnitustalk.com/attachments/improved-speech-intelligibility-fx-322-phase-1b-pdf.43487/
But, only GSK3i is listed in the FX-345 presentation on November 9th.
Is increasing the amount of VPA an issue?
Is it an error in the presentation slide?
Forgot the slide about VPA?
In this slide, there is an error in writing 66-85 y / o in 201.
https://www.tinnitustalk.com/attachments/improved-speech-intelligibility-fx-322-phase-1b-pdf.43487/
But, only GSK3i is listed in the FX-345 presentation on November 9th.
Is increasing the amount of VPA an issue?
Is it an error in the presentation slide?
Forgot the slide about VPA?
In this slide, there is an error in writing 66-85 y / o in 201.
Chad Lawton
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But that isn't bad. That at a minimum tells us it has a chance of working on at least some Severe etiologies. We know it was at least 2 patients it worked on. One with noise induced and one with SSNHL.
I don't quite understand where exactly this image is from. It's in vivo but pre-clinical? Is it in something like mice then? Someone please explain.
Yeah it's quite encouraging. Then again, what is the difference in the mouse ear that makes this actually happen there, but not apparently in the human ear? Because they are using the same delivery method, right? Would be interesting for them to comment on that.
Also, did they ever comment on the tinnitus outcomes from the "failed" Phase 2?
Mysteriously they were never mentioned as far as I know. Or did I miss it somewhere?
This is a study of Kyushu University in Japan.
It seems to be a technique for regenerating spiral ganglion neurons, not hair cells.
It may be effective for presbycusis.
This technology uses proteins rather than small molecule drugs.
I want Frequency Therapeutics to be able to do the same with small molecule drugs.
Growth factors with valproic acid restore injury-impaired hearing by promoting neuronal regeneration
I was in Japan and read a Japanese newspaper article about this study. The newspaper article stated that for the first time in the world, a hearing-impaired mice restored hearing. I thought this article was a mistake, because Frequency Therapeutics had already achieved hearing recovery in hearing-impaired mice in animal studies.
It seems to be a technique for regenerating spiral ganglion neurons, not hair cells.
It may be effective for presbycusis.
This technology uses proteins rather than small molecule drugs.
I want Frequency Therapeutics to be able to do the same with small molecule drugs.
Growth factors with valproic acid restore injury-impaired hearing by promoting neuronal regeneration
I was in Japan and read a Japanese newspaper article about this study. The newspaper article stated that for the first time in the world, a hearing-impaired mice restored hearing. I thought this article was a mistake, because Frequency Therapeutics had already achieved hearing recovery in hearing-impaired mice in animal studies.
RingingBrother
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- Oct 27, 2019
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I'm not sure but I think it was that they extracted the mouse ear and applied the drug directly which I don't think would be possible in a live human.
Street Novelist
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Shit, I was denied. Because my word scores were 100%, they said I wasn't eligible; even though I have hearing loss. This shit is so aggravating.
WR scores aren't going to help us with tinnitus. I have sudden hearing loss, steep slope starting at 2 kHz on my audiogram but like a 90 WR in the ear that had the loss. We need something that's going to improve our frequencies.
Street Novelist
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