Frequency Therapeutics — Hearing Loss Regeneration

[Deathtotinni]

If it is safe and works, I don't see why it would take 5-10 years to be released to the public. I can't believe I have to keep repeating this, but by December, they will know if the drug works. Long term side effects can't be measured unless you follow up over several years.

So if the drugs improve hearing and there are no known side effects, why would the FDA not fast track its release?

I've repeated the same thing so many times lol.

 

[Pero1234]

No you will know at the start of the new year. In just a couple of months we will know if it in fact works on humans. If it works on mice, maybe it'll work on my deaf dog lol

I do hope, if it works... and they've optimized the delivery methods for humans, that they start developing it for dogs as well...

There's a potential side-market there as well!

 

[PDodge]

Am I reading the study correctly? You have to have 70 dB hearing loss to have been enrolled?

 

[Mr Mister]

I tried to go through this long thread but could not find anything on actual decibels gained in previous animal studies.

Was it ever mentioned how many decibels the hearing of the tested mice improved after treatment?

That would give some guidance on what to expect from human trials.

 

[Philip83]

To be honest, I don't really care too much exactly how long it will take until FX-322 is on the market. If they report some groundbreaking results in a month or two from now, I can endure a few more years of tinnitus, simply from the joy of the knowledge that there IS something out there that is working.

 

[85dB T]

To be honest, I don't really care too much exactly how long it will take until FX-322 is on the market. If they report some groundbreaking results in a month or two from now, I can endure a few more years of tinnitus, simply from the joy of the knowledge that there IS something out there that is working.

Agree. Hopefully the number of years we've had tinnitus and/or hearing loss won't count against us regarding its effectiveness (assuming it's effective). Also that they don't take it off the market for some unexplained reason (assuming it goes to market). The sooner the better. Even if it has side effects how much worse could it be?

A lot of assuming.

It's Christmas soon, at least we have hope.

 

[PDodge]

Agree. Hopefully the number of years we've had tinnitus and/or hearing loss won't count against us regarding its effectiveness (assuming it's effective). Also that they don't take it off the market for some unexplained reason (assuming it goes to market). The sooner the better. Even if it has side effects how much worse could it be?

A lot of assuming.

It's Christmas soon, at least we have hope.

Hopefully not, I mean if you read the inclusion requirements -- these people getting enrolled have pretty bad hearing loss, so if it works for them, we should be good.

 

[jeff W]

There are other examples of eyes providing input but the brain lacking the ability to interrupt the information. I was born with an eye condition that required surgery. My brain relied heavily on my better eye, and as a result its connection to the bad eye weakened. Even when we correct the vision in my bad eye with glasses, the damage is done. My brain lacks the ability to interrupt what my eye correctly sends; there's a disconnect that cannot be fixed.

Hopefully the brain has more plasticity when it comes to our hearing.

It may have more to do with the information itself than how it is interpreted, the brain gets far too much focus for theories on perception and vision, it is a slave to the inputs of our sense organs.
Molyneux's Question

 

[85dB T]

the brain gets far too much focus for theories on perception and vision, it is a slave to the inputs of our sense organs.

Psychosis produces vivid hallucinations of sight, sound, touch, smell and taste.

 

[Rings-a-Bell]

There are other examples of eyes providing input but the brain lacking the ability to interrupt the information. I was born with an eye condition that required surgery. My brain relied heavily on my better eye, and as a result its connection to the bad eye weakened. Even when we correct the vision in my bad eye with glasses, the damage is done. My brain lacks the ability to interrupt what my eye correctly sends; there's a disconnect that cannot be fixed.

Hopefully the brain has more plasticity when it comes to our hearing.

That condition is called amblyopia. I have it too. It has been considered untreatable in adults until recently. There is now new work being done that involves playing video games like tetris while wearing 3d (red and blue) glasses, in which they have finally been able to improve people's amblyopic eyes and improve their stereo vision. That being said, I can't vouch for it cause I'm in a small island country and they don't exactly offer cutting edge therapies here.

 

[Striveon]

Am I reading the study correctly? You have to have 70 dB hearing loss to have been enrolled?

So severe / profound hearing loss? When is that study happening? Or is it already happening? Imagine it works?! Hopefully it does work for all hearing loss type, we deserve freedom and peace.

 

[Pero1234]

There are other examples of eyes providing input but the brain lacking the ability to interrupt the information. I was born with an eye condition that required surgery. My brain relied heavily on my better eye, and as a result its connection to the bad eye weakened. Even when we correct the vision in my bad eye with glasses, the damage is done. My brain lacks the ability to interrupt what my eye correctly sends; there's a disconnect that cannot be fixed.

Hopefully the brain has more plasticity when it comes to our hearing.

Good point @Tinker Bell.

You make me wonder...

Did the doctors say retraining your brain could help? For example wearing an eye patch over your good eye for several hours a day? To force your brain to pay more attention again to the visual stream coming from the eye that had surgery?

I'm no doctor and I'm just taking a wild guess here... but from what I've read on CBT and brain plasticity, my gut feeling is that the brain would need to be retrained.

Perhaps not the best comparison, but the first one I can come up with: if you were not able to move your leg for a long time, you will lose muscle. Your other leg will become stronger because it compensated. The balance will only be restored if you train the weak leg separately.

Forgive me if this post is ignorant... I do not know your history. It's just that this would be logical to me. I'm curious if your eye doctor said something about retraining your brain or obscuring your good eye to make your brain pay attention.

 

[PDodge]

So severe / profound hearing loss? When is that study happening? Or is it already happening? Imagine it works?! Hopefully it does work for all hearing loss type, we deserve freedom and peace.

This is the FX-322 trial that's ongoing.

 

[Manny]

Am I reading the study correctly? You have to have 70 dB hearing loss to have been enrolled?

It's the opposite. A hearing loss of 70 dB or greater (at 0.5, 1, 2, or 4 kHz) is one of the exclusion criteria (https://clinicaltrials.gov/ct2/show/record/NCT03616223).
That said, trial criteria are not necessarily a binding comment on the actual limitations of a treatment. David Lucchino mentioned in an interview that FX-322 is initially aimed at mild to moderate, but that it might help people with more severe hearing loss than that as well (https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio, 52:00)

It's interesting how they seem to be focusing on these frequencies specifically and not on .25 kHz or 8 kHz, despite these two frequencies also being included in the currently standard audiogram (that being a rant for another time).
Do they think it might work best in the middle of the cochlear spiral specifically?
Who knows.

 

[Rings-a-Bell]

Good point @Tinker Bell.

You make me wonder...

Did the doctors say retraining your brain could help? For example wearing an eye patch over your good eye for several hours a day? To force your brain to pay more attention again to the visual stream coming from the eye that had surgery?

Eye patching is effective only up until about 12 years of age. I did it myself when I was 4-6 years old and it brought my eye up from blind to about 1/2 of what normal vision should be. It doesn't do anything for adults though.

 

[Tinker Bell]

That condition is called amblyopia. I have it too. It has been considered untreatable in adults until recently. There is now new work being done that involves playing video games like tetris while wearing 3d (red and blue) glasses, in which they have finally been able to improve people's amblyopic eyes and improve their stereo vision. That being said, I can't vouch for it cause I'm in a small island country and they don't exactly offer cutting edge therapies here.

No, my eye condition is more complicated than amblyopia. Amblyopia can be a side effect but it's not my diagnosis.

I was temporarily blind several years ago due to optic nerve damage. The damage was to my good eye, but my bad eye still failed to improve or respond. Without my good eye's vision, I was blind. If my bad eye was going to improve, it should have then.

Good point @Tinker Bell.

You make me wonder...

Did the doctors say retraining your brain could help? For example wearing an eye patch over your good eye for several hours a day? To force your brain to pay more attention again to the visual stream coming from the eye that had surgery?

I'm no doctor and I'm just taking a wild guess here... but from what I've read on CBT and brain plasticity, my gut feeling is that the brain would need to be retrained.

Perhaps not the best comparison, but the first one I can come up with: if you were not able to move your leg for a long time, you will lose muscle. Your other leg will become stronger because it compensated. The balance will only be restored if you train the weak leg separately.

Forgive me if this post is ignorant... I do not know your history. It's just that this would be logical to me. I'm curious if your eye doctor said something about retraining your brain or obscuring your good eye to make your brain pay attention.

That would work for amblyopia but I do not have that. Patching, forcing the brain to rely on the weaker eye or even just glasses can correct amblyopia (a lazy eye). That is a common practice.

From the leg analogy, you would need to add in other complications such as severe nerve damage. No matter how much you try to strengthen the muscle in the bad leg, it will not improve if the nerve is severely damaged. Or if the portion of your brain that controls the leg is damaged, by for example a stroke.

Relating this back to tinnitus, I guess the question would be what if a patient has severe hearing loss, tinnitus and hyperacusis? A hearing aid may help with the hearing loss but may not be enough to stop the tinnitus, and it may aggravate the hyperacusis. Sometimes it's easier to treat a patient if they only have one of these ailments, all three can further complicate treatment.

Hopefully the FX-322 trials will uncover how the drug impacts all three conditions.

 

[PDodge]

It's the opposite. A hearing loss of 70 dB or greater (at 0.5, 1, 2, or 4 kHz) is one of the exclusion criteria (https://clinicaltrials.gov/ct2/show/record/NCT03616223).
That said, trial criteria are not necessarily a binding comment on the actual limitations of a treatment. David Lucchino mentioned in an interview that FX-322 is initially aimed at mild to moderate, but that it might help people with more severe hearing loss than that as well (https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio, 52:00)

It's interesting how they seem to be focusing on these frequencies specifically and not on .25 kHz or 8 kHz, despite these two frequencies also being included in the currently standard audiogram (that being a rant for another time).
Do they think it might work best in the middle of the cochlear spiral specifically?
Who knows.

Thanks for clearing that up for me! I'm guessing that's where most people show damage because they only measure to 8 kHz (stupid),

 

[Mr Mister]

It's the opposite. A hearing loss of 70 dB or greater (at 0.5, 1, 2, or 4 kHz) is one of the exclusion criteria (https://clinicaltrials.gov/ct2/show/record/NCT03616223).
That said, trial criteria are not necessarily a binding comment on the actual limitations of a treatment. David Lucchino mentioned in an interview that FX-322 is initially aimed at mild to moderate, but that it might help people with more severe hearing loss than that as well (https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio, 52:00)

It's interesting how they seem to be focusing on these frequencies specifically and not on .25 kHz or 8 kHz, despite these two frequencies also being included in the currently standard audiogram (that being a rant for another time).
Do they think it might work best in the middle of the cochlear spiral specifically?
Who knows.

My understanding is that the reason for excluding people with a hearing loss of greater than 70 dB is that they want to measure both the positive and negative effects on patient's hearing. And if the hearing loss is severe (>70 dB) to begin with then it will be difficult to measure the potential negative effects on hearing. It does not necessarily mean that the expected effect is less for those with greater hearing loss.

 

[RB2014]

My understanding is that the reason for excluding people with a hearing loss of greater than 70 dB is that they want to measure both the positive and negative effects on patient's hearing. And if the hearing loss is severe (>70 dB) to begin with then it will be difficult to measure the potential negative effects on hearing. It does not necessarily mean that the expected effect is less for those with greater hearing loss.

I don't think they are taking people with good hearing and looking for negative effects on them. If they screw up their hearing and they can't get it back, it's pretty life changing. I'm pretty sure they have said once you reach that point the effects of the drug aren't as promising, so they are looking for people with better hearing that have their supporting cells intact so that their results look better.

I think once you go over a certain threshold your supporting cells can die as well and this no longer works.

They have mentioned that it still might work on people with losses greater than that, but at this point all we can do is speculate.

 

[jeff W]

Psychosis produces vivid hallucinations of sight, sound, touch, smell and taste.

As do religious experiences and some drugs. Cognitive neuroscience has become a self obsessed religion. We want results, not fairy tales. https://scienceblogs.com/pharyngula/2015/02/08/the-neuroplasticity-bait-and-switch

 

[85dB T]

As do religious experiences and some drugs. Cognitive neuroscience has become a self obsessed religion. We want results, not fairy tales. https://scienceblogs.com/pharyngula/2015/02/08/the-neuroplasticity-bait-and-switch

Agree. And I've never paid TRT or CBT any attention. Nor am I hopeful about MuteButton, being dependent on "spike-timing-dependent-nueroplasticity".

When you mentioned the brain being hardwired to the senses I could not help but to mention psychosis (hallucinations providing false input totally independent of the senses).

Mine wasn't drug induced or a religious experience. It was caused by clinical depression. I functioned in a different reality for months before being taken to a mental hospital. I didn't know psychosis was possible. I believed my brain was processing real sensory input, not false experiences indistinguishable from reality.

You guys know a lot about these topics. I'm only sharing my experience because no one cares and you don't have to read it. I'm just a washed up tinnitus sufferer.

(I've never done drugs or experienced anything similar.)

 

[Olive27]

I have been following thus thread from afar and really really REALLY hope that Frequency Therapeutics is successful. I'm cautiously optimistic.

My question is that there seems to be a lot of hype surrounding Frequency Therapeutics and rightly so it is very exciting. However there seems to be a very similar trial in the UK - see link below.

I'm just wondering why this isn't being discussed as much. Is there a reason?

https://www.regainyourhearing.eu/trial/

 

[Mr Mister]

I don't think they are taking people with good hearing and looking for negative effects on them. If they screw up their hearing and they can't get it back, it's pretty life changing. I'm pretty sure they have said once you reach that point the effects of the drug aren't as promising, so they are looking for people with better hearing that have their supporting cells intact so that their results look better.

I think once you go over a certain threshold your supporting cells can die as well and this no longer works.

They have mentioned that it still might work on people with losses greater than that, but at this point all we can do is speculate.

Current trials are to evaluate the safety of FX-322. I agree with you and hope there are no negative effects but that is what Frequency Therapeutics has to evaluate to get FDA clearance for Phase 2a. And to evaluate safety they need to set up the trials so that potential negative effects are measurable. If a patient has very little hearing left then potential negative effects can not be measured accurately.

I see little reason to speculate about whether this works for people with severe hearing loss as it has not been tested yet by Frequency Therapeutics. Those are the ones suffering most and we should be careful not to take away hope from them.

 

[d'Wooluf]

My question is that there seems to be a lot of hype surrounding Frequency Therapeutics and rightly so it is very exciting. However there seems to be a very similar trial in the UK - see link below.

I'm just wondering why this isn't being discussed as much. Is there a reason?

Regain Hearing has its own thread.

Frequency Therapeutics are better at promoting themselves. Check the number of videos they've put out. I don't recall seeing any for the Regain Project. Regain Project's drug is supposed to convert supporting cells directly into hair cells. FX-322 is supposed to activate cell division in supporting cells with some of the new cells being hair cells. This leaves a healthy population of supporting cells, which seems kind of safer to most of us paying attention.

 

[JohnAdams]

I have been following thus thread from afar and really really REALLY hope that Frequency Therapeutics is successful. I'm cautiously optimistic.

My question is that there seems to be a lot of hype surrounding Frequency Therapeutics and rightly so it is very exciting. However there seems to be a very similar trial in the UK - see link below.

I'm just wondering why this isn't being discussed as much. Is there a reason?

https://www.regainyourhearing.eu/trial/

Because certain "tinnitus associations" that get on television and have other connections to the media won't talk about it. They sure do promote the "management strategies" though.

 

[Manny]

I have been following thus thread from afar and really really REALLY hope that Frequency Therapeutics is successful. I'm cautiously optimistic.

My question is that there seems to be a lot of hype surrounding Frequency Therapeutics and rightly so it is very exciting. However there seems to be a very similar trial in the UK - see link below.

I'm just wondering why this isn't being discussed as much. Is there a reason?

https://www.regainyourhearing.eu/trial/

They seem to be taking quite a while with their process, Frequency Therapeutics appears to be moving along much quicker.

 

[Pero1234]

They seem to be taking quite a while with their process, Frequency Therapeutics appears to be moving along much quicker.

I agree... although some people would like to see them move even faster, I feel like Frequency Therapeutics are moving at a healthy speed.

Determined and with a sense of urgency... but at the same time rigorous and careful.

Hence the phase 1b they are doing now.

Fingers crossed! Even if they don't get it first time right... they're doing groundbreaking work!

 

[Mr Mister]

I have been following thus thread from afar and really really REALLY hope that Frequency Therapeutics is successful. I'm cautiously optimistic.

My question is that there seems to be a lot of hype surrounding Frequency Therapeutics and rightly so it is very exciting. However there seems to be a very similar trial in the UK - see link below.

I'm just wondering why this isn't being discussed as much. Is there a reason?

https://www.regainyourhearing.eu/trial/

It is really interesting that two completely unrelated entities are using small molecules trying to cure hearing loss and it's almost like a validation that this is the way to do it. Regain's development is moving ahead about the same pace with Frequency Therapeutics with both expected to end safety studies in the end of 2018. Could they combine forces if both work...? Always room for another small molecule in the syringe

Regain does not seek and get a lot of publicity as they are not looking for external funding like Frequency Therapeutics but are funded by European Commission. It is run by a consortium of 7 entities including Eli Lilly, ear institutes, universities, etc. My guess is that these parties are providing resources and maybe partly covering their costs as well.

 

[Coleoptere]

Very off-topic! But Audion (Regain) completed phase I and will move into phase II in the next few weeks. Phase I is safety where they injected 24 people. So Audion is ahead of Frequency Therapeutics. They are recruiting for phase II and that is encouraging. You can follow them on Twitter @evidENT_UCL

 

[Mr Mister]

Very off-topic! But Audion (Regain) completed phase I and will move into phase II in the next few weeks. Phase I is safety where they injected 24 people. So Audion is ahead of Frequency Therapeutics. They are recruiting for phase II and that is encouraging. You can follow them on Twitter @evidENT_UCL

That is great news!!! Did they get already an EU approval for the completed safety trials? I guess that is the assumption if they are already recruiting for phase II.

It would be really interesting to get just any information on how many decibels Frequency Therapeutics and Regain have managed to improve hearing of animals or humans. They state like they have "improved hearing" or "regained lost hearing" but it all depend how one defines "improve hearing". It could mean for example 10 dB or 50 dB which is huge difference and I have no idea what is the ballpark they are talking about