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Frequency Therapeutics — Hearing Loss Regeneration

#18,272
Gb3 said:
Did Frequency Therapeutics claim FX-322 improved hearing thresholds before?
Click to expand...
They had shown the small handful (I think 3 or 4?) of patients that sustained a threshold improvement of 10 dB+ at 8 kHz on the audiogram. However, those outcomes at the group-level are not statistically significant, so that is why they do not make the claim.
 
#18,273
Notes from the Goldman Q&A today:

Overview:
  • Over 200 patients + data points have received FX-322
  • Largest known database of patients receiving a treatment for hearing loss

Phase 2A details:
  • Plan to disclose in 2H/2021

Phase 1B studies (ARHL/severe):
  • Exploratory focus to understand patient populations for future Phase 2/3 design
  • All have lead-in measures to eliminate bias seen in Phase 2A

Specific patient etiologies that appear to be best candidate to respond to drug with single dose:
  • Moderate -> Moderately Severe hearing loss (Severe TBD)
  • Permanent NIHL or SSNHL
  • Association with a noise trauma
  • Analysis of 200+ patient database is ongoing to better define makeup of responders for inclusion in future trials

What to expect from future Phase 2/3 design:
  • Lead-in period with multiple baseline measures
  • Focus on single dose
  • Speech perception
  • Using other long-term measures not currently used in trials (didn't disclose what those are)

On expanding the Hearing Program and team:
  • Continued support from Langer + Board + Clinical advisory panel to proceed with FX-322 single dose trials
  • Continued support from external experts and consultants in the field
  • Two studies that show signal are enough to proceed - "No doubt they should expand clinical trial."
  • Continuing to expand Frequency team focusing on Drug Delivery + Audiology

ENT/audiologist/community awareness:
  • Many are following work closely
  • Shift to useage in the clinical setting is a focus of the firm
  • They are still working on creating inroads with Audiologist field
  • Voice of patient is becoming front-and-center

Other hearing related PCA approach efforts:
  • Other efforts in-discovery in the hearing program (TBD: 2H/2021)
  • Focusing on other pathways+Drug delivery

R&D Day is 2H/2021? Assuming this will be like Tesla Battery Day?

Capital to fund the firm:
  • Have 2 years of cash
  • Can still get cash payment milestones from Astellas
  • May leverage dilution to get additional funding if needed
 
#18,284
Diesel said:
Notes from the Goldman Q&A today:

Overview:
  • Over 200 patients + data points have received FX-322
  • Largest known database of patients receiving a treatment for hearing loss

Phase 2A details:
  • Plan to disclose in 2H/2021

Phase 1B studies (ARHL/severe):
  • Exploratory focus to understand patient populations for future Phase 2/3 design
  • All have lead-in measures to eliminate bias seen in Phase 2A

Specific patient etiologies that appear to be best candidate to respond to drug with single dose:
  • Moderate -> Moderately Severe hearing loss (Severe TBD)
  • Permanent NIHL or SSNHL
  • Association with a noise trauma
  • Analysis of 200+ patient database is ongoing to better define makeup of responders for inclusion in future trials

What to expect from future Phase 2/3 design:
  • Lead-in period with multiple baseline measures
  • Focus on single dose
  • Speech perception
  • Using other long-term measures not currently used in trials (didn't disclose what those are)

On expanding the Hearing Program and team:
  • Continued support from Langer + Board + Clinical advisory panel to proceed with FX-322 single dose trials
  • Continued support from external experts and consultants in the field
  • Two studies that show signal are enough to proceed - "No doubt they should expand clinical trial."
  • Continuing to expand Frequency team focusing on Drug Delivery + Audiology

ENT/audiologist/community awareness:
  • Many are following work closely
  • Shift to useage in the clinical setting is a focus of the firm
  • They are still working on creating inroads with Audiologist field
  • Voice of patient is becoming front-and-center

Other hearing related PCA approach efforts:
  • Other efforts in-discovery in the hearing program (TBD: 2H/2021)
  • Focusing on other pathways+Drug delivery

R&D Day is 2H/2021? Assuming this will be like Tesla Battery Day?

Capital to fund the firm:
  • Have 2 years of cash
  • Can still get cash payment milestones from Astellas
  • May leverage dilution to get additional funding if needed
Click to expand...
Awesome summary. Thank you.
 
#18,285
Diesel said:
  • Using other long-term measures not currently used in trials (didn't disclose what those are)
Click to expand...
This makes my eyes roll. "Other long-term measures" like, maybe, um... an audiogram? You know, the go-to metrics for audiologists to determine how well you hear??? Is that too much to ask?

giphy.gif


This avoidance of audiograms as a metric is my #1 red-flag for this company.

They're beating around the bush because they know that audiograms will show little to no hearing improvement (extended audiogram or no).
 
#18,286
GlennS said:
This makes my eyes roll. "Other long-term measures" like, maybe, um... an audiogram? You know, the go-to metrics for audiologists to determine how well you hear??? Is that too much to ask?

View attachment 45294

This avoidance of audiograms as a metric is my #1 red-flag for this company.

They're beating around the bush because they know that audiograms will show little to no hearing improvement (extended audiogram or no).
Click to expand...
I'm not sure what you mean? Audiogram is being used in all the trials. So measures other than audiogram are in consideration for these other Phase 2 trials. No follow up question was asked on this during the Q&A.
 
#18,287
GlennS said:
This makes my eyes roll. "Other long-term measures" like, maybe, um... an audiogram? You know, the go-to metrics for audiologists to determine how well you hear??? Is that too much to ask?

View attachment 45294

This avoidance of audiograms as a metric is my #1 red-flag for this company.

They're beating around the bush because they know that audiograms will show little to no hearing improvement (extended audiogram or no).
Click to expand...
You never ever complete your thoughts. It's like right when the critical thinking stage starts, you peace out.

Ask yourself this. What do you want achieved by the company ignoring other metrics? Do you think that Will McLean and Robert Langer are scam artists? Do you think McLean sits in the lab and goes "No! I don't want audiogram improvements. That would be horrible. Fuck man, I had goals, but an improved audiogram is just too rich for my blood"?

Or is it more likely that he's shooting for audiogram improvements, but will be happy for the drug to succeed on some level so that he can get the drug to market, obtain more funding, and, in turn, help you get your sexy audiograms?

Do you think Robert fucking Langer advises this situation and says "Whatever you do, no audiograms"?

Holy shit man, science is hard. It really is. You think these additional metrics are some sort of grand cover up or something. It's the total opposite. They are introducing them out of competency.

Can you please explain to me where I am incorrectly interpreting your posts? Where is the value in saying audiograms or bust?
 
#18,290
People just bitch because of massive disappointment. For many here FX-322 is like a very bad break up... I hated my ex girlfriend even after 5 years. Hopefully we can look back and say it didn't matter one bit.

Frequency Therapeutics does the best they can with what they have on hands.

The stock price is revealing.
 
#18,291
Zugzug said:
Do you think Robert fucking Langer...
Click to expand...
What I see here is someone giving a company trying to survive wwwwaaaayyyy too much benefit of the doubt and ascribing too much good-faith.

Try to look at it from the vantage point of those with hearing damage, not the corporate board. Patients judging this treatment are going to want to see improvements in the audiogram before anything else.

giphy.gif


The omission of the audiogram to the point of not even including the word is suspicious in the extreme. It's trying to steer and spin around a lack of efficacy. You may not want to see that, but that's how it is to anyone who hasn't decided for whatever reason to circle wagons around FREQ.
 
#18,292
Zugzug said:
You never ever complete your thoughts. It's like right when the critical thinking stage starts, you peace out.

Ask yourself this. What do you want achieved by the company ignoring other metrics? Do you think that Will McLean and Robert Langer are scam artists? Do you think McLean sits in the lab and goes "No! I don't want audiogram improvements. That would be horrible. Fuck man, I had goals, but an improved audiogram is just too rich for my blood"?

Or is it more likely that he's shooting for audiogram improvements, but will be happy for the drug to succeed on some level so that he can get the drug to market, obtain more funding, and, in turn, help you get your sexy audiograms?

Do you think Robert fucking Langer advises this situation and says "Whatever you do, no audiograms"?

Holy shit man, science is hard. It really is. You think these additional metrics are some sort of grand cover up or something. It's the total opposite. They are introducing them out of competency.

Can you please explain to me where I am incorrectly interpreting your posts? Where is the value in saying audiograms or bust?
Click to expand...
GlennS said:
What I see here is someone giving a company trying to survive wwwwaaaayyyy too much benefit of the doubt and ascribing too much good-faith.

Try to look at it from the vantage point of those with hearing damage, not the corporate board. Patients judging this treatment are going to want to see improvements in the audiogram before anything else.

View attachment 45302

The omission of the audiogram to the point of not even including the word is suspicious in the extreme. It's trying to steer and spin around a lack of efficacy. You may not want to see that, but that's how it is to anyone who hasn't decided for whatever reason to circle wagons around FREQ.
Click to expand...
Frequency Therapeutics are just trying to make the best of what they have got. As we have mentioned, at this point their plan is to just go to market with what they have so that the company doesn't go bankrupt. Maybe in time they can figure out why FX-322 didn't work as intended and improve on it. I think we can all agree on this point.
 
#18,293
GlennS said:
What I see here is someone giving a company trying to survive wwwwaaaayyyy too much benefit of the doubt and ascribing too much good-faith.

Try to look at it from the vantage point of those with hearing damage, not the corporate board. Patients judging this treatment are going to want to see improvements in the audiogram before anything else.

View attachment 45302

The omission of the audiogram to the point of not even including the word is suspicious in the extreme. It's trying to steer and spin around a lack of efficacy. You may not want to see that, but that's how it is to anyone who hasn't decided for whatever reason to circle wagons around FREQ.
Click to expand...
Seems like you're following FREQ verrrrrry closely for someone who doesn't believe in it.
 
#18,295
GlennS said:
What I see here is someone giving a company trying to survive wwwwaaaayyyy too much benefit of the doubt and ascribing too much good-faith.

Try to look at it from the vantage point of those with hearing damage, not the corporate board. Patients judging this treatment are going to want to see improvements in the audiogram before anything else.

View attachment 45302

The omission of the audiogram to the point of not even including the word is suspicious in the extreme. It's trying to steer and spin around a lack of efficacy. You may not want to see that, but that's how it is to anyone who hasn't decided for whatever reason to circle wagons around FREQ.
Click to expand...
True or false.

Say you're right. All of these additional (along with an audiogram!) metrics are a hoax and you're the only one onto it. The only way to evaluate hearing health is through audiograms™. It turns out OHC, IHC, synapses, demyelination, ECochGs all really boil down to some delusional dimwit like myself pressing a button when they think they hear a beep. There's no room for anything else or any other diagnostics of these functions.

Okay, nonetheless, FREQ gets this thing to market on fraud, even though all of the diagnostic tests were not invented by them. Some people on this forum or maybe some friends of yours get the drug and their tinnitus vanishes.

But the audiogram results still blow. Maybe there's objective proof through OAE that OHC are indeed functioning better, but ultimately most of the gains stay within the error margin of about 10 dB.

Do you put your foot down and refuse the drug? If the answer is no, then I'm not sure what you're arguing in favor of. If the answer is yes, then your whole life has to be based on pride and pride only.
 
#18,296
FX-322 is safe, demonstrated efficacy in earlier studies (single dose) and fulfills an unmet need.

ENTs have nothing for the inner ear. Steroids (maybe they work? nobody knows) for hearing loss; that's it. Like it or not; FX-322 is going to market. And truth be told it's better than the present options: nothing.

Maybe FX-322 regenerates hair cells but they aren't connected to synapses properly? I don't know. But I would put money FX-322 (and many others) will be going to market as there are no other treatments available and anything that shows an ounce of promise is going to make it through. Additionally it might only be good for young people, or cancer survivors, and not sufferers of presbycusis or people who don't have cochlear supporting cells intact. I don't know, but it probably won't work for everyone. And as we know the ear heals notoriously slowly. Even in birds the regeneration process takes many months. I would like to see the audiogram follow ups from many months later.

There isn't going to be a magic treatment that cures hearing loss for all. Different drugs will work for different purposes. Someone who lost hearing from an IED explosion will require different treatment approaches than someone who was born congenitally deaf or lost their hearing from presbycusis.
 
#18,297
To use an analogy:

Just because this flying test failed... it does not mean they give up and stop trying. Understanding how their invention works and reacts under certain conditions is key... and even if it does fly and succeeds in "crossing the ocean"... the first iteration will always be far removed from the luxurious airplanes we have today...

Of course FX-322 may not work in the end, but even then it will be important step in the learning process... and an important step towards others "crossing the ocean" one day...

That's the way I try to look at it at least.

Failing for Success: The Wright Brothers
 

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#18,298
Pero1234 said:
To use an analogy:

Just because this flying test failed... it does not mean they give up and stop trying. Understanding how their invention works and reacts under certain conditions is key... and even if it does fly and succeeds in "crossing the ocean"... the first iteration will always be far removed from the luxurious airplanes we have today...

Of course FX-322 may not work in the end, but even then it will be important step in the learning process... and an important step towards others "crossing the ocean" one day...

That's the way I try to look at it at least.

Failing for Success: The Wright Brothers
Click to expand...
They made the first airplane after many failed attempts and now they have fighter jets that can break the sound barrier. After FX-322 is released maybe one day they'll be able to make a better version that restores 90% of hearing with one dose.
 
#18,299
GlennS said:
What I see here is someone giving a company trying to survive wwwwaaaayyyy too much benefit of the doubt and ascribing too much good-faith.

Try to look at it from the vantage point of those with hearing damage, not the corporate board. Patients judging this treatment are going to want to see improvements in the audiogram before anything else.

View attachment 45302

The omission of the audiogram to the point of not even including the word is suspicious in the extreme. It's trying to steer and spin around a lack of efficacy. You may not want to see that, but that's how it is to anyone who hasn't decided for whatever reason to circle wagons around FREQ.
Click to expand...
FX-322 has already restored hair cells in donated cochlea. I would say that's enough to have some faith in the drug.
 
#18,300
OptimusPrimed said:
FX-322 is safe, demonstrated efficacy in earlier studies (single dose) and fulfills an unmet need.

ENTs have nothing for the inner ear. Steroids (maybe they work? nobody knows) for hearing loss; that's it. Like it or not; FX-322 is going to market. And truth be told it's better than the present options: nothing.

Maybe FX-322 regenerates hair cells but they aren't connected to synapses properly? I don't know. But I would put money FX-322 (and many others) will be going to market as there are no other treatments available and anything that shows an ounce of promise is going to make it through. Additionally it might only be good for young people, or cancer survivors, and not sufferers of presbycusis or people who don't have cochlear supporting cells intact. I don't know, but it probably won't work for everyone. And as we know the ear heals notoriously slowly. Even in birds the regeneration process takes many months. I would like to see the audiogram follow ups from many months later.

There isn't going to be a magic treatment that cures hearing loss for all. Different drugs will work for different purposes. Someone who lost hearing from an IED explosion will require different treatment approaches than someone who was born congenitally deaf or lost their hearing from presbycusis.
Click to expand...
Sh*t, if it's safe and doesn't do anything, I'll take it. Can't be that much different than the TRU NIAGEN sitting in the back of my drawer.
 

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