Frequency Therapeutics — Hearing Loss Regeneration

[AfroSnowman]

I have been reading this thread and seeing all of the discussion about damage and hypothetical efficacy of future drugs on noise induced damage vs ototoxicity. In my case my tinnitus and unknown portion of my hearing loss was due to a virus or maybe God giving me a wet Willy.

If it was viral and not of divine origin what parts of the hearing system would be damaged and would I be a good candidate for FX322?

 

[Jaysterk]

If I am understanding the document correctly, it can be added/requested through an amended IND, and needs to be done before the end of Phase 2, similar to the Breakthrough Status.

Let's make them request RMAT!

 

[Tweedleman]

I have been reading this thread and seeing all of the discussion about damage and hypothetical efficacy of future drugs on noise induced damage vs ototoxicity. In my case my tinnitus and unknown portion of my hearing loss was due to a virus or maybe God giving me a wet Willy.

If it was viral and not of divine origin what parts of the hearing system would be damaged and would I be a good candidate for FX322?

I'm no expert, but from what the others have deduced I think it will depend on the presence of your support cells still being there for FX-322 to work. The consensus seems to be that certain ototoxicities tend to wipe out support cells more than noise. But Chen is apparently working on regenerating support cells so all hope is not lost. I would think it's definitely still worth a shot for you, regardless.

 

[monkey124]

@Tweedleman
Hi there,

sorry for the total randomness of this question but have been lurking a bit and noticed you crop up in a lot of the threads and just wanted to get your opinion? No worries at all if not.

Lucy

 

[FGG]

I have been reading this thread and seeing all of the discussion about damage and hypothetical efficacy of future drugs on noise induced damage vs ototoxicity. In my case my tinnitus and unknown portion of my hearing loss was due to a virus or maybe God giving me a wet Willy.

If it was viral and not of divine origin what parts of the hearing system would be damaged and would I be a good candidate for FX322?

Viral is a common cause of SSHL and it is not exclusionary for this trial. My guess is you are good.

 

[Diesel]

Has anyone taken a look at some of their recent (2019) patent applications? Although patents aren't necessarily indicative of the actual science, they can provide additional insight to the product.

http://appft.uspto.gov/netacgi/nph-...eutics+&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

I have only scanned it, but the most recent patent application mentions a method for increasing the cell density of supporting cells in a population of supporting cells. Starts at line 0078.

Can someone else take a look at this? My interpretation is that a bi-product of FX-322 or a similar drug in-progress may also include the replication or support cells.

Interested to read your interpretations.

 

[FGG]

Has anyone taken a look at some of their recent (2019) patent applications? Although patents aren't necessarily indicative of the actual science, they can provide additional insight to the product.

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=Frequency+Therapeutics+&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

I have only scanned it, but the most recent patent application mentions a method for increasing the cell density of supporting cells in a population of supporting cells. Starts at line 0078.

Can someone else take a look at this? My interpretation is that a bi-product of FX-322 or a similar drug in-progress may also include the replication or support cells.

Interested to read your interpretations.

Thanks for finding this. I think the increase in support cells is for their in vitro assay for testing, unless i read that wrong.

 

[mrbrightside614]

Has anyone taken a look at some of their recent (2019) patent applications? Although patents aren't necessarily indicative of the actual science, they can provide additional insight to the product.

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=Frequency+Therapeutics+&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

I have only scanned it, but the most recent patent application mentions a method for increasing the cell density of supporting cells in a population of supporting cells. Starts at line 0078.

Can someone else take a look at this? My interpretation is that a bi-product of FX-322 or a similar drug in-progress may also include the replication or support cells.

Interested to read your interpretations.

"In one such embodiment, the composition induces and maintains stem cell properties by proliferating to produce stem cell that can divide for many generations and maintain the ability to have a high proportion of the resulting cells differentiate into hair cells."

I take this to mean the progression of (1) support cell induced by FX-322 does not definitively = (another) (1) support cell + (1) active hair cell. The math presented by previous videos and slideshows etc. is not set-in-stone. I think this takeaway is only bolstered by the following passage:

"In certain embodiments, the present disclosure relates to inducing, promoting, or enhancing the growth, proliferation or regeneration of inner ear tissue, particularly inner ear supporting cells and hair cells."

So, it appears I could be wrong, and this could be repeatedly dosed for those of whom have comparatively fewer support cells. Each injection may disproportionately increase cochlear support cells and active hair cells, thereby justifying the strategy of repetitive dosing.

 

[FGG]

Has anyone taken a look at some of their recent (2019) patent applications? Although patents aren't necessarily indicative of the actual science, they can provide additional insight to the product.

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=Frequency+Therapeutics+&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

I have only scanned it, but the most recent patent application mentions a method for increasing the cell density of supporting cells in a population of supporting cells. Starts at line 0078.

Can someone else take a look at this? My interpretation is that a bi-product of FX-322 or a similar drug in-progress may also include the replication or support cells.

Interested to read your interpretations.

Just noticed this too: it looks like they are using the same surfactant Otonomy and Pipeline are using. Pipeline confirmed their drug diffuses across the whole human cochlea so now I'm wondering:

Clearly using a small dose would incur a problem of "reach" with FX-322 but the fact that they mentioned likely audiogram measurable efficacy over 3500 Hz makes me believe, at current concentrations, FX-322 preferable targets IHCs. IHC don't show up on audiograms until greater than 80%-85% loss but they are instrumental in "perceived loudness" and clarity. Mechanistically, it would make sense for FX-322 to target more IHCs since there are many more LGR+ cells (the target of the drug) that surround IHCs than OHCs.

I am really wondering now if FX-322 (in first incarnation) would treat IHCs all the way down the cochlea but only treat OHCs less efficiently until the reformulated with a much more concentrated gel (as a bonus, this seems easier than trying to entirely reformulate).

I'm also wondering if IHC damage has more directly to do with tinnitus (though OHCs help modulate glutamate with normal use so I guess they would still be relevant, too).

Just more to think about. The trial data really just needs to get here for us to interpret accordingly.

 

[mrbrightside614]

I wonder if people will start having FX-322 parties, the way they have botox parties?

You know, invite some people over.

Have a few drinks.

Administer intratympanic injections of hydrogel-suspended FX-322 into everyone's ears and call it a night.

In all seriousness if this ends up being a cure/significant relief to many I'd love to have a party and rejoice with all of you fine people that have become like family to me. The bond forged between tinnitus sufferers, to me, is so deep that it is hard to even articulate. To finally have that "we did it" moment would be unimaginably euphoric.

 

[FGG]

"In one such embodiment, the composition induces and maintains stem cell properties by proliferating to produce stem cell that can divide for many generations and maintain the ability to have a high proportion of the resulting cells differentiate into hair cells."

I take this to mean the progression of (1) support cell induced by FX-322 does not definitively = (another) (1) support cell + (1) active hair cell. The math presented by previous videos and slideshows etc. is not set-in-stone. I think this takeaway is only bolstered by the following passage:

"In certain embodiments, the present disclosure relates to inducing, promoting, or enhancing the growth, proliferation or regeneration of inner ear tissue, particularly inner ear supporting cells and hair cells."

So, it appears I could be wrong, and this could be repeatedly dosed for those of whom have comparatively fewer support cells. Each injection may disproportionately increase cochlear support cells and active hair cells, thereby justifying the strategy of repetitive dosing.

That's a really good point about repetitive dosing...

 

[Lucifer]

In all seriousness if this ends up being a cure/significant relief to many I'd love to have a party and rejoice with all of you fine people that have become like family to me. The bond forged between tinnitus sufferers, to me, is so deep that it is hard to even articulate. To finally have that "we did it" moment would be unimaginably euphoric.

It does feel like we are a family. I would love to meet all of you guys when this is over.

 

[FGG]

It does feel like we are a family. I would love to meet all of you guys when this is over.

And if one group of sufferers is helped before others, let's not quit until we are all free!

 

[mrbrightside614]

And if one group of sufferers is helped before others, let's not quit until we are all free!

I've been giving this a lot of thought actually. If I were to heal naturally (which is unlikely at 7 months because my sleep difficulties are once again re-emerging, great) I would certainly stick around because I would not feel safe until known therapeutic modalities are available to abate/reverse future damage.

If I am cured by drugs or devices, I don't know. I'll still stop in here and there, but I won't let this continue to be a life sentence after years of struggle. I haven't even been able to start a job/career yet and I'll be (happily) facing so many different life issues (e.g. relocation, housing, etc.) assuming I'm able to drive again at some point. But right now these are the least of my concerns. Just shows how debilitating even moderate tinnitus can be.

Right now, doing activities related to tinnitus are actually helpful in ignoring the sound. My doing something hopefully helpful to the community is one of the three coping mechanisms I have left. Those of whom contend that involvement in the community is to the bane of the sufferer are toxic and dismissive IMO.

 

[FGG]

I've been giving this a lot of thought actually. If I were to heal naturally (which is unlikely at 7 months because my sleep difficulties are once again re-emerging, great) I would certainly stick around because I would not feel safe until known therapeutic modalities are available to abate/reverse future damage.

If I am cured by drugs or devices, I don't know. I'll still stop in here and there, but I won't let this continue to be a life sentence after years of struggle. I haven't even been able to start a job/career yet and I'll be (happily) facing so many different life issues (e.g. relocation, housing, etc.) assuming I'm able to drive again at some point. But right now these are the least of my concerns. Just shows how debilitating even moderate tinnitus can be.

Right now, doing activities related to tinnitus are actually helpful in ignoring the sound. My doing something hopefully helpful to the community is one of the three coping mechanisms I have left. Those of whom contend that involvement in the community is to the bane of the sufferer are toxic and dismissive IMO.

I wouldn't blame anyone for feeling that way. It would feel like a re-birth and the inclination would be to just enjoy life again and, maybe even more importantly, build life again.

I think people like @threefirefour (who was cured after TMJ treatment I think) and @JohnAdams (who seems to have dramatically improved but stuck around to help the rest of us) are really rare and I really appreciate them. But I really don't blame people who need to move on. I just hope enough people want to stick around to provide support and keep up with research for the more esoteric or hard to treat causes.

 

[HootOwl]

When I had more moderate tinnitus I felt that as soon as a treatment worked for me I would want absolutely nothing more to do with the tinnitus world. I would simply leave it all behind and forget this dark chapter in my life.

But now that I suffer from severe reactive tinnitus and other hearing distortions I am more committed than ever to see that every single last one of us is helped.

I don't think I could ever leave anyone behind having lived on the severe side of the wall. I will do everything in my power to stay involved, if I (really fucking hoping) get better and propel research in whatever direction it needs to take.

 

[BBakkers]

I wonder if people will start having FX-322 parties, the way they have botox parties?

You know, invite some people over.

Have a few drinks.

Administer intratympanic injections of hydrogel-suspended FX-322 into everyone's ears and call it a night.

Where do we plan this future FX-322 party? Maybe we can sniff some FX-322 as well, to cure our inner and outer nose cells. LOL!

 

[mrbrightside614]

I wouldn't blame anyone for feeling that way. It would feel like a re-birth and the inclination would be to just enjoy life again and, maybe even more importantly, build life again.

I think people like @threefirefour (who was cured after TMJ treatment I think) and @JohnAdams (who seems to have dramatically improved but stuck around to help the rest of us) are really rare and I really appreciate them. But I really don't blame people who need to move on. I just hope enough people want to stick around to provide support and keep up with research for the more esoteric or hard to treat causes.

I don't think I'll ever entirely drop out of the community. As soon as I'm done with this last semester in my master's program, I plan to devote 100% of my productivity to Tinnitus Talk. Hopefully in a year's time we'll be able to mobilize the veterans community quite a bit and build a strong enough relationship with them to persuade them into funding more sophisticated approaches (e.g. DNA reprogramming which I think will be the ultimate tinnitus/hearing loss trump card one day). Also funding basic, easy studies like dexamethasone in acute (<1 month) tinnitus so people don't have to put up their houses for treatment. Hopefully by that time we'll be shouting Bernie 2020 from the rooftops and they won't have to face such a dilemma.

 

[FGG]

When I had more moderate tinnitus I felt that as soon as a treatment worked for me I would want absolutely nothing more to do with the tinnitus world. I would simply leave it all behind and forget this dark chapter in my life.

But now that I suffer from severe reactive tinnitus and other hearing distortions I am more committed than ever to see that every single last one of us is helped.

I don't think I could ever leave anyone behind having lived on the severe side of the wall. I will do everything in my power to stay involved, if I (really fucking hoping) get better and propel research in whatever direction it needs to take.

Will join you in sticking around .

 

[Tweedleman]

Will join you in sticking around .

Same. I've got lots of hidden hearing loss to keep me busy with even if I manage to get rid of the tinnitus.

 

[Lucifer]

 

[Jack V]

Where do we plan this future FX-322 party? Maybe we can sniff some FX-322 as well, to cure our inner and outer nose cells. LOL!

We'll bathe in it, a glowing pool of viscous hydrogel, and become hairy bastards inside and out.

 

[Jack V]

When I had more moderate tinnitus I felt that as soon as a treatment worked for me I would want absolutely nothing more to do with the tinnitus world. I would simply leave it all behind and forget this dark chapter in my life.

But now that I suffer from severe reactive tinnitus and other hearing distortions I am more committed than ever to see that every single last one of us is helped.

I don't think I could ever leave anyone behind having lived on the severe side of the wall. I will do everything in my power to stay involved, if I (really fucking hoping) get better and propel research in whatever direction it needs to take.

Thing is, unless you experience it yourself, the torture of it, you don't know what it's like.

So, with that knowledge, the visceral understanding of how it can torture you during the day and rob you of sleep at night, at least in its severe form, I think I'd feel an obligation to help in whatever way I could, however this all shakes out for me personally.

 

[mrbrightside614]

Thing is, unless you experience it yourself, the torture of it, you don't know what it's like.

So, with that knowledge, the visceral understanding of how it can torture you during the day and rob you of sleep at night, at least in its severe form, I think I'd feel an obligation to help in whatever way I could, however this all shakes out for me personally.

Moderate still robs you of sleep bro lol.

 

[Daniel Lion]

When I had more moderate tinnitus I felt that as soon as a treatment worked for me I would want absolutely nothing more to do with the tinnitus world. I would simply leave it all behind and forget this dark chapter in my life.

But now that I suffer from severe reactive tinnitus and other hearing distortions I am more committed than ever to see that every single last one of us is helped.

I don't think I could ever leave anyone behind having lived on the severe side of the wall. I will do everything in my power to stay involved, if I (really fucking hoping) get better and propel research in whatever direction it needs to take.

Hi HootOwl, thank you for getting involved and making important contributions to our cause. What made your tinnitus slide from moderate to severe, if it's not too personal? If it is personal, then no worries. Was curious as my tinnitus is very bad and if it got worse it would be catastrophic... scary. Thanks.

Thank you good people, the FX-322 die hards and regular contributors. You are great people, and we are family.

 

[Tweedleman]

I love the activity and hope on this thread. I know I'm still kinda in early days guys, but my whole auditory system still feels trashed. I have spent every minute of every day thinking about my hearing damage. It's utterly dominated me for 3 months and has shown an infinitely minuscule amount of improvement in that time. I'm in the depths of depression and this forum and this thread has been a life raft for me. I know you guys don't know me at all, but I love you all and am grateful for your contributions. I bet I speak for many lurkers out there, too, when I say you're keeping me going.

 

[KyleM]

I love the activity and hope on this thread. I know I'm still kinda in early days guys, but my whole auditory system still feels trashed. I have spent every minute of every day thinking about my hearing damage. It's utterly dominated me for 3 months and has shown an infinitely minuscule amount of improvement in that time. I'm in the depths of depression and this forum and this thread has been a life raft for me. I know you guys don't know me at all, but I love you all and am grateful for your contributions. I bet I speak for many lurkers out there, too, when I say you're keeping me going.

Yep decided to make an account to echo this. I watch a lot of threads on here for news and developments. The news and updates of real viable treatments is what keeps me going.

That and my cat.

 

[rei]

I love the activity and hope on this thread. I know I'm still kinda in early days guys, but my whole auditory system still feels trashed. I have spent every minute of every day thinking about my hearing damage. It's utterly dominated me for 3 months and has shown an infinitely minuscule amount of improvement in that time. I'm in the depths of depression and this forum and this thread has been a life raft for me. I know you guys don't know me at all, but I love you all and am grateful for your contributions. I bet I speak for many lurkers out there, too, when I say you're keeping me going.

I feel exactly the same. I'm about three months in and this thread in particular has been keeping me going. Thanks to everyone who has contributed, I am very grateful and very impressed.

 

[HootOwl]

Hi HootOwl, thank you for getting involved and making important contributions to our cause. What made your tinnitus slide from moderate to severe, if it's not too personal? If it is personal, then no worries. Was curious as my tinnitus is very bad and if it got worse it would be catastrophic... scary. Thanks.

Thank you good people, the FX-322 die hards and regular contributors. You are great people, and we are family.

No not too personal at all. A bad combination of split second noise exposure (multiple times over - a scream here, a shout there). It tough to see people attend 2 hour concerts at 100 dB sound levels and come out fine, and here I am being exposed to 10 seconds of shouting and it gets worse and worse. It feels like something just broke inside my ears.

The thing is that it's only the reactivity that gets worse. My normal tinnitus has not worsened, or at least not in any dramatic way. Even though I categorize my normal tinnitus as moderate it is live able and I wish I had that back. Although having clean ears (for the most part) is still my dream.

 

[Joly]

Hello, everyone, I don't understand one thing about the FX-322 and the patent:

- How can they know that the FX-322 is replacing support cells?
- And in what cases?