Frequency Therapeutics — Hearing Loss Regeneration

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

    1. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

      Location:
      Ireland
      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      Measure it how? What are you measuring? How do you differentiate signals and their meanings? I'm sure if it were easy then it would be known. There are a lot of medical issues that aren't fully comprehended by the medical world.
       
    2. VTae

      VTae Member Benefactor

      Tinnitus Since:
      09/2022
      Cause of Tinnitus:
      ultrasonic dental cleaning
      Perhaps I'm being extremely dumb here, but aren't we debating whether damaged hair cells stop sending signals to the brain, or if they instead send a 24/7 signal? Couldn't that question be easily answered by simply measuring the nerve fibers that come out of the hair cells? I mean, specifically, here:

      R7m0MSMl.jpg

      I don't see how such a thing could be unknown for so long. Either the nerve is firing, or it isn't, right? We know where the nerve is, and we have the tech to measure electric signals, so why can't we just measure it? Is it of hard access, or something like that? Am I completely off the track on my understanding?
       
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    3. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      Cynical viewpoint: If they abandoned FX-322, the share price would tank again and they're all heavily invested. Or maybe they really believe what they're saying? Hope so.
      Clinically significant I would have thought. No point to it if the effect is not worth the effort.
       
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    4. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

      Location:
      Ireland
      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Factory noise + Headphones + Clubbing + Vaccine? + Stress
      It's all surrounded by bone. It is very small and delicate. No chance of being able to measure signals from individual hair cells. Some people got the auditory nerve severed and they still had tinnitus.
       
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    5. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Statistical significance is twice the bar of clinical significance. Clinical significance is considered a 5 word improvement, statistical significance improvement is considered 10+ words.
       
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    6. Nobody19

      Nobody19 Member Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Thank you for correcting me. The results will indeed be published in the second half of next year, not the first.
       
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    7. SmallRonnie
      Ape-like

      SmallRonnie Member Podcast Patron Benefactor

      Location:
      Ireland
      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Factory noise + Headphones + Clubbing + Vaccine? + Stress
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    8. Gorbeh3

      Gorbeh3 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing Loss
      TL;DR: 2023 is do or die for Frequency Therapeutics. There is something here but the results haven't been as consistent as desired and there are a ton of questions remaining. They only have $111M left in cash and operating expense were $98M last year.

      If it doesn't see strong enough results to move towards market or at the least attract further capital it will sit on the shelf for quite while.
       
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    9. Nobody19

      Nobody19 Member Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Even if their hearing drug flops, their MS drug might save them; who knows.
       
    10. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Don't lose the forest for the trees though. They have seen consistent results from their Phase 1/2 study & their open label study where they saw up to a 40% response rate in particular etiologies & severities. It only feels inconsistent because their later probing studies targeted etiologies & severities that weren't included in the earlier studies and it so happens that these populations didn't show a robust response. The chart I have attached breaks down the response rates they've seen by etiology & severity. The orange dotted circle indicates the populations they are targeting for the current 208 trial.

      Funding wise, FREQ has slowed their cash burn rate by laying off 30% of staff as well as subleasing out half of their building to save a few million a year so the company has done a good job trying to preserve capital. They also have $90 million coming to them once Astellas initiates a Phase 2b overseas and another $140 million coming to them when they start Phase 3 so depending on the timing of those payments, they may not need to raise additional funding before FX-322 makes it to market.
       

      Attached Files:

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    11. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      I gotta be careful here. I don't want to be pouring cold water on the efforts of free enterprise who are trying to bring a workable product to the market. They are a welcome addition to the halls of academia who come out with these reams and reams of learned papers but as for curing hearing loss or tinnitus, they don't seem to be able to hack it.

      But to sum up much of the discussion... and I'm sure this has been said before:

      Concentrating on early onset tinnitus... well, a generous percentage of this group are going to be completely cured or they reach habituation anyway in the course of 12 months till chronic status sets in.

      And

      If FX-322 tackles the higher frequencies' hair cells, it should be able to cure or alleviate the high frequency tinnitus patients, no?

      It could very well be that they are on the right track, but that there are some other co-factors involved.

      Roll on the next trials. We gotta stay optimistic.
       
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    12. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Too many people have too high of expectations for this space. Expecting them to cure hearing loss with the first ever drug to be potentially approved in this space is like expecting the field of oncology to have cured cancer on their first try.

      FREQ was the first one that was able to achieve a >2000 fold expansion of cochlear hair cells in the lab. The failure to successfully expand cochlear hair cells in the past was the largest bottleneck that was stifling innovation in the hearing space as it was extremely difficult to get hands on enough cochlear hair cells to be able to successfully test compounds against. Due to FREQ's contribution to the space, it is now much easier for researchers and companies to grow cochlear hair cells to test compounds against.

      Here is the study outlining the process they used:

      Clonal Expansion of Lgr5-Positive Cells from Mammalian Cochlea and High-Purity Generation of Sensory Hair Cells

      So it is not that they contributed a paper or two to the field of hearing loss research, they laid the groundwork that many hearing loss focused biotech companies of today are built upon.
       
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    13. jeff W

      jeff W Member

      Location:
      nakatomi plaza
      Tinnitus Since:
      04/2012
      Tony Ricci, Vestibular nerve caps, type 1 and 2 hair cells. Compound Action Potential (CAP).

      photo_2022-08-17_15-31-15.jpg
       
    14. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      @Chad Lawton, what is it you see in previous FX-322 trials that go above and beyond the results of the OTO-413 trials?

      From memory OTO-413 had 57% responder rates on the safety trial. 40% on the efficacy trial. No failed OTO-413 trials or excuses for failed trials i.e. too many doses, participants lied.

      All I see are weak but maybe positive signals for FX-322.
       
    15. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      I don't really compare OTO-413 to FX-322 as it is comparing apples to oranges in my opinion. They work on completely different parts of the underlying biology. It also depends on which hat you want me to wear.

      If I put on my personal hearing loss/tinnitus sufferer hat, OTO-413 sounds promising but I don't think I will be able to benefit from it. Same goes for FX-322, I doubt I will benefit from it.

      But if you ask me to put on my investor hat which I wear most of the time since I'm heavily invested in FREQ, I think FREQ will be the winner versus OTIC in the long run based on the fact that FREQ's platform is broadly applicable across a wide range of diseases with unmet medical needs where as OTIC has painted themselves into a corner by only focusing on the ear. Plus, FX-322 is barely touching the tip of the cochlea, maybe 15% to 20% of it at best and we are already seeing up to 40% response rate in particular etiologies. So even if the results aren't mind blowing, it is still a giant proof of concept for their technology so I can only imagine what they may be able to achieve once they can get deeper penetration into the cochlea with FX-345 and beyond.

      Serious question, does OTIC have a patent on BDNF injection into the ear? Because I truly don't know if they do or not. I know FREQ has patents on not only the compounds they are using but the pathways they are activating as well. Does OTIC have patents preventing others from trying to put BDNF in the middle ear?
       
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    16. Sunshine007

      Sunshine007 Member

      Tinnitus Since:
      unknown
      Cause of Tinnitus:
      Unknown
      The responder definitions are not the same, Frequency Therapeutics uses the Thornton Raffin scale to classify a responder which is a pretty high bar. If you have a reliable history of word recognition scores and end up being a responder in that scale, that's a very significant response.
       
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