Frequency Therapeutics — Hearing Loss Regeneration

[AtlasFainted]

If that happens, it's probably a good idea to gather some evidence that you've tried other treatments to no avail, or you might be excluded.

I'm not going to argue tinnitus can be life-threatening, but the thing is, how does one prove it to the outside world and thus he or she should be entitled to compassionate use?

You don't have to prove it's life threatening, only that it seriously impacts your life. As I understand it this is a simple matter of telling your physician that it seriously impacts your life.

There are no other existing therapies that actually treat hearing loss, so I don't think you'd have to prove that you tried all and any alternative methods. TRT for an example is just a mind game, not an actual drug that treats the cochlea...

 

[FGG]

I listened to their presentation. Nothing new as far as I can tell. They are still recruiting for Phase IIa so that means, as has been pointed out, they're not going to release results in the second half of 2020 since they are following patients for 9 months. Mid 2021 is more likely.

They also stated their financial position is looking good with funding up until at least 2022 and mentioned that there are payment milestones with Astellas if they conduct trials in Europe or Asia. If Phase IIa goes well I think we will see a Phase IIb trial in Europe.

Listening to their talk it's clear to me again they are settling for high frequency hearing loss (for now at least) which is understandable considering Phase 1/2 results. Sucks for people with Meniere's and people with hearing loss across the board though.

Their last presentation actually did say pre-clinically they fixed both high and low frequencies in rodents. Which means it's not a problem with the drug but rather delivery. There are a lot of ways to address this.

Reformulation for a version 2.0 is one way and the re-formulation would only need a brief additional 505 2b trial (median time a year). They had a recent job posting for a formulations expert in intratympanic drugs which suggests they may already be looking at this.

There are also very novel delivery approaches coming soon (ultrasound delivers microbubbles, Otomagnetics, a new surgical procedure for AAV drugs that could actually work here too--that one actually starts at the apex etc). The hardest part and the biggest delay is just getting the first version with the first formulation out.

I totally agree that there is almost no way they are going to meet their initial trial deadline at this point, though.

 

[serendipity1996]

You don't have to prove it's life threatening, only that it seriously impacts your life. As I understand it this is a simple matter of telling your physician that it seriously impacts your life.

There are no other existing therapies that actually treat hearing loss, so I don't think you'd have to prove that you tried all and any alternative methods. TRT for an example is just a mind game, not an actual drug that treats the cochlea...

Also TRT seems to be commonly presented as "it can take up to two years and doesn't even guarantee a full recovery" so it seems a bit inadequate if they're going to portray it as a legitimate therapy in contrast to regenerative medicine.

 

[Emgee]

Listening to their talk it's clear to me again they are settling for high frequency hearing loss (for now at least) which is understandable considering Phase 1/2 results. Sucks for people with Meniere's and people with hearing loss across the board though.

Does anyone know if there is a specific frequency range they are aiming to restore? I will have to get an extended audiogram sooner or later. I know my issue is either high-frequency hearing loss or synapse damage.

Had to see an ENT for eustachian tube dysfunction issues this week. He wanted to test my hearing, which I knew would be pointless but agreed for whatever reason. Scored "100%" on the standard audiogram. To him, I can't have hearing loss in the untested frequencies if my 250 through 8000 kHz test doesn't show any loss. He said there's no way my tinnitus is a result of hearing damage. You can't make this stuff up.

 

[AtlasFainted]

The waiting game sucks, but we're lucky to be seeing this stuff happen in our lifetime. I believe many of us will have better hearing than we were ever supposed to at our respective ages when this is said and done.

I've started to refocus on things I have control over, but check this forum daily in case of any good news. I truly hope the FDA streamlines their approval process as a result of COVID-19 sooner rather than later... in my opinion this is long overdue.

Fingers crossed for the next couple years. Hopefully I'll be a way better individual by the time this all becomes accessible.

 

[Lucifer]

Also TRT seems to be commonly presented as "it can take up to two years and doesn't even guarantee a full recovery" so it seems a bit inadequate if they're going to portray it as a legitimate therapy in contrast to regenerative medicine.

Also TRT can make Tinnitus worse. I wouldn't want to continue with the treatment if it did and hope the doctor doesn't force you try it even though you are sensitive to artificial sounds. I know my doctor would let me get compassionate use.

 

[serendipity1996]

Also TRT can make Tinnitus worse. I wouldn't want to continue with the treatment if it did and hope the doctor doesn't force you try it even though you are sensitive to artificial sounds. I know my doctor would let me get compassionate use.

Personally my hyperacusis has improved a lot regarding the artificial sounds but yeah Category 4 patients especially are not really served well by TRT (these are funnily enough the ones who are often victim-blamed!)

 

[Tweedleman]

Also TRT seems to be commonly presented as "it can take up to two years and doesn't even guarantee a full recovery" so it seems a bit inadequate if they're going to portray it as a legitimate therapy in contrast to regenerative medicine.

It's not a legitimate therapy, it's a scam currently filling the void in an underresearched and apparently underregulated area of medicine. And they'd be hard pressed to prove that any improvement in tinnitus volume or intrusiveness was the direct result of TRT and not just the passage of time. I hold homeopathic medicine in a higher regard.

Had to see an ENT for eustachian tube dysfunction issues this week. He wanted to test my hearing, which I knew would be pointless but agreed for whatever reason. Scored "100%" on the standard audiogram. To him, I can't have hearing loss in the untested frequencies if my 250 through 8000 kHz test doesn't show any loss. He said there's no way my tinnitus is a result of hearing damage. You can't make this stuff up.

I had the same experience with an ENT recently. On the standard audiogram I am between 5 and 10dB across the board in both ears. I also inquired about the potential of UHF loss being to blame for my tinnitus, and he thought that was unlikely purely because my hearing trends up at 8 kHz. He had never heard of cochlear synaptopathy or any of the current research and regenerative medicine in clinical trials. He told me to look into TMJ with my dentist, maybe get a nightguard. Ahh yes, it must've been a mere coincidence that TMJ causes tinnitus and muffled mangled hearing immediately after an absurdly loud concert.

But of course he mentioned fucking TRT. Although to his credit even he didn't think it was worth it. He said it was like another form of CBT to essentially get you to accept it.

 

[serendipity1996]

This guy has been posted here before but I just saw this recent video where he discusses the future of audiology and the prospect of regenerative medicine on the horizon - he talks about FX-322. He actually has a pretty positive and measured take on it all which is great to see. Didn't realise that he himself actually has hearing loss too.

 

[Bartoli]

You don't have to prove it's life threatening, only that it seriously impacts your life. As I understand it this is a simple matter of telling your physician that it seriously impacts your life.

There are no other existing therapies that actually treat hearing loss, so I don't think you'd have to prove that you tried all and any alternative methods. TRT for an example is just a mind game, not an actual drug that treats the cochlea...

Then I hope they don't start bickering over what hearing loss would mean. I'm well outside the trial group for now with my current audiogram but I do have high frequency loss (>8kHz) and mad tinnitus.

 

[Emgee]

I had the same experience with an ENT recently. On the standard audiogram I am between 5 and 10dB across the board in both ears. I also inquired about the potential of UHF loss being to blame for my tinnitus, and he thought that was unlikely purely because my hearing trends up at 8 kHz. He had never heard of cochlear synaptopathy or any of the current research and regenerative medicine in clinical trials. He told me to look into TMJ with my dentist, maybe get a nightguard. Ahh yes, it must've been a mere coincidence that TMJ causes tinnitus and muffled mangled hearing immediately after an absurdly loud concert.

My ENT said to try a splint for TMJ too. He also wants me to undergo multiple lab tests and an MRI to rule out other potential causes - no thank you. My tinnitus is bad enough as is.

I wish there was a way to diagnose the type of damage (hair cell vs. synapse). I guess we'll have to wait and see how it plays out.

 

[Spiral]

Reformulation for a version 2.0 is one way and the re-formulation would only need a brief additional 505 2b trial (median time a year). They had a recent job posting for a formulations expert in intratympanic drugs which suggests they may already be looking at this.

There are also very novel delivery approaches coming soon (ultrasound delivers microbubbles, Otomagnetics, a new surgical procedure for AAV drugs that could actually work here too--that one actually starts at the apex etc). The hardest part and the biggest delay is just getting the first version with the first formulation out.

I totally agree that there is almost no way they are going to meet their initial trial deadline at this point, though.

Not too familiar with the 505 2b trial. Does that mean that the product will hit the market albeit with an inferior delivery method or would it delay the whole thing for another year?

 

[FGG]

Not too familiar with the 505 2b trial. Does that mean that the product will hit the market albeit with an inferior delivery method or would it delay the whole thing for another year?

Neither. It means a product once released can do a very abbreviated trial later for a reformulation with the same active ingredient.

 

[Allan Mcmillan]

Does anyone know if there is a specific frequency range they are aiming to restore? I will have to get an extended audiogram sooner or later. I know my issue is either high-frequency hearing loss or synapse damage.

Had to see an ENT for eustachian tube dysfunction issues this week. He wanted to test my hearing, which I knew would be pointless but agreed for whatever reason. Scored "100%" on the standard audiogram. To him, I can't have hearing loss in the untested frequencies if my 250 through 8000 kHz test doesn't show any loss. He said there's no way my tinnitus is a result of hearing damage. You can't make this stuff up.

Most ENTs are completely clueless about this condition and have basic textbook knowledge of the condition. I once walked into an ENT clinic when I had hearing distortions and he said it was anxiety because my audiogram is normal.

 

[Christiaan]

Does anyone know if there is a specific frequency range they are aiming to restore? I will have to get an extended audiogram sooner or later. I know my issue is either high-frequency hearing loss or synapse damage.

Had to see an ENT for eustachian tube dysfunction issues this week. He wanted to test my hearing, which I knew would be pointless but agreed for whatever reason. Scored "100%" on the standard audiogram. To him, I can't have hearing loss in the untested frequencies if my 250 through 8000 kHz test doesn't show any loss. He said there's no way my tinnitus is a result of hearing damage. You can't make this stuff up.

@Emgee The conservative estimate is that FX-322 will fix hearing loss in the frequency range of 8000 Hz - 20000 Hz if you have hair cell damage. Current research results have shown that FX-322 can reach the limit of 8000 Hz. However, they're trying to aim for the range 3500 Hz - 20000 Hz by adjusting the volume/ mass of the formula + dosage during the trials.

 

[AtlasFainted]

This guy has been posted here before but I just saw this recent video where he discusses the future of audiology and the prospect of regenerative medicine on the horizon - he talks about FX-322. He actually has a pretty positive and measured take on it all which is great to see. Didn't realise that he himself actually has hearing loss too.

In this video, his tone seems almost reversed from the last one on the subject. This makes me wonder why in this one he tells viewers to check out the previous video, but I guess it's just him being a YouTuber & wanting as many views as possible...

He's gone from being almost completely dismissive of FX-322 to making it sound like he'll have to find a new career path in the near future. His whole take on "if people don't need hearing aids anymore, I don't deserve to sell them!" makes me feel good.

Instead of digging his heels in for the sake of his own job/industry, he actually acknowledges how the market should work and expresses as much. This video changed my opinion of him for the better.

 

[Diesel]

In this video, his tone seems almost reversed from the last one on the subject. This makes me wonder why in this one he tells viewers to check out the previous video, but I guess it's just him being a YouTuber & wanting as many views as possible...

He's gone from being almost completely dismissive of FX-322 to making it sound like he'll have to find a new career path in the near future. His whole take on "if people don't need hearing aids anymore, I don't deserve to sell them!" makes me feel good.

Instead of digging his heels in for the sake of his own job/industry, he actually acknowledges how the market should work and expresses as much. This video changed my opinion of him for the better.

I would argue that the need for audiologists may actually increase in a world where FX-322 is available for doctors to treat.

Consider scenarios where a patient experiences hearing loss and is given FX-322. It is highly likely they would need to continue to return to the audiologist in some type of interval (6-mo, maybe?) to confirm the hearing is restored to normal levels, or if more dosing is needed.

For some professions where noise exposure is a constant risk, or military roles, I would imagine insurance/government programs requiring these folks to stay up to date with their hearing treatments for safety matters. Again, an Audiologist would be required.

Finally, for the undiagnosed market that Frequency refers to; these are people that don't know they have hearing loss. This is a HUGE market, that will only keep growing. So, with regeneration available, the ability to market to these folks to get an annual "check up" like the dentist or eye doc seems more valuable.

It would be beneficial in the short-term to not hype FX-322 as a cure for hearing loss; especially from an Audiologist. When I see "cure" I interpret that as a one-and-done cure. Like, no more hearing loss. Even after FX-322 is applied to some people, there will be instances where they will need to come back due to an incident; or on-going wear (see professional). In other words, FX-322 won't make the new hair cells in the cochlea invincible to new damage / normal wear-and-tear.

 

[Lucifer]

I would argue that the need for audiologists may actually increase in a world where FX-322 is available for doctors to treat.

Consider scenarios where a patient experiences hearing loss and is given FX-322. It is highly likely they would need to continue to return to the audiologist in some type of interval (6-mo, maybe?) to confirm the hearing is restored to normal levels, or if more dosing is needed.

For some professions where noise exposure is a constant risk, or military roles, I would imagine insurance/government programs requiring these folks to stay up to date with their hearing treatments for safety matters. Again, an Audiologist would be required.

Finally, for the undiagnosed market that Frequency refers to; these are people that don't know they have hearing loss. This is a HUGE market, that will only keep growing. So, with regeneration available, the ability to market to these folks to get an annual "check up" like the dentist or eye doc seems more valuable.

It would be beneficial in the short-term to not hype FX-322 as a cure for hearing loss; especially from an Audiologist. When I see "cure" I interpret that as a one-and-done cure. Like, no more hearing loss. Even after FX-322 is applied to some people, there will be instances where they will need to come back due to an incident; or on-going wear (see professional). In other words, FX-322 won't make the new hair cells in the cochlea invincible to new damage / normal wear-and-tear.

Another possibility is that maybe Audiologists may be able to do the FX-322 shots themselves in the future if they get the training required. If it does not take that long then maybe the Audiologists may see it as a benefit.

This could be a way to allow Audiologists to still continue their business and gain profits if hearing aids were to not be sold.

 

[d'Wooluf]

Another possibility is that maybe Audiologists may be able to do the FX-322 shots themselves in the future if they get the training required.

I really don't see that happening and if it did you can count me out.

 

[FGG]

I really don't see that happening and if it did you can count me out.

Possibly a nurse practitioner who works with ENTs but absolutely not an audiologist. Agree. No way.

 

[Lucifer]

I really don't see that happening and if it did you can count me out.

Well if they can't sell hearing aids where are they going to get their money from? They have to think of something because most of their profits come from hearing aids.

As soon as regenerative hearing medicine comes out I have a bad feeling they will shut down a lot of their practices/stores. People would only be able to get hearing tests from hospitals if that were the case.

Audiologists will either have to brush up their skills to be able inject FX-322 or close their store. I see there being no other option if they want to continue their business operations.

 

[JohnDoe8776059]

In this video, his tone seems almost reversed from the last one on the subject. This makes me wonder why in this one he tells viewers to check out the previous video, but I guess it's just him being a YouTuber & wanting as many views as possible...

He's gone from being almost completely dismissive of FX-322 to making it sound like he'll have to find a new career path in the near future. His whole take on "if people don't need hearing aids anymore, I don't deserve to sell them!" makes me feel good.

Instead of digging his heels in for the sake of his own job/industry, he actually acknowledges how the market should work and expresses as much. This video changed my opinion of him for the better.

I hope more people are aware of this drug because he also talked about in his video that this direction of innovation can lead to people losing their current jobs if FX-322 cures some types of hearing loss. I fear that there's a chance not everyone is going to like the idea of starting a new career path and perhaps some will try to stop this drug from coming into the market. It sounds similarly to the idea that big pharma is withholding the cure to cancer because they receive more profits from cancer treatments than from a cure.

 

[DoNotGoGentle]

https://www.bloomberg.com/news/audio/2020-02-19/baystate-business-politics-and-fish-radio

Not sure if this was shared before. Breakthrough Status!!! Maybe...

 

[xyz]

Does somebody know where Frequency Therapeutics has published the results of the two previous already finished studies? When I search on ClinicalTrials.gov for FX-322 I get three results with two completed trials but in no case are results posted.

 

[Jurger]

@Emgee The conservative estimate is that FX-322 will fix hearing loss in the frequency range of 8000 Hz - 20000 Hz if you have hair cell damage. Current research results have shown that FX-322 can reach the limit of 8000 Hz. However, they're trying to aim for the range 3500 Hz - 20000 Hz by adjusting the volume/ mass of the formula + dosage during the trials.

Do you have a source on the adjustments of the formula or dosage? All I know is they were hiring someone for formulation purposes but that's it. The dosage in Phase 2a is exactly the same, but 4 times (max) instead of 1. Reason for the 4 injections is that they want to test if results are dose dependent (which would be a very good sign). I haven't heard them say it's to see if the drug travels further down the cochlea that way.

 

[Jurger]

Does somebody know where Frequency Therapeutics has published the results of the two previous already finished studies? When I search on ClinicalTrials.gov for FX-322 I get three results with two completed trials but in no case are results posted.

Both phases were not published, although there was talk about publishing Phase 1/2 results. Maybe they'll do an article after Phase 2a.

 

[d'Wooluf]

Audiologists will either have to brush up their skills to be able inject FX-322 or close their store. I see there being no other option if they want to continue their business operations.

There is nothing in their skill set to 'brush up' to do intra-tympanic injections. It's a bit like upgrading a psychologist's skills to do brain surgery. It's not going to happen.

 

[Pero1234]

I would argue that the need for audiologists may actually increase in a world where FX-322 is available for doctors to treat.

Consider scenarios where a patient experiences hearing loss and is given FX-322. It is highly likely they would need to continue to return to the audiologist in some type of interval (6-mo, maybe?) to confirm the hearing is restored to normal levels, or if more dosing is needed.

For some professions where noise exposure is a constant risk, or military roles, I would imagine insurance/government programs requiring these folks to stay up to date with their hearing treatments for safety matters. Again, an Audiologist would be required.

Finally, for the undiagnosed market that Frequency refers to; these are people that don't know they have hearing loss. This is a HUGE market, that will only keep growing. So, with regeneration available, the ability to market to these folks to get an annual "check up" like the dentist or eye doc seems more valuable.

It would be beneficial in the short-term to not hype FX-322 as a cure for hearing loss; especially from an Audiologist. When I see "cure" I interpret that as a one-and-done cure. Like, no more hearing loss. Even after FX-322 is applied to some people, there will be instances where they will need to come back due to an incident; or on-going wear (see professional). In other words, FX-322 won't make the new hair cells in the cochlea invincible to new damage / normal wear-and-tear.

I agree! They will finally be able to actually help their patients instead of just making note of what is broken!

 

[Pero1234]

There is nothing in their skill set to 'brush up' to do intra-tympanic injections. It's a bit like upgrading a psychologist's skills to do brain surgery. It's not going to happen.

No matter how much I like my audiologist, she's very kind and helpful...

I'm going to see a doctor in the hospital when it comes to needles and injections

 

[Christiaan]

Do you have a source on the adjustments of the formula or dosage? All I know is they were hiring someone for formulation purposes but that's it. The dosage in Phase 2a is exactly the same, but 4 times (max) instead of 1. Reason for the 4 injections is that they want to test if results are dose dependent (which would be a very good sign). I haven't heard them say it's to see if the drug travels further down the cochlea that way.

Hi there @Jurger. I think you're correct to state that the 4 injections/interventions are a way to see if the results are dose dependent.

You may correct me if I'm wrong, but from what I gather here on the forum and the Frequency Therapeutics presentation at the 38th J.P. Morgan health conference, it is mentioned that Frequency Therapeutics is looking to address over 3500 Hz. It's no certainty, but this may imply that they will have to adjust the formula and/or dosage for better diffusion of the drug (no change in delivery, however), or else they will still get stuck to the +/-8000 Hz limit. I believe it was also mentioned here in the thread.