Frequency Therapeutics — Hearing Loss Regeneration

[AtlasFainted]

Do you have a 6.5 kHz sound sample? I found 6.5 kHz (6500 hz) on YouTube but it is really trebly. My current tinnitus is trebly but no too high frequency. No improvements in volume...

I don't have one on hand but there should be some others online. Also I think that even if your tinnitus is lower than 6.5kHz, FX-322 could still fix it.

There's a theory on this thread that basically says there's a certain "threshold" of hearing loss that triggers tinnitus. So even if you have hearing loss/tinnitus below 6.5kHz, restoring all of the higher frequencies could in theory turn your tinnitus 'off'.

 

[MrCrybaby]

2.) It only seems to reach around 6.5 kHz, not lower than that. Hopefully increased dosing during the current phase 2a trial will show some improvement here.

I believe that claim is based on legality and not data. We'll know how deep it reaches when we get the results from phase 2a.

 

[AtlasFainted]

I believe that claim is based on legality and not data. We'll know how deep it reaches when we get the results from phase 2a.

They could be playing it on the safe side for sure, but you also have to keep in mind that most of the improvement in phase 1 was at the 8kHz mark. Maybe because the patient's ears were so destroyed the drug was absorbed before it hit the lower frequencies? Idk, just spit-balling here.

It's also been mentioned on this thread that delivery vehicle formulation specialists have recently been hired by Frequency Therapeutics.

I do hope you're right, though... It seems pretty likely that I have actual damage at the lower frequencies. Until recently I thought all my damage was above 6.5kHz, but now I am not so certain.

 

[Lucifer]

They could be playing it on the safe side for sure, but you also have to keep in mind that most of the improvement in phase 1 was at the 8kHz mark. Maybe because the patient's ears were so destroyed the drug was absorbed before it hit the lower frequencies? Idk, just spit-balling here.

It's also been mentioned on this thread that delivery vehicle formulation specialists have recently been hired by Frequency Therapeutics.

I do hope you're right, though... It seems pretty likely that I have actual damage at the lower frequencies. Until recently I thought all my damage was above 6.5kHz, but now I am not so certain.

Once they improved the delivery method I think it would be able to help everyone solve all their hearing problems through all the frequencies in the ear which are damaged and can be restored.

 

[AtlasFainted]

Once they improved the delivery method I think it would be able to help everyone solve all their hearing problems through all the frequencies in the ear which are damaged and can be restored.

Even then, synaptopathy will be an issue until the Hough Pill is released (I still can't believe how long that pill has been on this earth and how we're STILL looking at another 5 years before we get it. Things need to change.)

After that 99.9% of the noise-induced folks should be pretty well off, but those who have damage outside of the cochlea will still be waiting for other treatments.

 

[HootOwl]

Even then, synaptopathy will be an issue until the Hough Pill is released (I still can't believe how long that pill has been on this earth and how we're STILL looking at another 5 years before we get it. Things need to change.)

Right, pure synaptopathy will need to be treated separately. Using either the Hough Pill, OTO-413 or PIPE-505.

However, it is likely that if you have synaptic damage you also have some OHC damage, meaning that even those with mainly synaptic issues will see a certain (although perhaps minor) degree of relief if even some of the signal is re-established via the OHC.

 

[Lucifer]

Even then, synaptopathy will be an issue until the Hough Pill is released (I still can't believe how long that pill has been on this earth and how we're STILL looking at another 5 years before we get it. Things need to change.)

After that 99.9% of the noise-induced folks should be pretty well off, but those who have damage outside of the cochlea will still be waiting for other treatments.

Such a shame that the Hough pill could have been in Phase 3 by now or released in the market. They finished Phase 1 in 2015, like really, it took them 5 years to get more funding, it is unbelievable.

 

[HootOwl]

I believe that claim is based on legality and not data. We'll know how deep it reaches when we get the results from phase 2a.

Didn't their initial marketing refer to "therapeutic doses" penetrating to 3500 Hz? Or am I misremembering.

Wasn't this changed to 6500 Hz with wording around "full dose" instead? Definitely seems like more of a legal/marketing thing since they changed the frequency penetration before being unblinded from their phase 2a results.

 

[FGG]

Didn't their initial marketing refer to "therapeutic doses" penetrating to 3500 Hz? Or am I misremembering.

Wasn't this changed to 6500 Hz with wording around "full dose" instead? Definitely seems like more of a legal/marketing thing since they changed the frequency penetration before being unblinded from their phase 2a results.

The only thing that changed was a graphic and yes it very likely had to do with SEC rules on what can be seen predictive statements before the results of a trial. They can only "show" so far what they had seen in phase 1.

Which does make me wonder if they saw say 5dB improvements to about 6000Hz with the phase 1 dose but didn't release it because that's within a margin of error of a standard audiogram.

 

[Croaker]

All this discussion about hearing regeneration makes me want to cry. My grandmother took some sort of ototoxic medication while pregnant with my mother, which gave her (my mother that is) lifelong hearing loss (no tinnitus.) There's no guarantee that her damage is confined to her cochlea but this gives me hope that she might not need hearing aids within a matter of years.

Now I just need to keep my tinnitus/TTTS from getting worse so I can stay sane long enough to see her recover!

 

[Don Tinny]

There's a theory on this thread that basically says there's a certain "threshold" of hearing loss that triggers tinnitus. So even if you have hearing loss/tinnitus below 6.5kHz, restoring all of the higher frequencies could in theory turn your tinnitus 'off'.

I hope you are right. I have a nearly normal audiogram but maybe I need a new test.

Everything here sound so futuristic and complex. Sometimes I would like to be a time traveler.

 

[AtlasFainted]

Such a shame that the Hough pill could have been in Phase 3 by now or released in the market. They finished Phase 1 in 2015, like really, it took them 5 years to get more funding, it is unbelievable.

Yeah, we need more companies like Astella (the company funding FX-322). Their business model is really unique. The following is my understanding of it...

They front the money to biotech labs (in this case Frequency Therapeutics) for promising therapies to go through trials in exchange for licensing the product and taking a percentage of the profits, once it hits the market.

The biotech labs get to keep their independence and have control of the daily operations during trials. This means the original people who are passionate about the given therapy continue to work closely on it.

This is way better than biotech labs either

1.) Being bought out entirely by a big pharmaceutical company (who may shelf the therapy for years or abandon it entirely depending on their business strategy).

2.) Left to their own devices to find investors willing to give hundreds of millions.

The fact that any new drug needs to go through FDA trials (there is no alternative for vetting) before selling their drug on the market legally creates quite the obstacle for small to medium-sized biotech labs that don't have the required funding. Companies like Astella help build a bridge over that obstacle.

I'm not sure what happened to make the Hough Pill sit idle for 5 years, but I suspect it happens frequently with all sorts of new drugs that could be helping people with all sorts of ailments by now.

I will hold my tongue as far as criticizing the FDA/gov't to avoid having this thread go off-topic again.

 

[Lucifer]

All this discussion about hearing regeneration makes me want to cry. My grandmother took some sort of ototoxic medication while pregnant with my mother, which gave her lifelong hearing loss (no tinnitus.) There's no guarantee that her damage is confined to her cochlea but this gives me hope that she might not need hearing aids within a matter of years.

Now I just need to keep my tinnitus/TTTS from getting worse so I can stay sane long enough to see her recover!

I have hope that these drugs should help 99% of our hearing problems. We may need FX-322 combined with Hough Pill to cure us fully. I do believe your grandmother will benefit from this.

 

[Lucifer]

Yeah, we need more companies like Astella (the company funding FX-322). Their business model is really unique. The following is my understanding of it...

They front the money to biotech labs (in this case Frequency Therapeutics) for promising therapies to go through trials in exchange for licensing the product and taking a percentage of the profits, once it hits the market.

The biotech labs get to keep their independence and have control of the daily operations during trials. This means the original people who are passionate about the given therapy continue to work closely on it.

This is way better than biotech labs either

1.) Being bought out entirely by a big pharmaceutical company (who may shelf the therapy for years or abandon it entirely depending on their business strategy).

2.) Left to their own devices to find investors willing to give hundreds of millions.

The fact that any new drug needs to go through FDA trials (there is no alternative for vetting) before selling their drug on the market legally creates quite the obstacle for small to medium-sized biotech labs that don't have the required funding. Companies like Astella help build a bridge over that obstacle.

I'm not sure what happened to make the Hough Pill sit idle for 5 years, but I suspect it happens frequently with all sorts of new drugs that could be helping people with all sorts of ailments by now.

I will hold my tongue as far as criticizing the FDA/gov't to avoid having this thread go off-topic again.

I'm glad there are companies like Astellas willing to fund a potential product. I like the way they could come up with an agreement with Frequency Therapeutics without losing too much money if the clinical trials fail. They are basically paying Frequency Therapeutics with each successful phase in the clinical trials.

 

[Croaker]

I have hope that these drugs should help 99% of our hearing problems. We may need FX-322 combined with Hough Pill to cure us fully. I do believe your grandmother will benefit from this.

Yes, the success of individual drugs like FX-322 is great but the number of options coming is what gives me hope that at least one will work.

Also I realized my wording was confusing, sorry! It's my mother that has had serious loss from birth as a result of the ototoxic medication her mother took. I hope doctors nowadays are more careful about that but who knows...

 

[AtlasFainted]

Yes, the success of individual drugs like FX-322 is great but the number of options coming is what gives me hope that at least one will work.

Also I realized my wording was confusing, sorry! It's my mother that has had serious loss from birth as a result of the ototoxic medication her mother took. I hope doctors nowadays are more careful about that but who knows...

Nah, doctors are still pretty clueless when it comes to hearing.

My GP told me that my tinnitus should be gone within a week, and prescribed me ototoxic anxiety meds in the same visit. I only realized they were ototoxic weeks afterward and couldn't believe she prescribed them to me lol.

Definitely always check side effects for yourself to be double sure.

 

[Lucifer]

Yes, the success of individual drugs like FX-322 is great but the number of options coming is what gives me hope that at least one will work.

Also I realized my wording was confusing, sorry! It's my mother that has had serious loss from birth as a result of the ototoxic medication her mother took. I hope doctors nowadays are more careful about that but who knows...

I am sorry. My bad for not reading it properly. It's a shame how doctors still give people ototoxic meds to treat conditions where there could be a possibility that there might have been a more safer drug that does not cause much damage or none at all.

But yes so far it seems hearing issues, hyperacusis and tinnitus might get solved with these drugs which I am really happy about. Once this is over I can resume my life again and be reborn.

 

[Fanny1]

(Again, pardon my ignorance). Is the "vehicle" technology of getting through the ear window their discovery?

That seems almost as crucial (the delivery system) as the actual drug. Getting drugs right to the correct spot seems like a huge boost for any hearing drug.

 

[FGG]

I don't have one on hand but there should be some others online. Also I think that even if your tinnitus is lower than 6.5kHz, FX-322 could still fix it.

There's a theory on this thread that basically says there's a certain "threshold" of hearing loss that triggers tinnitus. So even if you have hearing loss/tinnitus below 6.5kHz, restoring all of the higher frequencies could in theory turn your tinnitus 'off'.

I haven't encountered this theory. Can you point me to what was said exactly?

 

[Tweedleman]

(I still can't believe how long that pill has been on this earth and how we're STILL looking at another 5 years before we get it. Things need to change.)

Ya it's mind blowing, I don't understand how any drug as revolutionary as the Hough Pill is purported to be could stall in limbo for so freaking long due to funding. You'd think there'd be a much greater impetus to get that shit to market. At least Frequency/Otonomy/Pipeline seem to have much better financial steam behind them, despite being for-profit. By 2030 I seriously hope regenerative medicine is the new standard for hearing care. It's long overdue.

 

[Zugzug]

It's also why I believe GABA potentiating drugs (e.g.. Benzos) are helpful at reducing tinnitus at first but when tolerance happens or with withdrawal they can make it so much worse because Glutamate has been increased and the receptor is now less sensitive to GABA.

Do you think there's a similar effect with magnesium? I sometimes wonder why magnesium isn't touted more. It is supposed to block NMDA receptors, thereby reducing excessive glutamate transmission. In theory, this should be great for tinnitus. Yet many users on here don't have success with it (I just started it).

 

[sssing]

The regenerated hair cells will reconnect and synapse with the spiral ganglion neurons. If you have synapse damage without hair cell damage in a particular location, this drug will not address this but there are other drugs in trial for that.

@FGG sorry a newbie here but I thought that FX-322 grew the hair bundles (circled in red) on TOP of an existing damaged hair cell...

I am confused... what does it actually regrow?

 

[Lucifer]

(Again, pardon my ignorance). Is the "vehicle" technology of getting through the ear window their discovery?

That seems almost as crucial (the delivery system) as the actual drug. Getting drugs right to the correct spot seems like a huge boost for any hearing drug.

The current version they are using now is similar to what ENTs use to inject people ear for Ménière but they are trying to find a way to make sure the substance can go further down in the round window to make sure they restore all frequencies of people's hearing.

 

[FGG]

Do you think there's a similar effect with magnesium? I sometimes wonder why magnesium isn't touted more. It is supposed to block NMDA receptors, thereby reducing excessive glutamate transmission. In theory, this should be great for tinnitus. Yet many users on here don't have success with it (I just started it).

Excessive glutamate/Neuroinflammation is only part of the picture. It should probably have *some* effect at least acutely imo though. Not sure what that window would be.

 

[FGG]

(Again, pardon my ignorance). Is the "vehicle" technology of getting through the ear window their discovery?

That seems almost as crucial (the delivery system) as the actual drug. Getting drugs right to the correct spot seems like a huge boost for any hearing drug.

It diffuses through the round window. There was a corporate video/graphic but I can't seem to find it now.

 

[FGG]

@FGG sorry a newbie here but I thought that FX-322 grew the hair bundles (circled in red) on TOP of an existing damaged hair cell...

I am confused... what does it actually regrow?

View attachment 38687

It regrows fully intact OHCs and it looks like IHCs too.

 

[grate_biff]

It diffuses through the round window. There was a corporate video/graphic but I can't seem to find it now.

 

[sssing]

Thanks @FGG, wow, that is amazing to me! I hope it will be able to clear all the trials and help us...

 

[Pero1234]

Nah, doctors are still pretty clueless when it comes to hearing.

My GP told me that my tinnitus should be gone within a week, and prescribed me ototoxic anxiety meds in the same visit. I only realized they were ototoxic weeks afterward and couldn't believe she prescribed them to me lol.

Definitely always check side effects for yourself to be double sure.

Same here. Standard procedure.

 

[Pero1234]

Ya it's mind blowing, I don't understand how any drug as revolutionary as the Hough Pill is purported to be could stall in limbo for so freaking long due to funding. You'd think there'd be a much greater impetus to get that shit to market. At least Frequency/Otonomy/Pipeline seem to have much better financial steam behind them, despite being for-profit. By 2030 I seriously hope regenerative medicine is the new standard for hearing care. It's long overdue.

Exactly... they must have had a terrible salesman / sales pitch to screw that up so badly!

A good idea / product is not enough. You must be able to sell it.