Frequency Therapeutics — FX-345

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

    1. Artemis2K
      Kick ass

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    2. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

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      I would guess that doctors will be much more lenient prescribing it if it does hit the market as opposed to criteria to enter clinical trials.
       
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    3. Street Novelist
      Depressed

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      I hope they add more sites because none of them are near me. Otherwise, this is very exciting.
       
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    4. Artemis2K
      Kick ass

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      I hope so. I would understand if there was caution, however, until they did a safety test for people with slight to mild hearing loss.
       
    5. Gb3

      Gb3 Member

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      It’s a safety trial. Not an efficacy trial.
       
    6. Nick47

      Nick47 Member Benefactor

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      @Gb3, yep, I was aware. It's just that they often have secondary outcome points that don't affect the trial progression, but measure other outcomes they may look at in later trials.
       
    7. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

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      These clinical trials are the safety tests.
       
    8. Artemis2K
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      Yes, but there could be considered risks for people with slight hearing loss. After all, they're putting an experimental serum into the round window of the cochlea. Perhaps there are concerns it could make hearing loss worse for people that have hearing good enough for it not to be worth it.
       
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    9. Street Novelist
      Depressed

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      It says they're enrolling only 36 people for the trial. Damn that's low!
       
    10. Aussie Lea
      Dramaqueen

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    11. Gb3

      Gb3 Member

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      Nope. Not low for a safety trial.
       
    12. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

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      I believe it's low on purpose since it's just a safety trial, so in case the drug ends up being extremely dangerous, they don't want to harm a large number of people.
       
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    13. Street Novelist
      Depressed

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      So they probably won't be adding more sites then?
       
    14. SmallRonnie
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      SmallRonnie Member Podcast Patron Benefactor

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      I have no idea to be honest. Phase 1 trials are always small as previously stated. If it's successful, then the Phase 2 trial will be larger.

      FX-322 will be recruiting for Phase 3 sooner than FX-345 Phase 2 if all goes well. Phase 3 recruits the largest amount of patients.
       
    15. Street Novelist
      Depressed

      Street Novelist Member

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      So, we're gonna have to wait a year just to see if there are any side effects from FX-345, but they won't be measuring effectiveness?
       
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    16. KoolKat

      KoolKat Member

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      Which of the two, FX-322 or FX-345, will help us the most though?
       
    17. ploughna

      ploughna Member

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      Tinnitus (TFI) is on the secondary outcome measures list for the FX-322 read-out due in Q1. If we see any benefit reported at that time, I think it's reasonable to assume that FX-345 should be even better.

      If there's no benefit seen with FX-322, then we just have to wait and see if the deeper penetration of FX-345 can make a difference.

      It'll be interesting to see for sure, given the whole debate of whether tinnitus is 'is the ear' or 'in the brain', or progresses from one to the other, or is different for different people, etc.

      Of course, the ideal scenario is between Frequency Therapeutics for damaged hearing, and XENON Pharmaceuticals, Biohaven and Dr. Susan Shore for the DCN in the brain, where we might end up with a robust improvement within the next few years through a combination of solutions - hopefully not too much wishful thinking on my part!
       
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    18. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

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      It's obviously entirely personal but I think if your tinnitus is high-pitched, then FX-322 could be beneficial since it targets the high frequency parts of the cochlea. And if you have lower frequency tinnitus, then FX-345 may be better for you.

      That could be completely wrong but it's how I see it.
       
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    19. Nick47

      Nick47 Member Benefactor

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      Tinnitus is in the DCN, given recent research/findings.
       
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    20. ploughna

      ploughna Member

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      No disagreement with the research and clinical trials that support this (Shore, Tzounopoulos, Trobalt, etc), but the reason we're all also following developments in hearing restoration is because of the evidence that shows some (not all) people get tinnitus relief from cochlear implants, and other experimental treatments involving stimulation of the cochlea. Time will tell of course, but for the moment, all research into either hearing restoration or direct action on tinnitus is a good thing and hopefully we get something positive out of it soon.
       
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    21. Gb3

      Gb3 Member

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      Tinnitus is a symptom. It may manifest in the DCN, but that doesn’t mean treating hearing loss couldn’t stop it. Also, people who had deep brain stimulation for Parkinson’s, have had their tinnitus go away. This means there could be multiple pathways to stop it.
       
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    22. Nick47

      Nick47 Member Benefactor

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      @ploughna, oh I agree, it's only one angle, but you would think increasing auditory input will cause changes in the DCN.
      @Gb3, yep, lots of ways to return signalling back to a healthy state.

      I don't know what you think but it looks like 2 main avenues:

      1) Increase auditory nerve input
      2) Depress DCN activity

      Many ways to look at doing that but limited treatments on the market.
       
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    23. Nobody19

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      Welcome to the world of clinical trials!
       
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    24. Chad Lawton

      Chad Lawton Member

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      I believe it's about 9 patients or so they are truly only testing for safety on first. Once it appears safe in the first subset of patients, they will continue the trial and dose the remaining patients and then they will also be testing for hearing outcomes such as audiograms and WR tests but the success of the trial is not contingent on said hearing outcomes.
       
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    25. CarlosEstan
      Inspired

      CarlosEstan Member Benefactor

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      Regenerative Medicine and Hearing Restoration:...


      This short directly discusses FX-322 and there is some mention of FX-345 for those who are interested.
       
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    26. Street Novelist
      Depressed

      Street Novelist Member

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      So, they are testing the hearing in some of the patients?
       
    27. Chad Lawton

      Chad Lawton Member

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      Yes.
       
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    28. scotty03874

      scotty03874 Member Podcast Patron Benefactor

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      I wonder why their stock has jumped up so much in the last the 3 trading sessions. Speculation of upcoming positive news possibly? Up almost two dollars in the last week and a half...
       
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    29. CRGC
      No Mood

      CRGC Member

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      My feeling is some of it has to do with the media attention the company has been getting lately (CBS segment, etc...).
       
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    30. Nobody19

      Nobody19 Member Benefactor

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      Like someone else said, it's probably the hype starting again. Although for once I hope it's insider trading :LOL:
       
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