Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      That could be the reason why the improvements weren’t so great with FX-322 by itself. I’m hoping if PIPE-505 shows proof of synapses regrowing then in the future you could take both FX-322 and PIPE-505 to restore IHCs, OHCs and synapses.

      At the end of June we will find out the results of PIPE-505. I’m glad there are many companies working on hearing restoration but too bad I got this way too early.
       
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    2. Tezcatlipoca
      Question it

      Tezcatlipoca Member

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      5-10 more years and we would just take Ebselen for spikes and protection while PIPE-505/FX-322 regrow hair cells and synapses.
       
    3. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Yea, we might not even need Ebselen if FX-322 and PIPE-505 solve our problems.
       
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    4. Jcmc

      Jcmc Member

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      FX-322 just failed. Or am I missing something?
       
    5. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Interesting thought.

      They’ve claimed that intact hair cells with damaged synapses will not regenerate with FX-322, and will remain in an “unsynapsed” state. This is where the belief that OTO-413 / PIPE-505 may be beneficial.

      Where damaged human hair cells are regrown in vitro, they’ve observed the cells creating a long nerve ending, which implies that it should reattach. I believe they did reattach in mice. This scenario assumes that the cell is damaged and not synapses to the nerve.

      Another scenario might be where a hair cell is damaged and is still synapsed. In this case, perhaps FX-322 causes the cell to regenerate and the cell a “reuses” the existing synaptic connection. This actually seems likely.

      If what Otonomy and Pipeline Therapeutics claim, that synapses are damaged much more quickly/easily than the hair cells themselves, then either of their synaptogenesis drugs may show significant improvements.
       
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    6. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

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      Honestly, I want at least one of them to solve a problem. That is my dream.
       
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    7. Guywithapug
      Dreaming

      Guywithapug Member

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    8. Tezcatlipoca
      Question it

      Tezcatlipoca Member

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      It failed a trial.
       
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    9. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

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      Interesting, but not related to hair cell regeneration. They studied a cell type called an ionocyte, which is a specialized support cell that Zebrafish have in their lateral line. This newly discovered cell type is unique in that in can change the fluid composition depending on the environment (i.e. salt or fresh water) and it can do so in the adult fish with different cell signaling. The researchers are hoping they can switch on similar genes to help cochlear fluid disorders (e.g., Meniere's).
       
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    10. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Weekly dosing of FX-322 failed but single dosage only had positive outcomes in the Phase 1b trials.
       
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    11. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Same. At this stage with the current timeline, PIPE-505 may come out around the same time as FX-322 or later. I’m betting it’s either FX-322 or PIPE-505 that will solve our issues.

      Loudness hyperacusis is more likely to be resolved with FX-322, and noxacusis with PIPE-505, but I reckon either one should give partial relief to the sufferer.

       
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    12. weab00
      Gloomy

      weab00 Member Benefactor

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      Bro, FX-322 or any regenerative medicine for that matter is not coming out before Ebselen. Accept it.
       
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    13. Tezcatlipoca
      Question it

      Tezcatlipoca Member

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      Sad to say, I agree. It's hard but we have to face the music. It's going to be really, really hard for FREQ to save Phase 2a, if that is even possible if the full readout is positive.

      Good thing is Ebselen is probably going to be a game changer.
       
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    14. newfie
      Spaced

      newfie Member

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      PIPE-505 may show greater results provided it actually restores the synapses. Synapses are more vulnerable to damage than hair cells. This may explain why some people develop tinnitus after brief short noise exposures that shouldn’t in theory be enough to damage their hair cells.

      As for FX-322, I don’t think it’s the end. Obviously it fares bad for Frequency Therapeutics but the initial two studies still showed good results. Regenerative medicine is growing at a fast pace now and there remains a great need for inner ear therapies and I believe that need will eventually be met if not by FX-332 then by other candidates. Eventually one of the companies is going to do something right, hearing loss might be a thing of the past in 30 or 40 years. Or much sooner if we’re lucky.

      As for Ebselen, I wonder if it’ll help any of us chronic sufferers. My tinnitus is caused by acoustic trauma. So obviously synaptic damage or hair cell damage.
       
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    15. Keith Handy
      Worried

      Keith Handy Member

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      Weekly multidosing failed.
       
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    16. kiki

      kiki Member Benefactor

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      In new Phase 1bs or Phase 2a (final report), if there is an improvement of ≥ 20 dB at 8 kHz (or more), will it change to "OHC first" or "IHC and OHC at the same time"?

      I think that OHC is related to WR because IHC receives the sound amplified by OHC.
      I think WR measures not only IHC but also OHC.

      I don't think that "WR measures IHC".
      I think "IHC cannot measure enough with PTA. It can measure considerably with WR".

      Even with a 10 dB improvement, IHC receives a three times amplified consonant sound.
       
    17. Keith Handy
      Worried

      Keith Handy Member

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      As a complete biological novice, I suspect the human systems are so complex and inter-related that to say any test absolutely measures only one type of cell has to be a gross over-simplification. I would think the different tests might lean towards indications of good or bad populations or health of certain cell types over others, though.
       
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    18. Chad Lawton

      Chad Lawton Member

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      I disagree. While it doesn't meet the game changing requirements that you were looking for, doubling word scores for some people is absolutely life changing.
       
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    19. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

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      I agree, but there really is some degree of differential as well. PTA is almost entirely OHC, unless the person literally lost every IHC and synapse lol. It seems like WR could be both, but because the test normalizes for volume, it's a good measure of IHC. Then WIN is well-known to measure synaptopathy. Again, the "noise" volume is held constant and comfortable. The signal is gradually increased in 4 dB chunks so everything is a perfectly comfortable volume.

      You're right though. Nothing is truly isolated.
       
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    20. Gb3

      Gb3 Member

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      I’m worried they didn’t mention anything about tinnitus. Imagine if at least they were able to say it showed improvement in tinnitus, the results wouldn’t look so bad.
       
    21. GlennS

      GlennS Member Podcast Patron Hall of Fame

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      Everyone here said the same thing about FX-322 after Lenire flamed out. Seems to be a torch-passing game going on here as far as hope goes.
       
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    22. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

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      How many people go to the doctor and say they have perfect hearing and they just have trouble understanding a few words... It is a very small subset of people.
       
    23. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      I would set my expectations low that they got any good data from the TFI in the Phase 2A. It’s completely subjective as-is, and in a trial that’s got some issues with entrance baselines to begin with.
       
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    24. Guywithapug
      Dreaming

      Guywithapug Member

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      I mentioned this in a previous post that it is concerning the amount of hype and expectations a drug has when going through trials, only to find failure after failure.

      Although, success (however it is defined) has to be built from trial and error. Edison is a good example of thousands of failures before perfecting the lightbulb.
       
    25. MrCrybaby

      MrCrybaby Member Benefactor

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      Things I’ve learned learned from this thread lately:

      - there is still reason to be hopeful
      - being hopeful is a sin and you’re a bad person
      - the Phase 1b results are unprecedented, this drug could be life changing and usher in a new era of medicine
      - the Phase 1b results aren’t as good as one would hope from widely regenerating hair cells, and indicate a categorical failure
      - 5 to 10 years for treatment is too long to wait for
      - 7 days between doses is too short to wait for
      - the less Frequency Therapeutics tells us the more we all have to say :p
       
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    26. Keith Handy
      Worried

      Keith Handy Member

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      Don't forget, though, @Aaron91 posted at least one interesting anecdote from a supposed participant.
       
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    27. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      I'm not sure what you’re getting at? When someone knows they have a hearing problem, they’re going to the doctor saying, “I can’t understand my kids, wife, TV, radio, etc...” and typically what they are losing first is the ability to distinguish high frequency sounds, or hear them at all. This is actually really common as hearing wears / ages.

      English also happens to be full of consonants that require utilizing high frequency hearing to distinguish them apart from each other, or understand them when used in words.

      This deficit shows up, and is the objective measure, on the word score tests. A doctor can measure performance of a patient’s word score to determine hearing loss levels, discuss next steps. This is why it’s so intriguing that FX-322 didn’t hit the entire cochlea, but did enough to cause a dramatic increase in recognizing words on a test used in a clinical setting.
       
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    28. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

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      Pretty much covers it. I would add "lessons in new lawn care" for all new homeowners.
       
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    29. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

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      By the time someone actually goes to the doctor, they are usually down 20 to 30 dB at the higher frequencies. It shows up in the audiogram and the word score tests. You need the word scores and the volume brought back up at those frequencies to really help someone. As of right now it is still iffy on how much FX-322 will help out with the audiogram portion of it.
       
    30. Gee82

      Gee82 Member

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      So true. It feels like tinnitus history keeps repeating itself in a cycle: hope-trial-failure-next hope and again. I was randomly reading through old posts from 8-9 years ago where people were as hopeful as we are now about potential treatments coming up; thinking that no relief has happened in such a long time shatters my hope for a better future.
       
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