Frequency Therapeutics — Hearing Loss Regeneration

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

    1. AtlasFainted

      AtlasFainted Member Podcast Patron

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Noise Exposure + Viral Infection
      Different protocols? Did she give any indication as to what she meant by this?

      I keep hoping they'll launch a trial for a new formulation that reaches all of the frequencies of the inner ear. Pretty sure I have at least mild loss in the lower frequencies, it'd be ideal (and cost-effective) to get them all fixed with the 1st treatment, as opposed to getting injected again a year or two later.
       
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    2. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      What did she mean by that? Phase 2b?
       
    3. Nathan
      No Mood

      Nathan Member

      Location:
      Indianapolis, Indiana, USA
      Tinnitus Since:
      06/2018
      Cause of Tinnitus:
      Loud Music, Concert, Bad Luck
      I’ve never had an extended audiogram, but I’ve looked up the thresholds in dbSPL and used an app that kind of functions as an extended audiogram. I’m nearly certain that if I did have an extended audiogram to 16kHz, it would be normal.

      My hearing starts declining around 13.5 to 14kHz, which is also my main tinnitus frequency. The frequencies that I feel more than hear are in the 17kHz range. I’m pretty much deaf past the low-mid 18kHz range where I can only hear the tone at the end. My right ear falls off a cliff after 16kHz. I can only hear higher if I crank the volume up.

      I know my hearing is nowhere near as bad as some other people on this forum, but it still sucks that my hearing is below average for my age. (18 going on 19). I worry that by the time I’m in my 50s, my hearing will be bad enough for a hearing aid, as one of my teachers played drums for marching band and has hearing aids at 57. If FX-322 is successful, I really hope that it’ll be available to people with normal but subpar hearing for their age.
       
    4. Nobody19

      Nobody19 Member Podcast Patron Benefactor

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      2012
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      A very interesting paper was released not too long ago. It shows that administrating blood plasma of young rats reverses aging in older rats! The doctor you mentioned seems to be very enthusiastic about it.

      https://www.biorxiv.org/content/10.1101/2020.05.07.082917v1.full.pdf

      The paper is not yer peer reviewed, so take it with a grain of salt until then.
       
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    5. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

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      She just said that she expected to have further trials with FX-322 using other parameters. I didn’t ask and she didn’t say about what phase.

      Maybe she was referring to phase 3.
       
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    6. Croaker
      Torn

      Croaker Member

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      Well at the very least it sounds like there is some optimism on the ground. I know these local test workers aren't in on the inner workings of the company but it's still nice to hear.
       
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    7. Lola808
      Amazed

      Lola808 Member Benefactor

      Location:
      Honolulu
      Tinnitus Since:
      4/2020
      Cause of Tinnitus:
      High frequency hearing loss wearing headphones to bed
      When I emailed Frequency Therapeutics they were still accepting patients for the current trial. They said it was ongoing till Fall, and for me to then to check on status of the next phase of clinical trials.

      Is anyone actively trying to be a part of the clinical trial? Are most people waiting for phase 3?

      Does anyone think FX-322 will work for hyperacusis?
       
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    8. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
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      Ear Infection
      I wonder if the other parameters she was talking about is hyperacusis or something else.
       
    9. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      Probably many hope that it will, but let's see. Unfortunately it is not listed as an outcome measure in the phase 2a trial. Maybe if FX-322 shows efficacy in this trial they will include hopefully also loudness/pain hyperacusis sufferers in follow up trials.
       
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    10. serendipity1996

      serendipity1996 Member

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
      The general consensus is that we really don't know. It may be more beneficial for loudness hyperacusis than pain hyperacusis but even then we won't know until further trials are carried out.

      Hyperacusis Research, which is devoted primarily to pain hyperacusis, said on their Facebook page a while back that their posts about Frequency Therapeutics are very popular and they get a lot of questions as to whether it will help but that we simply don't know at this point.
       
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    11. DoNotGoGentle

      DoNotGoGentle Member Benefactor

      Tinnitus Since:
      10/15 got worse 11/16
      Cause of Tinnitus:
      Earbuds, inner ear infection NHL and high frequency loss
      Gosh I really hope they get to phase 3. I would totally get in. Only thing is they better change the dB loss to go up to all frequencies. As of right now I just barely miss the dB loss need to have at least 26dB up to 8000 Hz. So I would not make it in right now. Just to think two years from now some of us might be in phase 3, pretty exciting times!!!
       
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    12. serendipity1996

      serendipity1996 Member

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
      If it gets that far I really hope they go for compassionate/expanded use.
       
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    13. Turgy

      Turgy Member

      Location:
      Germany
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      acoustic trauma
      Could it be that FX-322 skips phase 3 and is approved earlier?
       
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    14. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
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      I really hope that’s the case. If every patient in this trial improves their hearing by a lot due to getting the four doses of FX-322, it seems it could potentially be possible for them to skip and go to Phase 3 once Phase 2a is done or even releasing it into the market during Phase 3.
       
    15. Turgy

      Turgy Member

      Location:
      Germany
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      acoustic trauma
      I think if the hearing and tinnitus improved by 50% it would be a great success and nothing should stand in the way of the market launch.
       
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    16. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      50% will be considered a lot due to the current delivery method. Once they improve the delivery method it should be even better.
       
    17. BBakkers
      Tired

      BBakkers Member Podcast Patron Benefactor

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      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
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    18. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
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      Me too. As long as I notice some improvement I’ll be happy.
       
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    19. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
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      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      For what it's worth...

      The Phase 1/2 saw improvements of 20% - 30% in word score with a single dose. The mild participants created a ceiling effect on the outcomes.

      Looking at Page 20 of the May presentation; The improvements in the quiet background test can be calculated for participants with Moderate-Moderately Severe hearing loss. Collectively, the cohort of 6 patients had a 50-word baseline word score of 104/300 (34.6% Correct words). At 90-days after a single dose of FX-322, the cohort improved to a word score of 186/300 (62% Correct words). If I understand the math correctly, that indicates an improved word score of 82 words for the cohort, or a roughly 78% improvement.

      Based on what we're seeing in the Phase 2A, they're probably being much more selective choosing participants with similar losses in the moderate-moderately severe classification. I speculate that will show a substantial improvement (%) compared to placebo. Not to mention the effect of an array of multiple dose cohorts.
       
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    20. Nobody19

      Nobody19 Member Podcast Patron Benefactor

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      I want this thing to be released as much as you do. But please, let them make sure that this product is 100% safe* and efficacious. We don't want this research to regress because of mistakes or because they've rushed things.

      *No drug is ever fully safe, but there's a difference between side effects and danger to your health.
       
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    21. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
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      Now it should be even more potent with the four doses of FX-322 compared to one dose of FX-322.
       
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    22. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Ideally what we'd want to see among a similar cohort in word score is something along the lines of:

      1 Dose Cohort = 70%+ Improvement (similar to Phase 1/2)
      2 Dose Cohort = 80%+ Improvement
      4 Dose Cohort = 90%+ Improvement
       
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    23. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
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      Ear Infection
      If it does end up improving by that much they really need to release it ASAP. I’m hoping somehow the FDA gives Frequency Therapeutics permission to release the drug early whether that’s skipping phases or releasing it during Phase 3 trials.

      This could really make a difference in people’s lives if it ends up solving hyperacusis (pain and loudness), tinnitus and hearing loss.
       
    24. DoNotGoGentle

      DoNotGoGentle Member Benefactor

      Tinnitus Since:
      10/15 got worse 11/16
      Cause of Tinnitus:
      Earbuds, inner ear infection NHL and high frequency loss
      Right things have changed now they are doing multiply doses so safety might be a concern here.
      More of a risk too! Wishing the best for everyone in the study and all the scientists
      They might not need a new formulation just a better delivery. If that is what you mean? I have very high frequency loss in one ear. I feel like this treatment would help that but my 3-4 kHz loss this drug would not touch. Anyone have an idea, can they change the delivery method during the trial or do they have to start a new one?
       
    25. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      For those worried about drug delivery to the low frequencies, there is a new surgical approach called canalostomy. Unlike Novartis' surgical approach for their drug which significantly damages the cochlea (cochleastomy), this doesn't at all as it enters through the edge of the vestibular system and apparently only causes minor, temporary damage to that system (none to the hearing system).

      Seems like something that could be done without any additional trials if an otological surgeon wanted to do this off label.

      Here is one paper on the procedure but there are a few.

      https://www.jove.com/video/57351/canalostomy-as-surgical-approach-to-local-drug-delivery-into-inner

      This type of surgery was also mentioned in one of Chen's papers for viral vectored gene delivery and what's neat is it starts from Apex to Base and can use the natural fluid movement of the cochlea (in the perilymph) for the drug to flow to the whole cochlea evenly since you are going "with the current". If the drug needs to be injected into the endolymph because it was only tested in that environment, that can be accessed from this site, too.

      So low frequency sufferers with hair cell damage up to the moderately severe hearing loss range (possibly with severe too as long as you still have enough support cells) might have something they can discuss with an Otologic surgeon if they truly can't wait for FX-322 2.0 with better diffusion (for some people it is literally life or death). It definitely might be worth inquiring about for the severe sufferers.
       
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    26. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
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      Why stop there?

      Ear-Hair-Long-300x203.jpg
       
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    27. sssing

      sssing Member Benefactor

      Tinnitus Since:
      2019
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      cold
      Hi know this is rather off-topic for the ongoing discussion. I was really confused about the discussion on this thread about support cells. So was doing some reading on the background history of this project and support cells, stem cells, progenitor cells. Progenitor cells (they are called lgr5) are found in the support cells. Stem cells can transform into all kinds of cells but progenitor cells are not that 'flexible' so they transform into more ‘fixed' types.

      The breakthrough with FX-322 was that prior to FX-322, they could only cause the inner ear stem cells ALREADY present in support cells (found in the epithelium of organ of corti) to turn into a hair cell. But it was a rather small amount of hair cells.

      But now what they could do with FX-322 was that they figured out the FX-322 molecules were the reason why lgr5 progenitor cells in intestines divided and made copies of themselves in great quantities so they applied this signalling knowledge and increased manifold the amount of lgr5 progenitor cells in the inner ear.

      Also there’s also a video in this paper https://www.cell.com/neuron/fulltext/S0896-6273(12)00953-1?_returnURL=https://linkinghub.elsevier.com/retrieve/pii/S0896627312009531?showall=true
      from 2013 where Albert Edge talks about support cells. I find that he explains it in easier to understand terms. This was before they discovered FX-322 so they could only turn whatever stem cells that were there into hair cells. Not sure if my explanation is correct too. Most importantly, I just hope FX-322 does something good. There's just so much uncertainty and hope at the same time...:unsure:
       
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    28. sssing

      sssing Member Benefactor

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      2019
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      Agree. Because I read that some minute change to the cochlear could mean deafness. And also, some other hair cell regeneration drugs could even kill (in mice)!

      Hopefully this drug will be safe and also able to help like what @Lucifer mentioned about the person who could go back to his music playing profession. I am worried and the same time hopeful.
       
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    29. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
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      Ear Infection
      That’s what they are testing now. If the four doses of FX-322 causes patients to have no side effects and show major improvement in hearing and getting rid of tinnitus and hyperacusis then there's a very good chance for FX-322 getting Breakthrough Therapy status and it might be able to skip phases or release the drug during Phase 3 trials.

      If Phase 2a ends up being successful it should be release straight away. There are many of us suffering from this condition and are unable to continue with our lives. I always think everyday what would of happen if @Allan1967 had got a chance to try out FX-322. I also think about his kids and wife as well who he left behind. I miss him so much.
       
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    30. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      Is it even possible to release a drug when it's going through phase 3? I thought this wasn't possible. I thought phase 3 was needed to be passed before commercialisation.

      You know even when hundreds have been tested with FX-322 it still needs to be tested on thousands more.
       
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