Frequency Therapeutics — Hearing Loss Regeneration

[serendipity1996]

Anyone think FX-322 or regenerative medicine may help with Tonic Tensor Tympani Syndrome (TTTS)?

I know it's primarily a middle-ear issue, but could it have any relationship with inner-ear damage?

If middle ear hyperactivity is a consequence of inner ear damage then I suppose it's reasonable to speculate that FX-322 could help. Repairing the inner ear could potentially have a positive downstream effect on middle ear activity if it arises secondary to inner ear trauma. That said, I feel like I don't know enough about TTTS to say - I feel like TTTS seems to fall under the same category as pain hyperacusis in being relatively poorly understood. It definitely appears that TTTS is something experienced mostly by people who have had an acoustic trauma.

 

[bell]

So Frequency Therapeutics is stating the following:

• "Later this year the Company plans to commence a safety study of FX-322 in patients with age-related hearing loss, and also is evaluating other potential studies."

• "Planning for near-term studies in additional patient populations."

What could these studies be? Any idea? Besides the age-related thingy of course.

Starting a "new safety study" seems not not normal to me, what do you think?

 

[FGG]

Starting a "new safety study" seems not not normal to me, what do you think?

I would take that as they are trying to get fully labelled for more than one type of hearing loss and infer that they think they may get insurance coverage of this drug.

 

[WillBeNimble]

Starting a "new safety study" seems not not normal to me, what do you think?

That is interesting wording. Then again, it might be because it's technically different than SNHL that they already tested?

 

[Thuan]

Starting a "new safety study" seems not not normal to me, what do you think?

Seems like Frequency Therapeutics is implying additional safety studies. I applaud them for this. I would feel much more assured if they conduct additional safety studies. Hypothetically, I would really want them to follow up on patients in Phase 1 and Phase 2 for long term and assess if any former patients had developed adverse side effects.

I mean, look at Trobalt that has helped tinnitus but people suffered a lot of severe and negative side effects that we still don't know if those side effects are reversible.

 

[asey20]

Seems like Frequency Therapeutics is implying additional safety studies. I applaud them for this. I would feel much more assured if they conduct additional safety studies. Hypothetically, I would really want them to follow up on patients in Phase 1 and Phase 2 for long term and assess if any former patients had developed adverse side effects.

I mean, look at Trobalt that has helped tinnitus but people suffered a lot of severe and negative side effects that we still don't know if those side effects are reversible.

You can't really compare FX-322 to Trobalt in side effect profiles though, since Trobalt was affecting the CNS.

FX-322 is primarily affecting only the inner ear, so at least we can expect a much better side effect profile. Although I guess it would be good to know that it won't cause worse tinnitus later or even hearing issues.

 

[tommyd87]

Seems like Frequency Therapeutics is implying additional safety studies. I applaud them for this. I would feel much more assured if they conduct additional safety studies. Hypothetically, I would really want them to follow up on patients in Phase 1 and Phase 2 for long term and assess if any former patients had developed adverse side effects.

I mean, look at Trobalt that has helped tinnitus but people suffered a lot of severe and negative side effects that we still don't know if those side effects are reversible.

I think that this would have been done even if only briefly as part of the follow up.

If any actual participants had negative outcomes which could be traced back to FX-322 then there is no way the FDA wouldn't have known about it.

Frequency Therapeutics wouldn't have been able to hide it nor would they choose to hide it either as a failure to disclose. This would jeopardize the trial and the chances of FX-322 gaining approval. Not to mention the risk of it killing the whole company for good because I don't think the FDA would take too kindly to a company failing to follow the requirements.

 

[FGG]

Seems like Frequency Therapeutics is implying additional safety studies. I applaud them for this. I would feel much more assured if they conduct additional safety studies. Hypothetically, I would really want them to follow up on patients in Phase 1 and Phase 2 for long term and assess if any former patients had developed adverse side effects.

I mean, look at Trobalt that has helped tinnitus but people suffered a lot of severe and negative side effects that we still don't know if those side effects are reversible.

They have been following up long term on the patients from phase 1 and presumably they will for phase 2 as well.

 

[Thuan]

From the transcript of the Tinnitus Talk Podcast interview with Frequency Therapeutics:

"The intratympanic injection, as it's called, is a fairly straightforward procedure. You can do it in an office-based setting, under a little bit of topical anaesthetic applied to the ear drum."

"One last feature that we included in the study design is we dosed only one ear, so some subjects that come ear have hearing loss in both ears, but we typically would dose the worst hearing ear as long as it would qualify according to the requirements."​

The interview also describes how the injection is done for the ears. It's only one ear, not both ears.

 

[FGG]

Found this from when I applied but didn't get in the trial. It outlines the protocol (they do not inject your other ear as a placebo). The "placebo control" of using the other ear is just measuring hearing function.

It also states that they use EMLA topical anesthetic and not injectable lidocaine so that answers that. But it also says the pain is from the injection and not the substance used.

 

[Thuan]

Found this from when I applied but didn't get in the trial. It outlines the protocol (they do not inject your other ear as a placebo). The "placebo control" of using the other ear is just measuring hearing function.

It also states that they use EMLA topical anesthetic and not injectable lidocaine so that answers that. But it also says the pain is from the injection and not the substance used.

View attachment 40219
View attachment 40220

That's great information. Reading the side effects of the injection is a bit concerning. It can introduce new tinnitus or the perforated eardrum may not close needing extra surgery (which based on reports here on Tinnitus Talk might introduce new tinnitus).

Anyways, just me rambling...

 

[kiki]

https://investors.frequencytx.com/n...eutics-shares-clinical-data-exploratory-study

"In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."

Isn't a same dose the same molecular weight?
Wasn't the molecular weight of the injection 0.2ml in Phase 1/2?

The success of FX-322 is the light of hope to live now.

 

[all to gain]

That's great information. Reading the side effects of the injection is a bit concerning. It can introduce new tinnitus or the perforated eardrum may not close needing extra surgery (which based on reports here on Tinnitus Talk might introduce new tinnitus).

Anyways, just me rambling...

I brought up this concern quite a while ago. Imagine paying $10,000 for even worse tinnitus.
Wonder what the chances are of side effects or needing extra surgery?

 

[AtlasFainted]

I brought up this concern quite a while ago. Imagine paying $10,000 for even worse tinnitus.
Wonder what the chances are of side effects or needing extra surgery?

I don't think it's very likely. Someone on Reddit talked once about how he'd had over 30 or so ear injections and was fine afterwards.

I mean some people have gone blind from LASIK; any procedure has a small amount of risk. Personally I would take the first of 4 injections of FX-322 in each ear tomorrow if it were offered to me...

 

[tommyd87]

I brought up this concern quite a while ago. Imagine paying $10,000 for even worse tinnitus.
Wonder what the chances are of side effects or needing extra surgery?

I agree that would suck too.

https://pubmed.ncbi.nlm.nih.gov/27751619/.

The rate of persistent tympanic membrane perforation following intratympanic steroid injection is low. Patients with a history of radiation to the head and neck may be at increased risk for prolonged time for closure of perforation.

I think the likelihood of tinnitus getting worse from the injection is very low.

I'd expect that these side effects are being mentioned because they are required to and not because they are actually super serious.

 

[WillBeNimble]

That's great information. Reading the side effects of the injection is a bit concerning. It can introduce new tinnitus or the perforated eardrum may not close needing extra surgery (which based on reports here on Tinnitus Talk might introduce new tinnitus).

Anyways, just me rambling...

Unfortunately, any drug to treat tinnitus would probably carry the possibility of worsening it too. As for the ear drum damage, we've known it was a possibility for a while. Best advice would be to get a good ENT who's done a number of them before.

 

[WillBeNimble]

perforated eardrum may not close needing extra surgery (which based on reports here on Tinnitus Talk might introduce new tinnitus).

And, to be clear, the chances of it are small. It's possible, but small.

 

[RB2014]

Unfortunately, any drug to treat tinnitus would probably carry the possibility of worsening it too.

It's possible... But 99.999 percent of those will adapt and habituate again... It might also be temporary but again it should quiet down after a while.

I started this thread almost 4 years ago when I still had some hearing left... I'm now in the 110 dB loss range in anything after about 1 kHz... and 50 dB below 1 kHz.

If I can adapt, anyone can adapt!

 

[tommyd87]

It's possible... But 99.999 percent of those will adapt and habituate again... It might also be temporary but again it should quiet down after a while.

I started this thread almost 4 years ago when I still had some hearing left... I'm now in the 110 dB loss range in anything after about 1 kHz... and 50 dB below 1 kHz.

If I can adapt, anyone can adapt!

Are you looking at a cochlear implant for either ear?

 

[RB2014]

Are you looking at a cochlear implant for either ear?

Not yet. I still have 50 dB left below 1 kHz... My word scores are still acceptable. I was holding out for FX-322 but I think my hearing is too far gone now for it to work.

Probably another 3 to 5 years and I'll go the CI route.

 

[tommyd87]

Not yet. I still have 50 dB left below 1 kHz... My word scores are still acceptable. I was holding out for FX-322 but I think my hearing is too far gone now for it to work.

Probably another 3 to 5 years and I'll go the CI route.

You never know what might happen.

 

[Diesel]

And, to be clear, the chances of it are small. It's possible, but small.

In the seemingly rare event that an ear drum is perforated as a result of the injection of FX-322; the drug itself is still injected in the middle ear and treating the cochlea.

From what I have read, in most cases a perforated drum heals on its own; rarely needing surgical intervention.

I think we're getting a little too fixated on what is probably an edge case.

 

[Fields]

Not yet. I still have 50 dB left below 1 kHz... My word scores are still acceptable. I was holding out for FX-322 but I think my hearing is too far gone now for it to work.

Probably another 3 to 5 years and I'll go the CI route.

Fingers crossed. I hope that a viable alternative, such as FX-322, will become available to you before you go down the CI route.

 

[Chriscom]

In the seemingly rare event that an ear drum is perforated as a result of the injection of FX-322; the drug itself is still injected in the middle ear and treating the cochlea.

From what I have read, in most cases a perforated drum heals on its own; rarely needing surgical intervention.

I think we're getting a little too fixated on what is probably an edge case.

Agreed. Having read the excerpt above, everything sounds like the same risk as the steroid injection I received in a failed attempt to restore some hearing loss. Didn't help my hearing but I suffered no ill effects.

 

[Jack V]

That's great information. Reading the side effects of the injection is a bit concerning. It can introduce new tinnitus or the perforated eardrum may not close needing extra surgery (which based on reports here on Tinnitus Talk might introduce new tinnitus).

Anyways, just me rambling...

I spoke with an ENT about injections (socially, not as a patient, so he was pretty forthcoming). He said in all his time giving injections, he's never had a problem.

 

[Jack V]

Found this from when I applied but didn't get in the trial. It outlines the protocol (they do not inject your other ear as a placebo). The "placebo control" of using the other ear is just measuring hearing function.

It also states that they use EMLA topical anesthetic and not injectable lidocaine so that answers that. But it also says the pain is from the injection and not the substance used.

View attachment 40219
View attachment 40220

When I had ear injections, the ENT who did them made the case that putting anesthetic in the ear was as painful as getting the injection itself, and would introduce yet another poke in the ear, so why bother? Made sense to me so we did them without the anesthetic and it wasn't a problem. Not sure if that relates to potential FX-322 administration, but perhaps.

 

[Lucifer]

When I had ear injections, the ENT who did them made the case that putting anesthetic in the ear was as painful as getting the injection itself, and would introduce yet another poke in the ear, so why bother? Made sense to me so we did them without the anesthetic and it wasn't a problem. Not sure if that relates to potential FX-322 administration, but perhaps.

I'm definitely getting anaesthetic before getting the FX-322 shot.

 

[asey20]

When I had ear injections, the ENT who did them made the case that putting anesthetic in the ear was as painful as getting the injection itself, and would introduce yet another poke in the ear, so why bother?

For FX-322 they are using a numbing gel that is placed on the ear drum. I'm assuming this means not injected, but just rubbed onto the ear drum.

 

[dan]

It's possible... But 99.999 percent of those will adapt and habituate again... It might also be temporary but again it should quiet down after a while.

I started this thread almost 4 years ago when I still had some hearing left... I'm now in the 110 dB loss range in anything after about 1 kHz... and 50 dB below 1 kHz.

If I can adapt, anyone can adapt!

Adapting to severe hearing loss and adapting to severe tinnitus are two different things.

 

[Billy_Shears]

If FX-322 is on course to be the emancipator in curing mild to moderate hearing loss, meaning restoring clarity and raising word scores by up to 30%, and I believe it will, then the pain of the injection would be the outermost event from my mind.