Frequency Therapeutics — Hearing Loss Regeneration

#14,431
Bill Arsenault said:
We also don't yet know for sure that hair cell death is the only cause of tinnitus.
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Never said it was. It's already common knowledge it's not the only cause of tinnitus.
Bill Arsenault said:
Anything that poisons any part of the inner ear in anyway can be defined as Ototoxic. I believe that medication is causing a quite a bit of it- or even cigs and alcohol- regardless of what we are being told by the experts.
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Cigs have been shown to have a link (poison) to effects on the inner ear. I don't believe antidepressants have though. If you can link me direct evidence/research that would be great.

From my understanding even the link to actual toxicity within the brain from antidepressants is still debatable, but we're talking about the inner ear here.

Tinnitus originates from the brain and the effect antidepressants have on tinnitus are within the brain, not the ear as far as I am aware. So im not sure how it can be deemed ototoxic when ototoxicity is toxicity to the ear.
 
#14,432
Pero1234 said:
I had set a stop limit order for Otonomy prior to their Phase 3 news. But indeed, news came out after market hours.

When the markets opened, they opened lower than my stop limit, so I sold nothing. Still holding now.

I am a bit hesitant putting in a stop loss for FREQ, as it can sell for way below your purchase price, right? Depending on how fast the drop goes.

My average purchase price is about $24 USD. I don't want to end up selling everything at $8, $4 or $2 USD. Perhaps if I hold it will bounce up again later, with another product in the pipeline.

So I am in doubt over a stop loss... What are the rest of you FX-322 investors doing?
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I own 300 shares, averaged in at $50.00. The Phase 2A news will either make or brake the stock in 2021 in my opinion. If the news is good this could easily hit over $100 per share. Fingers crossed, I'm more interested in the meds working than the money. I'll take quality of life over money any day of the week. Money comes and goes. Health is wayyy more important!
 
#14,433
Is there any chance the Military/VA intervenes to make it available ASAP? Maybe even skip Phase 3?

I ask because I remember reading somewhere (I could be completely wrong) that FREQ took funding from the military back in the day, so the military could knock on their doors and collect their dues.
 
#14,435
AfroSnowman said:
I asked my audiologist about my extended audiograms where I clearly have some hearing loss and asked her how bad it was was. She said that it was hard to answer because there really aren't accepted medical standards for what hearing sensitivity at those ranges are supposed to be.

Is this right or is the 20 dB of loss still considered the standard?
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Partially true:

Frequency sensitivity in mammalian hearing from a fundamental nonlinear physics model of the inner ear

The cochlea is not uniformly sensitive to all frequencies and there is some genetic variability. I personally think measuring 16000 Hz to 20000 Hz is mostly useless but measuring up to 16000 Hz is very much not.
 
#14,436
Brian Newman said:
I heard 2023 but yeah I don't know if I could make it another 10 years. I hope sooner.
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#14,437
AfroSnowman said:
I asked my audiologist about my extended audiograms where I clearly have some hearing loss and asked her how bad it was was. She said that it was hard to answer because there really aren't accepted medical standards for what hearing sensitivity at those ranges are supposed to be.

Is this right or is the 20 dB of loss still considered the standard?
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A video was linked many pages back where this was discussed. It was believed that the sensitive range for "normal" may be wider and sloped. So, at say, 14 kHz normal might be 0 dB - 30 dB and 16 kHz might be 10 dB - 40 dB.
 
#14,438
Tezcatlipoca said:
Some guy on Twitter said that he "heard" FX-322 will be available "at the very least" in 2030, even Carl LeBel has pushed back the date by mid decade on his conservative estimate; more evidence on how much misinformation and ignorance the general public has on the drug.
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I saw that tweet, from "GM", who claims he/she heard it from someone... Yeah whatever, GM. I think Carl LeBel was just being cautious when he said mid-decade. I'm still hoping for 2023.
 
#14,441
Zugzug said:
To anyone who bought a bunch of stock:

Are you checking for news like every minute? I imagine if it's bad, you want to be the first to sell, right?
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I bought a pretty sizable amount of stock early on. I am in it for the long haul. I think FX-322 will be a winner at the end of the day.
 
#14,442
tracyNYC said:
I saw that tweet, from "GM", who claims he/she heard it from someone... Yeah whatever, GM. I think Carl LeBel was just being cautious when he said mid-decade. I'm still hoping for 2023.
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If the current trial shows only improvements above 8 kHz, they could still make Phase 3 and bring it to market afterwards, or am I mistaken? In this case we will have FX-322 already in 2023 but it will only help a special subgroup of us. I think it is clear, that they will try to make a better version to reach all the way down in the cochlear, which might then take a few more years.

What might be interesting is how OTO-6xx will perform. If it works as good as FX-322 but uses from the very beginning a better delivery method which reaches all the way down, maybe they could still outperform FREQ in the long run?
 
#14,445
Koz said:
Never said it was. It's already common knowledge it's not the only cause of tinnitus.

Cigs have been shown to have a link (poison) to effects on the inner ear. I don't believe antidepressants have though. If you can link me direct evidence/research that would be great.

From my understanding even the link to actual toxicity within the brain from antidepressants is still debatable, but we're talking about the inner ear here.

Tinnitus originates from the brain and the effect antidepressants have on tinnitus are within the brain, not the ear as far as I am aware. So im not sure how it can be deemed ototoxic when ototoxicity is toxicity to the ear.
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Interesting stuff and thanks for clarifying.

Fully realize you never said it was - and I was not trying to contradict you in anyway.

A lot of things are put forth as common knowledge on tinnitus by the experts.
And yet they all still say different things.

I believe there are very limited number of people who actually know for sure what really triggers the ringing to become permanent, where it comes from in the brain/ears and how it can be silenced.

Unfortunately it's still a baffling and insidious affliction and it's getting very late in the game for many of us here.
 
#14,446
spacehunter said:
If the current trial shows only improvements above 8 kHz, they could still make Phase 3 and bring it to market afterwards, or am I mistaken? In this case we will have FX-322 already in 2023 but it will only help a special subgroup of us. I think it is clear, that they will try to make a better version to reach all the way down in the cochlear, which might then take a few more years.

What might be interesting is how OTO-6xx will perform. If it works as good as FX-322 but uses from the very beginning a better delivery method which reaches all the way down, maybe they could still outperform FREQ in the long run?
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Yes, they can still push FX-322 to Phase 3 if it only shows EHF improvements. It would also show word score and words-in-noise improvements as well if that is the case. Also, the data from the two Phase 1B trials would also add to the data needed to advance the drug (assuming a similar Phase 1/2 outcome).
 
#14,447
Keith Handy said:
Do the right people in the Military/VA know this exists? Who do we contact? We need all the voices we can get.
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Yes, they do. In 2018, they received a grant from the Department of Defense for development of the PCA platform. This would be after the Phase 1 had shown promising results.
 
#14,454
I don't want to derail the thread but I see parallels between this talk of stock and discussions on Tesla forums. What tends to happen is people gravitate towards a company because they are working on something they may want for its own intrinsic value. Then they feel somehow compelled to buy stock in the company, to put their money where their mouth is, so to speak. But the moment they do that they are assuming conflict of interest. So before you know it Tesla fanbois are marginalizing reports of screens going blank, bumpers falling off, rear windows cracking, and even people dying with autopilot sending cars into gore-points.

So I guess it's sort of a pet-peeve of mine to see threads like these start to get dominated by what I would consider more investor discussions rather than tinnitus sufferer discussions. Sure, there is overlap, but anytime I know someone has stock, what they're saying is inherently biased, even more than tinnitus sufferers desperately seeking reason to hope.
 
#14,455
GlennS said:
I don't want to derail the thread but I see parallels between this talk of stock and discussions on Tesla forums. What tends to happen is people gravitate towards a company because they are working on something they may want for its own intrinsic value. Then they feel somehow compelled to buy stock in the company, to put their money where their mouth is, so to speak. But the moment they do that they are assuming conflict of interest. So before you know it Tesla fanbois are marginalizing reports of screens going blank, bumpers falling off, rear windows cracking, and even people dying with autopilot sending cars into gore-points.

So I guess it's sort of a pet-peeve of mine to see threads like these start to get dominated by what I would consider more investor discussions rather than tinnitus sufferer discussions. Sure, there is overlap, but anytime I know someone has stock, what they're saying is inherently biased, even more than tinnitus sufferers desperately seeking reason to hope.
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Tesla bears and bulls are *especially* obnoxious in ways I can't imagine this ever becoming but I do see your point.

I think there is some value to sufferers when talking about the financial planning of a company because funding can affect the scope and timing clinical trials (like you said, there is overlap) but every time the stock goes up or down and someone does a double rainbow style "but what does it mean???" it does kind of derail things a bit.
 
#14,458
GlennS said:
I don't want to derail the thread but I see parallels between this talk of stock and discussions on Tesla forums. What tends to happen is people gravitate towards a company because they are working on something they may want for its own intrinsic value. Then they feel somehow compelled to buy stock in the company, to put their money where their mouth is, so to speak. But the moment they do that they are assuming conflict of interest. So before you know it Tesla fanbois are marginalizing reports of screens going blank, bumpers falling off, rear windows cracking, and even people dying with autopilot sending cars into gore-points.

So I guess it's sort of a pet-peeve of mine to see threads like these start to get dominated by what I would consider more investor discussions rather than tinnitus sufferer discussions. Sure, there is overlap, but anytime I know someone has stock, what they're saying is inherently biased, even more than tinnitus sufferers desperately seeking reason to hope.
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This is fair and something I worry about.

However, this is why almost all of my focus has been on the pharmacokinetics study. I have many critical questions that I would ask them if I was in the room with them regarding their simulations using FluidSim v3.24. In my opinion, this is kind of everything since the medicine does induce PCA (proven). All of the unknowns pertain to the complicated physics within the cochlea and elimination rates.

The other big question is "does PCA really fix tinnitus, major hearing problems, and hyperacusis?" I think this question could lead to answering it with our hearts to some degree. I think most people agree that tinnitus is not "stuck in the brain," but that doesn't mean the story isn't more complicated. For example, maybe many brains need FX-322 to be far more effective than it actually is to greatly improve tinnitus. Maybe it's not "stuck in the brain" but requires a pretty long time for the brain to reconfigure to the improved healing signal. Maybe the "sweet spot" where FX-322 improves tinnitus the most is in a time frame that is beyond the study's timeline since tinnitus is only a secondary end point?

I do think we should be really cautious about expecting miraculously audiogram threshold shifts. The Phase 1/2 thresholds at 8 kHz were not statistically significant. While the EHF range is closer to the base (so much more likely to be improved by the drug), I think we should control our expectations for threshold shifts.
 
#14,460
Zugzug said:
This is fair and something I worry about.

However, this is why almost all of my focus has been on the pharmacokinetics study. I have many critical questions that I would ask them if I was in the room with them regarding their simulations using FluidSim v3.24. In my opinion, this is kind of everything since the medicine does induce PCA (proven). All of the unknowns pertain to the complicated physics within the cochlea and elimination rates.

The other big question is "does PCA really fix tinnitus, major hearing problems, and hyperacusis?" I think this question could lead to answering it with our hearts to some degree. I think most people agree that tinnitus is not "stuck in the brain," but that doesn't mean the story isn't more complicated. For example, maybe many brains need FX-322 to be far more effective than it actually is to greatly improve tinnitus. Maybe it's not "stuck in the brain" but requires a pretty long time for the brain to reconfigure to the improved healing signal. Maybe the "sweet spot" where FX-322 improves tinnitus the most is in a time frame that is beyond the study's timeline since tinnitus is only a secondary end point?

I do think we should be really cautious about expecting miraculously audiogram threshold shifts. The Phase 1/2 thresholds at 8 kHz were not statistically significant. While the EHF range is closer to the base (so much more likely to be improved by the drug), I think we should control our expectations for threshold shifts.
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I'm glad you brought this up, because I think people need to tame their expectations regarding any tinnitus data for the first (90-day) readout. It wouldn't surprise me if we saw no changes or even some kind of worsening while the brain rewires itself, assuming of course the drug does work in some cases of tinnitus. I will be holding my breath regarding tinnitus until the full read out.

As for only 4/15 patients seeing improvement at 8 kHz, it is important to remember that 7 of those patients received the low volume dose, which was 0.05 ml. Unfortunately there's nothing to suggest whether those 4 patients were also the ones who received the high dose, but this is something that I'd definitely be curious to know.

I do think the dosage differential though in Phase 1 is something that hasn't been spoken about much on here. I can only assume Frequency Therapeutics have gone with the high dose for Phase 2 (0.2 ml), so perhaps this is also another reason to be hopeful with regards to data readout. Having said all this, I must wonder why Frequency Therapeutics wouldn't make the point that the 4 patients who saw a benefit at 8 kHz were also the ones who received a higher dose, unless of course that wasn't the case. If it was, that would seem like quite a glaring oversight to make.
 

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