Frequency Therapeutics — Hearing Loss Regeneration

#8,883
Emgee said:
It's up to Frequency to allow expanded access. Unfortunately, they said they are not ready to do so at this time.
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Yes, I'm well aware of it and their policy has been shared as well:

https://www.frequencytx.com/expanded-access-policy/

Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).

But this only works if the pharma company in question works along with it. Is there no legal way to force a company to share its drug via compassionate use/expanded access? Otherwise this act is so useless. Because you can't push for your right to try, it's up to the pharma. Right to wait act. I'm just flaming over here, with probably zero success rate.
 
#8,884
BBakkers said:
Is there no way to legally demand "expanded access" use under the Right to Try act?
Click to expand...
Frequency has to consent to sell & also manufacture the drug.

Normally it would be in a company's best interest to sell their product, but the way things are set up Frequency has more incentive to focus & prioritize resources on FDA trials instead.

It's maddening, I know. I would gladly spend thousands on this, even if it weren't FDA approved in any capacity. Risk is part of life.

The best we can hope for is that Frequency will announce expanded use opening up sometime in the next year or so. They technically could have ever since Phase 1 trials deemed the drug safe.
 
#8,885
AtlasFainted said:
I agree 1000%. We could potentially all have had restored hearing by now if not for the behemoth time & resources that go into getting drugs approved.

However it's hard for me to imagine a 'Space X' approach to the FDA. Any actual ideas on what this would look like?

It's very illegal for two consenting parties to have a drug transaction unless the FDA approves it. Personally I think the FDA should be looked at as a guideline, not a draconian-style lockdown on what adults can & can't do...
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Space X found a way to get around the handful of people wasting time and money at NASA. Looks to me FDA has the same type of people, a small group of spoon fed people calling all the shots.

One idea is go to a university and collect a very smart crew to do an IRB and do a PMA but without the FDA submission. Do your own studies as you do anyway. Then you evaluate yourself or even better pay a bunch of independent PhDs to evaluate for you. Once a high level of agreement is achieved with these highly-educated doctors then you're good, start injecting all these suffering people.

The amount of time will be less to complete. Cost for the studies will be about the same. You indicate the risks in evaluations just as you would do for the FDA but you don't submit. Then you state when you sell the product that it has not been submitted to the FDA but we did evaluations with top university graduates from school(s) that follow a strict protocol. You indicate the side effects, go deaf, death, etc... that could occur the same way and you sell from your clinical evaluation.

Anybody who is educated can view the studies and take part in the risk to try.

If someone dies while taking a FDA approved drug guess whose fault it is? The FDA directs the business that created it! That's why the FDA is careful with wordings. When they approve a drug, they never say it's approved. It's simply 'cleared for use' so they release liability. What that means the FDA won't bother you when you are cleared for use. They never say they 'approve' you. They use the word cleared for use. It's a law thing. The FDA is a spoon fed entity of overrated ****.

Again, Elon Musk, Space X. He reduced those NASA peer review people and look how much more gets done compared to NASA. We're back in space again!

The proof is there. The FDA is an obstruction. But I do believe you need to have a regulatory type of system. I don't believe there should be one entity to control it like the FDA. The FDA is a type of monopoly that needs to be changed.

Another huge problem I have with the FDA is they created an environment where the bogus companies dupe investors to invest in their bogus treatments that take 10 years of FDA nonsense to finally bring the scam to light. It's a scam going on that gives us false hope and we put up with it all for who knows what reason.

If I've upset anyone with what I have written it was not my intention. I wish for all of us to end this suffering. I know there's a better way. Maybe I have it figured out, maybe I don't. Please, protect your ears.
 
#8,886
DoNotGoGentle said:
When do you think they will feel ready for the expanded access?
Click to expand...
My guess is early to mid 2022. I think they will open up expanded access after Phase 2a if the desired efficacy and safety profiles are shown. However, I think we will then need to wait until recruitment for Phase 2b or 3 is complete as @FGG highlighted. Otherwise, there would be no incentive to risk getting a placebo during the trial if you could just receive expanded access. Being that this will be the "pivotal" phase prior to submission for approval, it will certainly take some time to recruit such a large trial population. Therefore, I feel our best chance to try FX-322 is early to mid 2022.
 
#8,887
Emgee said:
My guess is early to mid 2022. I think they will open up expanded access after Phase 2a if the desired efficacy and safety profiles are shown. However, I think we will then need to wait until recruitment for Phase 2b or 3 is complete as @FGG highlighted. Otherwise, there would be no incentive to risk getting a placebo during the trial if you could just receive expanded access. Being that this will be the "pivotal" phase prior to submission for approval, it will certainly take some time to recruit such a large trial population. Therefore, I feel our best chance to try FX-322 is early to mid 2022.
Click to expand...
I dearly hope all of you are wrong! But all what you are saying is making too much sense, damn it.
 
#8,889
Jurger said:
I vote Eargasm
Click to expand...
There's already a trademark for that by an earplug company.
Jurger said:
In all seriousness, how much would a treatment per ear cost?
Click to expand...
What's the point of speculating? It's not going to be exorbitantly expensive, otherwise not many are going to be able to afford it and they want normal people to be able to afford it. I'm sure the treatment costs less than $5,000.
 
#8,891
Cernuto said:
Space X found a way to get around the handful of people wasting time and money at NASA. Looks to me FDA has the same type of people, a small group of spoon fed people calling all the shots.

One idea is go to a university and collect a very smart crew to do an IRB and do a PMA but without the FDA submission. Do your own studies as you do anyway. Then you evaluate yourself or even better pay a bunch of independent PhDs to evaluate for you. Once a high level of agreement is achieved with these highly-educated doctors then you're good, start injecting all these suffering people.

The amount of time will be less to complete. Cost for the studies will be about the same. You indicate the risks in evaluations just as you would do for the FDA but you don't submit. Then you state when you sell the product that it has not been submitted to the FDA but we did evaluations with top university graduates from school(s) that follow a strict protocol. You indicate the side effects, go deaf, death, etc... that could occur the same way and you sell from your clinical evaluation.

Anybody who is educated can view the studies and take part in the risk to try.

If someone dies while taking a FDA approved drug guess whose fault it is? The FDA directs the business that created it! That's why the FDA is careful with wordings. When they approve a drug, they never say it's approved. It's simply 'cleared for use' so they release liability. What that means the FDA won't bother you when you are cleared for use. They never say they 'approve' you. They use the word cleared for use. It's a law thing. The FDA is a spoon fed entity of overrated ****.

Again, Elon Musk, Space X. He reduced those NASA peer review people and look how much more gets done compared to NASA. We're back in space again!

The proof is there. The FDA is an obstruction. But I do believe you need to have a regulatory type of system. I don't believe there should be one entity to control it like the FDA. The FDA is a type of monopoly that needs to be changed.

Another huge problem I have with the FDA is they created an environment where the bogus companies dupe investors to invest in their bogus treatments that take 10 years of FDA nonsense to finally bring the scam to light. It's a scam going on that gives us false hope and we put up with it all for who knows what reason.

If I've upset anyone with what I have written it was not my intention. I wish for all of us to end this suffering. I know there's a better way. Maybe I have it figured out, maybe I don't. Please, protect your ears.
Click to expand...
I'm a huge Elon Musk fan, and I also believe 3 things are necessary for quality:

Competition, accountability, & incentives.

The FDA as it stands has none of these. I've made similar arguments as yours & I'm happy to see you on this forum. We should, as a people, absolutely push for a better solution.
 
#8,892
BBakkers said:
Yes, I'm well aware of it and their policy has been shared as well:

https://www.frequencytx.com/expanded-access-policy/

Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).

But this only works if the pharma company in question works along with it. Is there no legal way to force a company to share its drug via compassionate use/expanded access? Otherwise this act is so useless. Because you can't push for your right to try, it's up to the pharma. Right to wait act. I'm just flaming over here, with probably zero success rate.
Click to expand...
We shouldn't force anyone to sell anything, that wouldn't be ethical.

However if we reframed the system to allow drugs to hit the market labeled as non-approved/non-vetted, companies like Frequency might then have incentive to ramp up manufacturing & sell it to healthcare providers sooner than later, while also pushing the drug through trials.

As the system stands now, it's extremely likely they will prioritize trials over expanded use.
 
#8,893
ajc said:
There's already a trademark for that by an earplug company.

What's the point of speculating? It's not going to be exorbitantly expensive, otherwise not many are going to be able to afford it and they want normal people to be able to afford it. I'm sure the treatment costs less than $5,000.
Click to expand...
Only thing that might raise the price is that you don't need to keep using it to keep your hair cells. It's four injections. Maybe more with severe hearing loss, but ultimately you're probably done within 4-8 weeks.
 
#8,894
Jurger said:
On a lighter note, what do you think FX-322's name will be? I vote Eargasm.

In all seriousness, how much would a treatment per ear cost?
Click to expand...
Cochleum HF - $1000 per single injection (HF for High-Frequency).
 
#8,895
Jurger said:
Only thing that might raise the price is that you don't need to keep using it to keep your hair cells. It's four injections. Maybe more with severe hearing loss, but ultimately you're probably done within 4-8 weeks.
Click to expand...
Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.

This treatment will create a whole new class of people who don't change their perspective, unfortunately. Where they come in to the ENT with issues like we have, but get it fixed right away, and go back to abusing their hearing again because the lesson wasn't sustained.
 
#8,896
Diesel said:
Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.

This treatment will create a whole new class of people who don't change their perspective, unfortunately. Where they come in to the ENT with issues like we have, but get it fixed right away, and go back to abusing their hearing again because the lesson wasn't sustained.
Click to expand...
Yeah I can see this being the case, but that's still better than no one being able to get their issues fixed...

Personally I'll take care of my ears regardless.

Not only will the treatment be pricey, but I don't want to gradually lose hearing until the point that I need an injection again. It's like having bad eyes, you don't even know what you're missing.

And this is worst case scenario, but what if the economy goes to complete shit and you can't afford it? Or some other disaster happens that affects availability & then you're once again stuck without a way to get your hearing fixed...

It's the same reason I'm getting LASIK, and also some land one day. I want to be prepared for a "shit hitting the fan" scenario haha.
 
#8,898
Diesel said:
Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.

This treatment will create a whole new class of people who don't change their perspective, unfortunately. Where they come in to the ENT with issues like we have, but get it fixed right away, and go back to abusing their hearing again because the lesson wasn't sustained.
Click to expand...
Sure, but I mean it's not the same as insulin or anti-psychotic drugs.
 
#8,899
In the June presentation I see they enlarge slightly the area of potential restoring from 8000-20000 Hz (back in January or so) to 6500-20000 Hz (p15 in this presentation). So maybe the 4 doses are actually having an enhanced effect.

I saw some opinions here that they hope to address frequencies from 3500 upwards, but I didn't see any source.

Anyone has a better idea on the range they hope to heal? And from what losses onward in dB ranges? Mid/severe don't speak to me a lot in terms of actual numbers.

In terms of timeline, I think 2023 is still a bit optimistic to reach mass production and distribution. Plus they will have to advocate this a lot to the doctors so that patients can actually get it. But it's a good breakthrough!!! Keep the faith people!
 
#8,900
Stoie said:
In the June presentation I see they enlarge slightly the area of potential restoring from 8000-20000 Hz (back in January or so) to 6500-20000 Hz (p15 in this presentation). So maybe the 4 doses are actually having an enhanced effect.

I saw some opinions here that they hope to address frequencies from 3500 upwards, but I didn't see any source.

Anyone has a better idea on the range they hope to heal? And from what losses onward in dB ranges? Mid/severe don't speak to me a lot in terms of actual numbers.

In terms of timeline, I think 2023 is still a bit optimistic to reach mass production and distribution. Plus they will have to advocate this a lot to the doctors so that patients can actually get it. But it's a good breakthrough!!! Keep the faith people!
Click to expand...
Their first presentation had the drug in 20000-3500 Hz.

Mild hearing loss = 20/25-40 dB PTA
Moderate = 40-55 dB
Moderately severe = 55-70 dB
Severe = 70-90 dB
Profound = 90 dB and upwards

PTA = pure tone average
 
#8,903
dan said:
20,000Hz , so are we going to hear like a baby?
Click to expand...
Probably our ears are not that of a newborn after treatment. But as far as I understood it inner and outer hair cells are regenerated in the high frequencies. So in theory this should quieten high frequency tinnitus. Hopefully they are working to reach all frequencies. But if tinnitus is due to some nerve IHC connection problem, FX-322 won't help since the hair cell is still alive. There are some drugs in development that address this problem OTO-413, Hough Pill, Pipeline, but I am wondering whether it is also possible to take some targeted ototoxic drug, which just brings these disconnected but still alive IHCs over the edge.
 
#8,904
xyz said:
Probably our ears are not that of a newborn after treatment. But as far as I understood it inner and outer hair cells are regenerated in the high frequencies. So in theory this should quieten high frequency tinnitus. Hopefully they are working to reach all frequencies. But if tinnitus is due to some nerve IHC connection problem, FX-322 won't help since the hair cell is still alive. There are some drugs in development that address this problem OTO-413, Hough Pill, Pipeline, but I am wondering whether it is also possible to take some targeted ototoxic drug, which just brings these disconnected but still alive IHCs over the edge.
Click to expand...
Sounds extreme - I think OTO-413 or the Hough pill will become available before any drug that deliberately "finishes" off hair cells.

Although, I've wondered the same thing. If we see FDA reform or the system changed entirely, we could see shortened timelines for all these things.
 
#8,905

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#8,907
Even if it fails, there are so many other drugs in development that I'm sure we're gonna get something this decade.

Who knows, maybe you won't even have enough time to learn enough about biology before they're already finished.

But honestly, they already tested their drug on ex-vivo cochlea and proved that it actually reaches the inner ear. Most bases are covered. The only way it could fail is if it gave you tumors or something.
 
#8,908
Long time lurker here. This is the first I've checked this thread in about a year, but I must say 6500 Hz-20000 Hz seems pretty disappointing to me. I tested that range with various audio files on my computer with high-end speakers and I guess I'm not seeing how improving that range is really going to help much. I mean, anything is better than nothing, however, when you have to pay thousands or tens of thousands for it, I'm not sure it will be worth it.

Have they ever released any data on how many decibels recovered in the test subjects? If it's only a couple, I just don't see how this will make much of a difference. If it's substantial, I'd also worry about everything potentially sounding too high-fi in comparison to other frequencies, making everything sound like it's coming from an iPhone speaker.
 
#8,909
Xojo said:
Long time lurker here. This is the first I've checked this thread in about a year, but I must say 6500 Hz-20000 Hz seems pretty disappointing to me. I tested that range with various audio files on my computer with high-end speakers and I guess I'm not seeing how improving that range is really going to help much. I mean, anything is better than nothing, however, when you have to pay thousands or tens of thousands for it, I'm not sure it will be worth it.

Have they ever released any data on how many decibels recovered in the test subjects? If it's only a couple, I just don't see how this will make much of a difference. If it's substantial, I'd also worry about everything potentially sounding too high-fi in comparison to other frequencies, making everything sound like it's coming from an iPhone speaker.
Click to expand...
You normally lose the high frequencies first, which is why tinnitus is usually high pitched.

If you can regenerate them, the tinnitus could go away.

Also Frequency Therapeutics is planning to reformulate and hit all frequencies, not just the ones that it currently reaches.

We'll know more about improvements after this current FDA trial...

Also unlikely that it will cost tens of thousands. Likely cost will be comparable to hearing aids.
 
#8,910
Xojo said:
Long time lurker here. This is the first I've checked this thread in about a year, but I must say 6500 Hz-20000 Hz seems pretty disappointing to me. I tested that range with various audio files on my computer with high-end speakers and I guess I'm not seeing how improving that range is really going to help much. I mean, anything is better than nothing, however, when you have to pay thousands or tens of thousands for it, I'm not sure it will be worth it.

Have they ever released any data on how many decibels recovered in the test subjects? If it's only a couple, I just don't see how this will make much of a difference. If it's substantial, I'd also worry about everything potentially sounding too high-fi in comparison to other frequencies, making everything sound like it's coming from an iPhone speaker.
Click to expand...
Any data thus far is only on a single small safety test dose. There should be very different results reported at the end of the current trial. No one has those results yet but they used a higher dose given 4 times instead of a single injection.

In other words, stayed tuned. Results should be 4Q/2020 or early next year.
 

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