Frequency Therapeutics — FX-345

Discussion in 'Research News' started by Diesel, Nov 9, 2021.

    1. 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
      Starting this thread on Frequency Therapeutics new FX-345 drug for Sensorineural Hearing Loss.

      Here's what we know so far:
      • Second clinical program focused on regrowth of sensory cells using PCA.
      • Enables coverage of large portion of cochlea.
      • Potential to address additional SNHL patient types (in addition to FX-322)
      • Formulation enabling evaluation of a range of dose levels
      • Developing in addition to FX-322, and clinical data will drive commercial positioning
      What's planned so far:
      • IND Submission to FDA: Q2-2022
      • Clinical Study: H2-2022

      Screen Shot 2021-11-09 at 09.42.43.png
       
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    2. dmorg

      dmorg Member Benefactor

      Location:
      Philadelphia, United States
      Tinnitus Since:
      2011
      Cause of Tinnitus:
      don't know, hearing loss related?
      I only saw part of the webcast. Did they indicate why they think FX-345 may help a broader range of patients?
       
    3. AUTHOR
      AUTHOR
      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
      Because it penetrates more deeply into the cochlea compared to FX-322.
       
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    4. RingingBrother

      RingingBrother Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Noise induced hearing loss
      Did they say how?
       
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    5. AUTHOR
      AUTHOR
      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
    6. Street Novelist
      Depressed

      Street Novelist Member

      Location:
      Bay Area
      Tinnitus Since:
      February 2018
      Cause of Tinnitus:
      Listening to loud music through headphones
      It says quarter 2 of 2022 for the clinical study. That's very soon. Maybe I should hold off trying to get into the current trial for FX-322. This new drug sounds much better.

      EDIT: Oh wait, it says IND in Q2. So, I guess the clinical trial is not until later in the year. Fuck.
       
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    7. patorjk

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      It's H2 2022, which means the second half of next year. That could mean they won't start for another year. Phase I studies can be risky too, I personally would wait for a Phase 2, but it's whatever you're comfortable with.
       
    8. Clerkp

      Clerkp Member

      Tinnitus Since:
      2000
      Cause of Tinnitus:
      Loud Music
      This is fascinating research. However, they do not even use the word tinnitus in the presentation. Realistically, when could those of us with regular old tinnitus hope to have this available to them? Also, is it me or is taking a needle in my ear utterly terrifying?
       
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    9. Trevor_phillips

      Trevor_phillips Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      NIHL
      So FX-345 is exactly the same drug as FX-322 but goes deeper into the cochlea, am I right?
       
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    10. Tau
      In pain

      Tau Member

      Location:
      Europe
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      2019-Concert, 2021-headphones/acoustic trauma at 110dB,16kHz
      If you have HF hearing loss, try to get FX-322. If mid and low frequency hearing loss, then I'd think FX-345 would be better.
       
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    11. AUTHOR
      AUTHOR
      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
      The expected outcome is the same = more hair cells. But the drug is different because the chemical makeup is not the same as FX-322. Watch Chris Loose's part:

      https://investors.frequencytx.com/2021_Virtual_R-D_Event
       
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    12. ploughna

      ploughna Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      motor racing and power tools
      I'm in the latter camp (i.e. mid/lower frequency damage all the way up through the high frequency range), but if I could get in on the new FX-322 trials, I'm thinking why not try it and see what happens - any trial is 50% chance of placebo anyway.

      Would that exclude me from a later trial though? Or other trials e.g., OTO-413, also?
       
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    13. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      You’d have to look at their exclusion criteria.
       
    14. RingingBrother

      RingingBrother Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Noise induced hearing loss
      So this new drug can reach around 4 kHz does anyone know how far FX-322 could reach by comparison?
       
    15. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      They presented studies very early on that FX-322 reached all the way to the base with therapeutic amounts by studying people who were getting cochlear implants.
       
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    16. F-u-T

      F-u-T Member Podcast Patron Benefactor

      Location:
      AZ USA
      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Acoustic Trama
      C4A51275-1659-4D46-9552-70CB2A1B3F97.jpeg

      12 kHz according to this graphic.
       
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    17. Trevor_phillips

      Trevor_phillips Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      NIHL
      If FX-345 could reach 20-4 kHz, then it's great, but aren't the hair cells responsible for speech frequencies below 1 kHz-2kHz?
       
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    18. AUTHOR
      AUTHOR
      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
      Hair cells are responsible for hearing all sound frequencies. Moving from a lower limit of roughly 8 kHz with FX-322 to a lower limit of 4 kHz with FX-345 should help improve word recognition/clarity where consonants and vowels occupy the 4 kHz - 8 kHz range.
       
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    19. ThomasRobert

      ThomasRobert Member Benefactor

      Location:
      ME
      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Ototoxic
      Inner Hair Cells: Speech
      Outer Hair Cells: Audiogram
       
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    20. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      On the one hand I’m glad they’ve come with something new, but on the other hand I can’t help but feel “here we go again”. It’s like we’re back in 2017 when FX-322 was promising.
       
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    21. AUTHOR
      AUTHOR
      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
      FX-322 still appears to be promising. And FX-345 appears to be building on the learnings from it. What am I missing?
       
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    22. Tau
      In pain

      Tau Member

      Location:
      Europe
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      2019-Concert, 2021-headphones/acoustic trauma at 110dB,16kHz
      FX-322 is still promising if you look at their data in the presentation.
      FX-345 is just even more promising :p
       
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    23. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      The caution is justified, but it's like other human drivers. Fear, when you think about it, is good and necessary but in most cases panic is bad. Going all euphoric about this latest arrival should be postponed until it has been proven to be successful.

      Having said that, I am much cheered to see that the wheels of research are moving again.

      I think the Wright brothers took a kind of a long and a broad view when they were getting their bicycle with wings airborne in Kitty Hawk sands during the 1900s.

      It's cheering as well to see how the vocabulary is expanding to make different distinctions... like instead of just saying "deaf" they distinguish between sensorineural, age-related, sudden hearing loss etc.

      At least they are getting there.

      It might be in you grandchildrens' time but they are getting there.

      A bit like the climate change thing, you have to believe you can do it. If we didn't, we'd all be f**kd.
       
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    24. RingingBrother

      RingingBrother Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Noise induced hearing loss
      If the ingredients are different, would there be risks in getting both drugs?

      Also would this new version render FX-322 obsolete or can they both coexist and serve their own purpose?
       
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    25. Rings-a-Bell

      Rings-a-Bell Member

      Location:
      Barbados
      Tinnitus Since:
      April 2016
      Cause of Tinnitus:
      Accoustic Trauma
      My hearing loss & tinnitus tone is at exactly 4 kHz. I wonder if FX-345 will help, or if 4 kHz will be to close to the edge of the drug's effectiveness zone to receive much benefit?
       
    26. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      I don't see it being an issue to get a dose of FX-322 and then a few years later getting a dose of FX-345 as both drugs target the same pathways, FX-345 just happens to be more potent.

      I'm betting their current plan is to get FX-322 to market first to unlock a revenue stream and then once FX-345 gets approved a couple years later, FX-322 will be discontinued and replaced by FX-345.
       
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    27. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      A lot of individuals do not have hearing loss below/at 2 kHz anyway who would be in the target group for Frequency Therapeutics. Thus this is why even in certain CI candidates, there tends to be an approach where they don't do anything with these lower frequencies.

      From a lot of evaluations and research, it appears that the majority of individuals tend to have hearing loss to/around 4 kHz. It is also fairly probable that there will be further evaluations and/or development into another medicine which can go deeper than 3 kHz too.
       
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    28. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
      Sweden
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Question: I thought the delivery method is what decides how deep any drug can penetrate, not the drug itself?

      I’m happy Frequency Therapeutics is pushing forward, but looking at recent history, they have proven to be way better at talking the talk than walking the walk. Sure, good communication is advantageous, especially when it comes to keeping the money coming in, but at some point I hope there will be some properly potent, concrete results also from the medical side.
       
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    29. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      The purple seems to go past the 4 kHz and slowly fade out until 1.5 kHz.
       
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    30. AUTHOR
      AUTHOR
      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
      I suspect your strategy is correct here. Get FX-322 to market and create cashflow. Then, bring FX-322 patients back in for the more robust FX-345 treatment.

      And by then, there will probably be another FX-3XX in the works that goes even deeper once everyone gets FX-345.
       
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