Frequency Therapeutics — Hearing Loss Regeneration

[Danad]

Astellas' European clinic trial:

- Any hint when the clinical trial would start?
- Which countries do they take place in?
- How can you enroll in the clinical trial?

I live near Munich, where Astellas has its German headquarters.

I would be the perfect candidate.

I am 44, I have hearing loss in left ear beginning at about 6 kHz, in right ear at about 15 kHz.
I have constant severe, intrusive tinnitus (only the shower masks it), louder in the right ear than in the left.
The tinnitus was mild since 2010, intrusive since 04/2020.
With mental strength and help from various sides I have not gone completely mad (and kept my work for example)

FX-322 is my greatest hope to get back to a normal life.

I would rate the chance all in all (that there will be a clinical trial near me within the next year which I can take part in and that FX-322 helps me) at about 0,01%.

That's infinite times more than 0,00%. Some sarcasm, trying to lol, seems I am not completely mad).

Getting into a clinical trial means maybe a few squirts of placebo, and if you happen to get the drug it will probably be in only one ear which may not help bilateral tinnitus.

The probability is much greater than 0.01% that by 2023 we should have access to FX-322 and it will bring relief to many suffering with high frequency tinnitus.

 

[tommyd87]

It's unknown whether Astellas will even proceed to trials until the American phase 2 trial is completed. In my opinion it is unlikely, however not impossible.

I am also in agreement with @Danad that there is a high chance that FX-322 will be out by 2023 or probably sooner should the decision to allow compassionate access be made.

I also agree that there are limitations with what you can gain from a clinical trial. Therefore I would personally wait until the treatment is available for purchase because the benefit would be that you would get the optimum treatment for your needs. Not that there is going to be a clinical trial conducted near me.

 

[Oto]

The probability is much greater than 0.01% that by 2023 we should have access to FX-322

You mean 99.99%, don't you?

 

[NewLionel]

I could live with 2023

 

[FGG]

It's unknown whether Astellas will even proceed to trials until the American phase 2 trial is completed. In my opinion it is unlikely, however not impossible.

I am also in agreement with @Danad that there is a high chance that FX-322 will be out by 2023 or probably sooner should the decision to allow compassionate access be made.

I also agree that there are limitations with what you can gain from a clinical trial. Therefore I would personally wait until the treatment is available for purchase because the benefit would be that you would get the optimum treatment for your needs. Not that there is going to be a clinical trial conducted near me.

Some people are suffering enough where waiting is not the best option for them. I would say make your own choices about being in a clinical trial.

Some like @tommyd87 would wait (his choice and that's fair) but I tried to get in the trial knowing the risk of placebo and the very very small risk of ear drum rupture (which would be a risk regardless with compassionate use as well).

 

[Thuan]

Some like @tommyd87..I tried to get in the trial knowing the risk of placebo and the very very small risk of ear drum rupture...

This is my fear speaking and out of curiosity with these intratympanic injections (which patients will have to get multiple shots of), is there something patients can do to help the ear drum heal?

I'm not young anymore and I assume many people here aren't young either. Are there high risks for older population, where an ear drum puncture will not heal and could that introduce new tinnitus sounds?

 

[Zugzug]

Some like @tommyd87 would wait (his choice and that's fair) but I tried to get in the trial knowing the risk of placebo and the very very small risk of ear drum rupture (which would be a risk regardless with compassionate use as well).

Compassionate use has to be really hard to get, right?

I mean, in a large sense, hearing disorders are life-threatening because of suicide risk or permanent damage that leads to higher suicide risk, but this seems like the kind of thing that most doctors would just send someone to psychiatry for.

While the patient understands what they are doing, I feel like doctors would be hesitant. Hell, my doctor was hesitant to put me on steroids for a month (he recently agreed). It looks like an uphill battle.

 

[davidmp]

Astellas' European clinic trial:

- Any hint when the clinical trial would start?
- Which countries do they take place in?
- How can you enroll in the clinical trial?

I live near Munich, where Astellas has its German headquarters.

I would be the perfect candidate.

I am 44, I have hearing loss in left ear beginning at about 6 kHz, in right ear at about 15 kHz.
I have constant severe, intrusive tinnitus (only the shower masks it), louder in the right ear than in the left.
The tinnitus was mild since 2010, intrusive since 04/2020.
With mental strength and help from various sides I have not gone completely mad (and kept my work for example)

FX-322 is my greatest hope to get back to a normal life.

I would rate the chance all in all (that there will be a clinical trial near me within the next year which I can take part in and that FX-322 helps me) at about 0,01%.

That's infinite times more than 0,00%. Some sarcasm, trying to lol, seems I am not completely mad).

I live in Munich too, and also would likely volunteer for the trial!

 

[tommyd87]

Some people are suffering enough where waiting is not the best option for them. I would say make your own choices about being in a clinical trial.

Some like @tommyd87 would wait (his choice and that's fair) but I tried to get in the trial knowing the risk of placebo and the very very small risk of ear drum rupture (which would be a risk regardless with compassionate use as well).

I can see reasons for wanting to participate in this type of clinical trial from your and others' perspective and as a result also I would consider choosing to participate in the trial if I had the option. Obviously the treatment I need differs because it is needed in both ears. Thus I think that for someone like me this will mean that the commercial treatment is still going to be required after the clinical trial anyway.

I would definitely participate in other clinical trials however, like that of the ClearDrum Implant, because when FX-322 gets released, that would help to resolve the perforation in my ear. Therefore, I would agree with you that participating in a clinical trial should be left up to the discretion of the individual.

Here's hoping that FX-322 will be super successful in the current clinical trials, and then we can start using it maybe as early as next year. Unfortunately, I believe that, unless there is a vaccine found for coronavirus, I will face a further delay due to being unable to travel to the US to obtain the treatment.

 

[FGG]

@Thuan

Intratympanic injections are routine and almost always heal on their own (average time is 18 days if caused by an injection--you'd probably have an unpleasant few weeks though). I don't think you need to wait for ClearDrum. Just go to an experienced ENT.

Rate of tympanic membrane perforation after intratympanic steroid injection

 

[FGG]

Compassionate use has to be really hard to get, right?

I mean, in a large sense, hearing disorders are life-threatening because of suicide risk or permanent damage that leads to higher suicide risk, but this seems like the kind of thing that most doctors would just send someone to psychiatry for.

While the patient understands what they are doing, I feel like doctors would be hesitant. Hell, my doctor was hesitant to put me on steroids for a month (he recently agreed). It looks like an uphill battle.

The best solution to a doctor who won't help you is getting another opinion. There will be a doctor who sees severe suffering from hearing disorders as a valid reason for application. Frequency Therapeutics knows their drug qualifies for compassionate use that's why they put info on their website and discussed it on the Tinnitus Talk Podcast.

If we need a database eventually of sympathetic ENTs, maybe we can cross that bridge at some point here on the forum.

 

[tommyd87]

Compassionate use has to be really hard to get, right?

I mean, in a large sense, hearing disorders are life-threatening because of suicide risk or permanent damage that leads to higher suicide risk, but this seems like the kind of thing that most doctors would just send someone to psychiatry for.

While the patient understands what they are doing, I feel like doctors would be hesitant. Hell, my doctor was hesitant to put me on steroids for a month (he recently agreed). It looks like an uphill battle.

The best solution to a doctor who won't help you is getting another opinion. There will be a doctor who sees severe suffering from hearing disorders as a valid reason for application. Frequency Therapeutics knows their drug qualifies for compassionate use that's why they put info on their website and discussed it on the Tinnitus Talk Podcast.

If we need a database eventually of sympathetic ENTs, maybe we can cross that bridge at some point here on the forum.

It is incredibly simple - from my perspective - to obtain the treatment via compassionate use. I'd suggest a visit to one of the practices involved in the clinical trial.

Although there will be other ENTs willing to grant access to compassionate use, I'd suggest, should you have a troubling time at an ENT, to go to one of those practices involved in the clinical trial. They probably won't have a problem dealing with you.

 

[tommyd87]

@Toby1972 I think that England is where Astellas' headquarters is based in so they might conduct this trial there or they might do a multiple location trial too. It is a major benefit of Europe having multiple potential locations so close.

 

[tommyd87]

@Thuan my tinnitus did not get louder after I had the ear drum puncture many years ago. I am told that when I eventually get it repaired I may get an improvement from it. It is apparently causing a significant conductive hearing loss I have in this ear along with other issues.

 

[FGG]

@Thuan my tinnitus did not get louder after I had the ear drum puncture many years ago. I am told that when I eventually get it repaired I may get an improvement from it. It is apparently causing a significant conductive hearing loss I have in this ear along with other issues.

Was the puncture from an intratympanic injection?

 

[Thuan]

@Thuan my tinnitus did not get louder after I had the ear drum puncture many years ago. I am told that when I eventually get it repaired I may get an improvement from it. It is apparently causing a significant conductive hearing loss I have in this ear along with other issues.

Didn't @Ginagg738 post about getting tinnitus from a tympanic repair surgery? Reading her story was horrifying and scary. I'm so sad that it can happen.

 

[tommyd87]

Was the puncture from an intratympanic injection?

No, nearly almost certain that it came from a tympanostomy tube grommet.

 

[Chriscom]

Intratympanic injections are routine and almost always heal on their own (average time is 18 days if caused by an injection--you'd probably have an unpleasant few weeks though). I don't think you need to wait for ClearDrum. Just go to an experienced ENT.

I'm not sure if something is missing from the above--like maybe, you're talking about recovery after some type of damage. But I had one of these injections early this year for steroids. It was a late attempt to restore some of my hearing, and while it didn't help, it didn't damage anything either. Yes, a very small hole in your eardrum has to heal, but other than the moment of the injection itself (not agony but not fun), I felt little residual pain and of that, only occasionally and quickly passing. I returned to the ENT a week after the injection and while I forget if it had completely healed by then, he was satisfied with whatever he saw in there.

 

[FGG]

I'm not sure if something is missing from the above--like maybe, you're talking about recovery after some type of damage. But I had one of these injections early this year for steroids. It was a late attempt to restore some of my hearing, and while it didn't help, it didn't damage anything either. Yes, a very small hole in your eardrum has to heal, but other than the moment of the injection itself (not agony but not fun), I felt little residual pain and of that, only occasionally and quickly passing. I returned to the ENT a week after the injection and while I forget if it had completely healed by then, he was satisfied with whatever he saw in there.

No I'm talking about the same. That's how it goes for nearly everyone and it's not something to worry about if you go to a very experienced ENT.

 

[Greg Sacramento]

I wonder who linked to the Tinnitus Talk Podcast interview and placed it on Yahoo.

 

[tommyd87]

No I'm talking about the same. That's how it goes for nearly everyone and it's not something to worry about if you go to a very experienced ENT.

It is likely that the ones who end up dealing with this type of medication will be very good and competent at these types of injections.

 

[Jurger]

@Thuan

Intratympanic injections are routine and almost always heal on their own (average time is 18 days if caused by an injection--you'd probably have an unpleasant few weeks though). I don't think you need to wait for ClearDrum. Just go to an experienced ENT.

Rate of tympanic membrane perforation after intratympanic steroid injection

My perforations were healed each time I went to the clinic to get the next injection (shots spaced apart one week). Looking at that article, I think persistent perforations will not be a problem for most patients.

 

[Orions Pain]

What do you guys think will happen if FX-322 does prove to be successful? Doctors are constantly throwing around that tinnitus has over 200 causes, how hard do you guys think it will be to receive treatment?

Do you think they'll start normalizing extended audiograms that show high frequency loss? I just can't wait until FX-322 is out but I have a feeling I'm going to be severely disappointed.

 

[serendipity1996]

What do you guys think will happen if FX-322 does prove to be successful? Doctors are constantly throwing around that tinnitus has over 200 causes, how hard do you guys think it will be to receive treatment?

Do you think they'll start normalizing extended audiograms that show high frequency loss? I just can't wait until FX-322 is out but I have a feeling I'm going to be severely disappointed.

The lack of knowledge that so many ENTs/audiologists seem to display with tinnitus/hyperacusis as well doesn't really inspire confidence. In my experience, if you score 'perfect' on the standard audiogram it's as if your tinnitus/hyperacusis therefore can't possibly be related to hearing damage in the eyes of some of these practitioners. I think we'd have more luck with the audiologist/ENT practices that are affiliated with the clinical trial centres etc as others have said if we can't get a referral locally.

 

[Diesel]

What do you guys think will happen if FX-322 does prove to be successful? Doctors are constantly throwing around that tinnitus has over 200 causes, how hard do you guys think it will be to receive treatment?

Do you think they'll start normalizing extended audiograms that show high frequency loss? I just can't wait until FX-322 is out but I have a feeling I'm going to be severely disappointed.

If ALL Phase 2A outcomes are significant, an ENT diagnosing a patient with noise-induced or sensorineural hearing loss should be enough to treat with FX-322.

It's likely that the extended audiogram will become more common as ENTs will want to be able to measure improvements in hearing after treating with FX-322.

EDIT:

Keep in mind, the market for this drug even in the US is in the millions. For those in the US, you're used to seeing ads on TV for all kinds of drugs (even for relatively rare conditions) and hearing aids. Those, "Ask your doctor about... " type ads. There will be ads for FX-322 considering the market potential. Doctors won't be able to avoid it.

 

[Thuan]

I don't really want to get my hopes up and then get depressed when it fails but reading through all the other biomedical companies, FX-322's mechanism of action makes the most logical sense. Other companies, which I will not mention but you can easily look at on Tinnitus Talk, has questionable mechanism of actions (ahem anti-oxidant protection ).

With that said, tinnitus correlates with 50% of hearing loss victims. It's not a causative effect but a symptom along with hearing loss. Restoring hearing might or might not help tinnitus symptoms. Hell, my father has moderate hearing loss with zero tinnitus... But one can only hope it does help with tinnitus relief.

 

[Diesel]

I don't really want to get my hopes up and then get depressed when it fails but reading through all the other biomedical companies, FX-322's mechanism of action makes the most logical sense. Other companies, which I will not mention but you can easily look at on Tinnitus Talk, has questionable mechanism of actions (ahem anti-oxidant protection ).

With that said, tinnitus correlates with 50% of hearing loss victims. It's not a causative effect but a symptom along with hearing loss. Restoring hearing might or might not help tinnitus symptoms. Hell, my father has moderate hearing loss with zero tinnitus... But one can only hope it does help with tinnitus relief.

If we subscribe to tinnitus as a symptom to hearing loss; that is related to the damage/death of inner and/or outer hair cells. Then, restoring the inner/outer hair cells should reduce/eliminate the symptom if it is treated in the area where damage is present. Right now, we know that to be 8Khz to higher frequencies.

We have evidence unfortunately from members of this forum that tinnitus from noise tends to get worse when new damage takes place. Either a certain tone/sound gets louder, it becomes more "widespread," or multiple tones become present. So, we might accept that new hair cell death/damage is the source for these new symptoms.

We also have evidence from members on this forum, where a new tone/louder sound fades over time. The assumption is something healed. We also have evidence where hearing in a pure-tone audiogram is restored to a baseline over time. So, to an extent, the cochlea or hairs perhaps heal, and by healing the tinnitus symptom is reduced/eliminated back to a familiar baseline.

We also are aware from Carl LeBel on the Tinnitus Talk podcast that there were anecdotes of tinnitus improving from participants of the Phase 1/2 that were treated with FX-322. If I recall correctly, these anecdotes were received by ENTs of the participants, and likely relayed to Frequency Therapeutics.

It stands to reason that FX-322 might help treat tinnitus symptoms by repairing the cause; dead/damaged hair cells. Now it might certainly help some more than others, depending on the depth of damage in the cochlea causing the tinnitus (ie: What "tone" the tinnitus is.)

I personally would argue that if say, your tinnitus is a tone that FX-322 can't quite hit.. let's say it's 4Khz, and FX-322 can only restore down to 8Khz. You still may gain a benefit by the amount of restored hair-cells providing new signals to your auditory nerve. I am presuming that many with tinnitus have some level of wide-spread damage, even though they may not experience a tone at that site of damage. Therefore, increasing the number of new signal-providing cells may reduce the severity of the symptom.

 

[all to gain]

What do you guys think will happen if FX-322 does prove to be successful? Doctors are constantly throwing around that tinnitus has over 200 causes, how hard do you guys think it will be to receive treatment?

Do you think they'll start normalizing extended audiograms that show high frequency loss? I just can't wait until FX-322 is out but I have a feeling I'm going to be severely disappointed.

If you are willing to pay, it will not be difficult to receive the treatment. If you want it through the NHS in the UK then it will be more difficult. Not sure how things work in the US though.

 

[Orions Pain]

If you are willing to pay, it will not be difficult to receive the treatment. If you want it through the NHS in the UK then it will be more difficult. Not sure how things work in the US though.

My concern isn't about payment but more so convincing doctors to give treatment when there isn't any detectable hearing loss.

My audiogram shows as above average and all audiologists I see comment on how great my hearing is and how it's perfect so my concern would be that I wouldn't qualify for this treatment even though I have horrible tinnitus.

 

[annV]

My concern isn't about payment but more so convincing doctors to give treatment when there isn't any detectable hearing loss.

My audiogram shows as above average and all audiologists I see comment on how great my hearing is and how it's perfect so my concern would be that I wouldn't qualify for this treatment even though I have horrible tinnitus.

I don't think many doctors will give FX-322 to people who don't have detectable hearing loss.