Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Sunshine007

      Sunshine007 Member

      Tinnitus Since:
      unknown
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      Unknown
      One issue with the X+Y argument is that there might be a ceiling effect to X that dwarfs Y and you don't quite have the candidate profile to observe Y. Let us assume people with true scores of 45 whose baseline was established at 25, we are not going to see a 10 word increase that might have been observed had it been a true score of 25. We should not expect to see a 10 word increase on top of the 45 given the past responder data. Even if we have the true 25s move to 30/35 it will not appear meaningful compares to the explosive jump from 25 to 45.

      That we did not see an effect is a fact the reasons on the why range from the drug being a dud to flawed trial design and lawn effect.
       
    2. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
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      unknown
      There's a bit of a problem with your analogy
       
    3. UHPTS
      Wishful

      UHPTS Member

      Tinnitus Since:
      October 2019
      Cause of Tinnitus:
      Ear infection
      Where? :whistle:
       
    4. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      If your grandma was unable to have children she couldn't be your grandma? Maybe I'm missing something...

      Anyway, did anyone else notice that Frequency Therapeutics are now considering speech understanding as the sole measure of efficacy for FX-322. So we can finally stop speculating about how they're going to get their drug all the way through the cochlea. It doesn't matter any more!
       
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    5. sensualmosquito
      Insomnious

      sensualmosquito Member

      Location:
      New Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      6-8 khz HL, T and H from gunshots
      I appreciate your input here, as you break things down in a less emotional light. With so many of us (particularly on this website) emotionally invested in a potential solution to our problems it is only natural to take a side one way or another, to believe it's perfect or that it will never work and never will. I, of course, hope that it works very well as I also have an emotional investment in this working. However, I also understand that this field is very new, and many unknown variables at play, and this drug may not work as intended or as well as were all hoping. Or, maybe it will, time will tell.

      I am in some ways lucky that my tinnitus is moderate, not severe. My right ear may sound like a broken microphone but at least I have my left ear. I can wait years upon years for something to come out (provided my situation doesn't deteriorate significantly) while perhaps some of us are desperate for freedom from this terrible affliction.

      I noticed you take the known information and look at it in a systematic way which I appreciate. We all just need to take a deep breath, and do the best we can given our situations, as difficult or seemingly impossible as that may be.
       
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    6. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Why would that stop speculation about how they can get the medicine the whole way through the cochlea? Can't improve one's understanding of speech if this is not doable...
       
    7. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      It won't. Ninety percent of this thread is pure speculation based on almost nothing. My comment was mostly meant as tongue-in-cheek. But seriously, the pages and pages we spent discussion the minutiae of cochlea drug delivery because we all thought thresholds were important. Now it's just about improving speech understanding. Presumably that involves improving at least some aspect of hearing. Exactly what aspect? It's kind of a black box at this point.
       
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    8. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      This makes sense then. They are going to keep going with the existing formulation and see if they can get it approved as a speech understanding drug. This would allow them to start making money to keep the company going and continue research.

      The new drug candidate could be what they have developed after additional research and information received from the existing trials. So there is still hope that they will get something out there that could help with hearing loss.

      The concerning part is that the announcement diydnt even dent the stock price, so people are now skeptical that they have developed something that will truly work. It also seems like they can't issue additional stock to keep the company running to continue the research into the new formulation as their stock price is still declining.
       
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    9. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
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      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      You're on the money with the strategy in the first 2 paragraphs.

      As far as stock price. It's not live or die for them based on price. They have $200MM in the bank to keep them operating through 2023. They also have next to no debt, so that's an option if they really need to fund operations. My guess is that after the Phase 2A debacle, investors are looking for tangible positive outcomes: IE: trials that show improvements. Everything else is just talk now.
       
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    10. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Even if it is developed as a speech understanding drug, this is still helping with hearing loss even if there is no improvement on the audiogram. One such argument is that it is triggering the inner hair cells which deal with this.
       
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    11. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
      Sweden
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Pure speculation, but I think ear "strength" and "health" more broadly could benefit in any case (noxacusis, TTTS, inflammation, irritation, fullness...). In general, if you repair/improve individual parts in any integrated system, the whole system usually benefits.
       
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    12. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      I think “fixing” speech in noise is a valuable first step in curing hearing loss.

      Not only will it help many people and become commercially viable...

      It will show investors that therapeutic hearing loss companies / scientists are on the right track. Growing interest...
       
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    13. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Also have to take into account that when they did the audiogram tests, the maximum they tested was 8 kHz. If they had tested up to 20 kHz there would have been bound to have some improvements at the higher frequencies.

      I still believe that the patients who have experienced an improvement in speech in the trials should have experienced improvements in their audiograms but weren’t tested up to 20 kHz.
       
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    14. Tau
      In pain

      Tau Member

      Location:
      Europe
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      2019-Concert, 2021-headphones/acoustic trauma at 110dB,16kHz
      It could also be that they had had their synapses regrown, which does not impact PTA.
       
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    15. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
      Sweden
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      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Actually, I think they did test up to 18 or 20 kHz in Phase 2, but I'm too lazy to try and find where they stated that. Also, I don't think they ever released any results of pure tone tests at all from Phase 2, or did they?
       
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    16. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      My audiologist contacted me out of the blue, to come in for some additional free tests. And to compare my audiogram to that of three years ago.

      Apparently they have new equipment they want to try out on people diagnosed with tinnitus. I suspect they hope to sell some more hearing aids, but anyway… was pleasantly surprised by them reaching out.

      Curious what additional gear they have now… tests above 8 kHz? Or speech in noise?
       
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    17. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
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      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Let us know!
       
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    18. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      I believe you are a product of Belgium/Holland/Lux. Isn't that where the well-known tinnitus expert, Dirk de Ridder who gave a podcast for us, spends his time for part of the year?

      Who knows, he might have something to do with it. The tinnitus experts are a small community and most likely they know one another and help one another on projects.

      As they say,
      "The thick plottens".
      :whistle:
       
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    19. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I’m not sure but I know in Phase 1 they only went up to 8 kHz. It would have been nice to see if there were any improvements in audiogram at the higher frequencies.
       
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    20. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
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      2001
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      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Here it is from (https://clinicaltrials.gov/ct2/show/NCT04120116):
      So they do specify that they were testing "extended high range", which I can only assume would mean past 8 kHz. Does not seem to mention exactly how high though.

      I believe the statement about that none of the patients showed any improvement in PTA was a verbal one made by Lucchino during their webinar in September.
       
    21. 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
      Extended High Frequency Audiogram = 8 kHz - 16 kHz.
       
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    22. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
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      Sshl
      A new drug? What does this mean for FX-322?
       

      Attached Files:

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    23. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
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      FX-322 stays in the pipeline, at least through the current Phase 2B. If it shows positive outcomes in speech recognition, it moves to Phase 3.

      This new compound, that little is known about, gets a new set of trials, starting with a Phase 1 safety validation.
       
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    24. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
      Sweden
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      2001
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      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Interesting. I wonder if it's a "new" drug, or FX-322 2.0.
       
    25. Street Novelist
      Depressed

      Street Novelist Member

      Location:
      Bay Area
      Tinnitus Since:
      February 2018
      Cause of Tinnitus:
      Listening to loud music through headphones
      That's probably years away from clinical trials. Has it even been developed yet? They would have to start from scratch, a Phase 1.
       
    26. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
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      Clubbing
      Progress will be incremental, like with many things. I do hope the FX-322 trials will be successful so they can get cash to fund more R&D.
       
    27. Trevor_phillips

      Trevor_phillips Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      NIHL
      The new drug could be a FX-322 with improved delivery method, so it can reach the cochlea more profoundly or a completely new drug with new compounds, new delivery method (I hope nanoparticles) and which can reach the cochlea from the apex to the base.
       
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    28. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
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      20+ Years of Live Music, Motorcycles, and Power Tools
      That appears to be the strategy. Otherwise, if this new compound was truly better, they would have canned FX-322 and just started a Phase 1 in 2022.
       
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    29. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      There has already been a lot of development around nanoparticles and therefore it would seem a plausible and logical option.
       
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    30. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      Time to blow off all the dust and cob-web off of my Scientific degree from all them years back. Ha! Me a scientist.

      But a thought struck me one early morning.

      The recent tests for FX-322 that went awry mentioned some participants on placebo who actually had improved test-scores after the placebo. Then there was the case on one of the Otonomy trials of (I hope this is correct), @ChrisBoyMonkey (?), who seemed to suffer a very distressful spike when he participated in OTO-313 trial... and it later turned out that he was on placebo.

      Well to put it bluntly, maybe the scientists should focus some time on these outliers. How come the frequency placebo group improved their scores and @ChrisBoyMonkey (also on placebo) doing an OTO-313 trial seemed to suffer some sort of spike or trauma with his tinnitus?

      Well, we call this a research thread, don't we? Maybe the outliers deserve scientific scrutiny too.

      The way things look at the mo it seems the front-runners are "tapping in the dark".
      I mentioned in an earlier post that the intratympanic development goes back to during the Second World War.

      Well the 80s and 90s brought sound therapy, psychology and relaxation techniques.

      Will the 2020s bring the long sought after breakthrough with regenerative medicine, gene technology or neuromodulation?
       
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