Frequency Therapeutics — Hearing Loss Regeneration

[Emgee]

I hate to say it but it's not the system. It's Frequency Therapeutics. Compassionate use is built into the system for people that need it now but they haven't agreed to do that. I hate to be hard on them but it's true. We can't only blame the FDA.

It doesn't make a lot of sense from a business standpoint to grant compassionate use. @Diesel already alluded to this nicely below.

I know this is going to be an unpopular opinion; but I struggle to see from a business standpoint the value of putting any resources into enabling Compassionate Use in 2021/2022 if the drug may be in its pivotal phase. Why go through the work to start limited production with a drug manufacturer, price an experimental drug, deal with the individual paperwork, distribution, and deal with doctors. The price may be astronomical in low volumes for select use. Not to mention QUICKLY educating a workforce of ENTs on the drug and how it works, how to determine dosage, etc. Seems like a lot of resource and logistical problems.

Frequency Therapeutics want their product to be available in a widespread manner without having to exert a significant amount of additional resources, deal with individual paperwork, inform ENTs on the dosage and injection process, and start production only to limit it later before engaging in the pivotal phase. And they should be able to do just that. They deserve to reap the benefits of their innovation. The problem is they can't do that until they go through the lengthy FDA approval process to make their drug available to their entire target market. It's absolutely the system that is to blame.

 

[Diesel]

The Food and Drug Administration has literally hundreds of reviews going on with various pharmaceuticals, medical devices, cosmetics, food products, and more. Envision the FDA as being the planet Earth, Frequency Therapeutics would be a star, not the moon. This is why 2023 doesn't sound too bad after all.

Regarding the timeline:

It should be noted that Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.

Which would mean 2026.

FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.

IF Breakthrough Designation, they may get it to 5 years, or 2022.

Based on the plans disclosed thus far by Frequency Therapeutics to end 3 trials in 2021, and speculation that a pivotal trial may take place in 2022; it's likely they are beating the average Fast Track duration, with an FDA approval possible in 2023.

The one IF that might get the drug released early is the FDA Breakthrough Therapy designation. If all of these 3 trials end with significant improvements and favorable safety, I don't see why it wouldn't get the designation. Based on my research, this may allow them to release the drug commercially alongside the pivotal phase in 2022.

If so, compassionate use isn't even needed.

I don't see any of this as the FDA slowing Frequency Therapeutics down at all. I see it as Frequency Therapeutics and the FDA leveraging a partnership to get the drug out faster than average, while identifying risks, efficacy and effectiveness appropriately.

 

[tbuzz89]

FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.

IF Breakthrough Designation, they may get it to 5 years, or 2022.

I'm not sure if this has been addressed in the thread yet, but let's say the timeline predictions turn out right and FX-322 is released in 2022-2024 and it indeed works as we all hope, do we know any of Frequency Therapeutics' plans for marketing and doctor education? How available and accessible is FX-322 going to be upon release?

Most of us are aware how far behind so many GPs, ENTs and other specialists are when it comes to tinnitus, hyperacusis, and hearing loss as it stands, so what is the anticipated rate of knowledge and adoption, and thus ability to receive injections of FX-322 when it's fully released to market?

 

[Born To Slay]

Regarding the timeline:

It should be noted that Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.

Which would mean 2026.

FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.

IF Breakthrough Designation, they may get it to 5 years, or 2022.

Based on the plans disclosed thus far by Frequency Therapeutics to end 3 trials in 2021, and speculation that a pivotal trial may take place in 2022; it's likely they are beating the average Fast Track duration, with an FDA approval possible in 2023.

The one IF that might get the drug released early is the FDA Breakthrough Therapy designation. If all of these 3 trials end with significant improvements and favorable safety, I don't see why it wouldn't get the designation. Based on my research, this may allow them to release the drug commercially alongside the pivotal phase in 2022.

If so, compassionate use isn't even needed.

I don't see any of this as the FDA slowing Frequency Therapeutics down at all. I see it as Frequency Therapeutics and the FDA leveraging a partnership to get the drug out faster than average, while identifying risks, efficacy and effectiveness appropriately.

Just think, we could be cured in like a year and a half. Makes me wonder why I don't just get addicted to pain killers for a year waiting lol.

 

[Billy_Shears]

I am also wondering how you know it would only be veterans that would be eligible for compassionate use, if any is granted, out of interest?

I don't believe I said that veterans would be the only ones eligible for compassionate use, but the first to receive such, if at all. The U.S. military is huge as you may know and they have longed for ear protection for its members, and its relationship with Frequency Therapeutics has been close since the early trials.

 

[Gb3]

I'm not sure if this has been addressed in the thread yet, but let's say the timeline predictions turn out right and FX-322 is released in 2022-2024 and it indeed works as we all hope, do we know any of Frequency Therapeutics' plans for marketing and doctor education? How available and accessible is FX-322 going to be upon release?

Most of us are aware how far behind so many GPs, ENTs and other specialists are when it comes to tinnitus, hyperacusis, and hearing loss as it stands, so what is the anticipated rate of knowledge and adoption, and thus ability to receive injections of FX-322 when it's fully released to market?

It should be a pretty routine procedure for any ENT. You would probably need a referral from your GP. That's what I had to do to be seen at Mass Eye and Ear upon my incident of ISSHL. But then again I'm lucky I live in Mass where we have some of the best hospitals in the world. Mass Eye and Ear just raised around $250 million which will go towards a tinnitus research center.

 

[tbuzz89]

It should be a pretty routine procedure for any ENT.

This I understand as it was even alluded to in the Tinnitus Talk Podcast, so at least we know the procedure is routine. I guess I'm more concerned about Frequency Therapeutics' marketing plans; make sure doctors and patients alike know about whatever future name FX-322 will have. Last thing we want is to walk into our GP's or ENT's office and them have no idea about it.

@Gb3 I agree, Boston is one of my favorite cities and without a doubt has some top notch hospitals. Even better than NYC where I am, in my opinion.

 

[Gb3]

@tbuzz89 if your ENT is unaware about the "new drug" that cures hearing loss I would strongly seek a new referral. However I think it will definitely be well known for sure.

 

[tommyd87]

Regarding the timeline:

It should be noted that Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.

Which would mean 2026.

FX-332 received Fast Track, which lowers the estimate to 7 years: 2024.

IF Breakthrough Designation, they may get it to 5 years, or 2022.

Based on the plans disclosed thus far by Frequency Therapeutics to end 3 trials in 2021, and speculation that a pivotal trial may take place in 2022; it's likely they are beating the average Fast Track duration, with an FDA approval possible in 2023.

The one IF that might get the drug released early is the FDA Breakthrough Therapy designation. If all of these 3 trials end with significant improvements and favorable safety, I don't see why it wouldn't get the designation. Based on my research, this may allow them to release the drug commercially alongside the pivotal phase in 2022.

If so, compassionate use isn't even needed.

I don't see any of this as the FDA slowing Frequency Therapeutics down at all. I see it as Frequency Therapeutics and the FDA leveraging a partnership to get the drug out faster than average, while identifying risks, efficacy and effectiveness appropriately.

The question is are Frequency Therapeutics going to run a potential phase 2b trial for age-related hearing loss at the same time as the regular phase 3 trial? If everything is favourable in the current trial and if Frequency Therapeutics proceed with a phase 2 age-related hearing loss trial starting in the second half of next year.

If this phase 2 age-related hearing loss trial is successful, I can see Frequency Therapeutics being able to apply for release following this trial and being able to do so in conjunction with the phase 3/pivotal Asian/European trial. This would therefore potentially mean that FX-322 could be released in late 2022.

I certainly agree that the FDA seemingly is assisting Frequency Therapeutics to proceed promptly through the trials and therefore I don't see it getting held up unfavourably by the process.

 

[tommyd87]

@tbuzz89 if your ENT is unaware about the "new drug" that cures hearing loss I would strongly seek a new referral. However I think it will definitely be well known for sure.

I think that this applies to anything that a professional in any industry should know about.

If an ENT doesn't know about these medicines whether it be for example with treatments such as OTO-413 or FX-322 then I wouldn't bother with them and move to the next. I think it will be quite likely that a list of practices who were trained to deal with FX-322 will get released probably at some point so people have a guide on where to visit. This is not to say that there won't be other practices willing or able to treat you. If FX-322 or any of the other ear treatments work then I cannot see specialists passing up on them at all as they would be foolish to miss out on what might be a much simpler procedure to administer and charge for when compared to just say performing a surgical procedure like inserting grommets.

I think that it is going to help having hospitals or practices which specialise in ear matters. We have a couple around here who are awesome and as a result I really believe that they will be jumping on this treatment.

 

[Diesel]

The question is are Frequency Therapeutics going to run a potential phase 2b trial for age-related hearing loss at the same time as the regular phase 3 trial? If everything is favourable in the current trial and if Frequency Therapeutics proceed with a phase 2 age-related hearing loss trial starting in the second half of next year.

If this phase 2 age-related hearing loss trial is successful, I can see Frequency Therapeutics being able to apply for release following this trial and being able to do so in conjunction with the phase 3/pivotal Asian/European trial. This would therefore potentially mean that FX-322 could be released in late 2022.

I certainly agree that the FDA seemingly is assisting Frequency Therapeutics to proceed promptly through the trials and therefore I don't see it getting held up unfavourably by the process.

As @FGG mentioned, the pivotal phase could be a 2b/3 that is inclusive of Acquired SNHL, Age-Related, and Severe hearing loss. One big final trial that casts a net for the largest patient population.

 

[tommyd87]

As @FGG mentioned, the pivotal phase could be a 2b/3 that is inclusive of Acquired SNHL, Age-Related, and Severe hearing loss. One big final trial that casts a net for the largest patient population.

That is right. Though the question is what will Frequency Therapeutics do. I think that we will have some further answers possibly in March and probably some more definitive answers in May or July after the two trials are actually completed. The thing is that at the moment, Frequency Therapeutics could go either way with this:

-They could either do a release in the US (and any other applicable countries) after phase 2 trials through compassionate use

or

- They could do one giant pivotal trial phase that encompasses all relevant categories which could utilise FX-322.

 

[Diesel]

That is right. Though the question is what will Frequency Therapeutics do. I think that we will have some further answers possibly in March and probably some more definitive answers in May or July after the two trials are actually completed. The thing is that at the moment, Frequency Therapeutics could go either way with this:

-They could either do a release in the US (and any other applicable countries) after phase 2 trials through compassionate use

or

- They could do one giant pivotal trial phase that encompasses all relevant categories which could utilise FX-322.

The strategy released last week points to the latter...

I think they'll take the data from the SNHL Phase 2a, Age-Related Phase 1b, Severe Phase 1b, and get the Breakthrough Designation.

I think their strategy is that the data from all three trials provide significant evidence that using FX-322 to regenerate IHC/OHC improves these conditions in the same predictable way.

As an aside; I wonder if the 90-day Phase 2a release might be hinting that the relevant improvement measured from FX-322 occurs in the first 90 days. If so, this might mean a shorter participant duration in the pivotal phase at 90 days instead of 210 like the phase 2a.

 

[dan]

 

[Lucifer]

The strategy released last week points to the latter...

I think they'll take the data from the SNHL Phase 2a, Age-Related Phase 1b, Severe Phase 1b, and get the Breakthrough Designation.

I think their strategy is that the data from all three trials provide significant evidence that using FX-322 to regenerate IHC/OHC improves these conditions in the same predictable way.

As an aside; I wonder if the 90-day Phase 2a release might be hinting that the relevant improvement measured from FX-322 occurs in the first 90 days. If so, this might mean a shorter participant duration in the pivotal phase at 90 days instead of 210 like the phase 2a.

I do hope if the pivotal phase only needs to be up to 90 days instead of 210 days that this could mean a quicker release of FX-322. I don't know how long I can hold on for.

 

[Michael01]

If an ENT doesn't know about these medicines whether it be for example with treatments such as OTO-413 or FX-322 then I wouldn't bother with them and move to the next. I think it will be quite likely that a list of practices who were trained to deal with FX-322 will get released probably at some point so people have a guide on where to visit.

I wish that when it's released Frequency Therapeutics would have some kind of general list of all ENTs in all countries that were willing to work with them on FX-322. A list that they'd supply upon request. That way I'd know where and who to see to get this potential life-saving drug ASAP.

 

[Matt9]

Ok but what if FX-322 won't help tinnitus?

 

[frpp]

I think that this applies to anything that a professional in any industry should know about.

If an ENT doesn't know about these medicines whether it be for example with treatments such as OTO-413 or FX-322 then I wouldn't bother with them and move to the next. I think it will be quite likely that a list of practices who were trained to deal with FX-322 will get released probably at some point so people have a guide on where to visit. This is not to say that there won't be other practices willing or able to treat you. If FX-322 or any of the other ear treatments work then I cannot see specialists passing up on them at all as they would be foolish to miss out on what might be a much simpler procedure to administer and charge for when compared to just say performing a surgical procedure like inserting grommets.

I think that it is going to help having hospitals or practices which specialise in ear matters. We have a couple around here who are awesome and as a result I really believe that they will be jumping on this treatment.

I agree, if an ENT refuses or spend little to no time on these breakthrough therapies then toss 'em. I'm a firm believer that real doctors are always pushing for and staying on the cutting edge of treatments for the good of the patient, while the rest are just Dinosaurs/Pez dispensers in it for the money, the salutation, and occasional free haircut.

Ok but what if FX-322 won't help tinnitus?

If not, then there are several other companies with treatments on the way, and at the very least we'll be able to hear better and enjoy life a little more.

 

[Matt Bray]

Apologies, this may have been previously discussed within the thread, but is FX-322 thought to also tackle hidden hearing loss?

I am aware of other drugs in development that are specifically targeted for hidden hearing loss.

 

[FGG]

Apologies, this may have been previously discussed within the thread, but is FX-322 thought to also tackle hidden hearing loss?

I am aware of other drugs in development that are specifically targeted for hidden hearing loss.

It depends on if you have lost inner hair cells or not. If you had inner hair cell loss (audiograms mostly test outer hair cell loss), new synapses would form with the inner hair cells.

If you had *only* synapse damage, you would need a synaptopathy drug (e.g. OTO-413, PIPE-505 or Hough Ear Institute's pill).

 

[Diesel]

I agree, if an ENT refuses or spend little to no time on these breakthrough therapies then toss 'em. I'm a firm believer that real doctors are always pushing for and staying on the cutting edge of treatments for the good of the patient, while the rest are just Dinosaurs/Pez dispensers in it for the money, the salutation, and occasional free haircut.

If not, then there are several other companies with treatments on the way, and at the very least we'll be able to hear better and enjoy life a little more.

In the US, an ENT Doctor would be in violation of their license to practice if they refused to provide FX-322 knowing that was the appropriate treatment for the patient's hearing loss / symptoms. I think the bigger problem in the US will be volume of patients that may rush to their doctors to get an appointment, thus causing a massive wait time. I would image some follow-ups will be needed to confirm the patient's outcome is improving after the drug was administered.

If Frequency Therapeutics is correct and there are up to 40MM Americans that may benefit from FX-322, even 10% seeking treatment from the drug over the first year will overwhelm the population of ENT offices in the US.

Also note: If the Phase 2A, and both Phase 1B results are as encouraging as the the Phase 1/2, it will likely be national news-worthy in the United States. Usually the AP picks up clinical trial treatments that have successful Phase 2s. So, overnight knowledge of FX-322 as a 'hearing loss cure' will go from being circulated on sites like this and other industry rags to CNN, Fox News, ABC, NBC, etc. Bottom line: The demand will be unavoidable.

 

[Gb3]

In the US, an ENT Doctor would be in violation of their license to practice if they refused to provide FX-322 knowing that was the appropriate treatment for the patient's hearing loss / symptoms. I think the bigger problem in the US will be volume of patients that may rush to their doctors to get an appointment, thus causing a massive wait time. I would image some follow-ups will be needed to confirm the patient's outcome is improving after the drug was administered.

If Frequency Therapeutics is correct and there are up to 40MM Americans that may benefit from FX-322, even 10% seeking treatment from the drug over the first year will overwhelm the population of ENT offices in the US.

Also note: If the Phase 2A, and both Phase 1B results are as encouraging as the the Phase 1/2, it will likely be national news-worthy in the United States. Usually the AP picks up clinical trial treatments that have successful Phase 2s. So, overnight knowledge of FX-322 as a 'hearing loss cure' will go from being circulated on sites like this and other industry rags to CNN, Fox News, ABC, NBC, etc. Bottom line: The demand will be unavoidable.

Hospitals might have to devote a whole new department for this procedure. That being said, it's a fairly routine and quick procedure.

 

[tommyd87]

In the US, an ENT Doctor would be in violation of their license to practice if they refused to provide FX-322 knowing that was the appropriate treatment for the patient's hearing loss / symptoms. I think the bigger problem in the US will be volume of patients that may rush to their doctors to get an appointment, thus causing a massive wait time. I would image some follow-ups will be needed to confirm the patient's outcome is improving after the drug was administered.

If Frequency Therapeutics is correct and there are up to 40MM Americans that may benefit from FX-322, even 10% seeking treatment from the drug over the first year will overwhelm the population of ENT offices in the US.

Also note: If the Phase 2A, and both Phase 1B results are as encouraging as the the Phase 1/2, it will likely be national news-worthy in the United States. Usually the AP picks up clinical trial treatments that have successful Phase 2s. So, overnight knowledge of FX-322 as a 'hearing loss cure' will go from being circulated on sites like this and other industry rags to CNN, Fox News, ABC, NBC, etc. Bottom line: The demand will be unavoidable.

So in other words we will see crazy demand like we did when LASIK surgery suddenly got proven to be effective?

Essentially I could see doctors treating people in the same way as going to a vaccine centre. Line up a row of those exam couches with a curtain in between and start injecting one by one to get as many people treated in a session as possible.

 

[Gb3]

So in other words we will see crazy demand like we did when LASIK surgery suddenly got proven to be effective?

Essentially I could see doctors treating people in the same way as going to a vaccine centre. Line up a row of those exam couches with a curtain in between and start injecting one by one to get as many people treated in a session as possible.

When I got my injection in my ear for my sudden hearing loss, the ENT came in, did the shot in like 3 minutes and I lied there for 30 minutes. David Luchinno has done interviews where he says this is a very easy and routine procedure for the patient and the doctor.

 

[vttbx]

When I got my injection in my ear for my sudden hearing loss, the ENT came in, did the shot in like 3 minutes and I lied there for 30 minutes. David Luchinno has done interviews where he says this is a very easy and routine procedure for the patient and the doctor.

Did your hearing loss and tinnitus improve after the steroid injection?

 

[frpp]

Better start building relationships with ENTs now, preferably those already involved with the trials since they're the early adopters and will be the most prepared for it once the drug is released.

 

[Gb3]

Did your hearing loss and tinnitus improve after the steroid injection?

Unfortunately not lol. Why do you think I'm on here.

 

[frpp]

Anyone else dreaming of the day when we can move this thread into the Treatments category?

 

[KotaDomowa]

Anyone else dreaming of the day when we can move this thread into the Treatments category?

So many years...

 

[weab00]

Anyone else dreaming of the day when we can move this thread into the Treatments category?

It will happen someday soon.