Frequency Therapeutics — Hearing Loss Regeneration

[Piney]

After following these posts for about 8 months, I must say It's good to have this updated info out there.

I am on John Adams side with the frustration part though, I think the ATA should reach out to Frequency Therapeutics and put out an update, does this drug really work or not?

I am one of those receiving disability for it, and I would gladly give it all back for silence.

 

[Street Novelist]

What's truly sick is Frequency Therapeutics knows if FX-322 works.

They put out a press release on August 5th or 7th (I can't remember the exact date) saying people had been injected with the drug.

That was 3 months ago, plenty of time to regrow new hairs.

If the drug does work, there should be some kind of fast track to the market.

Why go through another trial if you know the drug works and is safe?

 

[Contrast]

What's truly sick is Frequency Therapeutics knows if FX-322 works.

They put out a press release on August 5th or 7th (I can't remember the exact date) saying people had been injected with the drug.

That was 3 months ago, plenty of time to regrow new hairs.

If the drug does work, there should be some kind of fast track to the market.

Why go through another trial if you know the drug works and is safe?

Why should they fast track a drug for hearing loss when hearing aids are already a treatment option, no need.

 

[d'Wooluf]

No dude this is all a fantasy, like you said.

Sarcasm now.

The fantasy is that you can somehow lobby the FDA to alter the duration of clinical trials because you personally know more than they do about how long they should take.

Add that to this paranoia you've got about audiologists, ENTs, and the whole freaking world collaborating to keep you from the cure that is so absolutely certain and so rightfully yours, makes you a complete pita.

 

[Ed209]

@JohnAdams, I love your enthusiasm and I'm not knocking your optimism, but please wait and see how this develops before you get ahead of yourself. All new drugs have a 70% chance of failing, and I know this all too well from the investment side of things.

Anything can happen between now and the end of phase IIa. Also, at no point do Frequency Therapeutics mention FX-322 as being a treatment for tinnitus. I know you are going to use the sensorineural hearing loss argument, but there is nobody on the planet who can claim to understand every root cause of tinnitus. There is more to it than just hearing loss, which is why many scientists have moved away from the hair cells of the cochlear and are focusing more on the fusiform cells in the DCN and other key areas of the brain.

We do not understand what allows the tinnitus signal to become chronic in some individuals but not in others. All we have are hypotheses, and many researchers are now moving towards the gating hypothesis as a possible explanation. This suggests there has been some maladaption in the brain's ability to suppress the noise, and this involves various regions.

I know some will say, "well why do hearing aids help, or cochlear implants", etc. To me this can be explained in the same way that it helps when you remove earplugs from your head. In other words, you are restoring your lost sense and this helps to camouflage the tinnitus signal in your brain. If you have a mild tinnitus signal being generated in your brain, and you lose some hearing through ototoxicity, for example, the mild tinnitus would immediately be perceived as being louder because there is less external sound to mask it. The big question is: has the tinnitus become louder, or is it louder because you have lost your ability to mask it?

Many people have no notable hearing loss, but have severe, chronic tinnitus. I am one of those people. I would assume this means as I age, and lose more hearing, I am likely to perceive my tinnitus as being even louder.

Tinnitus is a really complex issue, so I would urge you to wait a little longer before you get carried away with FX-322. I really hope it works, but we have to be pragmatic.

 

[JohnAdams]

Add that to this paranoia you've got about audiologists, ENTs, and the whole freaking world collaborating to keep you from the cure that is so absolutely certain and so rightfully yours, makes you a complete pita.

I have never said anything about ENTs and audiologists collaborating or conspiring to slow down cures. That's called a false accusation. Good job.

I have speculated that investment bankers that own biomed tech companies may be lobbying the FDA to slow down the review process of disruptive technologies to avoid bankruptcy. I also never said I know for a fact the FX-322 will definitely work, I have posted much evidence to suggest it will work. Here, I will say it again:
They have given the drug to patients with SNHL. IF it works, they will know by the end of this trial. Take it from there, and there shouldn't really be much of a need to do 2 or 3 more trials.

You are attacking me and accusing me of saying things I never have.

The FDA process is what is slowing things down. Congress and the President and numerous other organizations have also said this.

 

[JohnAdams]

but please wait and see how this develops before you get ahead of yourself.

Am I missing something here? I have said over and over again that we should WAIT until this trial is over in December, and then start taking action and asking IF it worked and IF so, start yelling at the FDA to loosen up and try and get allies in other organizations. I'm not getting ahead of anything. What I am seeing here is a tragic lack of reading comprehension skills from you and several others. If you aren't interested in whether or not FX-322 works at the end of this trial where they gave the real drug to people with the actual disorder they are trying to cure, then there is something really flaccid about you.

"But this is just a safety trial"

So what? The cochleas of the test subjects don't care what kind of trial this is. If the drug works, it will work right now and we deserve to know it.

There is nothing irrational or paranoid about anything I am saying here.

 

[Manny]

Does anyone know if the current Frequency Therapeutics trial participants are receiving presumed therapeutic-volume dose?

Or are they just receiving a small dose for safety studies? The clinical trials record notes that some will receive a "high dose" and some a "low dose". (https://clinicaltrials.gov/ct2/show/NCT03616223) but I don't see any explicit information about dose size assumed efficacy value.

Per this they are also doing doing audiometric testing as a safety index (presumably meaning, to see if hearing degrades as a result of the treatment) so they could start with a less-than-therapeutic dose to minimize risk?

This also means they will know if there is an audiometric improvement.

These thoughts are just conjecture of course.

 

[Ed209]

Am I missing something here? I have said over and over again that we should WAIT until this trial is over in December, and then start taking action and asking IF it worked and IF so, start yelling at the FDA to loosen up and try and get allies in other organizations. I'm not getting ahead of anything. What I am seeing here is a tragic lack of reading comprehension skills from you and several others. If you arent interested in whether or not FX-322 works at the end of this trial where they gave the real drug to people with the actual disorder they are trying to cure, then there is something really flaccid about you.

No, you're not missing anything, but I don't understand the timing of your campaign efforts. What exactly do you want people to do right now? You are repeatedly asking people to join in, but join in what? We are all aware of what Frequency Therapeutics are up to.

The safety trial ends in December, but when is the data from it going to be reviewed, and when will this information be released to the public?

Do Frequency Therapeutics want a public campaign at this very early stage? It's not our company, so it would be wise to open a dialogue with the CEO, David Lucchino, or one of Frequency Therapeutics's representatives before you take any action.

All new drugs have to go through a process, not just to prove their safety, but to understand dosages, and to check their clinical efficacy. Sometimes a problem can be revealed in the long-term data that isn't immediately obvious. This is why these things take time. Even when drugs are fast-tracked, they still take years. The average time for a new drug to go from the lab and into consumers' hands is around 12 years. Sometimes, drugs are taken off the market as risks are discovered, and this is because there is no better pool of data than long-term use by the general public.

Be patient and see how it develops. It's far too early to get onto the FDA about it; it won't be taken seriously and it may even work against your objectives; especially if Frequency Therapeutics take exception to it.

 

[Don Tinny]

It is true that we can not be 100% optimistic about the chances of success that the drug has. But I'm 95% sure that our tinnitus will improve substantially when we improve hearing. Either with FX-322 in 5 years or with another drug within 30 years. I hope this happens ASAP.

 

[grate_biff]

Also, at no point do Frequency Therapeutics mention FX-322 as being a treatment for tinnitus.

Maybe not, but it is firmly written between the lines.

For instance, for their current phase, they were looking for people with NIHL.
I mean, common!

Not presbyacusis
Not ototoxic damage
Not what ever

Maybe filling the "gaps" in hearing is the best approach to test their technology.
But it fits the bill for what most of us are looking for as well.

 

[Piney]

I'm just looking at the drug from a tinnitus perspective. This is a tinnitus forum and we give money to tinnitus associations. Maybe, a little transparency and some pressure from them wouldn't be a bad thing. I'm severely deaf in one ear with full tinnitus so to me the ringing is my focus. No hearing aid gets sound in and implant doesn't guarantee relief.

It's a simple question I wish the ATA could answer? Is any drug or machine currently made in attempt of getting rid of tinnitus?

 

[Paulmanlike]

@JohnAdams I don't think you understand the process of how biotech's work. At the end of the day, they are a business. With lots and lots of rules and regulations to follow.

There is also the concept of competition in the market, some things need to be kept secret. Have a look at the recent post about a new biotech start-up targeting "specific" ion channels, they aren't going to mention what ones are they that they think they've discovered from research from their own funding for somebody else to make.

 

[katri]

@JohnAdams I don't think you understand the process of how biotech's work. At the end of the day, they are a business. With lots and lots of rules and regulations to follow.

There is also the concept of competition in the market, some things need to be kept secret. Have a look at the recent post about a new biotech start-up targeting "specific" ion channels, they aren't going to mention what ones are they that they think they've discovered from research from their own funding for somebody else to make.

That or they don't have that much evidence. Trobalt fucked some people up. I'm all for ion channel research but in the end that seems way more risky than just going with FX-322.

 

[Johan_L]

@JohnAdams I don't think you understand the process of how biotech's work. At the end of the day, they are a business. With lots and lots of rules and regulations to follow.

There is also the concept of competition in the market, some things need to be kept secret. Have a look at the recent post about a new biotech start-up targeting "specific" ion channels, they aren't going to mention what ones are they that they think they've discovered from research from their own funding for somebody else to make.

Frequency Therapeutics has patented their formula (or parts of it, I think JohnAdams shared it previously) - and when that is done it's public. Patenting also puts pressure to get the drug to the market as the expiry of a patent is based on when it was granted, and they "only" have 20 years.

"In the United States, for utility patents filed on or after June 8, 1995, the term of the patent is 20 years from the earliest filing date of the application on which the patent was granted"

(Unless I'm misinformed?)

 

[lymebite]

The new FDA Commissioner, Scott Gottlieb, has set as one of his primary goals to speed up the process for approving new drugs. So, it might actually be productive to email him about tinnitus and FX-322. Maybe he would take an interest in the situation and think about how the rules should be reformed to help patients who are suffering. If he hears from a number of us, it could make a difference, given this is one of his top priorities. Sometimes that sort of communication can make a difference.

The email address for Scott Gottlieb is:

CommissionerFDA@fda.hhs.gov

https://www.newsweek.com/trumps-fda-pick-speeding-new-drug-approvals-798406

 

[Telis]

Many people have no notable hearing loss, but have severe, chronic tinnitus.

Believe me, if you can the hear the test beeping through your tinnitus in a hearing test at threshold, you do not have severe tinnitus. I hear screaming tinnitus, not the beeps unless they start blasting them at me.

If you're hearing at a level that you can distinguish between next to silence over your tinnitus, you're in good shape. Some of us would kill to have our hearing back, if I could listen to TV or music instead of dead hearing and screaming tinnitus, that's good enough for me, I'll consider myself cured at that point.

 

[JohnAdams]

@JohnAdams I don't think you understand the process of how biotech's work.

Me:
BS: biomedical engineering technology
MS: engineering technology

Job: software developer for a very large global corporation.

I know more than you think about all of this.

 

[TheDanishGirl]

Can someone please give me concrete arguments or proof of why this regeneration could lessen/erase our tinnitus and/or hyperacusis in human language, I'm not a native speaker..

Thank you beforehand <3

There is sadly zero evidence of that, which is why there is no reason to get excited about this.......yet.

 

[JohnAdams]

The new FDA Commissioner, Scott Gottlieb, has set as one of his primary goals to speed up the process for approving new drugs. So, it might actually be productive to email him about tinnitus and FX-322. Maybe he would take an interest in the situation and think about how the rules should be reformed to help patients who are suffering. If he hears from a number of us, it could make a difference, given this is one of his top priorities. Sometimes that sort of communication can make a difference.

The email address for Scott Gottlieb is:

CommissionerFDA@fda.hhs.gov

https://www.newsweek.com/trumps-fda-pick-speeding-new-drug-approvals-798406

If we could get the ATA, BTA, tinnitustalk.com, and everyone organized to hit up the media, the FDA, the WWP, FasterCures, all of us together in sync we would have an exponentially greater chance of success.

This is a good idea. This could help many people, not just us.

 

[just1morething]

The mice didn't grow extra heads... so that's a good thing.

Not necessarily, the extra head might not have tinnitus.

There is sadly zero evidence of that, which is why there is no reason to get excited about this.......yet.

Yeah, a lot of people got hyped up for Autifony and it bombed. Even if it does work for tinnitus, how long will it be before ENT's can inject it into your ear(s)?

 

[TheDanishGirl]

Yeah, a lot of people got hyped up for Autifony and it bombed. Even if it does work for tinnitus, how long will it be before ENT's can inject it into your ear(s)?

Precisely! We need not to get ahead of ourselves as we could end up being seriously disappointed.

 

[JohnAdams]

There is sadly zero evidence of that, which is why there is no reason to get excited about this.......yet.

But! This question may be answered soon which is very important and exciting.

 

[Tinker Bell]

@JohnAdams, I love your enthusiasm and I'm not knocking your optimism, but please wait and see how this develops before you get ahead of yourself. All new drugs have a 70% chance of failing, and I know this all too well from the investment side of things.

Anything can happen between now and the end of phase IIa. Also, at no point do Frequency Therapeutics mention FX-322 as being a treatment for tinnitus. I know you are going to use the sensorineural hearing loss argument, but there is nobody on the planet who can claim to understand every root cause of tinnitus. There is more to it than just hearing loss, which is why many scientists have moved away from the hair cells of the cochlear and are focusing more on the fusiform cells in the DCN and other key areas of the brain.

We do not understand what allows the tinnitus signal to become chronic in some individuals but not in others. All we have are hypotheses, and many researchers are now moving towards the gating hypothesis as a possible explanation. This suggests there has been some maladaption in the brain's ability to suppress the noise, and this involves various regions.

I know some will say, "well why do hearing aids help, or cochlear implants", etc. To me this can be explained in the same way that it helps when you remove earplugs from your head. In other words, you are restoring your lost sense and this helps to camouflage the tinnitus signal in your brain. If you have a mild tinnitus signal being generated in your brain, and you lose some hearing through ototoxicity, for example, the mild tinnitus would immediately be perceived as being louder because there is less external sound to mask it. The big question is: has the tinnitus become louder, or is it louder because you have lost your ability to mask it?

Many people have no notable hearing loss, but have severe, chronic tinnitus. I am one of those people. I would assume this means as I age, and lose more hearing, I am likely to perceive my tinnitus as being even louder.

Tinnitus is a really complex issue, so I would urge you to wait a little longer before you get carried away with FX-322. I really hope it works, but we have to be pragmatic.

Agreed. Frequency Theraputics is working to cure hearing loss, but what if one of the side effects is . . . tinnitus.

 

[Street Novelist]

The guy in charge of the trial at San Antonio told me Frequency Therapeutics would be posting the results of the trial on their website in December. If the drug is successful and restores hearing, what would be the point of another trial? They would already know the drug works and is safe. I just don't see what they could possibly gain.

 

[Don Tinny]

Agreed. Frequency Theraputics is working to cure hearing loss, but what if one of the side effects is . . . tinnitus.

Yes. Kill the head, the body will die

 

[Tinker Bell]

The guy in charge of the trial at San Antonio told me Frequency Therapeutics would be posting the results of the trial on their website in December. If the drug is successful and restores hearing, what would be the point of another trial? They would already know the drug works and is safe. I just don't see what they could possibly gain.

I suspect the point of another trial would be to use a larger base. How many people are currently being tested? Is it a good representative sample of the overall hearing loss population?

 

[spedgas]

This current study involves 24 people. Eight are being given a "low" dose and eight people are getting a "high" dose. The remaining eight are getting a placebo. I would think that any regulatory government body is going to need to see more results than 16 people receiving the drug before they get interested.

 

[JohnAdams]

Many people have no notable hearing loss, but have severe, chronic tinnitus

You said you're a musician. I am (was) too. But I also know electronics backwards and forwards because I'm an engineer. High frequency waves carry far more energy than low frequency waves. Therefore our hearing loss is more than likely associated with damage to our high frequency regions of our cochleas. Our hearing damage is not from the bass speakers but the tweeters. Most sounds in our natural environment aren't above 16kHz. That's why we don't perceive our hearing loss. Trust me, it is there. Our hair cells are like Hiroshima in those frequencies. Your tinnitus is from loud noise. Get with the program doug. Think about it. Stop naysaying me. If you want we can have a guitar shred-off to settle this.

Also, stop defending the FDA, lest you look stupid. Most intelligent people in the US understand how fucked up the government is. Plus the powers of the FDA are blatantly unconstitutional per the non delegation clause.

Seriously, wise up.

 

[Paulmanlike]

When will we know, or will we even know what the results were?