Frequency Therapeutics — Hearing Loss Regeneration

[Manny]

I think the reason they might need placebo may be due to the stated minimum efficacy measurement factor of 10 dbhl improvement. I think it's plausible that placebo could affect (i.e. effectively improve) hearing perception to the minor degree of 5-10 DB, much the same as stress or tiredness might. Remember, they're trying to isolate and detect a minimal degree of improvement at this point.
But just rememebered that hearing improvement is not actually a stated endpoint here. Still posting this as it may be generally relevant.
Placebo could also be relevant in terms of harmful effects: if, say 10% of the trial (real treatment group) report inner ear pain following treatment; but 10% of the placebo group report the same, that would suggest that the side effect of pain is not due to the drug specifically.

 

[d'Wooluf]

if, say 10% of the trial (real treatment group) report inner ear pain following treatment; but 10% of the placebo group report the same, that would suggest that the side effect of pain is not due to the drug specifically.

It could be due to the gel (which is common to all of the groups).

I think it's plausible that placebo could affect (i.e. effectively improve) hearing perception to the minor degree of 5-10 DB, much the same as stress or tiredness might

Have to disagree on this one. It's a bit like telling someone that the drug you're giving them will regrow their missing leg. It's still not going to happen. The control group could be there to account for changes that would have occurred during the length of the study anyway. The numbers are so small though, I don't see what kind of statistical analysis they could do that would be significant

 

[JohnAdams]

http://www.frequencytx.com/news-events/news-events-press-release-08-7-2018.php

 

[d'Wooluf]

One wonders (well I do)... If it's a safety study what does it matter who they recruit? They're narrowing their pool of subjects down to a specific type of hearing loss. If all they're doing is measuring safety, participants could have perfect hearing or almost none. I think they might sneak a few hearing tests in here or there.

So the best case scenario for those looking for free treatment via a trial is treatment for one ear only.

 

[IvanRus]

 

[JohnAdams]

One wonders (well I do)... If it's a safety study what does it matter who they recruit? They're narrowing their pool of subjects down to a specific type of hearing loss. If all they're doing is measuring safety, participants could have perfect hearing or almost none. I think they might sneak a few hearing tests in here or there.

So the best case scenario for those looking for free treatment via a trial is treatment for one ear only.

Yeah well if you had perfect hearing would you let them inject this experimental goo in your eardrum?

 

[Silvio Sabo]

I think fx322 will be safer than gene therapy. I'm going to go to the clinical trail. I need another Audiogram. I had one maybe 7 months ago and need another one to get in. My uncle who has unilateral hearing loss is likely going to try to go with me but I think he's 64 or 65 not sure if they will take him. I also had what I think is vestibular injury without apparent balance issues. I feel unbalanced but it's not bad enough to be messureable. I'm also 29 years old and used to workout a lot so maybe that's helping with my balance? I do notice my Bain fog gets better and better the more I walk and move around. I suffered a skull fracture which damaged my ear and then sound trauma made it worse then suffered a mild concussive blow to the head. I'm hoping if I fix my hearing loss/vestibular system I'll improve in a lot of areas. Sometimes I feel as though trying to focus on balance creates mental fog. But I'm going just need another Audiogram.

Maybe but gene therapy, if it were to work, would make you be able to regrow hair cells when damaged forever since you would actually alter the genetics of the cells in your cochlea. This would, at least in theory, give a person the ability to heal any future damage as well. If we manage to make it work it would be the holy grail.

I think if the problem would not be solved with restoring the cochlea, for instance in case the nerves are already dead and aren't restored, which could be the case for people that have had it for a long time. I think that in the future we will be able to fix that with very advanced cochlear implants that are going to be able to perfectly mimic the human hearing organ. It's just a matter of technical advancement. If this happens I think that giving the brain the same input as it would receive from a normal cochlea would fix pretty much everything. This would also be a kind of holy grail situation as a technical solution such as this would be very future proof. A device doesn't get damaged by noise for instance and you could simply turn it off when you want total silence.

But for now I really don't care how it's done as long as we all get some help. Be it a drug, therapy or surgery. I DON'T CARE!

 

[Autumnly]

http://www.frequencytx.com/news-events/news-events-press-release-08-7-2018.php

"The clinical evaluation of FX-322 for hearing restoration is a priority for us based on the unmet medical need of millions of patients around the world who have lost varying degrees of hearing function from chronic noise exposure or sudden hearing loss, and we look forward to reporting the results from this study toward the end of 2018."

 

[Phendran]

"we look forward to reporting the results from this study toward the end of 2018."

That's quite a thing is they can find out whether or not the drug works before next year.

Hopefully that is not only the plan, but also done in time.
Would be amazing if these guys will pull through to save us.

 

[JohnAdams]

Maybe but gene therapy, if it were to work, would make you be able to regrow hair cells when damaged forever since you would actually alter the genetics of the cells in your cochlea. This would, at least in theory, give a person the ability to heal any future damage as well. If we manage to make it work it would be the holy grail.

I think if the problem would not be solved with restoring the cochlea, for instance in case the nerves are already dead and aren't restored, which could be the case for people that have had it for a long time. I think that in the future we will be able to fix that with very advanced cochlear implants that are going to be able to perfectly mimic the human hearing organ. It's just a matter of technical advancement. If this happens I think that giving the brain the same input as it would receive from a normal cochlea would fix pretty much everything. This would also be a kind of holy grail situation as a technical solution such as this would be very future proof. A device doesn't get damaged by noise for instance and you could simply turn it off when you want total silence.

But for now I really don't care how it's done as long as we all get some help. Be it a drug, therapy or surgery. I DON'T CARE!

That's quite a thing is they can find out whether or not the drug works before next year.

Hopefully that is not only the plan, but also done in time.
Would be amazing if these guys will pull through to save us.

In 3 months we may be that much closer to knowing that relief is possibly coming. This is big news. Possibly the biggest news we as a community have ever had.

 

[Tempest]

You guys do realize that they will probably only announce if the drug was safe, yet again. Phase 1.5 won't tell us if the drug works or not.

 

[JohnAdams]

You guys do realize that they will probably only announce if the drug was safe, yet again. Phase 1.5 won't tell us if the drug works or not.

Perhaps. They may or may not choose to release more info.

 

[Soren]

You guys do realize that they will probably only announce if the drug was safe, yet again. Phase 1.5 won't tell us if the drug works or not.

Yes phase II will be where fx-322 will be put to the test.

 

[TheDanishGirl]

You guys do realize that they will probably only announce if the drug was safe, yet again. Phase 1.5 won't tell us if the drug works or not.

Yes. Nothing to get exited about just yet.

 

[IvanRus]

You guys do realize that they will probably only announce if the drug was safe, yet again. Phase 1.5 won't tell us if the drug works or not.

Yes?! I thought they already passed the safety trial.

How many more stages do they theoretically need to go through in order to start the test in public? How much time can this take?

 

[IvanRus]

They're narrowing their pool of subjects down to a specific type of hearing loss

Why are they doing that? Do they only select patients with mild hearing loss with acoustic trauma?

I have been worried for a long time whether this technology, even theoretically, will be effective in other cases of damage to the inner ear - ototoxicity, barotrauma, presbyacusis and so on.

 

[grate_biff]

Would be amazing if these guys will pull through to save us.

Amen! And I think they will.

Btw, I´ve contacted the trial site in Texas twice by email. No answer!

 

[Soren]

Yes?! I thought they already passed the safety trial.

How many more stages do they theoretically need to go through in order to start the test in public? How much time can this take?

After phase I comes II and III. my guess is between 3-7 years before fx-322 will come to market. Phase II can take from months to up to 2 years. Phase III between 1-4 years. This is not taking into account setbacks. Sorry for depressing news.

 

[JohnAdams]

Yes?! I thought they already passed the safety trial.

How many more stages do they theoretically need to go through in order to start the test in public? How much time can this take?

Aw man, what if someone died or turned into a frog or something in the first trial and they're taking a mulligan?

 

[JohnAdams]

After phase I comes II and III. my guess is between 3-7 years before fx-322 will come to market. Phase II can take from months to up to 2 years. Phase III between 1-4 years. This is not taking into account setbacks. Sorry for depressing news.

It's not news, it's speculation, based on what you wrote the lowball estimate could be in as soon as 2 years. Especially if it gets fast track status.

 

[Silvio Sabo]

After phase I comes II and III. my guess is between 3-7 years before fx-322 will come to market. Phase II can take from months to up to 2 years. Phase III between 1-4 years. This is not taking into account setbacks. Sorry for depressing news.

It's not news, it's speculation, based on what you wrote the lowball estimate could be in as soon as 2 years. Especially if it gets fast track status.

Phase III can also be done "on the market" meaning that a drug can be offered to the public already after a successful phase II.

 

[Soren]

Phase III can also be done "on the market" meaning that a drug can be offered to the public already after a successful phase II.

Ahhhhh i would like to see the "receipts" first.

 

[Enclave]

I think there's reason to be very positive here. 1/3 of the participants in this 1.5 trial are receiving a high dose. This is VERY significant and they are going to be watching this group closely. Even though hearing improvement isn't in the primary outcome measures yet, they did specifically state that they will be conducting audiometrey and otoscopy testing throughout this specific trial.

They're gonna know from this group whether or not what they have is real or bullshit. There will be an answer from this trial one way or another.

 

[JohnAdams]

Ahhhhh i would like to see the "receipts" first.

I think there's reason to be very positive here. 1/3 of the participants in this 1.5 trial are receiving a high dose. This is VERY significant and they are going to be watching this group closely. Even though hearing improvement isn't in the primary outcome measures yet, they did specifically state that they will be conducting audiometrey and otoscopy testing throughout this specific trial.

They're gonna know from this group whether or not what they have is real or bullshit. There will be an answer from this trial one way or another.

Well it worked in the mice to restore, and now they'll have humans to give verbal feedback instead of "squeak squeak".

What if the new hair cells rewire in a weird way and it makes every sound like Barry White or a crazy clown or something? I just think we are close to this type of technology exploding and we will start to see a cascading tsunami of regenerative medicine. Life extension stuff.

 

[Enclave]

I think it's also important to keep in mind, too, that Frequency is a privately funded startup that has MIT's and Harvard's brightest scientists at the helm of their science board. This is a significant factor to take into consideration. Companies that seek public investment do so to decrease their financial exposure and risk to failure, meaning, if they have significant reason to believe their product might be fallible, then they're gonna want to seek public investment to push their product through to see what the outcome might be while simultaneously reducing their financial risk and exposure.

Frequency is not posting results and information to pimp their stock profile. They're disclosing their breakthroughs in the name of science. If their product is a magic bullet that improves hearing with minimal side effects, then they are going to stay privately funded to maximize their earnings and intellectual property profile. Frequency would have to have definitive and substantial proof of concept to get 6-8 investors to drop millions in private cash. This motive gives me hope that what they have isn't a roll of the dice idea based on loose science.

Food for thought, the two significant players in the game right now (Frequency, Decidel) are privately funded.


Novartis/Genvec, Otonomy, Auris, Eli Lilly, Otologic Pharmaceuticals, they're all publicly traded and are all treading water in the hearing disorder game. None of these groups have succeeded or provided anything meaningful to our group. All this mindfulness training, signal timing, risky seizure drug therapies are all bullshit. They truly are. The real advancement, the real change, the REAL cure is in the regenerative medicine technology.


I'm very positive on Frequency and Decibels contributions to our ailments. These two are our only hope.

 

[JohnAdams]

I think it's also important to keep in mind, too, that Frequency is a privately funded startup that has MIT's and Harvard's brightest scientists at the helm of their science board. This is a significant factor to take into consideration. Companies that seek public investment do so to decrease their financial exposure and risk to failure, meaning, if they have significant reason to believe their product might be fallible, then they're gonna want to seek public investment to push their product through to see what the outcome might be while simultaneously reducing their financial risk and exposure.

Frequency is not posting results and information to pimp their stock profile. They're disclosing their breakthroughs in the name of science. If their product is a magic bullet that improves hearing with minimal side effects, then they are going to stay privately funded to maximize their earnings and intellectual property profile. Frequency would have to have definitive and substantial proof of concept to get 6-8 investors to drop millions in private cash. This motive gives me hope that what they have isn't a role of the dice idea based on loose science.

Food for thought, the two significant players in the game right now (Frequency, Decidel) are privately funded.


Novartis/Genvec, Otonomy, Auris, Eli Lilly, Otologic Pharmaceuticals, they're all publicly traded and are all treading water in the hearing disorder game. None of these groups have succeeded or provided anything meaningful to our group. All this mindfulness training, signal timing, risky seizure drug therapies are all bullshit. They truly are. The real advancement, the real change, the REAL cure is in the regenerative medicine technology.


I'm very positive on Frequency and Decibels contributions to our ailments. These two are our only hope.

Yeah it's going to change the world. I have a good reason to suspect that. It is all in the name.

 

[Deathtotinni]

Maybe but gene therapy, if it were to work, would make you be able to regrow hair cells when damaged forever since you would actually alter the genetics of the cells in your cochlea. This would, at least in theory, give a person the ability to heal any future damage as well. If we manage to make it work it would be the holy grail.

I think if the problem would not be solved with restoring the cochlea, for instance in case the nerves are already dead and aren't restored, which could be the case for people that have had it for a long time. I think that in the future we will be able to fix that with very advanced cochlear implants that are going to be able to perfectly mimic the human hearing organ. It's just a matter of technical advancement. If this happens I think that giving the brain the same input as it would receive from a normal cochlea would fix pretty much everything. This would also be a kind of holy grail situation as a technical solution such as this would be very future proof. A device doesn't get damaged by noise for instance and you could simply turn it off when you want total silence.

But for now I really don't care how it's done as long as we all get some help. Be it a drug, therapy or surgery. I DON'T CARE!

I'm a little on the fence about changing my genes. That could have some horrible side effects

 

[john paul]

What if the new hair cells rewire in a weird way and it makes every sound like Barry White or a crazy clown or something?

Ill take Barry White over Tinnitus any day.

 

[Deathtotinni]

3 groups.

High Dose: 8 participants
Low Dose: 8 participants
Placebo: 8 Participants

That's a 67% chance of receiving the drug.

Also, I find it very interesting they're utilizing a high dose this early in the study.

I'm very curious to see if FX-322 is believed to have therapeutic impact on frequency ranges 6000hz - 800ohz. In the inclusion criteria they only reference 500hz, 1000hz, 2000hz, and 4000hz. No mention of 6000hz-8000hz. These frequencies are still important for human speech and hearing as a whole. Hopefully these ranges can be restored with this drug, but this is ambiguous at best at this point.

That's a fairly small trail. Only 24 people? That's disappointing

 

[JohnAdams]

That's a fairly small trail. Only 24 people? That's disappointing

I think they've scientifically decided that that's an adequate set of data points. Either it performs a miracle or it doesn't. You don't need a huge population in your study to ascertain that.