Frequency Therapeutics — Hearing Loss Regeneration

[Tezcatlipoca]

The picture shows it going up the Eustachian tube.

View attachment 43920

Yeah that's a no from me.

 

[dmorg]

The last "president" couldn't for COVID-19, so neither can the DoD for hearing loss.

The military can and has sponsored its own experimental drug trials on soldiers in the recent past, and they've done so outside of the jurisdiction of the FDA.

I respectfully disagree. I think the last President/Administration did in fact facilitate the COVID-19 vaccines by ensuring those drug companies (Pfizer, Moderna, Johnson & Johnson) had all the resources they needed. I'm sure they went to the head of the line anytime they needed the FDA's attention/approval. How else would those drugs get Emergency Use Authorization inside of a year. They just couldn't interfere with the actual approval process.

I believe our friends at the Hough Ear Institute received a grant from the DoD (maybe still do) to research their "Bomb Blast Pill".

 

[Christiaan]

Hi @Bambam0, @AfroSnowman, @Tezcatlipoca, @Zugzug, @Diesel, @FGG!

I just want to add, on behalf of Tinnitus Hub, that we are more than willing to facilitate such an effort. I agree such initiatives should be well coordinated — though of course anyone is free to lobby on their own behalf, but doing this as a community will be much more impactful! Grassroots activism has always been part of who we are and it's a major part of why we run this community. If the Phase 2 90-Day readout is positive, I feel like a working group should be formed.

You can sign me up as well @Hazel. I was already planning to write a letter to the CEO of Astellas the Netherlands with recommendations from my ENT, psychologist & psychiatrist for compassionate use but an international coordinated effort sounds way more ambitious.

 

[Trevor_phillips]

I have one question:

Since the highest concentration of FX-322 is in the high frequencies, does it mean that the more high frequencies we can hear (for example up around to 17 kHz and nothing above), the better the results will be? Or there will be less place to PCA?

 

[Bill Arsenault]

Here is a schematic. Not sure if it is exactly to scale but shows an approximation of what you are asking anyway:

View attachment 43895

Oh no - it's gotta travel up-hill after 5 kHz.

 

[Keith Handy]

And through the eardrum. I see what you mean but I put it down to a badly designed diagram. I think it means that the drug starts 'here' (outside the round window).

... [edit] or it doesn't matter where the drug comes from. Once it's in the middle ear, the vibration does its thing.

All the other arrows show flow, movement, and/or direction. Pointers are just plain black lines.

 

[d'Wooluf]

All the other arrows show flow, movement, and/or direction. Pointers are just plain black lines.

So you can inject your drug through the eardrum OR via catheter through the eustachian tube. Once in the middle ear it permeates through the round window and down through the cochlea with help from the low frequency vibration.

 

[FGG]

So you can inject your drug through the eardrum OR via catheter through the eustachian tube. Once in the middle ear it permeates through the round window and down through the cochlea with help from the low frequency vibration.

How precise is this? Would a small hole in the eardrum interfere with a "closed acoustic system"? If that's the case, you'd almost have to go through the Eustachian tube or a well engineered work around (very slow release gel, wait for hole to heal).

 

[d'Wooluf]

Would a small hole in the eardrum interfere with a "closed acoustic system"?

I'd be more worried about whether the stresses put on the eardrum would turn the little hole into a big hole. In the experiment they opened up the middle ear. I have no idea how that worked with the 'closed acoustic system'. I think we can assume that there's a way to go on this one.

 

[Gb3]

And through the eardrum. I see what you mean but I put it down to a badly designed diagram. I think it means that the drug starts 'here' (outside the round window).

... [edit] or it doesn't matter where the drug comes from. Once it's in the middle ear, the vibration does its thing.

I think the drug goes up through the eustachian tube and the low frequency sounds are played through the ear drum.

 

[FGG]

I'd be more worried about whether the stresses put on the eardrum would turn the little hole into a big hole. In the experiment they opened up the middle ear. I have no idea how that worked with the 'closed acoustic system'. I think we can assume that there's a way to go on this one.

It seems it would have to be Eustachian tube delivered as everyone is pointing out. Would suck awake, but sedated with a small gauge red rubber Cath, probably not too bad at all (I think the surgical approach in your link was probably just due to size of rodent model and visualization ease).

 

[Still-Hope]

I hope it will reach at least partially to my loss (30 dB) of hearing and tinnitus at 3 kHz.

Same here!

 

[GregCA]

Would a small hole in the eardrum interfere with a "closed acoustic system"?

I doubt it, given the size of a typical intratympanic needle.

 

[Aleksandar]

I doubt it, given the size of a typical intratympanic needle.

Intratympanic is completely harmless. I received 8 of them in my right ear (every 3 days in a row) without any consequences. It is inconvenient but without consequences.

 

[Willlly]

Do we know that FX-322 diffuses into both sides of the cochlea tube via the round window? Or would it require going all the way round (the long way) in order to cover the high frequencies next to the oval window and stapes?

I have only had tinnitus (after a very loud club gig) for just under 2 years at this stage but feel so lucky to have some relief and maybe even a cure within the next few years.

 

[FGG]

I doubt it, given the size of a typical intratympanic needle.

This was more of an oscillation dynamics thought, not a safety one. Intuitively, it shouldn't make much difference, but they must have chosen the alternate route for some related reason.

 

[Fields]

I was already planning to write a letter to the CEO of Astellas the Netherlands with recommendations from my ENT, psychologist & psychiatrist for compassionate use but an international coordinated effort sounds way more ambitious.

Which hospital does your ENT work at? I've recently been referred to an ENT at the Erasmus MC for a separate issue with my eardrum, but I'm going to ask him about tinnitus and (possible) future treatments as well.

Unfortunately, all the ENTs I've spoken to so far weren't really willing to administer anything outside of their scope of experience.

As such, I'm passively looking for an ENT who might be willing to administer treatments such as FX-322.

 

[Piet]

Which hospital does your ENT work at? I've recently been referred to an ENT at the Erasmus MC for a separate issue with my eardrum, but I'm going to ask him about tinnitus and (possible) future treatments as well.

Unfortunately, all the ENTs I've spoken to so far weren't really willing to administer anything outside of their scope of experience.

As such, I'm passively looking for an ENT who might be willing to administer treatments such as FX-322.

If you may find one, please let me know since I'm also from the Netherlands. I've been trying as well but they all seem so clueless.

 

[Tezcatlipoca]

Honestly, we should stick to our audiograms. Not many ENTs will write a letter for compassionate use on a drug they don't even know about.

 

[d'Wooluf]

This was more of an oscillation dynamics thought, not a safety one. Intuitively, it shouldn't make much difference, but they must have chosen the alternate route for some related reason.

My understanding is they surgically opened up the middle ear cavity and placed the drug directly onto the round window.

 

[MarkRule]

Maybe you talked about this already and this is a little old, but is this something normal?

View attachment 43822

I see this has been responded to as normal activity but are the frequency (no pun) of his sales usually this much? I would have thought that if you were privy to to good information and you were able to stop or change sale of shares then you would.

I like to invest but I never invest in companies in which there is insider selling.

 

[Diesel]

I see this has been responded to as normal activity but are the frequency (no pun) of his sales usually this much? I would have thought that if you were privy to to good information and you were able to stop or change sale of shares then you would.

I like to invest but I never invest in companies in which there is insider selling.

Totally normal. 10b5-1 plans are decided 6-12 months in advance.

 

[tommyd87]

Which hospital does your ENT work at? I've recently been referred to an ENT at the Erasmus MC for a separate issue with my eardrum, but I'm going to ask him about tinnitus and (possible) future treatments as well.

Unfortunately, all the ENTs I've spoken to so far weren't really willing to administer anything outside of their scope of experience.

As such, I'm passively looking for an ENT who might be willing to administer treatments such as FX-322.

This will be why you will need to go and see specialists working at a FX-322 affiliated practice or go and see an otologist first, should the treatment end up being successful.

It is incredibly likely that it will take time to either educate ENTs on the merits and administration of this medicine (as has been mentioned previously) or there will be some ENTs who are incredibly conservative and won't even contemplate looking to treat you with FX-322 at all.

As a result it is likely that your best bet might be an otologist as they specialise in ears and are literally more likely to know about FX-322 and be much more willing to treat with it too.

The lack of education and information about FX-322 and the unwillingness to treat people which comes with it will be a big part of why Frequency Therapeutics will be looking to spend significant time and resources into making ENTs know that the medicine is both safe and also OK to treat you with.

 

[Ehren M]

Oh no - it's gotta travel up-hill after 5 kHz.

The direction of drug travel should not matter much at the molecular scale that defines the interior of the cochlea. At the spatial scale relevant to molecules inside bodies, diffusion via osmotic gradients play a major role in molecular motion. Also, considering that the cochlea is fluid-filled, it would seem that the delivery medium would simply need to be sufficiently soluble in the cochlear fluid to pervade the whole organ. I really suspect that facilitating thorough diffusion through the cochlea would be a pretty elementary task once researchers turn their attention to it.

 

[JPGL]

For better delivery of FX-322 to the cochlea, there is a device called Otomagnetics.

Does anyone know if it is available?

 

[FGG]

For better delivery of FX-322 to the cochlea, there is a device called Otomagnetics.

Does anyone know if it is available?

As far as I know, they have only done rat toxicology studies so far. That would put the product at the pre-clinical testing phase.

 

[FGG]

Totally normal. 10b5-1 plans are decided 6-12 months in advance.

Thanks for the tireless task of repeating this every two pages

 

[AfroSnowman]

This will be why you will need to go and see specialists working at a FX-322 affiliated practice or go and see an otologist first, should the treatment end up being successful.

I imagine early on we will have a list being shared on Tinnitus Talk of specialists that are giving FX-322 in different countries. Better get on their waiting list early or it will be a long noisy wait.

 

[Christiaan]

Which hospital does your ENT work at? I've recently been referred to an ENT at the Erasmus MC for a separate issue with my eardrum, but I'm going to ask him about tinnitus and (possible) future treatments as well.

Unfortunately, all the ENTs I've spoken to so far weren't really willing to administer anything outside of their scope of experience.

As such, I'm passively looking for an ENT who might be willing to administer treatments such as FX-322.

My ENT works at the Bronovo hospital in The Hague. My ENT wasn't actually aware of FX-322 when I asked her about it at my first appointment, but she was open-minded enough to do some digging on this treatment. At the second visit, the ENT said she was willing to write a recommendation for compassionate use if the results point to tinnitus alleviation, but she also added that she didn't expect the treatment to become mainstream at general hospitals for years to come, and that it would be more realistic to expect that we receive treatment at clinics or hospitals that are closely aligned with Astellas/Frequency Therapeutics in the short term.

 

[Diesel]

I imagine early on we will have a list being shared on Tinnitus Talk of specialists that are giving FX-322 in different countries. Better get on their waiting list early or it will be a long noisy wait.

It's highly likely that Frequency Therapeutics will provide a "search map" on their website for health care providers / clinics offering FX-322 injections. If we learn that multiple injections of this first generation of FX-322 do indeed provide an additional benefit, it would mean that doctors providing the drug would need to have some type of training to understand the dosage amount / schedule needed per patient, and the proper protocols to assess the patient's individual hearing performance.

In the US, where a majority of our doctors offices are privately run as a business, this would be seen as a benefit to the practice to be listed / certified on Frequency Therapeutics' website as it will drive more business for qualified patients. In turn, this will ultimately take business away from those clinics that have not adopted the drug.

So, for the people on here, it makes finding a doctor who is willing and certified to provide the injection 100% easy.