Frequency Therapeutics — FX-345

Discussion in 'Research News' started by Diesel, Nov 9, 2021.

    1. AUTHOR
      AUTHOR
      Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Have you watched the R&D event video / read the November investor deck? I think they did a good job of bringing all the data together from the single dose trials; and highlighted a lot of lessons learned in trial design AND got more specific on patient target for FX-322. When looking at the trials individually, yeah, it's underwhelming, and you can tell they have struggled to fine tune their recruiting; but in aggregate, it does start to make sense the signal they're seeing, and how FX-345 can build on the learnings.

      This science is young (PCA), and this is how they learn to get it to market + iterate it. We're seeing it happen in real-time.

      If you haven't I would encourage that you take the hour or so and watch it.

      https://investors.frequencytx.com/2021_Virtual_R-D_Event
       
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    2. hopetohear

      hopetohear Member

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      I've been following FX-322 for a while now and am interested in how FX-345 will go, as I’m sure you all are.

      Wondering what everyone thinks the timeline might be? Obviously guesswork at this point. Do we think they might not have to run as many Phase 2 trials this time around? Thoughts on if FX-345 will be the same target population as FX-322?
       
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    3. ThomasRobert

      ThomasRobert Member Benefactor

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      My guess is a Phase 3 FX-322 trial will run simultaneously with a FX-345 phase 2/pivotal trial in 2023...

      Since Frequency Therapeutics is on a fast track designator, an approval for the drug can come in 6 months after the above-mentioned trial in 2023.
       
    4. hopetohear

      hopetohear Member

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      That would be great!

      Is it possible they might only need the one Phase 2 trial this time around? Also I’m guessing the fast track status is only for FX-322? Or for Frequency Therapeutics as a company, so it could cover FX-345?

      Really hoping they’ve learnt from their mistakes and this next lot of trials etc run a whole lot smoother/faster.
       
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    5. RingingBrother

      RingingBrother Member

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      I wish there was a way the FDA can just let us all try it now and assume the risks.
       
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    6. Gb3

      Gb3 Member

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      Definitely not going to be faster considering they said some people take longer to achieve effect.
       
    7. AUTHOR
      AUTHOR
      Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      There is. It's called Compassionate Use. It's really not up the FDA, it's up to the company. I honestly don't see this happening with either of the FX's though.
       
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    8. hopetohear

      hopetohear Member

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      Ah yes, good point. Wishful thinking on my behalf.
       
    9. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

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      I read the deck, but haven't watched the video yet. And I agree with what you're saying, they are doing a great job at communicating details and that's good. But yeah, hopefully better results will come in time. In the past they've made it seem that it's sooner rather than later though, but it seems to be later. However it of course could have been an honest miss-estimation on their part and not only to callously "lure" investors in. :D
       
    10. RingingBrother

      RingingBrother Member

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      I wonder if Frequency Therapeutics has an email we can write and ask for that. I would sign a release form to try it.
       
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    11. 2noist

      2noist Member

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      Hardly any reason to ask, they know people would be lining up for compassionate use. Didn't they say in some interview that they will revisit the compassionate use in future?
       
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    12. Gb3

      Gb3 Member

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      It’s on their website. It’s not an option at this time.
       
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    13. RingingBrother

      RingingBrother Member

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      When do you think they would allow compassionate use if they have good results in their trials?
      Just had one in my right ear for steroids, it wasn't so bad.
       
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    14. Gb3

      Gb3 Member

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      Prolly never. If it works, it would come to market, if it doesn’t, then why would you want it.
       
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    15. Chad Lawton

      Chad Lawton Member

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      Not necessarily. In this case, it is the composition of the gel.

      I believe they have found a way to design their gel so that it can hold a higher dose of a more potent GSK3 inhibitor while still retaining its gel like properties. The problem with FX-322 is that they couldn't increase the potency by simply adding more drug to the mix because the gel would not retain its desired viscosity at the desired temperature if they did so. FX-322 is likely penetrating just as deeply into the cochlea as FX-345 is but the amount that makes it past 8 kHz is not potent enough to be therapeutically active versus this more highly potent compound which doesn't take nearly as high of levels to activate the progenitor cells. Someone correct me if I'm wrong.

      As for the the purple fading out until 1.5 kHz, it appears this way as a result of the gradient applied to the cochlea in the background. Look at the FX-322 cochlea they used in that same presentation and that same area is shaded the same color. It looks like FX-345 fades out around 3 kHz.
       

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    16. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

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      If I may speculate with some hopeful bias, I do think reaching further into the cochlea, even with the same amount of drug, could make a difference for the treatment as a whole.

      Covering only a quarter of a flesh-wound with bandage is going to make way less of a difference, even for that particular part, then if you cover a bigger part or the whole wound.
       
    17. Jim51042

      Jim51042 Member

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      I disagree with that assessment. Talking the talk would be more like promoting their product to investors and never testing it. Frequency Therapeutics injected people in their trials aka they tangibly did something.
       
    18. aorelia

      aorelia Member

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      Trying to understand the science around this. If someone has hearing loss around 5 kHz, but no hearing loss above that, would the drug still reach that 5 kHz level?
       
    19. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

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      I did use the word "better" for that reason. ;)
       
    20. Jim51042

      Jim51042 Member

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      Fair enough.

      It's just my view that the commenters can view different companies maybe not equivalently. I'm specially talking about all the love Decibel Therapeutics was receiving back in 2017/2018. They were taking in ton of cash yet had no interest in human testing on the horizon and were entirely focused on a prevention drug. I didn't understand the commenters' praise/celebration then and don't get it now.
       
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    21. Jim51042

      Jim51042 Member

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      My understanding is it would reach 5 kHz and frequencies above.
      You have hearing loss above 5 kHz. You may not realize you have hearing loss because you haven't been tested to 16 kHz or 20 kHz but at least somewhere in the 20 kHz range some of your hair cells have died.
       
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    22. kiki

      kiki Member Benefactor

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      I don't think Phase 3 is necessary for FX-322 because there are no competing drugs.

      What about if FX-322 is approved, is FX-345's competitor FX-322? Do you need Phase 3 for FX-345?
       
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    23. kiki

      kiki Member Benefactor

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      And the big thing is the success fee paid by Astellas.

      It is very important to show that FX-322 is an active drug (especially in HFPTA) and get FDA approval.

      If successful, they can sign a better deal with Astellas for FX-345.
       
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    24. dbeats

      dbeats Member

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      Does FX-345 aim to also fix existing hair cells, or is it mainly to generate new and functional hair cells?
       
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    25. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

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      I don't think there is any official info yet other than it reaching further into the cochlea.
       
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