Frequency Therapeutics — Hearing Loss Regeneration

[MrCrybaby]

I think a downstream cascade of process cause the nerve to regrow and reconnect.

That's awesome! This whole approach is so interesting, the drug kicks things off then the body just takes over and does its thing.

 

[FGG]

Nerve fibers can regrow though, albeit at an incredibly sluggish pace. I remember hearing a 1mm/day estimate. Hoping that a combination of time and FX-322 would fix most of us here.

I think that's the peripheral nerve fiber rate for natural healing that you are quoting. That's a whole different animal than cranial nerves and associated structures.

 

[JohnAdams]

I know they started testing for tinnitus for Phase 2a but surely they must of have participants in Phase 1b that had tinnitus and said it was reduced or gone. Do we really need to wait till end of September to tell us if tinnitus was reduced or not?

Sorta, yeah.

 

[patorjk]

I know they started testing for tinnitus for Phase 2a but surely they must of have participants in Phase 1b that had tinnitus and said it was reduced or gone. Do we really need to wait till end of September to tell us if tinnitus was reduced or not?

They occasionally do Q&As. If on the slim chance anyone here will be at the below conference, they could ask:

https://investors.frequencytx.com/e...business-and-pipeline-overview-38th-annual-jp

 

[davidmp]

Maybe everybody knows already, just found this interesting info about the actual FDA "Fast Track" duration:

http://www.pharmexec.com/how-fast-are-fda-fast-lanes

So it could be around 200 days, if the progression continues like in the article. What I don´t know is from when.

 

[JohnAdams]

That's awesome! This whole approach is so interesting, the drug kicks things off then the body just takes over and does its thing.

That's right.

 

[Caveman]

Maybe everybody knows already, just found this interesting info about the actual FDA "Fast Track" duration:

http://www.pharmexec.com/how-fast-are-fda-fast-lanes

So it could be around 200 days, if the progression continues like in the article. What I don´t know is from when.

Yeah, according to this data it takes about 230 days to approve a fast-track designated drug. THAT'S SHOCKING.
It means we may get the FX-322 injections by the end of THIS YEAR!!!

 

[papu]

Interesting conundrum. They are doing both studies at the same time (FX-322 and OTO-413). I don't really know which one would potentially benefit more since I mostly recovered from my mild hearing loss during these four years but still have tinnitus (high frequency) in right ear (I know I have hearing loss in the 9000 Hz and 12000 Hz range but have not found a way to officially measure it). I guess tinnitus will be my primary concern. Wish I knew whether it was from broken synapses (OTO-413) or from loss of hair cells in that high range.

 

[Coleoptere]

From the article:

..... President Trump has called the FDA approval process slow and burdensome and not only that, but he's suggested that the agency process has kept too many advances from getting to those in need.

 

[JohnAdams]

Yeah, according to this data it takes about 230 days to approve a fast-track designated drug. THAT'S SHOCKING.
It means we may get the FX-322 injections by the end of THIS YEAR!!!

Doubt it. If everything goes perfectly and all fate is on our side, the absolute soonest that patients would start getting this would be sometime next year and even that is a very optimistic estimate.

 

[Caveman]

Doubt it. If everything goes perfectly and all fate is on our side, the absolute soonest that patients would start getting this would be sometime next year and even that is a very optimistic estimate.

I don't know what to think… the author of the article seems to know his stuff…

 

[JohnAdams]

I don't know what to think… the author of the article seems to know his stuff…

The current trial is not going to be completed until the Fall. They aren't going to test THI scores until like 200 or so days after the treatment. Then they would have to start mass producing the drug and partnering with ENT's to distribute it. Anything could happen but I don't see it becoming available this year unless there is a full blown miracle.

 

[FGG]

The current trial is not going to be completed until the Fall. They aren't going to test THI scores until like 200 or so days after the treatment. Then they would have to start mass producing the drug and partnering with ENT's to distribute it. Anything could happen but I don't see it becoming available this year unless there is a full blown miracle.

Fully agree. Frequency just posted jobs that have to do with drug manufacturing efficiency a month ago. It means they are at minimum expecting this to go to phase 3 and at most prepping for full scale production. However, there is very little chance this would all be done by end of year imo.

Even next year would be amazing, though.

 

[Caveman]

The current trial is not going to be completed until the Fall. They aren't going to test THI scores until like 200 or so days after the treatment. Then they would have to start mass producing the drug and partnering with ENT's to distribute it. Anything could happen but I don't see it becoming available this year unless there is a full blown miracle.

And how long will it take to bring the treatment here into the European Union, in your estimation?

 

[JohnAdams]

And how long will it take to bring the treatment here into the European Union, in your estimation?

I have no clue how that works. I'd think pretty quickly.

 

[davidmp]

In any case the pure tone improvements from phase 1 don´t seem very promising, let´s see about the phase 2.

 

[MrCrybaby]

And how long will it take to bring the treatment here into the European Union, in your estimation?

They partnered with an international distributor for outside US. I'm hoping the distributor will announce their plans after phase 2a is finished, assuming it is successful.

 

[Lucifer]

Since Astellas have rights outside US does it matter if a country does not have Astellas located in their country?

 

[ChrisBoyMonkey]

They may start phase 3 this year if they keep up the pace. What I really wanted to know is what they say it does to tinnitus.

 

[FGG]

In any case the pure tone improvements from phase 1 don´t seem very promising, let´s see about the phase 2.

They used a tiny dose once for phase 1 and got completely unheard of word score changes and small changes at 8000 Hz in some individuals. Now imagine dosing that dose 4x at a *much* higher dose that penetrates fully into the 3500-8000 Hz area.

Their phase 1 results were great from that perspective.

 

[FGG]

They may start phase 3 this year if they keep up the pace. What I really wanted to know is what they say it does to tinnitus.

I think those with hair cell loss and tinnitus resulting from that will benefit enormously if not fully. I feel confident about this.

I just wish everyone had access to an extended audiogram (and was able to look for notches in between) to see exactly who will get relief from this and who needs synaptopathy drugs instead.

 

[HootOwl]

They may start phase 3 this year if they keep up the pace. What I really wanted to know is what they say it does to tinnitus.

The fact that they even created an experimental arm tells me it does *something*. >.> You don't just create those out of nowhere.

 

[ChrisBoyMonkey]

The fact that they even created an experimental arm tells me it does *something*. >.> You don't just create those out of nowhere.

Yes, that fact is interesting. But I want to hear exactly what it does. Nothing? Reduce? Reduce a lot? Full on cure?

That is what I'm most interested in. I want them to come out and say what they're seeing.

 

[ChrisBoyMonkey]

I think those with hair cell loss and tinnitus resulting from that will benefit enormously if not fully. I feel confident about this.

I just wish everyone had access to an extended audiogram (and was able to look for notches in between) to see exactly who will get relief from this and who needs synaptopathy drugs instead.

I want them to say what it does specifically. If it does nothing, reduces, cures, etc. We may have to wait until about halfway this year for those answers.

 

[FGG]

I want them to say what it does specifically. If it does nothing, reduces, cures, etc. We may have to wait until about halfway this year for those answers.

I think tinnitus of cochlear causes is going to be like Horner's syndrome. In that I mean lesions anywhere from the brain to the spine to the eye can all cause a certain set of symptoms and are all addressed differently (in Horner's).

In the cochlea this means: OHC in some people, IHC in others, synapses in others, etc. Whatever interrupts the normal signal somewhere on the pathway in each individual.

I think Frequency Therapeutics will greatly improve or outright cure tinnitus caused by hair cell death. That's why it's important that only people with evidence of hair cell death are in trial. If you *only* have hair cell death, I think it will be a cure as your brain adjusts back to normal. If you also have synaptopathy, etc I think it will be an improvement.

Since they are selecting people with audiometric evidence of hair cell loss for the trial, I think we will see improvements in some and cures in others. By the end of the year, we will know for sure, thankfully.

 

[john paul]

I want them to say what it does specifically. If it does nothing, reduces, cures, etc. We may have to wait until about halfway this year for those answers.

Just watch the stock price, bearing in mind speculation will push this thing up significantly.

 

[FGG]

Just watch the stock price, bearing in mind speculation will push this thing up significantly.

In the meantime, look at their job postings to see what they are anticipating.

 

[Lucifer]

In the meantime, look at their job postings to see what they are anticipating.

I really hope this trial is successful. I would feel really gutted if this isn't the real deal.

But from what we seeing so far it's going well. They even got Astellas which is a big company to help them out. They wouldn't have paid that much if it wasn't successful.

 

[JohnAdams]

I think tinnitus of cochlear causes is going to be like Horner's syndrome. In that I mean lesions anywhere from the brain to the spine to the eye can all cause a certain set of symptoms and are all addressed differently (in Horner's).

In the cochlea this means: OHC in some people, IHC in others, synapses in others, etc. Whatever interrupts the normal signal somewhere on the pathway in each individual.

I think Frequency Therapeutics will greatly improve or outright cure tinnitus caused by hair cell death. That's why it's important that only people with evidence of hair cell death are in trial. If you *only* have hair cell death, I think it will be a cure as your brain adjusts back to normal. If you also have synaptopathy, etc I think it will be an improvement.

Since they are selecting people with audiometric evidence of hair cell loss for the trial, I think we will see improvements in some and cures in others. By the end of the year, we will know for sure, thankfully.

Suppose the initiation of a new hair cell's genesis causes a set of unique growth factors to be secreted from the supporting cell that initiates neurogenesis and neuritogenesis which is what causes the underlying nerves to grow and reconnect in the first place. I understand that there are more supporting cells than hair cells and if true, then FX-322 could cause supernumerary hair cells which would still induce the downstream neuronal improvements. Right?

 

[d'Wooluf]

Now imagine dosing that dose 4x at a *much* higher dose

I get that some people in the current trial will receive four doses. Do we know for sure that each dose will have a higher concentration of active ingredients than the phase 1b doses? They've said in the past that a larger dose volume probably wouldn't make any difference.