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
      Phase 4 is where a drug is released to the market but the company has to follow it and acquire data.
       
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    2. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      A rough timetable taking into account the time passed between previous studies and the current Phase 2 study could look something like this:

      Phase 2a - October 2019 to September 2020 (how many injections?)
      Phase 2b - April 2021 to May 2022 (maximum amount of injections per Phase 2a, possibly expanding to >70 dB hearing loss)
      Phase 3 - December 2022 to February 2024 (larger patient population)
      FDA approval - March 24 to September 24

      And this all dependent on the Fast Track status, what they find in trials etc. They started with Phase 1 in 2017 so this would still be pretty fast. I think 2025 would be more realistic.
       
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    3. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
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      Ear wax removal
      Would it still be possible that after Phase 2a they will go to Phase 3?

      When do you think they will let us know if it helps with tinnitus and hyperacusis? You reckon at the end of Phase 3 or when the drug gets released?

      What about pricing wise. How much do you think it will cost us?
       
    4. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      On their website they’re even calling it Phase 2a. So no, highly unlikely. Tinnitus is listed as a secondary outcome measure in the trial design, so yes, they will most likely report on that. Hyperacusis isn’t mentioned I believe.
       
    5. John Queen

      John Queen Member

      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Unknown
      Eek, so 4 injections, one per week. They will basically know how effective it is after one month, but the study ends September next year... damn, that's unfair. (I know, they want to prove that the effects will last and also record more stuff.)

      And does anyone know why on Earth would they test it against placebo? Why not open-label? It's not like hearing could improve with placebo. Some folks are gonna get useless intratympanic injections, which, if you ask me, is not completely ethical and has no real purpose for a study like this. Did I miss anything?...

      PS: I still hope that Astellas will get involved and will try to get the drug approved in Europe/Asia. In the US the things are moving too damn sloooooowly.
       
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    6. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
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      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      A testicle or a significant part of female anatomy... actually we be able to afford it... by any means required... I am guessing ten grand with the surgery, and other deuce bag things we will need to pay for, such as coffee in the waiting room and disingenuous smiles, those cost a lot...
      Not happy today... sorry.
       
    7. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Found an interesting study with regards to nanoparticle drug delivery and the apex of the cochlea (lower frequencies). Keep in mind phase 1/2 of FX-322 only established 4 patients with a 10 dB gain in the 8000 Hz frequency, which I think could be a problem going forward:

      “Superparamagnetic nanoparticles can be driven inside the cochlea toward the apex with a preserved hearing up to 1 month in rats.”

      https://www.ncbi.nlm.nih.gov/m/pubmed/31478462/
       
    8. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      More like three months. But still. Too long for sure.

      The only thing that would help speed things up would go something like this:

      The American Tinnitus Association and Hearing Loss Association of America teamed up to raise awareness of these drugs and successfully lobbied Congress to pass a law to fund expanded and accelerated testing of them, or to get this to the attention of Trump and have him sign an executive order to do the same. This would be warranted because right to try laws were made for fatal illnesses, well what's worse, a disease that kills you, or a disease that compels you to kill yourself? Unless something like that happens then we are just going to have to wait. Unfortunately, organizations like the ATA and HLAA are staffed by normies that would probably never do something like that because they are hypnotized by authority and would side with the FDA's long process because they think that's just the way it has to be.

      HLAA:
      301.657.2248
      ATA:
      800-634-8978
       
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    9. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Hall of Fame Advocate

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    10. Kain
      Disappointed

      Kain Member

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    11. Jackjohnson183

      Jackjohnson183 Member Benefactor

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    12. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      No. They’re even still calling it Phase 2a in their press release. My guy, unless this drug also happens to cure ebola, they’re not gonna be able to skip a trial. Fast Track means they’ll have more and quicker contact with the FDA. The FDA does not just come into play after Phase 3, but continuously monitors drug development. Even clinical trials have to be approved by the FDA.

      And yes, AM-101 got it in 2016.
       
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    13. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      Surely it could get released earlier with the help of Astellas. Maybe they could conduct their own trials and release it in other markets where it’s less strict in terms of the FDA.
       
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    14. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Sure the cash helps, but it’s not gonna save them years. If you really want this, participate in a trial.
       
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    15. Heinrich_S7
      Psychedelic

      Heinrich_S7 Member

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    16. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
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      We will never know if it helps tinnitus.

      For people with hearing loss and tinnitus, they will be helped because better hearing = lower tinnitus.

      But for those tinnitus sufferers who have no hearing loss, it's not yet known. Theoretically it should work.
       
    17. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      lol what?
      It seems like that if your tinnitus is not caused by hair cell damage then this wouldn't affect your tinnitus.
       
    18. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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    19. Jurger

      Jurger Member

      Tinnitus Since:
      2004
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      Did you guys know there’s a BBC News presenter - Lewis Vaughan Jones - who suffered sudden hearing loss and now has raging tinnitus in one ear? Might he be interested in hearing about news like this? The interview with him I read has him saying he was frustrated his ENT can’t do anything about it. This all happened two years ago or something.
       
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    20. Markku
      Inspired

      Markku Founder Staff Podcast Patron Benefactor Hall of Fame Advocate

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    21. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
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    22. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      unknown
      Some people with tinnitus have perfect hearing and their tinnitus is sound induced.
      That said, a drug improving your hearing might not improve your tinnitus. My feeling is it should... but tinnitus can have a completely different mechanism from dead hair cells. No one knows.

      The Hough Ear Institute are working on a pill for tinnitus and another pill for hearing loss, likely meaning that those 2 conditions are not originating from one source.
       
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    23. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      I think they do know that hair cell loss doesn't always cause tinnitus.
       
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    24. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Yes, I have severe hearing loss in one ear, but most of the time just a light buzz in terms of tinnitus.
       
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    25. Walid5

      Walid5 Member

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Acoustic trauma
      What can we do to make Frequency and others more known? I’m pretty sure we can make things move faster. Hundred of millions of people are suffering from hearing loss and tinnitus, the problem is that those sufferers have difficulties in claiming their rights.

      Yes I think that today it’s our right to ask for a cure since we live with a scientific community that has started research to reverse aging! I got hearing loss and tinnitus just by going to a night club and I’m only 21. I was really shocked when I knew that there’s no medication for this and I’m obliged to pay the consequences for the rest of my life.

      The Fast Track designation obtained by Frequency make things more serious for us as sufferers. We need to create more attention and consciousness around hearing loss and tinnitus in order to obtain a cure in the next few years.
       
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    26. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      I’m not even asking for a cure... If I can get in the mild-moderate hearing loss category, I’m good. I have a PTA of around 70 now. If it gets to 25-35, I’m cool.
       
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    27. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      Not without support from organizations like the ATA, the BTA etc. and I really don't think they are going to lift a damn finger to actually help us.
       
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    28. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      A nice first step would be to get Will McLean or someone like that on the Podcast. See where we stand with this drug. There’s not that much data to lobby with.
       
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    29. Street Novelist
      Depressed

      Street Novelist Member

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    30. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      A fabulous opportunity for all US citizens on Tinnitus Talk, with demonstratable hearing loss, to get themselves into the trial.
       
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