Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      From what I’m understanding, you’re essentially getting the same hardware that you got in the womb. So, yeah it’s going to take a while for the new hair cells to noticeably wear from a performance perspective, but they aren’t any more durable than the original equipment you got at birth.
       
      • Optimistic Optimistic x 2
    2. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      Not saying they're more durable, but if a hair cell can take, say, 40 years of a certain amount of "abuse," then assuming that person isn't subjecting their ears to anything worse, the shiny new hair cells should have more life on them than the older ones. Like mileage on a car.
       
      • Agree Agree x 2
      • Helpful Helpful x 1
      • Optimistic Optimistic x 1
    3. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Currently, the FDA has granted the drug the Fast Track Status, which based on the Phase 1 and 1/2 data, they have indicated that FX-322 meets ONE or MORE of the following criteria:
      • Shows superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
      • Avoiding serious side effects of an available therapy
      • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
      • Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
      • Ability to address emerging or anticipated public health need
      At the END-OF-PHASE 2 Meeting, FDA will directly consider the data from the Phase 2A and both Phase 1Bs based on the FX-322 dosages outlined in the specific trials. Note, the Fast Track Status offers that the FDA can review data prior to the End-Of-Phase 2 meeting, and make suggestions for future trial design, or assist in expediting future trials, among other things.

      The Primary Outcome data to be assessed will be:
      1. Speech Intelligibility
        Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.

      2. Speech Intelligibility
        Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists

      3. Standard Pure Tone Audiometry
        Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)

      4. Systemic Safety: Number of patients with treatment-related adverse events
        Number of patients with treatment-related adverse events assessed by CTCAE v5.0

      5. Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
        Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.

      6. Local Safety: The number of patients with abnormal changes from baseline in tympanometry
        Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.

      7. Columbia-Suicide Severity Rating Scale (C-SSRS)
        Risk assessment through a series of simple, plain-language questions
      The Experimental Outcome data to be assessed will be:
      1. Extended High Frequency Pure Tone Audiometry
        Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)

      2. Tinnitus Assessment
        Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.

      3. Hearing Handicap Inventory
        The Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational). The subject will self-report one of the following answers for each item on the scale: Yes, Sometimes, No.

      4. Hearing Screening Inventory
        The Hearing Screening Inventory (HSI) is a 12 item self report inventory to assess hearing impairment. The subject will self report one of the following answers, for each question from 1 to 8: Never, Seldom, Occasionally, Frequently, Always, and for each question from 9 to 12: Good, Average, Slightly below average, Poor, Very Poor. The HSI is designed to assess subjective change during the study.

      Based on the significance of the Primary Outcomes (Safety + Efficacy) from both a statistical and clinical standpoint will determine if the drug is assigned the Breakthrough Therapy Status, AND/OR if FX-322 is approved for a pivotal trial. Usually at this point the FDA will also provide comments to Frequency Therapeutics for future trial design.

      So yes, there will be a lot of doctors + experts scrutinizing the data; and they have already done so for the Phase 1 + 1/2 which has led to the Fast Track Designation. Indicating that the FDA already sees the drug as promising. This is what we want to see. Experts reviewing the data and moving the process forward, or suggesting that Frequency Therapeutics make changes to a future trial to more clearly answer ambiguous results.

      I do not see in any of my research on the clinical trial process the FDA bringing in outside influences (Like Julian Cowan Hill, the ATA, hearing aid manufacturers) to weigh in on decisions that are data specific. The sponsor can provide peer-reviewed research to reinforce the data found from specific primary outcomes, which I expect Frequency Therapeutics to do; for example: the recent data on hearing loss being the largest modifiable risk to developing depression / dementia, and that age-related hearing loss is largely just hair cell loss. The FDA does accept petitions in the case of some drugs in clinical trials, but they do so in a way that weighs those petitions FOR and AGAINST.
       
      • Informative Informative x 12
      • Agree Agree x 4
      • Like Like x 2
    4. Gorbeh3

      Gorbeh3 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing Loss
      Guys, do you think there is anything we can do collectively to try to get expanded access/compassionate use offered ASAP?

      I'm the type of person who has been googling Frequency Therapeutics everyday (literally every fucking day) for every single update for the past 4 years.

      I unfortunately wasn't able to participate in the clinical trials.

      I'm honestly at my limit. This is crushing my soul.
       
      • Hug Hug x 6
      • Agree Agree x 2
      • Good Question Good Question x 1
    5. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      There was a study I posted here awhile ago where they found that people with profound hearing loss on the standard audiogram but normal ultra high frequencies had "unusually good speech". It's a rare subset of people but it does happen.

      Maybe one day extended audiograms will be the norm because it's so much more informative.
       
      • Like Like x 1
    6. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Yes, you can petition the FDA and Frequency Therapeutics to make FX-322 available for compassionate use.
       
      • Like Like x 4
      • Agree Agree x 1
      • Informative Informative x 1
    7. Gorbeh3

      Gorbeh3 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing Loss
      What's the best way to do this?
       
      • Good Question Good Question x 3
      • Like Like x 2
    8. Diesel

      Diesel Member Benefactor Hall of Fame

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


      I would advise to wait for the Phase 2A 90-day results to be released. If they look favorable, that would be a good time to get the ball rolling on the petition. I'm sure it would raise some eyebrows amongst this community and other hearing loss communities.

       
      • Like Like x 1
      • Agree Agree x 1
      • Helpful Helpful x 1
    9. scotty03874

      scotty03874 Member

      Location:
      Boston / Miami Beach
      Tinnitus Since:
      4/7/19
      Cause of Tinnitus:
      Slap to the ear / Leading to more issues
      That's what I'm praying for...!
       
    10. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I’ve tried twice to enter the FX-322 trials and twice denied due to bad words scores.
       
      • Hug Hug x 5
    11. annV
      Fine

      annV Member

      Tinnitus Since:
      2005
      Cause of Tinnitus:
      unknown - possibly hereditary
      @Diesel, do you have a background in medicine, you seem to know a lot? Or are you self-taught? I hope after all the effort you've given making this difficult topic understandable to us stupid people you get relief from FX-322 as soon as possible.
       
      • Agree Agree x 7
      • Like Like x 2
      • Friendly Friendly x 1
    12. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      MBA. Really just figuring it out and contributing so that all are well informed. Although, a background working in roles that involve a lot of complex stakeholders (engineering, tech, finance, government, etc) may have helped.
       
      • Like Like x 7
    13. Jcmc

      Jcmc Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Headphones and stress
      0C3C7F5E-7711-4EAF-BCCA-474B89234B28.jpeg
       
      • Like Like x 9
    14. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Hell
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Frequency Therapeutics have been posting a lot on their Twitter feed recently.

      Any indication that the reason for these recent postings are due to the success in the Phase 2a clinical trial?
       
      • Like Like x 2
      • Good Question Good Question x 1
      • Winner Winner x 1
    15. scotty03874

      scotty03874 Member

      Location:
      Boston / Miami Beach
      Tinnitus Since:
      4/7/19
      Cause of Tinnitus:
      Slap to the ear / Leading to more issues
      More FX-322 promotion. Let's keep the positive tweets going guys...!
       
      • Like Like x 6
      • Funny Funny x 1
    16. Jack V

      Jack V Member Benefactor

      Tinnitus Since:
      1/2020
      Could be that one of the executive's kids told them they need to do more social media :dunno:
       
      • Funny Funny x 5
    17. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      One of their recent hires is leading the marketing strategy; so probably increased focus on it.
       
    18. matthew_bk
      Crappy

      matthew_bk Member

      Location:
      Brooklyn, NY, USA
      Tinnitus Since:
      Feb 2021
      Cause of Tinnitus:
      sudden hearing loss - left ear only
      This is one heck of a thread! I have tried my best to search through it. I was just curious if FX-322 - if the trials prove out - seems promising for idiopathic unilateral sudden hearing loss? There are so many ways we can experience hearing loss and for now mine is not determined. Would be uplifting to read that there's maybe hope on the horizon.

      Thanks for taking the time and excuse me for just jumping in with a question that might be answered in the previous 400+ pages! :D
       
      • Like Like x 3
    19. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      When Frequency Therapeutics has a TikTok account I'll buy that theory.
       
      • Funny Funny x 10
      • Agree Agree x 2
      • Like Like x 1
      • Informative Informative x 1
    20. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      I suffered ISSHL as well. Yes it seems promising.
       
      • Like Like x 1
      • Agree Agree x 1
      • Helpful Helpful x 1
    21. matthew_bk
      Crappy

      matthew_bk Member

      Location:
      Brooklyn, NY, USA
      Tinnitus Since:
      Feb 2021
      Cause of Tinnitus:
      sudden hearing loss - left ear only
      Thank you. I needed a bit of hopefulness today.
       
      • Hug Hug x 3
    22. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      How does falling under "primary" or "experimental" impact the extent to which the FDA will take said data into consideration?
       
      • Good Question Good Question x 2
    23. L34

      L34 Member

      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      Unknown, but little dip at 7000 Hz
      This is surprising I think. If they tried to make room for significant improvement, they should go for people with bad word scores... but I guess there is more to it than what I think :):(
       
      • Agree Agree x 1
    24. Diesel

      Diesel Member Benefactor Hall of Fame

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Primary outcomes are what the FDA is going to use to determine if the drug should proceed to future trials and ultimately be approved for certain conditions.
       
      • Informative Informative x 3
    25. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      So if the experimental outcome data is the stuff that really means something to us, we're going to have to fight for this.
       
      • Agree Agree x 1
    26. Keith Handy
      Worried

      Keith Handy Member

      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      I was looking through older videos on Frequency Therapeutics' Vimeo account and found this one from three months ago. Maybe it has already been posted in here, but from about 23:40 to 25:40 there's a connection made between extended audiograms, tinnitus, and regenerative meds.

       
      • Like Like x 2
      • Winner Winner x 2
      • Informative Informative x 2
    27. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Right, you don't seek approval for secondary outcomes but they provide additional information that providers can use for off label use.
       
      • Like Like x 1
    28. Bailes
      Sunshine

      Bailes Member

      Tinnitus Since:
      04/2007
      Cause of Tinnitus:
      Stress
      It's so helpful to have others here that have the knowledge or the motivation and energy to dig out the information and then share with us mere mortals.

      I hope to be able to contribute something useful, however apart from keeping an eye on this forum and trying to keep an eye on the share price... hope is all I have to offer.

      Maybe of note is the fact that there are more and more eyes watching the share price... Maybe the money vultures are sensing a feast!

      Good luck all... level 5 restrictions here in Ireland so hopefully we will exit restrictions and I can get a few jabs of vaccine and FX-322, now that would be sweet!
       
      • Agree Agree x 4
      • Like Like x 1
    29. Barber27

      Barber27 Member

      Tinnitus Since:
      1998
      Cause of Tinnitus:
      Load noises
      My gut feeling from all the tweets Frequency Therapeutics are sending out that this will only help those with hidden hearing loss... How I wish I only had that!
       
      • Like Like x 1
    30. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      That makes no sense physiologically, though.
       
      • Agree Agree x 11
      • Like Like x 1
      • Funny Funny x 1
Loading...

Share This Page