Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      I just hope we all get the most benefit with FX-322. We will be waiting a lot longer for OTO-413 to come out unless we can get compassionate use.

      Since we know how many IHCs and OHCs we have, do we know how much synapses a person has?
       
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    2. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      This has been said a million times but, at some point, diagnostics will have to catch up to treatments.
       
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    3. jordan chis

      jordan chis Member

      Tinnitus Since:
      06/20
      Cause of Tinnitus:
      acoustic trauma
      Do you think it's possible that a few of the 96 participants have hyperacusis? Or even just one person? I really do hope that this can treat hyperacusis.
       
    4. Joly

      Joly Member

      Tinnitus Since:
      22/08/2019
      Cause of Tinnitus:
      Traumatisme sonore
      Hello! Do you think that with the second wave of COVID-19 in the United States, the testing of the FX-322 could be even further delayed?
       
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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
      It wasn't an exclusion factor so it's possible.
       
    6. Diesel

      Diesel Member Benefactor

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

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Interesting stuff. Reading the actual text, I think FX-322 would be applicable under SEC 524B - Eligibility, provided the Phase 2A data meets significant primary and secondary endpoints.

      “(3) a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning."

      The full text: https://www.congress.gov/bill/116th-congress/senate-bill/3872/text?r=2&s=1

      The challenge would be the length of time this bill is going to sit in both houses before landing on the President's desk, and implemented at the FDA. Could be well after Phase 2A data is released in 2021, rendering it useless.

      The good news is, it seems to have some support from both sides of the aisle; and a Trump or Biden presidency would likely pass it.

      TBH, this is the type of legislature the tinnitus community should be working to get behind.
       
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    8. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      It is I think definitely going to be supported by both parties. Got no idea why it wouldn't. I was also aware both parties pretty much support this type of stuff, see the over the counter hearing aids etc.

      For an outsider (I am in Australia) does this then mean you can obtain the drug after phase 2 if you want assuming that the trial demonstrates positive results?
       
    9. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      The more likely looking factor is whether hyperacusis can be mentioned in the trial results. There is a possibility it won't with this trial as hyperacusis is actually not a target of it. I think they thus can't make claims which haven't gone through the process.
       
    10. AtlasFainted

      AtlasFainted Member Podcast Patron

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Noise Exposure + Viral Infection
      Agreed.

      Also, it might not be very useful as far as FX-322 goes, but it seems like it could help us access things like the Hough Pill or OTO-413 faster.

      As I understand it, if you have noise-induced hearing loss, you likely not only have inner/outer hair cell loss, but synapse damage as well.
       
    11. Mr.tdog15

      Mr.tdog15 Member

      Tinnitus Since:
      March 2020
      Cause of Tinnitus:
      Ototoxic meds ciprofloxacin
      Does ototoxic medication cause damage to hair cells or synapses or both? If so, are people with damage from ototoxic meds going to need FX-322 and OTO-413??
       
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    12. Emgee

      Emgee Member Podcast Patron Benefactor

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Modern Society = Too Loud
      Does anyone know if there were any anecdotes of tinnitus improvement for participants in the Phase 1/2 study?
       
    13. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      No there were not; only speculation.

      A few of the more chatty folks in this thread (myself included) have gathered that perhaps the tinnitus questionnaire was added to the Phase 2A because there was some patient feedback from the Phase 1/2 of improvements. However, "qualitative" feedback cannot be included in the outcomes from the trial.

      My personal perspective: Considering what we continue to learn about the thought process behind the Phase 2A from the leadership at Frequency (through recent conference interviews); it's likely that they included secondary outcomes including: TFI, HHIA, and HSI to help quantify the "qualitative" improvements observed from the Phase 1/2. We know recently that Frequency has continued to communicate with the Phase 1/2 participants.

      One thing is for certain, FX-322 did not make tinnitus worse or cause tinnitus for any of the participants in the Phase 1/2. It would have clearly failed from a safety standpoint, and wouldn't be a secondary outcome measure in the Phase 2A.
       
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    14. Emgee

      Emgee Member Podcast Patron Benefactor

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Modern Society = Too Loud
      Thanks for the clarification. I didn’t see any mentioning of tinnitus in the Phase 1/2 results and wanted to make sure I hadn’t missed it if it was addressed.

      I think you’re right, and it’s logical to presume that there was positive qualitative feedback regarding tinnitus improvement in Phase 1/2. Adding it to Phase 2a, even as a secondary outcome measure, wouldn’t make sense unless they had some indication of a connection between hearing regeneration and tinnitus. As mentioned many times, in theory, one would stand to think these two items should be directly correlated.

      I can’t wait for the Phase 2a results to be announced. I’m optimistic as the safety profile and word score improvements from Phase 1/2 looked promising. I hope four injections yield the results we are looking for. Hopefully, we know more by the end of this year.
       
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    15. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Every ototoxin is different and some are poorly studied. Which ototoxin are you referring to?
       
    16. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      No, the closest we have are people with hearing loss and tinnitus who get a hearing aid or cochlear implant. It does seem to a have a beneficial effect on some of these patients. If that’s the case I see no reason why restoration of natural hearing wouldn’t have that (or even more beneficial) effect.
       
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    17. sssing

      sssing Member Benefactor

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      cold
      Thanks. I hope that it will improve hearing and as a consequence improve tinnitus.
       
    18. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      15 per cent drop in share price today... Why? Or is this normal for biotechs?
       
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    19. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I can conclude convincingly from my perspective that as the hearing loss has gotten worse, the tinnitus has gotten worse as well. This would be a pretty positive indication they are inherently linked.
       
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    20. patorjk

      patorjk Member

      Tinnitus Since:
      2005
      Cause of Tinnitus:
      Several reasons
      With Frequency it seems normal. There have been several instances where it'll jump 10% or drop 10% for unknown reasons (I think on Thursday last week the stock jumped by a little over 10%). The stock is basically back to where it was 2 weeks ago, so the drop could be some people taking their profits.

      Looking at insider trades, the only recent ones I see are by Christopher Loose (Chief Scientific Officer), who's been selling 4,500 shares every two weeks since April. He currently holds 170,782 shares. At the current rate he's selling, he'll have around 139,282 shares when the Phase 2a top-line results are released (assuming they get released at the end of September). It makes me uneasy when insiders sell, but as along as they keep most of their shares it's a good sign. After all, if Phase 2a fails, he loses a ton, so he's probably making sure all his eggs aren't in one basket.
       
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    21. Emgee

      Emgee Member Podcast Patron Benefactor

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Modern Society = Too Loud
      Part of the game for biotechs. Very volatile due to the risk involved - most biotechs fail. Many biotech investors are in one day and out the next solely due to gut feelings, especially since it’s hard for many investors to understand the science behind these products enough to feel comfortable. Even though Frequency has considerable cash on hand, they don’t yet have revenue-generating products to be profitable. See their negative net margins, which are common for the industry. Their cash is tied up in R&D and costly clinical trials to seek approval. Biotechs burn through their cash reserve.

      Also, since it’s an ongoing double-blind study, not even the study staff is aware of the results at this point. Currently, the drop in share price is under 12%. This will change too much to monitor, especially since we’re a good deal of time away from learning the results of Phase 2a.
       
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    22. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Have had a look and actually am seeing that there has been quite a similar slide in biotech today. Thus I think that this is a trend. Nothing noticeable to worry about and I actually think that this is more towards the general sentiment to this area of the market.
       
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    23. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Normal.
       
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    24. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I think that's because he currently wants cash rather than the shares since it seems somewhat highly likely he has had his pay partially put into this. I think it is completely normal. Notice how new companies do this often on account of the fact that flicking shares to someone simply is cheaper than trying to pay them cash which will be much more useful and also valuable.
       
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    25. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Very normal.

      It's incredibly common to see "insiders" periodically sell positions for drugs (even ones that turn out to be blockbusters).

      Trust me, if it wasn't, anyone could be an easy millionaire looking at the filings and investing in biotech and that's very much not the case.
       
    26. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      This probably means we have to wait then until the complete study is finished. And I thought we would maybe already get some appetiser this fall.
       
    27. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      I've made over a £1,000 buying and selling Frequency Therapeutics in the past 3 weeks. The other day I held stock for 1 hour and 15 minutes and made £340. I normally invest long term, but this is paying for my treatment if they succeed and I guess I'm reaping my cash I wasted in the past on so called tinnitus treatments. All part of the game I guess (I'm new to short term trading).

      Anybody else having success? I would invest long term as long as the science progresses and things go well. The benefit of this stock is that I regularly read about the company.

      Obviously, my biggest hope is for this to succeed, if I didn't suffer from tinnitus I probably never would have heard of this company. Dark clouds, silver linings I guess. I'd rather have a cure for tinnitus though than a million.
       
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    28. Diesel

      Diesel Member Benefactor

      Location:
      Ohio
      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      I've been holding long, buying a few shares monthly over time, relying on cost average.

      Although I believe that the PCA approach looks promising for a number of treatments over the very long term, I'll probably sell the gains for the treatment.
       
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    29. patorjk

      patorjk Member

      Tinnitus Since:
      2005
      Cause of Tinnitus:
      Several reasons
      With how obessively I've been watching this company it probably would make sense for me to do short term trading (they're up 6% today). I have a long position, but what you're saying makes a lot of sense. Next time it dips I may try this.
       
    30. AtlasFainted

      AtlasFainted Member Podcast Patron

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Noise Exposure + Viral Infection
      Do you guys think that hearing restoration could also curb or possibly erase ETD symptoms?

      Mine started shortly after my tinnitus did, and at times it's more annoying than the tinnitus itself.

      I'm not very well versed on what causes ETD but I can't help but think it's related to hearing loss in some way, at least for me.
       

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