Frequency Therapeutics — Hearing Loss Regeneration

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

    1. tommyd87

      tommyd87 Member

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      They would, however they would reduce a lot of the lead time since a lot of the lead in work such as the preclinical studies etc is already completed.
      Well wasn't the reason people improved in the FX-322 placebo group due to them falsifying their word scores to enter into the trial though? Then there seemed to also be the issue of Frequency Therapeutics possibly not going back far enough with patient related information and discovering that some of the people had oddities with the information they had provided.
      Nothing to do with one compound being better than the other from what I see. Seems more like that Frequency Therapeutics believes there is merit in both compounds and that it is feasible they can get both of them approved also.

      As a result they are trying to get the first one approved to offer benefit to people now.
       
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    2. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I really hope they don’t delay FX-322 from coming out by working on the new candidate. They should focus on releasing FX-322 in its current version first but also having separate trials on the new candidate so nothing gets delayed.

      Overheard at Frequency Podcast: Episode 3 Part 1
       
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    3. Pinball

      Pinball Member

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      I would love to see if there is any info on FX-322 regarding "stabilization". It would be such a relief to know if the drug had the potential to preserve hearing. For example - maintain your audiogram as is. I always hear how hearing will get worse over time and if I knew that this drug had the potential to protect my hearing as is - that would be amazing news.
       
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    4. Nobody19

      Nobody19 Member Podcast Patron Benefactor

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      Check for otoprotective medicine @Pinball, there are some in development.
       
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    5. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

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      Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical Advancement of FX-322, a New Potential Restorative Treatment for Hearing Loss and In Vivo Data for Its Remyelination Program in Multiple Sclerosis
       
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    6. Nobody19

      Nobody19 Member Podcast Patron Benefactor

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      It's pretty awesome to see that they're able to improve their product already!
       
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    7. RingingBrother

      RingingBrother Member

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      I feel like it's going to progress similar to how when they made the first airplane and now we have fighter jets and newer versions being released. Also I'm sure when the first airplane failed to take off there was a lot of negativity and people saying we will never fly. Maybe one day Frequency Therapeutics will make a pill that can just fully restore all hearing in a matter of days.
       
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    8. Gorbeh3

      Gorbeh3 Member

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      Summary of this morning's presentation:

      Encouraging results and they seem to have something here and be on the right path, but it is not a "golden ticket" at this time, there is much more work to be done but there is justification to be optimistic.

      One of the biggest hurdles is delivery of the product so it reaches deeper into the cochlea. They are working to solve this.

      Two individuals who receive FX-322 may see improvements at completely different times, someone may see improvements at one month and another maybe not until six months later.

      Their focus is on noise induced and sudden sensorineural hearing loss. It appears it is least effective for age-related hearing loss.

      I might have missed it if they did say anything because I was distracted towards the end but they said nothing regarding tinnitus or hyperacusis.

      Best case scenario this will hit the market in 3-4 years, in my opinion.

      Keep your heads up my tinnitus homies.
       
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    9. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Did they say anything about severe hearing loss trial results?
       
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    10. kiki

      kiki Member Benefactor

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      "Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related)."

      Does this include clinical trials for severe hearing loss?
       
    11. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      D60A511D-05FC-43FC-B62C-71232B57A4A0.jpeg

      On page 54 of the Frequency Therapeutics presentation it mentions about the colour of the circle representing the people that responded to FX-322 and you notice that with the severe trials it has a darker circle and says 100%. Does this mean everyone who was treated in the severe hearing loss trial experienced improvements?
       
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    12. Wrfortiscue
      Probing

      Wrfortiscue Member Benefactor Hall of Fame

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      One can only hope.
       
    13. kiki

      kiki Member Benefactor

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      Where can I find the materials for this presentation?
       
    14. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Yes. BUT. The circle is smaller indicating a small sample size. Which is why it isn't highlighted with the dotted orange circle. We won't know truly how well this drug does for severe loss until the readout.
       
    15. Trevor_phillips

      Trevor_phillips Member

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      I do think everyone experienced improvements. Severe hearing loss sufferers had great response because they have more inner ear hair cell death, so the hearing improvement can be easily seen unlike in other types of hearing loss.
       
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    16. Gb3

      Gb3 Member

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    17. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Yea sample size is smaller because I think they only have 24-30 participants for the severe hearing loss trial.

      But if it’s true that 100% of patients experienced improvements for the severe hearing loss trial, I am really shocked. I was not expecting it to do so well.
       
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    18. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      No, I mean the sample of patients with Severe loss that HAPPENED to get FX-322 in one of the other trials is probably a handful of patients; making it too small to be meaningful for this chart.

      The Severe Trial results have not been released.
       
    19. kiki

      kiki Member Benefactor

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      The size of these two circles is too small because the number of patients with severe hearing loss and the number of patients with presbycusis are about the same.

      Also, unlike the others, the numbers are white.

      I think they're probably writing that they're close to this.

      Because it has not been confirmed.
       
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    20. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      Yea I guess so but not sure what the 100% means for the severe hearing loss category if the official results haven’t come out yet.
      If the severe hearing loss trial results have not been released yet then it’s bad they added the severe category in that diagram which says 100%.
       
    21. Chad Lawton

      Chad Lawton Member

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      Some patients with Severe hearing loss were in the 201, 111 & 112 studies and those are the patients they are referring to in that chart. The Severe hearing loss trial is labeled 113 and is not included in those results so they have not yet disclosed the Severe trial results. We can infer that the trial will likely have at least some success seeing that Severe patients in the other trials saw improvement.
       
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    22. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I thought 201, 111 and 112 trials went up to moderately severe. The only severe trials that have been done are those that are in 113 so when they stated 100% for the severe hearing loss trial, this must be for 113. What we don’t know is if the 100% that experienced improvements in the severe hearing loss trial is true or false.
       
    23. kiki

      kiki Member Benefactor

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      I understand. So it means that it will not be confirmed until the reading of 113 is completed.

      The reason for the white letters.

      111 contained severe.
       
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    24. Chad Lawton

      Chad Lawton Member

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      The 113 data isn't included and there are 3 reasons why I say that.

      1. At the top of the image you provided, 113 is not listed. It only says 201, 111 & 112.

      2. The Open label 111 study did include Severe patients. It says so on slide 10 of the current slide deck posted on their website. For all we know, that 100% bubble in the slide you shared could be 1 patient or it could be a few.

      2. If you look at slide 15 of the current slide deck, it says the N count of patients dosed for the single dose studies combined thus far is 71.

      Phase 1/2 had 15 patients dosed with FX-322
      Open Label 1b had 32 patients dosed with FX-322
      Age related trial had approx 23/24 patients dosed with FX-322

      That adds up to 70/71 patients. If the Severe trial were included in that, that number would be in the mid 90s.

      Current slide deck - https://investors.frequencytx.com/static-files/d0fdfc76-ef0f-426b-8b15-21f4d6ffd61b
       

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    25. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      They’re being transparent. A few patients has severe hearing losses in past trials, 100% saw improvements, but not enough to draw a final conclusion. How is that bad?
       
    26. kiki

      kiki Member Benefactor

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    27. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I mean bad in terms of the 100% for the severe category as we don’t know how many severe participants were in the trial. That 100% could only be 1 patient.
       
    28. Chad Lawton

      Chad Lawton Member

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      But that isn't bad. That at a minimum tells us it has a chance of working on at least some Severe etiologies. We know it was at least 2 patients it worked on. One with noise induced and one with SSNHL.
       
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    29. ringingfeet

      ringingfeet Member

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    30. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

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      I don’t quite understand where exactly this image is from. It’s in vivo but pre-clinical? Is it in something like mice then? Someone please explain.

      6E556638-8563-4A0E-90BC-00058B3C8AA2.png
       
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