Frequency Therapeutics — Hearing Loss Regeneration

[Gb3]

I imagine early on we will have a list being shared on Tinnitus Talk of specialists that are giving FX-322 in different countries. Better get on their waiting list early or it will be a long noisy wait.

I'm glad I'm already a patient at Mass Eye and Ear.

 

[FGG]

It's highly likely that Frequency Therapeutics will provide a "search map" on their website for health care providers / clinics offering FX-322 injections. If we learn that multiple injections of this first generation of FX-322 do indeed provide an additional benefit, it would mean that doctors providing the drug would need to have some type of training to understand the dosage amount / schedule needed per patient, and the proper protocols to assess the patient's individual hearing performance.

In the US, where a majority of our doctors offices are privately run as a business, this would be seen as a benefit to the practice to be listed / certified on Frequency Therapeutics' website as it will drive more business for qualified patients. In turn, this will ultimately take business away from those clinics that have not adopted the drug.

So, for the people on here, it makes finding a doctor who is willing and certified to provide the injection 100% easy.

Yep. Not all ENTs are comfortable with IT injections. Many never do them at all.

All Otologists do them however, and ENTs who specialize in Meniere's almost always do them routinely, too. Keep in mind that an ENT practice that doesn't perform this procedure with steroids now is much less likely to initially offer a new IT drug.

 

[aot]

Would Eustachian Tube Dysfunction prevent treatment by FX-322, even if your tinnitus was caused by hearing loss?

 

[GregCA]

This was more of an oscillation dynamics thought, not a safety one. Intuitively, it shouldn't make much difference, but they must have chosen the alternate route for some related reason.

I wasn't talking about safety either. I was talking about the effects of a small perforation in a membrane to the sound energy carried to its other side.

There are various studies about this (specifically for ear drums) and the gist of it is that it depends on the size and location of the perforation. I guess that sounds obvious.

What I can't tell from the diagram is whether the effect is carried by the energy going through the stapes/oval window or the round window. The latter seems like it would be a lot weaker since air propagation doesn't benefit from the mechanical lever effect from the ossicles, and is harder to focus.

 

[FGG]

Would Eustachian Tube Dysfunction prevent treatment by FX-322, even if your tinnitus was caused by hearing loss?

If it was patulous I could see gel leaking out of the injection reservoir more easily but maybe it could be plugged first in that case?

 

[GregCA]

Intratympanic is completely harmless. I received 8 of them in my right ear (every 3 days in a row) without any consequences. It is inconvenient but without consequences.

It does have consequences on your hearing until the hole heals and closes up. Generally minor though, given the size of the hole.

It is also possible that the scar tissue from the healing modifies your hearing.

Lastly, it's also possible that the hole doesn't heal on its own and requires some surgical attention. I wouldn't say that a myringoplasty a simple inconvenience.

Ask me how I know...

 

[GregCA]

My understanding is they surgically opened up the middle ear cavity and placed the drug directly onto the round window.

But after that, they use a particular sound to induce the diffusion through the cochlea, right? I think that's what we were discussing.

 

[Gabriel5050]

I imagine early on we will have a list being shared on Tinnitus Talk of specialists that are giving FX-322 in different countries. Better get on their waiting list early or it will be a long noisy wait.

Well, damn. I'm in Romania, so I'll wait literally years, because our medical system is one of the worst in Europe. :/

 

[GBB]

Let's see if it consistently reduces tinnitus before we dream/lament about futures that may never be.

 

[AfroSnowman]

Well, damn. I'm in Romania, so I'll wait literally years, because our medical system is one of the worst in Europe. :/

I'll tell you what, I wouldn't let a little thing like a national border stand in the way of a treatment. Remember it is very likely it will take a while for insurance to cover it so you'll probably have to go outside your local insurance plan and pay out of pocket if you don't want to wait for the extra years.

 

[Sironketchup]

I'm so excited, and I just can't hide it nana nana nana yea! Can't wait for the results.

 

[Gabriel5050]

I'll tell you what, I wouldn't let a little thing like a national border stand in the way of a treatment. Remember it is very likely it will take a while for insurance to cover it so you'll probably have to go outside your local insurance plan and pay out of pocket if you don't want to wait for the extra years.

I'm just as happy as anyone here to pay my savings for the treatment. The bigger obstacle I think will be getting ENTs to do the treatment with FX-322. I am doubtful of their ability to adopt new treatments quickly. No one does it, no ENT loses money because they don't do it, and the patient loses as always. I really, really hope I'm wrong, but that's what seems most likely to me.

 

[Diesel]

I'm just as happy as anyone here to pay my savings for the treatment. The bigger obstacle I think will be getting ENTs to do the treatment with FX-322. I am doubtful of their ability to adopt new treatments quickly. No one does it, no ENT loses money because they don't do it, and the patient loses as always. I really, really hope I'm wrong, but that's what seems most likely to me.

You're probably wrong over the long term.

There will be an initial lift to get ENTs/Otologists educated and trained on administering the drug. They can also charge a fee for the shot, and probably for more return visits to confirm the drug is working, or if more injections are needed. This isn't possible today. There are also millions in the US alone that have no treatment options, so this opens up an entirely new stream of patients for hearing loss treatment.

We also have to remember that FX-322 is a treatment and not a cure or vaccine. There will always be someone who loses hearing for the first time, or has to return for more treatment due to a new event that caused a new loss post treatment.

 

[falafel]

Let's see if it consistently reduces tinnitus before we dream/lament about futures that may never be.

Take into account that not all tinnitus are the same... A high pitched noise tinnitus at 10kHz (white noise, etc) is not the same as a unique tone kind of tinnitus at 1 kHz. So saying "it doesn't cure tinnitus" doesn't mean anything... In case this forum arrives to that negative conclusion at some point...

If it restores your hearing at some frequencies, well, why not try it out? At least you'll leave with better hearing. For me that's the important part of this.

 

[AfroSnowman]

I'm just as happy as anyone here to pay my savings for the treatment. The bigger obstacle I think will be getting ENTs to do the treatment with FX-322. I am doubtful of their ability to adopt new treatments quickly. No one does it, no ENT loses money because they don't do it, and the patient loses as always. I really, really hope I'm wrong, but that's what seems most likely to me.

Imagine if tens of thousands, eventually millions, of people are waving around their credit cards trying to find someone to take their money, service providers pop up to serve that need. It's not a perfect comparison, but LASIK created a whole new class of providers, separate from traditional ophthalmologists. It doesn't seem out of the realm of reason to suspect if this goes forward as an effective hearing treatment that some ENTs and Otologists will set up clinics which will specialize in the service.

Look at stem cell therapy for knees and backs, there is pretty weak data as to its efficacy, it's not FDA approved, insurance won't cover it but a Google search will show you stem cell clinics are all over the place. Actually this is a pretty equivalent situation in that you need an expert to administer it, it is pricy ($5000 and way up) and can often times require multiple treatments over the course of a few weeks.

I just believe if we are willing to pay someone, they will find a way to take our money.

 

[Pharz]

My ENT works at the Bronovo hospital in The Hague. My ENT wasn't actually aware of FX-322 when I asked her about it at my first appointment, but she was open-minded enough to do some digging on this treatment. At the second visit, the ENT said she was willing to write a recommendation for compassionate use if the results point to tinnitus alleviation, but she also added that she didn't expect the treatment to become mainstream at general hospitals for years to come, and that it would be more realistic to expect that we receive treatment at clinics or hospitals that are closely aligned with Astellas/Frequency Therapeutics in the short term.

I wonder if it would require some sort of an approval for the administration of this drug, i.e. would the clinical trial's result which was done in the US be sufficient for them to actually consider this drug and do the injections? Do you perhaps know the rules for the compassionate use?

When I asked my ENT for Prednisone and Dexamethasone intratympanic shots, she told me that in Netherlands it is not prescribed.

 

[Tezcatlipoca]

Let Capitalism do its work people, build it and they will come!

 

[tommyd87]

I'm just as happy as anyone here to pay my savings for the treatment. The bigger obstacle I think will be getting ENTs to do the treatment with FX-322. I am doubtful of their ability to adopt new treatments quickly. No one does it, no ENT loses money because they don't do it, and the patient loses as always. I really, really hope I'm wrong, but that's what seems most likely to me.

Imagine if tens of thousands, eventually millions, of people are waving around their credit cards trying to find someone to take their money, service providers pop up to serve that need. It's not a perfect comparison, but LASIK created a whole new class of providers, separate from traditional ophthalmologists. It doesn't seem out of the realm of reason to suspect if this goes forward as an effective hearing treatment that some ENTs and Otologists will set up clinics which will specialize in the service.

Look at stem cell therapy for knees and backs, there is pretty weak data as to its efficacy, it's not FDA approved, insurance won't cover it but a Google search will show you stem cell clinics are all over the place. Actually this is a pretty equivalent situation in that you need an expert to administer it, it is pricy ($5000 and way up) and can often times require multiple treatments over the course of a few weeks.

I just believe if we are willing to pay someone, they will find a way to take our money.

LASIK is offered here by practitioners and practices who solely conduct LASIK. I could see the same possibly happening with FX-322 also. Another factor which could come into play is that the treatment might end up being administered in specialist hospitals also which would potentially eliminate the need to go find a clinic which offers it in some areas.

The stem cell comparison is an interesting one because like is potentially the case with ear medicines, we might have regular/mainstream doctors trying to play down and criticise the benefits of these treatments because they are seen as 'experimental' and 'false.' This is despite the fact that the evidence suggests that there has been positive outcomes obtained in people with stem cell treatments. The fact of the matter is that some doctors are so conservative that they'll avoid engaging in some procedures even if there is merit in having them done or it turns out that a patient has positive outcomes from having it done. This has happened in my case personally with trying to get my botched septum surgery redone with other private ENTs and ironically it was ENTs working in the public hospital who supported this getting done.

Long story short is that there will be resistance and unwillingness for certain practitioners to engage in the treatment using any of these ear treatments.

 

[RichieTheKid]

Imagine if tens of thousands, eventually millions, of people are waving around their credit cards trying to find someone to take their money, service providers pop up to serve that need. It's not a perfect comparison, but LASIK created a whole new class of providers, separate from traditional ophthalmologists. It doesn't seem out of the realm of reason to suspect if this goes forward as an effective hearing treatment that some ENTs and Otologists will set up clinics which will specialize in the service.

Look at stem cell therapy for knees and backs, there is pretty weak data as to its efficacy, it's not FDA approved, insurance won't cover it but a Google search will show you stem cell clinics are all over the place. Actually this is a pretty equivalent situation in that you need an expert to administer it, it is pricy ($5000 and way up) and can often times require multiple treatments over the course of a few weeks.

I just believe if we are willing to pay someone, they will find a way to take our money.

I will do whatever it takes to get this, man. Hopefully we can start a movement on here.

 

[GBB]

Take into account that not all tinnitus are the same... A high pitched noise tinnitus at 10kHz (white noise, etc) is not the same as a unique tone kind of tinnitus at 1 kHz. So saying "it doesn't cure tinnitus" doesn't mean anything... In case this forum arrives to that negative conclusion at some point...

If it restores your hearing at some frequencies, well, why not try it out? At least you'll leave with better hearing. For me that's the important part of this.

Okay, well we have different perspectives. My hearing is fine, my tinnitus is hell. You're on a tinnitus forum btw.

You also start from a false premise which is that I've insisted this won't work. I just said let's not get sad over something that may never come to pass.

Is English your first language?

 

[Diesel]

My hearing is fine, my tinnitus is hell.

Then, your hearing is probably not fine.

 

[AliasM]

I just feel depressed about it all. IF it is successful, and IF I am even a candidate (probably not with an "essentially normal" 0-8 kHz hearing test) It will be decades before it is approved in Australia. We still can't even buy CBD oil. It's black market stuff.

 

[GBB]

Then, your hearing is probably not fine.

What I mean is my ability to discern noise is in no way disruptive to my life. When my tinnitus abates from time to time, like on benzos, my perceived ability to hear is acute.

It's one of the reasons I harbor a fear I have brain damage and not ear damage, but I have no idea.

 

[Tezcatlipoca]

I just feel depressed about it all. IF it is successful, and IF I am even a candidate (probably not with an "essentially normal" 0-8 kHz hearing test) It will be decades before it is approved in Australia. We still can't even buy CBD oil. It's black market stuff.

You can still travel to a nearby country that does offer the treatment, it's better than not having any alternatives.

 

[Diesel]

I just feel depressed about it all. IF it is successful, and IF I am even a candidate (probably not with an "essentially normal" 0-8 kHz hearing test) It will be decades before it is approved in Australia. We still can't even buy CBD oil. It's black market stuff.

It's probably not as much an IF, it's really a matter of "how well" the drug treats hearing loss / tinnitus at this point.

I suspect that depending on how well the drug treats tinnitus and high-frequency hearing loss, you'd probably need to go to a clinic with complaints of tinnitus or have a EHF audiogram done to provide the evidence for FX-322.

FX-322's very first trial was in Australia, and Astellas owns the rights for distribution. I don't see why they would take another decade to get the drug distributed there. It's a little different than a hemp extract.

 

[AfroSnowman]

I just feel depressed about it all. IF it is successful, and IF I am even a candidate (probably not with an "essentially normal" 0-8 kHz hearing test) It will be decades before it is approved in Australia. We still can't even buy CBD oil. It's black market stuff.

If it really works then it will just mean taking out a bigger loan and taking a trip out to Singapore or the USA for treatment. Again right now this is all conjecture and fantasy maybe it won't work at all, maybe it won't do anything for tinnitus, but if it does then it is all logistics and financing to make it happen. For example when Lenire came out I flew halfway around the world and stayed in Ireland for a week. A bit of a will-o'-the-wisp solution there but my point is just because they won't offer it where you are doesn't mean you won't be able to get it.

For me now that I'm somewhat habituated to my endless screeching there is some limit to what I would pay to get better (I'd like to retire some day) but I would easily delay retirement for another 2-5 years if that's what it took to travel around the world to make the sound stop.

 

[Princebeyel]

I'm just praying every minute of every day for compassionate use/expanded access. Hopefully we can make this a reality.

 

[d'Wooluf]

I just feel depressed about it all. IF it is successful, and IF I am even a candidate (probably not with an "essentially normal" 0-8 kHz hearing test) It will be decades before it is approved in Australia. We still can't even buy CBD oil. It's black market stuff.

Are you sure about the CBD oil?

CBD oil, Cannabidiol, now available over the counter in Australian pharmacies

I think we'll get FX-322 when/if everyone else does.

 

[falafel]

You also start from a false premise which is that I've insisted this won't work. I just said let's not get sad over something that may never come to pass.

Yes I understood that. I didn't say that you insisted on that. Sorry if you got that from my reply. What I just wanted to say is that since FX-322 is not an anti-tinnitus drug, it will be very difficult to say "it doesn't work" or "it works!" until a lot of people have tried it out and several months have passed and different kinds of tinnitus have been analysed. There are people who cured their tinnitus with waaay different approaches, so saying that something cures or doesn't cure tinnitus is very difficult. What we can say is that something "cures" or "doesn't cure" a specific kind of tinnitus. At least that's how I see it after all the knowledge I gathered through the years, you may differ though.

Also what I said is that each tinnitus is different in origin, cause, symptoms and probably, possible treatments, as you may know. The problem I see with the typical kind of conclusions and tinnitus studies is that they don't classify the different subjects depending on their cause and kind of noises they hear, etc, and I think it's important. I have friends with tinnitus and each one of us has different reactions to different sounds or stuff... so it's very difficult for me put all tinnitus sufferers in the same category...

Therefore a tinnitus treatment could have a 90% efficacy on patients with tinnitus and hearing loss above 10 kHz, and 30% efficacy on patients with tinnitus and hearing loss on 3 kHz only, and 0% efficacy on patients with tinnitus but not hearing loss. Then the average between all the tinnitus patients won't represent accurately the reality.

Have a nice day!

 

[Tezcatlipoca]

It's probably not as much an IF, it's really a matter of "how well" the drug treats hearing loss / tinnitus at this point.

I suspect that depending on how well the drug treats tinnitus and high-frequency hearing loss, you'd probably need to go to a clinic with complaints of tinnitus or have a EHF audiogram done to provide the evidence for FX-322.

FX-322's very first trial was in Australia, and Astellas owns the rights for distribution. I don't see why they would take another decade to get the drug distributed there. It's a little different than a hemp extract.

Thank you @Diesel for having to repeat yourself every 10 pages.

People, it works. It's just a matter of how well does it work. And this is just the first formulation, they'll keep working on this for years and years and years, until they get the results we all dream of.