Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Foamearplugssuck
      Angry

      Foamearplugssuck Member

      Location:
      new dorp new york
      Tinnitus Since:
      05/26/19
      Cause of Tinnitus:
      Doing concert photography
      I hope I'm reading incorrectly. Please someone tell me that my reading comprehension skills got fucked up in a bizarre turn of events and I come to only understand the opposite of things.

      Investigation announced for Long-Term Investors in Frequency Therapeutics, Inc. (NASDAQ: FREQ) over potential Wrongdoing
      Great, great, great, sounds fucking great. All the hope and buzz was nice while it lasted.

      *Turns to Otonomy*

      thelasthope.jpg
       
      • Like Like x 4
      • Funny Funny x 3
      • Hug Hug x 1
    2. 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
      This is old news. It has been going on since March, and heavily discussed here, and mentioned in the firm’s quarterly filing to investors.

      Yet, the severe trial still has results TBD, they have an upcoming R&D event, and are planning a second Phase 2 for FX-322 to be announced in Q4.
       
      • Like Like x 6
    3. Foamearplugssuck
      Angry

      Foamearplugssuck Member

      Location:
      new dorp new york
      Tinnitus Since:
      05/26/19
      Cause of Tinnitus:
      Doing concert photography
      .........oh.

      I got it as a Google alert last night, so I assumed otherwise. I'll have to do a better job of searching for mentions of these kinds of updates on here in the future.
       
    4. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Not to mention that there tends to be little merit to their claims and little evidence it will succeed either. Essentially it just looks like they are fishing for claims. They are going to have to demonstrate that Frequency Therapeutics exaggerated claims and presently there is very little evidence to say they did, and no statements from this group to say why Frequency Therapeutics did either.
       
      • Like Like x 1
      • Agree Agree x 1
    5. r34d1ng

      r34d1ng Member

      Tinnitus Since:
      Unknown
      Cause of Tinnitus:
      Unknown
      Frequency Therapeutics Announces New FX-322 Results Showing That Additional Study Participants Gain Hearing Improvements at Later Time Points

      LEXINGTON, Mass.--(BUSINESS WIRE)--Sep. 22, 2021-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore human function, today announced that four additional sensorineural hearing loss (SNHL) subjects from its FX-322-111 open-label study achieved statistically significant hearing improvements when evaluated 8 to 12 months following initial dosing.

      Including the five initial responders, there are now a total of nine subjects that participated in the FX-322-111 study (n=32) that have been shown to have statistically significant improvements in word recognition scores, a key measure of speech perception, at time points between 90 days and one year.

      These new results suggest that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods. The longer-term measures of their treated ear demonstrated word recognition score improvements when compared to pre-treatment baseline levels and no significant changes were detected in their untreated ears. Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance.

      [...]
       
      • Like x 6
      • Winner x 2
      • Informative x 2
      • Agree x 1
      • Hug x 1
    6. 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
      Looking forward to seeing that data.
       
      • Agree Agree x 10
      • Like Like x 2
      • Winner Winner x 1
    7. rei

      rei Member Benefactor

      Tinnitus Since:
      2006 but not a problem till 10/19
      Cause of Tinnitus:
      loud music spiked with lyme disease
      Looks like the ear fertilizer needs a little time to get the lawn growing. Today is a good day.
       
      • Agree x 9
      • Like x 1
      • Winner x 1
      • Friendly x 1
      • Optimistic x 1
    8. Zugzug

      Zugzug Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      05/2019
      Cause of Tinnitus:
      Autoimmune hyperacusis from Sjogren's Syndrome
      Here's what confuses me. Four out of four available responders return at months 8-12 and see enough regression to be within their baseline margin of error. So in one breath, they are saying gains are maxed at a few months before they become trivial.

      Then they are also saying that four different patients saw their major improvements later on that were observed at months 8-12. Are we to then predict that at months ~16-24 (so 8-12 months after their "response" recording at 8-12 months), these people should also regress to their original baseline margin of error?

      What are we seeing here? It doesn't make any sense to me. So an equal number of people improve as regress in an open-label study. Seems pretty unclear if this means anything.
       
      • Good Question Good Question x 6
      • Agree Agree x 3
    9. F-u-T

      F-u-T Member Podcast Patron Benefactor

      Location:
      AZ USA
      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Acoustic Trama
      Is this good news? Curious why the stock dipped on this news. I would think it would be positive but I digress.
       
      • Good Question Good Question x 1
    10. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Great news, and then this in the middle of the press release:

      “Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance.”

      What the hell is going on with this drug?
       
      • Agree Agree x 3
      • Funny Funny x 2
    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
      IMO - The severity of the hearing loss may be a factor.
       
      • Useful Useful x 1
    12. Tau
      In pain

      Tau Member

      Location:
      Europe
      Tinnitus Since:
      2019
      Cause of Tinnitus:
      2019-Concert, 2021-headphones/acoustic trauma at 110dB,16kHz
      Maybe synapses are not restored in large enough numbers even after the growth of new IHCs? I see no PTA results, I would expect the audiograms to be at least slightly better.
       
    13. ploughna

      ploughna Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      motor racing and power tools
      Just thinking out loud here, but if they were only barely above the statistically significant threshold to begin with, it wouldn't take much of a reduction in improvement to put them below it. IIRC, the long term measurements of the phase1 participants all showed small reductions over time, but those results were a lot stronger leaving those patients still safely in positive territory. Bottom line seems to be more testing needed!
       
    14. Philip83
      Jaded

      Philip83 Member Podcast Patron Benefactor

      Location:
      Sweden
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Moped (2001) Noise blast (2014) Club (2017) Snowboard (2018)
      Yeah, this is very confusing, and not very assuring, to me as well...
       
      • Agree Agree x 2
      • Hug Hug x 1
    15. ColinUK

      ColinUK Member

      Tinnitus Since:
      2013 initial, worsened 2020
      Cause of Tinnitus:
      Initial Music Gig, Worsened Cinema or possible covid
      Just let's all get injected and see what happens :wacky:
       
      • Like Like x 3
      • Funny Funny x 2
      • Agree Agree x 1
    16. Ed209

      Ed209 Member Podcast Patron Benefactor Ambassador Hall of Fame

      Tinnitus Since:
      07/2015
      I think we have to wait and see what comes out. I'm not their greatest fan when it comes to communication, but I'm interested to learn more.
       
      • Agree Agree x 1
    17. Cernuto
      Spaced

      Cernuto Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise Induced
      Clearly Frequency Therapeutic botched the clinical.
      Yes, and I don't even care about the hearing loss aspect of it.
       
    18. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Why do you think Frequency Therapeutics botched the clinical?
       
    19. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      This is somewhat inline with their Phase 1/2 results where most of the patients saw a small regression after a year or two but 3 of the 5 patients still managed to stay in the statistically significant category. Maybe some of the initial benefit fades after awhile but you are still better off than before you go the drug.
       
      • Like Like x 1
      • Agree Agree x 1
    20. patorjk

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      It looks to me like they're spinning the news and burying the lede. I saw the headline and thought it was good news, I was confused as to why the stock dropped. Then I read the full release and saw that sentence. It's very disconcerting. It almost seems like the threshold they're using for statistical significance is too low and it's capturing noise. I suppose they do have the untreated ear to act as a placebo, but are they injecting anything into that ear (i.e, do the patients know which ear gets the drug)?
       
    21. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      They definitely put a spin on the headline. Getting kinda tired of this drug. No PTA improvements and no durable word scores. It’s ridiculous when compared to the hype when this all started.
       
      • Agree Agree x 5
    22. Cernuto
      Spaced

      Cernuto Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise Induced
      Two reasons. Poor job of weeding out candidates and a poor dosage schedule.
       
    23. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      The candidacy issue is indeed Frequency Therapeutics' issue.

      The dosage schedule not so much. Majorly difficult to know and/or predict how a medicine will operate until it is trialled.
       
    24. kiki

      kiki Member Benefactor

      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      noise
      Did they measure PTA in FX-322-111?

      Or are they not announcing it because there are no significant improvements?
       
    25. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      Pure bullshit spin. Nine people achieved statistically significant improvements at some point in the trial! Pity that at least four of them fell below statistical significance later on. Put it in two separate paragraphs and hope nobody notices.
       
      • Agree Agree x 4
      • Like Like x 2
    26. aorelia

      aorelia Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Headphones
      Interesting results. I wonder if any of these participants that had improvements in hearing had tinnitus as well.
       
      • Good Question Good Question x 2
    27. Cernuto
      Spaced

      Cernuto Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise Induced
      How about don't do another dose until the current dose shows efficacy and stabilization? What's majorly difficult to know about that?
       
    28. Ed209

      Ed209 Member Podcast Patron Benefactor Ambassador Hall of Fame

      Tinnitus Since:
      07/2015
      This is what I’ve never liked about the company; they are never clear and consistent with their information. If you say that here, though, you can expect to get a hard time about it. Some of their previous news outputs have been so unclear that it has led to pages of debate and speculation on here. I want to see detail beyond their latest news statement before I pass judgement.

      As for the stock, I didn't like how the directors were dumping theirs. It's not a good look for an early-stage biotech company. If they were confident about what they had, they'd be holding onto that shit.
       
      • Agree Agree x 3
    29. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I don't think that there was any evidence at the time to demonstrate that the multi dosing would result in adverse outcomes which was why Frequency Therapeutics ran with it.

      It is also the case that Frequency Therapeutics did do only single dosing as an element of their mucked up Phase 2 trial too. The troubles with the outcomes appear on face value to stem from the way they determined the participants much more so that with the dosing.

      Which is also consistent with their claims/theory that there would be a need to obtain booster/follow up dosings.
       
    30. grate_biff
      Depressed

      grate_biff Member Benefactor

      Location:
      Moss, Norway
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma and/or benzo withdrawal
      Poor delivery, maybe too weak concentration of compound!
       
      • Winner Winner x 2
Loading...

Share This Page