Frequency Therapeutics — Hearing Loss Regeneration

[dan]

@dan,

I think the podcast transcript might make you feel more optimistic. A few points that might be less obvious:

--A 10 dB change means something is twice as loud. That's not insignificant. Factoring that on with doubling word scores, restoring hearing is happening. Those results are unprecedented. If you don't believe it, ask your audiologist what they think of the doubling word score results.

--Frequency believes the audiogram changes were much greater above 8000 Hz, that's why they are measuring 8000 Hz to 16000 Hz in phase 2A. They also believe multiple dosing should likely have an additive effect in terms of penetrance, but they don't know the range yet. They are measuring 250 Hz to 16000 Hz so we will know after 2A. Based on pre-clinical studies and the recent German cochlear explant studies, the drug does reach therapeutic concentrations and results in hair cell growth in the cochlea in humans.

--On the Tinnitus Talk Podcast, they mentioned while not having data yet because it wasn't an endpoint in phase 1, they did have anecdotes that tinnitus improved.

This later is a huge deal for tinnitus sufferers because in order for Frequency to have this info, patients reported it significant enough to their ENTs (there were 3 different practices in the San Antonio area used for phase 1) for them to report it to Frequency. Frequency was blinded to the study which means they got the testimonials from the ENTs after full completion of Phase 1 and not directly from these patients and these testimonials must have been strong enough (and likely from more than one ENT) for them to add tinnitus to their phase 2a endpoint. ENTs must have told Frequency "I know you weren't checking for tinnitus in phase 1, but we are hearing good reports."

Thank you FGG, fingers crossed.

 

[serendipity1996]

Yeah I agree, if hyperacusis and tinnitus are due to hearing damage then I believe FX-322 will help us. I have more faith that hearing treatment will treat both hyperacusis and tinnitus rather than a specific treatment for tinnitus as it would not be solving the underlying issues in the ear.

I think especially with pain hyperacusis the type 2 theory indicates that it's more a change in the peripheral organ itself as opposed to the brain.

 

[Diesel]

I didn't expect this but Frequency Therapeutics posted an update on their Twitter about the Tinnitus Talk Podcast interview.

View attachment 39963

Everyone prepare for new entrants to the Frequency Therapeutics thread!

 

[tommyd87]

Everyone prepare for new entrants to the Frequency Therapeutics thread!

LOL that is not going to be a bad thing, although it will lead to more discussion and debate.

 

[Gb3]

Let's say expanded/compassionate use was offered by Frequency Therapeutics. What does that entail? Would you have to contact Frequency Therapeutics directly to begin the treatment?

 

[tommyd87]

Let's say expanded/compassionate use was offered by Frequency Therapeutics. What does that entail? Would you have to contact Frequency Therapeutics directly to begin the treatment?

This basically sums up all the rules regarding this, the requirements, the responsibilities of all parties pertaining to treatment through Expanded Access.

https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients#what-is-it

Although a doctor can choose to refuse access to you, I do not actually see why they would and I think that there would be multiple doctors willing to grant Expanded Use.

 

[Lucifer]

I think especially with pain hyperacusis the type 2 theory indicates that it's more a change in the peripheral organ itself as opposed to the brain.

Me too. I don't think the brain is causing the hyperacusis and tinnitus, it's the damage of the hair cells and synapses that is causing the problem.

 

[FGG]

Let's say expanded/compassionate use was offered by Frequency Therapeutics. What does that entail? Would you have to contact Frequency Therapeutics directly to begin the treatment?

No, your doctor would have to petition your case. It would have to go through an MD (I assume an otologist or ENT).

 

[d'Wooluf]

For me personally, I'm not banking on a cure. I just want my hearing loss reduced a bit. I'm not counting on discarding my hearing aids any time soon.

Agree. For me, a little improvement would make a big difference because of the load it would take off my hearing aids. Even more would be a treatment for synaptopathy because hearing aids can't help with that at all.

 

[Piney]

I wish they could apply for Operation Warp Speed, like they are doing with COVID-19. Or even a job completion incentive or in this case a cure incentive; would be for the Government to pay you more money for an earlier success. They use it in construction at times, the quicker the completion, the more money you get paid, this keeps the labors or scientists in this case with their eye on the prize. Increasing competition and work rate.

 

[tommyd87]

No, your doctor would have to petition your case. It would have to go through an MD (I assume an otologist or ENT).

I'm pretty positive it says that the treatment request needs to go through a relevant doctor like the one responsible for delivering treatment to the type of condition which it is for. So you couldn't go see an endocrinologist for a medication that treats foot fungus. I feel that the most appropriate place to go would have to be the trial center surgeries as I am certain that they totally would petition for patients.

 

[kiki]

If I need more FX-322 injections, to get better effects at lower frequencies and accelerating effects, would I be able to have 10 or more injections after it's available in the market, rather than 4? Assuming I have the money. I hope that there are no side effects in the ultra-high frequency range.

 

[Jurger]

If I need more FX-322 injections, to get better effects at lower frequencies and accelerating effects, would I be able to have 10 or more injections after it's available in the market, rather than 4? Assuming I have the money. I hope that there are no side effects in the ultra-high frequency range.

It's not uncommon to go beyond four steroid injections with sudden sensorineural hearing loss, Meniere's etc. There is a risk of leaving a hole in the eardrum with multiple injections, but they can fix that. I think going beyond four injections FX-322 is within the realm of possibility if they still see improvement in patients after the fourth injection. Because that could mean they haven't reached the ceiling.

 

[Diesel]

I wish they could apply for Operation Warp Speed, like they are doing with COVID-19. Or even a job completion incentive or in this case a cure incentive; would be for the Government to pay you more money for an earlier success. They use it in construction at times, the quicker the completion, the more money you get paid, this keeps the labors or scientists in this case with their eye on the prize. Increasing competition and work rate.

I realize this is probably a sarcastic comment, but if the bill becomes a law, the Promising Pathway act would enable the FDA to give FX-322 provisional approval for production/patient access if the Phase 2A continues to show safe and effective outcomes. The bill is in committee at this time, though.

 

[NewLionel]

Does anyone know if there are FX-322 trials in Europe upcoming?

 

[FGG]

Does anyone know if there are FX-322 trials in Europe upcoming?

There will be. When and where they will occur has not been released yet, however.

 

[WillBeNimble]

Does anyone know if there are FX-322 trials in Europe upcoming?

There will be trials in Europe at some point in the future assuming all goes well. No dates were given yet.

 

[GlennS]

I didn't expect this but Frequency Therapeutics posted an update on their Twitter about the Tinnitus Talk Podcast interview.

View attachment 39963

High praise that Frequency Therapeutics is treating Tinnitus Talk with respect.

 

[GregCA]

It's not uncommon to go beyond four steroid injections with sudden sensorineural hearing loss, Meniere's etc. There is a risk of leaving a hole in the eardrum with multiple injections, but they can fix that.

Note that "fixing that" is no walk in the park. There are no non-surgical approaches for a tympanoplasty. It's quite an ordeal, and it carries some risks (total hearing loss, etc).

 

[FGG]

Note that "fixing that" is no walk in the park. There are no non-surgical approaches for a tympanoplasty. It's quite an ordeal, and it carries some risks (total hearing loss, etc).

Just going to repeat this again. Anytime you get an IT injection, go to someone very experienced to minimize this risk. This is more routine for ENTs who treat a lot of Meniere's, for instance. Or otologist vs general ENTs.

When any regenerative therapy hits the market, you will want to already be an established patient at one of these doctors to minimize your wait time and your risk of tympanic membrane damage.

 

[Diesel]

High praise that Frequency Therapeutics is treating Tinnitus Talk with respect.

This early recognition is incredibly meaningful. Acknowledging the unmet needs of those who cope/suffer with tinnitus every day, and demonstrating that there is a tangible, real demand for treatment for the symptom.

Perhaps this action is the first step in reminding ENTs that tinnitus may soon be treatable with FX-322. We want the doctors to be ready to treat us before we step into the office, not the other way around.

 

[NewLionel]

I'm thinking about getting a FX-322 tattoo...

 

[patorjk]

This early recognition is incredibly meaningful. Acknowledging the unmet needs of those who cope/suffer with tinnitus every day, and demonstrating that there is a tangible, real demand for treatment for the symptom.

Perhaps this action is the first step in reminding ENTs that tinnitus may soon be treatable with FX-322. We want the doctors to be ready to treat us before we step into the office, not the other way around.

Maybe this is wishful thinking, but I wonder if curing/reducing tinnitus is FX-322's ace in the hole. Carl LeBel mentioned that several Phase I/II patients told their ENTs that FX-322 improved their tinnitus. This leaves me with several questions:

* How many of the 15 patients treated with FX-322 had tinnitus?
* How many of these tinnitus suffers experienced a reduction? (all we know is that it was more than 1)
* How big of a reduction did they experience?
* Why did a reduction in tinnitus occur? (if tinnitus is being reduced, it probably means that theory about the brain memorizing the sound is wrong)

Hearing restoration may be the bigger market, but if this drug improves tinnitus then they'll want to go full steam ahead in making sure ENTs know.

 

[tommyd87]

I wish they could apply for Operation Warp Speed, like they are doing with COVID-19. Or even a job completion incentive or in this case a cure incentive; would be for the Government to pay you more money for an earlier success. They use it in construction at times, the quicker the completion, the more money you get paid, this keeps the labors or scientists in this case with their eye on the prize. Increasing competition and work rate.

I do too, however I think that rushing it is not going to lead to as good of an outcome over releasing it slowly and methodically. Mainly because, unlike coronavirus vaccines, FX-322 needs some further playing around with to get it right. I reckon this is a case of good things come to those who wait.

 

[FGG]

Maybe this is wishful thinking, but I wonder if curing/reducing tinnitus is FX-322's ace in the hole. Carl LeBel mentioned that several Phase I/II patients told their ENTs that FX-322 improved their tinnitus. This leaves me with several questions:

* How many of the 15 patients treated with FX-322 had tinnitus?
* How many of these tinnitus suffers experienced a reduction? (all we know is that it was more than 1)
* How big of a reduction did they experience?
* Why did a reduction in tinnitus occur? (if tinnitus is being reduced, it probably means that theory about the brain memorizing the sound is wrong)

Hearing restoration may be the bigger market, but if this drug improves tinnitus then they'll want to go full steam ahead in making sure ENTs know.

We will have all this data end of Phase 2A.

And the brain memorizing sound doesn't make any sense because neuroplasticity isn't a switch that gets stuck. People who have treatable causes: TMJ, conductive loss in some cases, fluctuating tinnitus with Meniere's, inflammatory causes etc etc. already show the brain responds to treating the underlying cause. No one would ever get better if it was "stuck in the brain."

 

[Emgee]

I'm thinking about getting a FX-322 tattoo...

Ditto. Provided it works, I'm all in. I love tats, and I honestly can't think of a better way to showcase my gratitude for giving me my life back.

 

[tommyd87]

Note that "fixing that" is no walk in the park. There are no non-surgical approaches for a tympanoplasty. It's quite an ordeal, and it carries some risks (total hearing loss, etc).

There is a procedure being worked at in Australia called ClearDrum Implant where they can patch the hole with a film made of silk directly through the ear. It is another surgery but it is apparently about as straight-forward and riskless as inserting a grommet. It will have further clinical trials soon.

 

[FGG]

Ditto. Provided it works, I'm all in. I love tats, and I honestly can't think of a better way to showcase my gratitude for giving me my life back.

If it gives me my life and music back, I'm in too.

 

[Emgee]

If it gives me my life and music back, I'm in too.

100% with you on the music aspect. Personally, the hardest part of this entire experience was having to stop playing in bands/listening to music. I went from playing guitar around 6 hours a day on average to not picking it up in months. Music was quite literally my life.

 

[sensualmosquito]

We will have all this data end of Phase 2A.

And the brain memorizing sound doesn't make any sense because neuroplasticity isn't a switch that gets stuck. People who have treatable causes: TMJ, conductive loss in some cases, fluctuating tinnitus with Meniere's, inflammatory causes etc etc. already show the brain responds to treating the underlying cause. No one would ever get better if it was "stuck in the brain."

I've been getting all antsy about phase 2a. I hope they have the data out by the time frame, without delays.