Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      They are using the same dose in Phase 2, only four times. They are not using a higher dose per injection.
       
    2. Pink Noise
      Artistic

      Pink Noise Member

      Location:
      UK
      Tinnitus Since:
      09/2019
      Cause of Tinnitus:
      Probably headphones (Overear) coupled with age (sigh)
      What if it's a combination of problems? FX-322 could help a bit and OTO-413 could finish up. Each treatment could deliver their own improvements increasing the quality of life with each treatment.
       
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    3. Pink Noise
      Artistic

      Pink Noise Member

      Location:
      UK
      Tinnitus Since:
      09/2019
      Cause of Tinnitus:
      Probably headphones (Overear) coupled with age (sigh)
      I think initially it may until your brain gets used to it. Plasticity.
       
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    4. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      I think it’s very likely that effective treatment for hearing loss and tinnitus will entail a combination of treatments, just like most complex diseases.
       
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    5. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I understand they are doing both, Berger dose and repeat dosing.
       
    6. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      I think they explicitly stated recently that the dosage they are using is exactly the same as the dosage in phase 1b. It may have been in their press statement after the Germany trial.

      Edit:

      Ok: "In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company’s Phase 1/2 study and its ongoing Phase 2a study."

      https://www.businesswire.com/news/h...eutics-Shares-Clinical-Data-Exploratory-Study
       
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    7. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      To quote their press release of the Hannover study:

      “In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company’s Phase 1/2 study and its ongoing Phase 2a study.”

      https://investors.frequencytx.com/n...eutics-shares-clinical-data-exploratory-study

      In other words, Phase 2a uses the same dose per injection as the Phase 1/2 study.
       
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    8. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      https://investors.frequencytx.com/n...eutics-shares-clinical-data-exploratory-study

      In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company’s Phase 1/2 study and its ongoing Phase 2a study.

      This sounds like its same dose.
      Sure. Hopefully OTO-413 will work. I think they said in their recent presentation that the results of the efficacy study will be published in Q4 this year.
       
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    9. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      My interviewer told me they were using a higher dose when I applied for the trial.
       
    10. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      That was the dose used for the perilymph study, not 2A.

      The perilymph study is separate. The current 2A uses a different dose.
       
    11. serendipity1996

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
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    12. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Cumulatively sure, but Frequency says not per injection.
       
    13. GregCA
      Jaded

      GregCA Member Benefactor Hall of Fame

      Tinnitus Since:
      03/2016
      Cause of Tinnitus:
      Otosclerosis
      10 dB is very perceptible by our hearing apparatus.

      Whether that is enough for our doctors to qualify it as "hearing loss" is orthogonal to our ability to perceive it. I'd love to have 10 dB improvements to my hearing (anywhere).
       
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    14. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      Can you point me to where they said it's the same phase 1 dose 4 times. I have not seen that reported anywhere apart from the Pharmocokinetics study they just did with the phase 1 dose in Germany on the cochlear implant patients.
       
    15. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      I did, not much new information. Here are some things I found interesting that Carl LeBel said, I’m paraphrasing here.

      “We’re either close to a breakthrough or there.”

      “Hearing drug trials have the advantage of patients not being subjective to improvement.”

      “Approval is still a few years away, but a therapeutic will be released this decade.”

      “We’re thinking of hundreds instead of thousands of patients participating in the entire trial process.”
      Where does it say they use a different dose? C’mon now, it’s in their own press release from just a few weeks ago.
       
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    16. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      It was mentioned in the Goldman Fireside chat. Carl LeBel mentioned that the Phase 2A was using the same dose as the Phase 1/2, except 1x 2x 4x delivered. He also reiterated that they are hoping to see the similar results from single-dose patients in the Phase 2A as they did in the Phase 1/2.
       
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    17. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Notes from the HLAA discussion:

      Generally not too much new... some key take-aways:

      Bringing Regenerative Medicine into Practice

      Who benefits the most?
      • Anyone can benefit
      • Mild hearing loss to profound
      • As long as hearing signal can be turned on through regeneration
      • Regenerating structures of the ear also means helping cochlea stay healthy

      What is needed to bring FX-322 into practice

      • Clinical trials reviewed and approved by FDA
      • Experts to help shape policy and practice guidelines
      • Working with patient groups
      • By the time the drug is approved, everybody is ready to get to work.
      Comments on Phase 3 and "When will it be available" by Carl Lebel:
      • Will happen in this decade, available in several years.
      • Phase 3
        • Most likely on the "Shorter end of the Phase 3 spectrum"
        • Likely require hundreds of patients, not thousands
       
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    18. HootOwl

      HootOwl Member Podcast Patron Benefactor Advocate

      Location:
      California
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      2009
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      Explanation in About You
      I was pretty astounded by this exact thing when my audiologist tested me for word recognition in quiet.

      He started at 15 dB and then dropped to 10 dB and finally to 5 dB. The difference between 15 dB and 5 dB was extremely noticeable, despite only being 10 decibels apart which kind of shocked me.

      I could barely hear 5 dB but could easily make out and understand the words at 15 dB.
       
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    19. Sloth
      Happy

      Sloth Member

      Tinnitus Since:
      03.05.2020
      Cause of Tinnitus:
      Blow to ear
      I intented to but I only caught the end :/
      My brother graduated today so I got caught up.
       
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    20. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      At least the placebo dose is the same. :)

      It is very interesting that they may inject a higher dose than dring the 1/2 phase. Did not consider that the FDA allowed a dose higher than the safety one.
       
    21. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      They don’t. It’s the same dose as in Phase 1/2. The notion it’s a higher dose seems to be something that just won’t die.
       
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    22. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
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      That's really strange because the investigator during my trial interview *specifically* told me higher dose and multiple dosing.
       
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    23. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      The investigator could have just misspoken. It wouldn’t make any sense to do a safety Phase 1/2 trial for a dose and then up the dose for Phase 2. What’s the point of the safety study then?

      Plus, Frequency is publicly traded now and still recruiting patients. You can’t just announce incorrect information with regards to such a key component as dosage and not get in trouble.

      I see no reason to assume that the Phase 2 dosage is higher per injection.
       
    24. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I have been told by my audiologist that the research at present suggests that they can fix it although the two impediments at the moment are that the treatment needs to do what it is wanted to do and that they can deliver it in the area effectively. As a rule for the first part he suggests that you cannot use a treatment that results in cells continuously multiplying because that is actually cancer so they need to get it to just regrow damaged cells. It's also almost absolutely certain that tinnitus is caused by a loss in hearing as a lot of information suggests that noise enhancing devices like headphones or hearing aids reduces tinnitus. Of course you can link the two.
       
    25. Philip83
      Jaded

      Philip83 Member Benefactor

      Location:
      Swede living in Austria
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Noise trauma from loud moped (2001) Noise blast (2014)
      Anyone know what this is about? 10% daily move!

      stock.png
       
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    26. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      It is incredibly likely they will attempt higher drug dosing as it is necessary to try and determine the effect of this too. This variant allows them to see how well the stuff works at different doses etc.
       
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    27. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      If perilymph dose = 1b dose AND 2a dose, then 1b dose = 2a dose.
       
    28. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      It’s interesting you mention the cells multiplying. In an interview with one of the founders he mentioned that it was observed that after the cell population reaches a certain density, the progenitors stop responding to the drug. So, there’s something in the biology of the cells that keeps them from over multiplying.

      Also, in a JP Morgan session late last year, they claimed specifically that FX-322 would only activate progenitors where cells are damaged or missing; not where healthy cells exist.

      I also tend to believe that if FX-322 was causing some amped-up over-population of hair cells in the cochlea, like you might see with stem cell therapy, it would have failed the safety trial. This is the same reason why some stem-cell treatments have failed safety trials, because there is no way to "switch them off" or its easy to over-do it.
       
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    29. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      It really doesn’t seem to matter what Frequency themselves say about this on their website. They obviously don’t know what’s going on in their own trials.
       
    30. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Probably not based on any news but it's funny how everyone gets worried with a sell off but kind of ignores the jumps.
       
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