Frequency Therapeutics — Hearing Loss Regeneration

Discussion in 'Research News' started by RB2014, Dec 8, 2016.

  1. Watch Hazel share good news about tinnitus
    1. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      That is highly risky. Perhaps there is a suitable experimental population in the form of people with cochlear implants and people with certain kinds of deafness?

      I guess it's in this case that something like OTO-313 or OTO-413 would be very beneficial in this case. Like I said, I guess hearing loss is going to require a combination of multiple treatments. That kind of makes me nervous considering the costs of these treatments.

      Only Susan Shore's device is even considering cost. Every other drug out there, especially for regen, isn't considering cost in the slightest. I hope Medicaid covers this. At least, I hope my state does.
      I don't know what that is or how it relates to progenitor cells.
       
    2. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      No can do. Cochlear implants damage the cochlea and it's highly likely PCA won't work. Deafness of a genetic cause requires a different treatment path. It appears that people with severe hearing loss wont benefit from FX-322 in its current form.

      Tinnitus experienced by most of the population is highly correlated with Acquired SNHL. It is therefore clearly a symptom of an underlying cause at a peripheral source: the cochlea. The two general structures in the cochlea that deteriorate from Acquired SNHL under the age of 65 are: Synapses and Hair Cells. It stands to reason then, that "tinnitus brains" that cannot adapt to missing signal from these structures would be provided relief by regenerating these structures. Prominent tinnitus / hearing loss and researchers seem to agree here.

      Scientists at FOUR therapeutic developers (Otonomy, Frequency Therapeutics, Pipeline Therapeutics, and Hough Ear Institute) also agree with researchers and point to the peripheral structures as the source of hearing loss and its symptom (tinnitus).

      It definitely stands to reason for that majority population that experience tinnitus from acquired SNHL, that a trial treat of a hair cell regen/repair drug + synaptogenesis drug should do one or any of the following:

      - Reduce the tinnitus experienced by the individual by restoring missing signal to the brain. (If the brain is "creating tinnitus" because it cannot adapt to missing signal, then re-introducing signal-sending structures should help remedy).
      - Reduce/stop the advancement of tinnitus worsening or other co-factors (hyperacusis, distortions, spikes, etc)
      - Improve hearing in areas where there are deficits, making tinnitus easier to mask.

      Note: I totally realize this comment will cause a Tinnitus Talk flare-up. So I'm taking a break after this comment.
       
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    3. SD7
      Angry

      SD7 Member

      Tinnitus Since:
      Mid /June 2021
      Cause of Tinnitus:
      Vaccine + Noise
      Five if you consider super-slow-way-behind-everyone-else-but-oooo-gene-therapy-Decibel-tx ;)
       
    4. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      A mere claim without references is hard to believe.

      The possibility that FX-345 will reach 4 kHz and have an effect must be calculated based on the data of FX-322.

      Data such as gel performance and drug concentration.

      I think there is a possibility of success of FX-345.
       
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    5. SD7
      Angry

      SD7 Member

      Tinnitus Since:
      Mid /June 2021
      Cause of Tinnitus:
      Vaccine + Noise
      It's real ;)
       
    6. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      So I won't be helped then? I can only hear up to 12,000 Hz so far. According to the graph, shouldn't I be able to be helped with FX-322?

      As for the rest of your post, based on what you're saying, do you believe that Susan Shore would not adequately fix tinnitus? I actually have the opposite opinion from you. I believe that there are more possibilities of failure from this approach than from Susan Shore's (which aims to directly meddle with the neurons causing the tinnitus).

      Frequency Therapeutics' approach can certainly fix and eliminate hearing loss and that would be an achievement but I struggle to believe that this would eliminate tinnitus in every case. The source of tinnitus is in those overactive neurons; not everyone with SNHL has tinnitus. Subduing those connections seems like a better way forward (and far more cheaper too) than eliminating hearing loss.

      Once again, there is a possibility that what you suggest could eliminate some people's noise-induced tinnitus. But I don't think it's something that can consistently remove tinnitus. I believe (may be wrong) that, after a while, tinnitus becomes centralized in the brain. As a result, only a neurological solution would help with that.

      By the way, feel free to correct me on anything I say. I am still learning.
      Yeah this is why my tinnitus is annoying. Everything sounds so muddled (at least in comparison to before) to the extent that I can't even properly hear rain. As a result, despite my tinnitus being objectively quieter than I think a majority of people's tinnitus, I can still hear it because my hearing has degraded to the degree that it has.
       
    7. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      Why would you believe that FX-345 could reach that far back but not Otonomy? How are they expecting to reach that far back?

      Also for Otonomy, I believe they patented the way they were going to reach that deep so I think that counts for something. Its drug delivery is not based on the drug itself. I don't have good information on the topic so I could be wrong. Maybe you know about this and have a response?
       
    8. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      I want Otonomy to show evidence. I can't believe their gel actually penetrates the entire cochlea just because they have a patent. Why is it just a claim? Do they have evidence from clinical trials?

      I think there was a patent that FX-322 also reached 4 kHz. But it didn't actualize.
       
    9. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
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      I believe FX-322 can reach at least 8 kHz. This is due to the fact that a few of the patients in the Phase 1b trials had improvements in their audiograms at 8 kHz.

      Anything lower than 8 kHz may require FX-345.
       
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    10. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      Speaking of audiograms, to what degree were there improvements at 8 kHz? Is it to the level of "normal" hearing? I guess that depends on the actual amount of damage within the cochlea but I am still interested in knowing.
       
    11. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      Slide P33 in October 2019.

      It was an improvement of 10 dB or more. In a slide created after this, probably one year later, one of the four had an improvement of 15 dB.

      2019.10 freq slide P33.png

      P22 on the same slide.

      They said it would reach up to 4 kHz. 4 kHz is the area where noise first attacks and destroys hair cells. With FX-345 they aim to reach deeper than 4 kHz.

      2019.10 freq slide P22.png
       
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    12. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      Thank you for your time!

      How does this compare with normal hearing?
       
    13. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      Unfortunately, I only know that it has improved by 10 dB or more. These four people seemed to be the same people with moderate hearing loss with significantly improved word recognition. It was announced that these four people had moderate hearing loss.

      But, I think there may be people with mild hearing loss who improve to "normal hearing" at 8 kHz, if FX-322 can be cumulatively effective with multiple injections at appropriate intervals. Even if a single injection only provides an improvement of 5 dB.
       
    14. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      So does that mean "it didn't reach levels of normal hearing" or "I don't know if it reached levels of normal hearing"?

      Also how does that work? How can it be cumulative? It's not like you'll end up with extra regenerated hair cells.

      By the way, do the progenitor cells disappear after regeneration or do they remain (so, for instance, if your regenerated hair cells got damaged, could you get the treatment again)? Because, according to the Tinnitus Talk Podcast interview, Frequency Therapeutics' approach to hair cell regeneration is to make use of progenitor cells which stem cell therapy destroys.

      Furthermore, what do you know about the recent reports that those administered FX-322 reported changes after the trials were done?
       
    15. rei

      rei Member Benefactor

      Tinnitus Since:
      2006 but not a problem till 10/19
      Cause of Tinnitus:
      loud music spiked with lyme disease
      FX-322 induces an asymmetrical division of cells creating both a new hair cell and a new progenitor cell.
       
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    16. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      Slide P28 from March 2021:

      2021.3 freq slide P28.png
       
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    17. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      The most important metric I think people here are looking at is a reduction in tinnitus severity, something that neither WR scores or audiograms give us, but between the two, improved high frequency hearing would logically have a stronger correlation.
       
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    18. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      What do you think is the reason why TFI was not published in Phase 2a?

      1) It really didn't work.
      2) Since there were many improvements in placebo, it could not be said that it was effective in comparison.
      3) There was improvement in the medication group, but because there were many improvements in placebo due to improvement in word recognition and high frequency, the reason (correlation) could not be found and they could not publish it.
      4) Something else.
       
    19. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      1.
       
    20. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      I doubt they are hiding good news.

      Considering that Neuromod released data to suggest their treatment worked and it really doesn't, I now have a pretty big barrier before I get onto the hype train.
       
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    21. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I feel like it could be 3.

      We did hear some anecdotes from Carl LeBel that there were tinnitus improvements in some patients. We should know more by the end of this year with the single dose Phase 2b trial.
       
    22. ColinUK

      ColinUK Member

      Tinnitus Since:
      2013 initial, worsened 2020
      Cause of Tinnitus:
      Initial Music Gig, Worsened Cinema or possible covid
      Wasn't that only after the initial safety trial though with a handful of patients? Since then there had been no mention of tinnitus? Or did I miss some other news?

      I just cannot fathom that they wouldn't say "hey you know what, during our trials we had a few folk who reported an improvement in their tinnitus."

      How would that take away from anything or muddy the waters? Surely it would just be a positive signal. I really want there to be some hope and positive news from any of these drugs, I really do, but after speaking to a community of patients, i.e. Tinnitus Talk Podcast, prior to the trials and knowing how much some people need hope to cling onto holding back any sort of positive feedback would seem unusually cruel?
       
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    23. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      This was the Phase 1b trial with a single dose of FX-322 that saw some patients with lower tinnitus level so hopefully the Phase 2b trial has similar outcomes to Phase 1b.
       
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    24. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      They state that Phase 2a could not confirm the effect of the drug for at least two reasons. One is the unusual effect of placebo and the other is multiple injections per week.

      In addition, I think that the short-term multiple injections that inhibited the effect also include placebo injections.

      I think Phase 2b without these two points may give the same result as Phase 1b.
       
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    25. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      That was not in their data. It was anecdotal reports. Are we just making stuff up now?
       
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    26. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      Was TFI a survey item in Phase 1b?

      Since there was an anecdote about improving tinnitus, wasn't it adopted as a survey item in Phase 2a?

      Originally, FX-322 is a drug whose purpose is not to improve tinnitus but to restore hearing.
       
    27. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I think some patients had improvements in Phase 1b so they decided to add it into Phase 2a but now they will redo the trial again with the single dose of FX-322 in Phase 2b which should give similar results to Phase 1b but with more patients.
       
    28. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
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    29. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      40th Annual J.P. Morgan Healthcare Conference

      Has anyone had a look at the video yet? Did they say anything that hasn’t been stated yet such as more information about the severe hearing loss trial results or the current Phase 2b trial?
       
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    30. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
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      I listened to most of it. More of the same. Focused on word recognition again. No mention of actual hearing improvement or tinnitus.
       
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