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Frequency Therapeutics — Hearing Loss Regeneration

Hyperacusis (ear pain) is my main issue. I really hope it does work.
I completely relate. Don't lose any sleep though, regeneration can only help. Restoring hair cells COULD help ear pain, it's just that science on hyperacusis isn't far along enough to know either way until we try it out.
 
This is my worry. Even in the Frequency Therapeutics video they mention how "elegantly complex" the hearing system is. Considering how relatively recent cochlear synaptopothy was discovered, my big concern is, have we accounted for everything that can break down leading to hearing loss/tinnitus? For arguments sake let's assume FX-322 can completely regenerate all hair cells and the synaptopothy drugs can repair all synapses. Would that be enough to restore the cochlea, at least in the more generic noise-induced/ototoxic cases?
Let me put it do you this way. Some time back in the 90's I was visiting an old friend of mine. Couch surfing may be something like what you'd call it today. But he had a one-roomed apartment with kitchen. I wanted to intrude as little as possible so I asked him could I roll out my sleeping-bag in his kitchen. Well the first night was cramped as there was not enough room -- I was lying diagonally trying to stretch out but couldn't do it fully. Next night I discovered that if I could open the press door at my head, that little bit extra room would allow me to place my head and stretch out. Next night I installed a pillow and could sleep OK all fine and dandy.
My struggle with Tinnitus was a little but like that. Finding just that little bit extra room so that I could just about manage. If this FX-322 can afford us just that little bit of extra quiet so that we can get on with the main event, then it's a big, biii…..iiiiig win.

Here is a very interesting link about what is going on in the research world:

https://www.tinnitushub.com/towards-tinnitus-subtyping-or-finding-a-key-for-each-keylock/

The PhD student noticed the heterogeneity (difference) among tinnitus sufferers and the heterogeneity of what worked among some and not among others and he's doing his thesis on it to find the right combinations of therapies for each sufferer. For example TRT helped me a lot...
But doesn't any more :(….
CBT helps me a little bit...
But I'm still hanging around these tinnitus chat boards ain't I?

Who knows. 2021 or 2022 could see us much much better but still hanging around jere.
 
What is the likelihood that the 4 clinical trial locations that are shown as not yet recruiting are actually recruiting at the moment?

They may not have updated the clinical trial website just like the estimated amount of participants have not been updated.

I really hope that's the reason why it states they are not recruiting yet for those 4 locations.

I really do not want there to be a delay.
 
What is the likelihood that the 4 clinical trial locations that are shown as not yet recruiting are actually recruiting at the moment?

They may not have updated the clinical trial website just like the estimated amount of participants have not been updated.

I really hope that's the reason why it states they are not recruiting yet for those 4 locations.

I really do not want there to be a delay.
Think of the miracle of hearing generation as one long delay.

Everyday we struggle and fight to reconcile ourselves to our new life with pain, new parameters and maybe, I hope, new possibilities. The developers and founders all enjoy quality lives and awesome salaries as is... they are not desperate or cracking the whip like we would be. This has never been done. They are focusing on this trial now. 4 months here, 6 months there, and 1 year here and another 2 there is standard operating procedure.

Mr. Jack Johnson you are going get your goop, for sure. It's just going to take a few years (what's a few you ask)... you know what I mean. We will have our day.
 
The developers and founders all enjoy quality lives and awesome salaries as is... they are not desperate or cracking the whip like we would be.
I agree with most of what you're saying but can we PLEASE kill this attitude? There are scientists and all over the world doing research to better understand ear disorders and find cures. They work VERY hard and have a much clearer idea of what they're doing than we ever will. They want to go to market ASAP and I'm sure they're doing everything they can to make it happen. It's their job. They care about us!
 
What is the likelihood that the 4 clinical trial locations that are shown as not yet recruiting are actually recruiting at the moment?

They may not have updated the clinical trial website just like the estimated amount of participants have not been updated.

I really hope that's the reason why it states they are not recruiting yet for those 4 locations.

I really do not want there to be a delay.
You could call the numbers of those locations' trial information desks and ask. I'd actually like to know the answer as well. I understand the sense of urgency all too well and don't want any delays in this either.
 
Think of the miracle of hearing generation as one long delay.

Everyday we struggle and fight to reconcile ourselves to our new life with pain, new parameters and maybe, I hope, new possibilities. The developers and founders all enjoy quality lives and awesome salaries as is... they are not desperate or cracking the whip like we would be. This has never been done. They are focusing on this trial now. 4 months here, 6 months there, and 1 year here and another 2 there is standard operating procedure.

Mr. Jack Johnson you are going get your goop, for sure. It's just going to take a few years (what's a few you ask)... you know what I mean. We will have our day.
Honestly, every angle by which I've analyzed Frequency Therapeutics' activities reveals they are moving as fast as they possibly can. The fact that Lucchino literally said the words BREAKTHROUGH THERAPY without any direct input from our community is incredibly heartening. These are big Stanford grads with big money behind them. They will have every asset at their disposal to ensure they get this to market ASAP, pending phase 2 success.
 
Honestly, every angle by which I've analyzed Frequency Therapeutics' activities reveals they are moving as fast as they possibly can. The fact that Lucchino literally said the words BREAKTHROUGH THERAPY without any direct input from our community is incredibly heartening. These are big Stanford grads with big money behind them. They will have every asset at their disposal to ensure they get this to market ASAP, pending phase 2 success.
Agree. I have followed biotech for a decade and Frequency Therapeutics is on top of this at a level I rarely have observed. They are extremely motivated. Even getting this to the market as early as 2022 would be directly related to their dedication and drive. I really like Lucchino as a CEO. Actually I like the whole team for this job.
 
You could call the numbers of those locations' trial information desks and ask. I'd actually like to know the answer as well. I understand the sense of urgency all too well and don't want any delays in this either.
I'm not in the US so it would cost money to make the call. Anyone else willing to call and ask?
 
I agree with most of what you're saying but can we PLEASE kill this attitude? There are scientists and all over the world doing research to better understand ear disorders and find cures. They work VERY hard and have a much clearer idea of what they're doing than we ever will. They want to go to market ASAP and I'm sure they're doing everything they can to make it happen. It's their job. They care about us!
Cut me some slack please... I believe in this drug. I always have.

I was just trying to inject some temperance and calm. My attitude has always been positive concerning this drug, read anything I have written over the last 2/3 years on this thread. Positive and optimistic always.

C'est la vie.

Same team Folks.
 
Cut me some slack please... I believe in this drug. I always have.

I was just trying to inject some temperance and calm. My attitude has always been positive concerning this drug, read anything I have written over the last 2/3 years on this thread. Positive and optimistic always.

C'est la vie.

Same team Folks.
Yes same team and positive thoughts. I too also believe in FX-322 would work for us. They have already had successful candidates who had improvements in their word scores.
 
Yes same team and positive thoughts. I too also believe in FX-322 would work for us. They have already had successful candidates who had improvements in their word scores.
I know my Friend, I know. I have been here for a while and my ears are shot to shit. A massive ski slope with sudden hearing loss history. My tinnitus is relentless and loud. I have lost my work and my profession and much more.

Lucifer, I really need this. But I need to soldier on until I am in a waiting room and an ENT is preparing my goop.

Let's all pray that Frequency Therapeutics smashes the next phase and the restoration is bigger and better with 4 shots.
 
Cut me some slack please... I believe in this drug. I always have.

I was just trying to inject some temperance and calm. My attitude has always been positive concerning this drug, read anything I have written over the last 2/3 years on this thread. Positive and optimistic always.

C'est la vie.

Same team Folks.
Oh, I wasn't by any means targeting you. I was just injecting some certainty & positivity into your very realistic picture of scientific evolution =)
 
I know my Friend, I know. I have been here for a while and my ears are shot to shit. A massive ski slope with sudden hearing loss history. My tinnitus is relentless and loud. I have lost my work and my profession and much more.

Lucifer, I really need this. But I need to soldier on until I am in a waiting room and an ENT is preparing my goop.

Let's all pray that Frequency Therapeutics smashes the next phase and the restoration is bigger and better with 4 shots.
They will most likely do well in the clinical trials. Let's hope they receive as much help from the FDA to get FX-322 out in the market ASAP.

The people who live in the US are very lucky to be able to get FX-322 first unless Astellas (Japan) releases it before the US.
 
Oh, I wasn't by any means targeting you. I was just injecting some certainty & positivity into your very realistic picture of scientific evolution =)
Cool... no worries. Fingers crossed friend.
They will most likely do well in the clinical trials. Let's hope they receive as much help from the FDA to get FX-322 out in the market ASAP.

The people who live in the US you are very lucky to be able to get FX-322 first unless Astellas (Japan) releases it before the US.
Things could be released at the same time, depending on production and distribution.
If you have to, you can fly over to the United States and stay with my family while you get the shots. As a community we will rally and help each other.

Let's just nail phase 2a and hope the 4 injections show big changes in the audiograms.
 
Cool... no worries. Fingers crossed friend.

Things could be released at the same time, depending on production and distribution.
If you have to, you can fly over to the United States and stay with my family while you get the shots. As a community we will rally and help each other.

Let's just nail phase 2a and hope the 4 injections show big changes in the audiograms.
Thanks for the offer Daniel. I really appreciate it.
 
What I've been noticing recently is that Frequency Therapeutics have been really active on Twitter for the past month.

Hopefully they continue giving us updates.
 
Do we have anecdotal evidence from phase 1 that it helps tinnitus? (Did any of the participants have tinnitus and reported an improvement?). Of course the dose might not have been sufficient for a change since phase 1 is only the safety check.
 
This has probably been asked, but i've only read the last 20-30 pages, but when/if FX-322 hits the market in the US will it be available to those with insurance who only have a specific amount of hearing loss? Will the rest have to go private?

I'm not a US citizen, so I wonder what redtape I would have to go through to go to the US to pay for medical treatment?
 
Do we have anecdotal evidence from phase 1 that it helps tinnitus? (Did any of the participants have tinnitus and reported an improvement?). Of course the dose might not have been sufficient for a change since phase 1 is only the safety check.
It depends on who you ask but it seems strongly implied to me. For all the arguments back and forth, you might have to go digging through the last few months of posting on this thread.
 
This has probably been asked, but i've only read the last 20-30 pages, but when/if FX-322 hits the market in the US will it be available to those with insurance who only have a specific amount of hearing loss? Will the rest have to go private?

I'm not a US citizen, so I wonder what redtape I would have to go through to go to the US to pay for medical treatment?
You can get any treatment you want here if you are willing to pay for it out of pocket. No one will be able to tell you what that price will be at this point.
 
Their Cowen presentation is up on their website. Nothing really new imo.

Unfortunately, their Q and A was not available online.
 
Their Cowen presentation is up on their website. Nothing really new imo.

Unfortunately, their Q and A was not available online.
I think the next Frequency Therapeutics event is in June unless they have an event earlier on. I thought they would update us with new news but maybe they will do it at a June event.
 
For me personally, I d
I think the next Frequency Therapeutics event is in June unless they have an event earlier on. I thought they would update us with new news but maybe they will do it at a June event.
Where are they speaking in June?
 
Do we have anecdotal evidence from phase 1 that it helps tinnitus? (Did any of the participants have tinnitus and reported an improvement?). Of course the dose might not have been sufficient for a change since phase 1 is only the safety check.
In a previous Q and A the question was asked about benefits seen in secondary endpoints (of which one is tinnitus); the reply was "We saw trends across the population." We can reasonably assume that a tinnitus reduction was reported by one or more subjects since it is unlikely that they would have added the TFI to the secondary outcome measures without expecting a benefit. Of course when phase 2a is unblinded the million dollar question will be answered.
 

Attachments

  • Fx-322 QnA (1).wav
    3.7 MB · Views: 69
Phase1/2
・0.05mL (fx322)
・0.2mL (fx322)
・placebo

https://www.sec.gov/Archives/edgar/data/1703647/000119312519239976/d72917ds1.htm
P106
"This is consistent with published work showing drug delivery to the cochlea depends more on the concentration of the drug than the volume of injection."

Phase2a
・? mL(fx322)*4
・? mL(fx322)*2 +placebo*2
・? mL(fx322)*1 +placebo*3
・placebo*4

What are the injection volumes and concentrations?
 
Phase1/2
・0.05mL (fx322)
・0.2mL (fx322)
・placebo

https://www.sec.gov/Archives/edgar/data/1703647/000119312519239976/d72917ds1.htm
P106
"This is consistent with published work showing drug delivery to the cochlea depends more on the concentration of the drug than the volume of injection."

Phase2a
・? mL(fx322)*4
・? mL(fx322)*2 +placebo*2
・? mL(fx322)*1 +placebo*3
・placebo*4

What are the injection volumes and concentrations?
The concentrations for phase 2a have not been made public. In fact, I even asked when I applied for the trial and she said could not say.
 
One question: what is the speed of action of the drug? I mean, once we get the injection, how quickly would the ear cells grow back? How long before we notice benefits? Are we talking hours, days, weeks. months? The experiment on the removed cochlea from a cancer patient was mentioned, what was the speed of growth there?

Thanks.
 

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