Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Keith Handy
      Dreaming

      Keith Handy Member

      Location:
      Rochester, NY, USA
      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      You need to stop making every post about other people here who have disagreed with you. This obsession is unhealthy.
       
      • Agree Agree x 5
    2. Ed209

      Ed209 Member Podcast Patron Benefactor Ambassador Hall of Fame

      Tinnitus Since:
      07/2015
      That's a bit of a one-sided exaggeration. I haven't posted that much in this thread, so I wasn't really referring to my posts, but all the other reactions I've seen. From what I've read, whenever anyone has criticised Frequency Therapeutics, it's been met with a pretty hardline defence of the company, even though they bring these criticisms on themselves, in my opinion.

      In what way are all my posts about people disagreeing with me? I've engaged in some debate, for sure, but isn't that what forums are all about? I've given Frequency Therapeutics a bit of stick, but that's just my opinion of them based on the news statements they release and their stock activities. It's nothing personal (unless there are people here who actually work for them or something :cautious:).
       
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    3. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Apparently they are contacting patients who didn’t get into previous trials that their next trial is about to start (source: people on Facebook).
       
    4. Keith Handy
      Dreaming

      Keith Handy Member

      Location:
      Rochester, NY, USA
      Tinnitus Since:
      11/2020
      Cause of Tinnitus:
      Stress + sleep deprivation + noise
      Once again, it's about the other people on the forum, even in response to me trying to point out that you're obsessed with the other people on the forum. I don't think you can write a post about the drug or the company without alluding to your disappointment in other people here.
       
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    5. patorjk

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      I've noticed this across the web in my discussions with people about Frequency Therapeutics, and prior to their Phase 2a failure I was probably guilty of it too. I think it happens because people get emotionally invested in the company. They read up on what the company's doing and realize that in a few years maybe they'll be cured of tinnitus and have good hearing again. When someone questions or challenges the company, I think on a subconscious level there's resistance to it because it's tearing down that dream. It's hard to be unbiased about something when you're directly affected.
       
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    6. Ehren M
      Nerdy

      Ehren M Member

      Location:
      USA
      Tinnitus Since:
      01/24/2021
      Cause of Tinnitus:
      acoustic trauma
      Good. From the small bit of attention I've paid to this thread lately, it seems like their sample sizes tend to be smaller than we might all hope for. We need a healthy balance of selectivity and inclusiveness of participants. It's certainly not an easy task, and my heart goes out to those poor clinical statisticians trying to draw meaningful conclusions from subjective data reported by cantankerous Homo sapiens.
       
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    7. Pete88

      Pete88 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      Likely noise
      Agreed. At least prior to the Phase 2a results, all the available evidence looked very favorable. Coming out against it was more based in pessimism.

      Now they have single dose studies that can't live up to the assumptions set by the safety study.
       
      • Agree Agree x 2
    8. Amv

      Amv Member

      Tinnitus Since:
      16/7/2017
      Cause of Tinnitus:
      -
      Probably I am wrong, but I really believe our solution to tinnitus comes more from neuromodulation than from hearing regeneration. I hope I am wrong!
       
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    9. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      I disagree. In Phase 1/2 the drug didn’t result in PTA improvements and WR scores improved marginally in about 35% of patients. Frequency Therapeutics didn’t even talk about WR until after the results of Phase 1/2. I wasn’t impressed after Phase 1/2, and for good reason.
       
      • Agree Agree x 1
    10. Justin Mills

      Justin Mills Member

      Tinnitus Since:
      2 year
      Cause of Tinnitus:
      loud music
      That's not right, no. Tinnitus is usually from damage to hearing, so having a drug that can regenerate the damage would treat the underlying cause of tinnitus AND would also improve hearing perception and clarity. It would also address such issues as hyperacusis that again are caused by the structural damage.

      My concern with FX-322 is that is focuses just on restoring the hearing hair cells. But we know that greater damage occurs to the synapses. I wonder why none of these companies try a two pronged approach. Like using the hair regeneration drug plus a drug that regenerates synapses like OTO-413 and PIPE-505. Maybe with this kind of more aggressive approach using two medications instead of one we would see clear results.
       
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    11. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      I think for now, the need is to verify that one drug focused on one underlying cause works as anticipated. In the ideal future state, treatment might be something like: the first pass is synaptic regen, then hair cell regen if outcomes aren't favorable.

      The challenge with creating cocktails - like an FX-322+OTO-413 is that right now, there's no pre-clinical data on the effects of the drugs interacting with each other or within the cochlea at the same time.

      There's also the problem of competition; The two different firms don't have a mutual benefit to partner on the drugs in the clinical stage. If these drugs were in the market, might be a different story. There's also no pre-clinical data to show to the FDA that the combination produces any more favorable data than a single drug.
       
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    12. Street Novelist
      Depressed

      Street Novelist Member

      Location:
      Bay Area
      Tinnitus Since:
      February 2018
      Cause of Tinnitus:
      Listening to loud music through headphones
      Does anyone know when Frequency Therapeutics plan on starting their next trial? Do they still plan on this year?
       
      • Good Question Good Question x 1
    13. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Please refrain from discussing trial recruitment. Have we learned nothing?
       
    14. Pete88

      Pete88 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      Likely noise
      I can't be bothered to bring up the exact numbers and percentages but I remember that if you really looked at the numbers, there was only a small percentage of people that had the room to get better by an amount that could be classified as statistically meaningful. So it actually was a decent outcome.

      Regarding the PTA, these people also had improvements at 8,000 Hz and extended audiograms were not done. This led to a reasonable theory that the extended audiograms would have shown improvements.

      The results were good enough to warrant excitement. This was in combination of various pre-trial experiments that showed hair cell regeneration. Unfortunately, every trial since has not lived up to what the safety trial suggested. They haven't even been able to replicate the previous results, let alone prove what we assumed regarding extended audiograms. They included extended audiograms but the company has not mentioned the results on that. The lack of details suggest there's no exciting news.

      The "good news" from the newer trials is a fraction of what we got from the safety trial. "Multiple people double their word scores" along with a detailed breakdown of numbers has become vague statements along the lines of "some people had at least a 10 percent increase".
       
    15. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      They mention Q4 so they could start at the earliest in October. I really hope these phases can go by quickly. A year for each phase is too long.
       
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    16. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      I wonder when they will announce the severe hearing loss trial results. Hopefully the end of this month or early October.

      I have a feeling, when they announce the severe hearing loss trial results, that it is when they will start Phase 2 again with single dosing of FX-322 this time.
       
    17. Amv

      Amv Member

      Tinnitus Since:
      16/7/2017
      Cause of Tinnitus:
      -
      Probably, theoretically, you are right, but in a more realistic way, I believe we are still far away from regenerating our ears wisely. I believe neuromodulation is far ahead in terms of research and is probably a less invasive and safe way to treat tinnitus today.
       
    18. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Ehhhhh kind of/sort of. They did administer some patients a single dose of FX-322 but then subsequently shot 3 doses of placebo into that same ear as well so I don't count that as a clean, single dose.
       
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    19. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      As the company has stated, they need to find out who their drug works on and who it doesn't since they are a leader in the field and this has never been done before. All these little studies are exploratory to find that out. So the Phase 1/2 had a range of etiologies and severities and they said that those with mild hearing loss have little room to improve so since mild hearing loss patients were included in the study, 35% of patients improving isn't that bad.

      Then on top of that, just because those with mild hearing loss don't "improve", it doesn't mean the drug isn't working/helping for them. It just means that current clinical tests aren't refined enough to detect the nuanced improvements that may occur in mild patients.
       
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    20. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Every so often, the reminder needs to be made that the FDA approval process, if it were to be simplified depends on three criteria:

      1. Risk: Is the drug safe enough to be administered to humans? Or, do the benefits outweigh the possible side-effects?
      2. Patient Population: What specific patient population has been identified that this drug can help?
      3. Clinical Outcomes: What specific assessment data shows that the Patient Population improved in a significant way vs. Placebo?

      These 3 factors are very might interrelated. However, clearly defining #2 is the seriously big problem for hearing loss pharma right now.

      One that continues to become more clear from this drug's trial, Otonomy's, Pipeline's, and others, is that being really specific in terms of Patient Population will decide whether or not these drugs get approval. Turns out, that the nuances between one type of / underlying cause of hearing loss or another matter.

      Currently, the Phase 1 datas aren't that impressive, when only 1/3 of the participants move the needle. We all want that to be better. But, for both of them, they casted a wide/vague net to capture willing participants. So, by ignoring those nuances in hearing loss that matter, factor #2 doesn't look so great.

      If Frequency can improve the specifics of the Patient Population in the next Phase 2, then they should see improvement in 2 and 3 mentioned above; and have a much less risky path to FDA approval.

      I think this is another reason to explain why they published that PR the other day about patients responding to the drug much later than others. It's possible they think there is a nuanced difference between those "late bloomers" verses "early bloomers." This information might help strengthen their knowledge on #2 above.
       
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    21. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      And now they have over 175 patients that have been dosed with FX-322 across all their trials so they should have a pretty good idea of their target population. It sounds like R&D day is when they are going to spill all the beans on all their learnings and how they are going to shape the new Phase 2 trial.
       
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    22. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      The question is though whether the placebo would have mucked up the dosing of the medicine in the same way. At present there is no information to confirm or deny this.
       
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    23. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      Just for a recap.

      It seems that tinnitus research is working broadly speaking on three fronts:

      1] Accessing the cochlea so as to grow hair cells and/or synapses
      2] Sound therapy with massaging some nerve
      3] Channel blockers or something that I don't know anything about
       
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    24. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      B402437E-8DC3-47F0-8C3C-9EBF8676EF51.jpeg
       
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    25. Pete88

      Pete88 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      Likely noise
      Without investing too much emotion, this seems like a good sign. Basically a secret trial that if it had bad results, would be swept under rug. I know people will point out the possible sketchiness of the scenario but this is promising!
       
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    26. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      Got to like the title. Does anyone know which cohort this trial was testing on?
       
    27. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      How is a “previously disclosed” trial a secret? If I’m correct this is the study of which they already shared results concurrent with the failed Phase 2a study.
       
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    28. Pete88

      Pete88 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      Likely noise
      Wow, I feel dumb. You are right. I read it as "previously undisclosed". This got less exciting. Now it sounds like they're just trying to salvage the lackluster results of one of those old studies.
       
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    29. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      Dare I say it? You seem to be implying that that German fellow Bob was spot on. (Well, he was right on the money.)

      I have to say that Frequency Therapeutics and Pipeline Therapeutics and maybe Hough Ear Institute deserve our attention and admiration in so far as that the method of intratympanic injections delivers a therapeutical agent to the local area where we assume tinnitus and hearing loss is located -- so this is a new approach and could be a game-changer, block-buster.

      It might be an imitation of one of nature tricks -- both fish and birds can regenerate damaged hair cells.

      However, maybe the crowdfunding method would be a better approach to conducting research. I have no doubt that there are lots of people in the tinnitus community and the hearing impaired community who are financially secure (sure ain't me) and would like to fund research.

      I guess a lot comes down to the people who are conducting the research.

      Having said that, if Frequency Therapeutics can deliver the goods, then all is forgiven.
       
      • Agree Agree x 3
    30. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      Yea I agree with everything you said, especially the last part about forgiving Frequency Therapeutics if they can deliver the goods.

      At least this time the participants will either get placebo or FX-322 in the Phase 2 trials instead of multiple dosing where the placebo may have mitigated the effect of FX-322 doing so well in the previous Phase 1 trials.
       
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