Frequency Therapeutics — Hearing Loss Regeneration

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

    1. StephanieLC

      StephanieLC Member

      Tinnitus Since:
      02/16
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      I don't completely agree with that funny review but I don't think efforts to try to lobby anything would bear fruit.

      Frequency's next step is the IPO, and that is serious business. They won't be giving the drug away to desperate AIDS tinnitus patients in the next 10 years before the clinical trials are formally done with and efficacy proven.

      They are money and investor driven, they are not going to risk any legal trouble.
       
    2. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      Oh well then I guess we shouldn't even try then huh? If you don't want to participate then don't. Just don't fight against those of us that would want to.
       
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    3. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      For now, just do what I'm doing and spam this idea on this thread periodically, the inner hair cell regeneration thread, and other threads where it won't be considered off topic. There are many lurkers on this site and we just have to plant the seed.

      Get on Twitter and spam this idea on all kinds of random threads.
       
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    4. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
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      No significant improvement in audiograms. Which contradicts their whole premise of hearing restoration via regeneration of hair cells. I'm sorry, but that was a big disappointment.
      Not to be a pessimist, but throwing millions of dollars and the brightest minds at something does not guarantee success. Look at Alzheimer's.
      Perhaps with more experimentation FX-322 results will improve. I don't see anything neurotic about that!
       
    5. F-u-T

      F-u-T Member

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      AZ USA
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      10/2018
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      Could FX-322 become available much sooner outside of US through Astellas?
       
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    6. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      You are correct and it is very strange that so many people here are in denial about it. Hearing loss drug that has no impact on audiogram does not need "just some fine-tuning" but requires another 10+ years of development to make it work, if it will work at all.
       
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    7. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      10 dB at 8 kHz is not no impact.
       
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    8. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
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      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      What puzzles me is how they can measure significant improvements in Word Recognization compared to placebo without changes in audiograms.
       
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    9. lobbypolice

      lobbypolice Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      acoustic trauma
      Audiogram tests for less than 50% of the human range of hearing.
       
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    10. FGG

      FGG Member

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      01/2019
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      Exactly. Though up to 8000 Hz is the most important range for speech, higher frequencies help "fine tune" and provide further clarity.
       
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    11. GregCA
      Jaded

      GregCA Member Benefactor Hall of Fame

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      That's a common misconception, due to the fact that we don't hear "linearly". Hearing tests usually cover 5 octaves from 250 Hz to 8 kHz. The "missing part" above 8 kHz is about 1 more octave.

      Not that it's not important, but it is incorrect to represent it as 50%, even though it is technically true. There are more octaves that we are missing below the standard 250 Hz threshold of the test.
       
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    12. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      When I first joined this site I posted my mistrust of this study. I said the companies put out these vague leading positive statements "hinting" at the messiah of all drugs. They then have this golden period where they raise cash. Everyone said "Oh no not these guys, they are a private company."

      So now we see they:
      1: Put out a positive vague statement.
      2: Raised a bunch of cash.
      3: Are going public to raise more cash.
      4: Test is now showing less than believable positive results.

      I hope I was wrong but time will tell.
       
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    13. Daniel Lion
      Ape-like

      Daniel Lion Member Benefactor

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      Sorry,

      I didn’t mean you were neurotic. I was referring to the character on Sesame St. Sincere apology there Flamingo1.

      I still remain optimistic. I am waiting for the next trial when more injections are given. I think that will be really telling. You may be right and I should lower my hopes and really start embracing the idea of hearing aids.

      Again, sorry. My words came at wrong and I appreciate your comments and insight.
       
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    14. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      It's disappointing not to have more conclusive results of success at the first attempt.

      We'll need Phase 2b results to get a better handle on FX-322's efficacy, but even if it fails at that point, it may still not be over.

      I recall reading reports of research into nano particle delivery of drugs into the inner ear by Prof. Andrew Wise at the Melbourne University Bionics Institute.

      He believed drugs that can repair inner-ear nerve damage are already available, but that no-one has yet been able to find a way to get them into the inner ear in the quantity required to work.

      His method injects little 'cake sprinkles' filled with the drug into the ear, which is released over a period of months. That's months! Not an hour or two.

      So perhaps that's where the solution may lie. Keeping the goop in the cochlea long enough for it to take effect.

      To lift the mood, on another note, we've still got Audion Regain's results to come. The news might be more hopeful there.
       
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    15. Daniel Lion
      Ape-like

      Daniel Lion Member Benefactor

      Location:
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      Hearing Restoration and Hair Cell Regeneration Symposium on October 8th in NYC.

      I believe William McLean from Frequency Therapeutics will be speaking. I can’t go, it is too far for me... but perhaps somebody could go who lives within striking distance. It could potentially be really informative. I need to check again, one may be able to purchase access through a “webinar”.

      I was just skimming over the thread @Hazel posted under Research News. One of the first quotes under the bio pharmacology section said it can take a drug 12 years from lab to patient and cost as much as 2.6 billion dollars... interesting.

      On a personal note, I’d like to apologize again for getting carried away. My hearing loss is really bad, and I just need to push on and accept that. My emotions get the better of me. Thank you all for understanding.
       
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    16. Coleoptere
      Alone

      Coleoptere Member

      Location:
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      Cause of Tinnitus:
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      So then they should also have audiogrammed the Phase 1B patients for 8 kHz to 16 kHz before and after. That would proof that FX-322 is working but something in the delivery should be tuned like @JohnAdams suggested earlier. Think for example exposure time or other variations that would satured the lower frequencies as well. The upcoming 2A does not show that variation though.
       
    17. sakrt
      No Mood

      sakrt Member

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      I don't understand the logic to this going on in 2017, when implant surgeries are known to further destroy the inner ear along with adding other possible complications.

      Why not aim to work at regenerating the ear(s) of those with SNHL to it's healthier natural state first without doing invasive implants? Was this tried prior 2017? That makes more sense.
       
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    18. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
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      No need to apologize, Daniel. You always bring up very good points and help to keep the discussion moving.
       
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    19. Daniel Lion
      Ape-like

      Daniel Lion Member Benefactor

      Location:
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      Thanks Flamingo1.
       
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    20. KJS

      KJS Member

      Tinnitus Since:
      July 2018
      Cause of Tinnitus:
      Had been under stress, anxiety, zoloft, slight hearing loss
      I would imagine they tested cochlea implant patients first since the first phase as a safety test. I assume they figured that a person's ear was completely damaged already so they want to make sure the drug would not cause more issues.

      The next phase will have patients that have stable SSNHL and testing efficacy at dosage levels and intervals will more closely aligned to what they are trying to solve.

      I believe the IPO is a good sign. While not in pharmaceutical industry I have been with several tech companies that went from start-up to IPO and in order to go public they had to have shown technical solution with broad market acceptance in order for the investors to get behind. The IPO was NOT an exit but a new beginning. Both of those companies have gone on to become multi-billion revenue and gained significant market share since their IPOs.

      If Frequency Therapeutics was trying to do something that not other animal species had ever proven to do then maybe the chance of success would be really low, but they know how other species do re-generate hearing. Humans have that same mechanism so I have to believe they will get it right... just when is the big question. I choose to stay bullish on them.
       
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    21. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      That is not statistically significant. Most of the patients didn't get any impact on any of the tested frequencies.

      I wanted them to succeed as much as you do but the audiogram results don't lie. They are trying to hide this fact by diverting attention to word scores which is pathetic.
       
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    22. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      While this could actually be true, I think it is too early to make such a declaration.

      "Quote da waben, NEBERMORE"
      -Jan Terri
       
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    23. FGG

      FGG Member

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      The word scores are not to be ignored, though. The p value was 0.01, which means these results were very unlikely to be due to chance.

      One possible way to interpret this is that the drug works but doesn't diffuse far enough in the dose provided for the safety study (ie only frequencies higher than 8 kHz were involved except for those 4 who got 10 dB improvements).

      Since the speech in noise scores also improved, it may have an even greater effect on synaptic connections than the hair cells. So many unknowns but with the p value provided, it is statistically unlikely the drug has no effect on hearing.
       
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    24. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      Do we know if they even tested higher frequencies than 8 kHz? That's a super question right there because if they didn't, then there could have been significant increases which would easily explain the word recognition scores.
       
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    25. FGG

      FGG Member

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      My hunch is it's unlikely they tested the higher frequencies.

      Per the otologist I saw at Hough, the reason most audiograms are only up to 8 kHz is not just because of the limitations of hearing aids, but it's much more difficult to calibrate that high. That's why only a few centers offer it. If the trial took place at centers that didn't offer high frequency audiograms *or* if the patients didn't have a baseline before treatment (very likely the case) because they didn't have the higher values as part of the safety trial design, then you couldn't get this information. Above 8000 Hz is not part of a standard audiogram, even in most big name centers, so you couldn't even base your trial participant selection on it.

      It's interesting that up to 16000 Hz is part of the investigational part of the next trial though.
       
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    26. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

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      I hope they didn't use the same words from the first test to the second after the injections... If you take one word score test, you naturally do better on the second because you know what to expect. If you know what words to expect it just made it a whole lot easier... Even the placebo group scored better on the word scores the second time... The control group did have better scores than the placebo group so that is a good sign. Agreed that the higher frequencies help fine tune wording understanding. Maybe 8 to 16 kHz saw some improvement.

      I'll stay optimistic, but I'm a lot more grounded after reading those results. I was really hoping for something better on the audiogram test.

      Did anyone read the risks on the IPO... Ouch.
       
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    27. Coleoptere
      Alone

      Coleoptere Member

      Location:
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      @JohnAdams: That's the major Q indeed. An easy test by the way which they should have included provided they didn't.
       
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    28. Coleoptere
      Alone

      Coleoptere Member

      Location:
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      2002
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      You are spot on :)
       
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    29. andreimatei

      andreimatei Member

      Tinnitus Since:
      May 2018
      Cause of Tinnitus:
      Ototoxic Antibiotics
      Guys, I think there is cause for optimism here. I know we all wanted to see massive improvements in audiograms, but we aren't there yet without more doses. I think the below quotes from the findings are important. And, if they weren't on to something here, would they really be moving towards IPO?

      "We believe that FX-322 has the potential to meaningfully improve overall hearing function and significantly enhance quality of life for patients with hearing loss."

      "We also performed a post hoc analysis that showed a statistically significant improvement in WR by all FX-322-treated patients versus all placebo patients (p=0.01)"

      "FX-322 treated patients saw improvements as early as 15 days after treatment that were sustained over 90 days."


      And it seems to work for hearing loss caused by ototoxic meds as well (at least in mice) and not just sound-induced...

      "To cause hair cell loss, we exposed the cochlea for 16 hours to an aminoglycoside antibiotic that is toxic to hair cells. We then treated the cochlea for 72 hours with the compounds comprising the active agents in FX-322. Aminoglycoside treatment (left panel in the figure below) killed more than 80% of the hair cells in the cochlea (shown in green). By contrast, cochlea treated with the compounds in FX-322 (shown in the middle panel) regenerated hair cells to a near native level, as shown graphically in the right panel."

      It's also helpful to know that we'll have phase 2a results second half of 2020. I guess we won't know if they are gonna go 2b or 3 until that time.

      Someone call me out if you don't view this as cautiously positive!
       
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    30. jeff W

      jeff W Member

      Location:
      nakatomi plaza
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      04/2012
      They are years ahead in ear research and clinical testing. Only dedicated MD lab in the world.
       
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