Frequency Therapeutics — Hearing Loss Regeneration

[PeteJ]

@kelpiemsp mentioned he felt less sensitive to noise after neuromodulation, see the Minnesota thread.

Perhaps we can only be helped by restoring hearing in a damaged area AND by stopping the brain from becoming hyperactive and turning the volume up.

There is still a lot to be learned...

I personally think hearing regeneration and neuromodulation are both part of the tinnitus puzzle. We may even need both to make a lasting cure.

Perhaps.

One of the things that worries me and I wonder if it is a concern to others is how fragile and complicated the ear is, especially the cochlear nucleus (region). In saying that, I am especially talking about related nerves. Then you have this complicated relationship with the brain. Our understanding of it is limited and there is a lot of guess work and theories.

How much do these scientists and researchers know? Can they learn significantly more following the clinical trials? Are any breakthroughs forthcoming, any that would help with tinnitus? :-/

 

[RB2014]

https://www.drugdevelopment-technology.com/news/frequency-fx-322-hearing-restoration-data/

Frequency's FX-322 improves hearing function in trial subjects

"Data also revealed improvements in hearing function, including audiometry and word scores, in multiple participants treated with the drug candidate."

"Based on the data from this trial, the company plans to launch a multi-dose Phase IIa trial later this year."


So they now know that one dose works. Maybe more doses provide even better results.

 

[Pero1234]

Perhaps.

One of the things that worries me and I wonder if it is a concern to others is how fragile and complicated the ear is, especially the cochlear nucleus (region). In saying that, I am especially talking about related nerves. Then you have this complicated relationship with the brain. Our understanding of it is limited and there is a lot of guess work and theories.

How much do these scientists and researchers know? Can they learn significantly more following the clinical trials? Are any breakthroughs forthcoming, any that would help with tinnitus? :-/

All good questions for which we will have to wait and see.

I think scientists can learn most by trial and error. Don't we all? That's why these trials are so important, even if they fail or only work for a subgroup of people. They can rule out what doesn't work and investigate why.

I don't think any scientist can crack the code for tinnitus with theoretical research or research in animals only. A lot of medical treatments are in fact accidental discoveries.

I don't have any answers but I do get hope from two things:

1) There were several mentions that tinnitus is reduced when audio input is restored. With hearing aids for example. This suggests a brain plasticity that would keep the door open for recovery when there are new audio signals coming from hair cells, through the nerves into the brain.

2) Concerning the nerves: I heard from two different scientists in videos that even though they cannot explain it, the synapses / nerves do reconnect to newly grown hair cells. One scientist even called it a miracle if I'm not mistaken. This in particular gave me hope because I never thought this would be possible. One video was recent from Frequency Therapeutics, another from a scientist back in 2012.

I'm sure @JohnAdams can give a more scientific explanation (or the links to the videos, they were posted in this thread before).

When it comes to hope, for me it works better to expect a treatment to work unless proven otherwise. That's my attitude to most things in life... Although I am realistic enough to know it can fail.

 

[Daniel Lion]

Perhaps.

One of the things that worries me and I wonder if it is a concern to others is how fragile and complicated the ear is, especially the cochlear nucleus (region). In saying that, I am especially talking about related nerves. Then you have this complicated relationship with the brain. Our understanding of it is limited and there is a lot of guess work and theories.

How much do these scientists and researchers know? Can they learn significantly more following the clinical trials? Are any breakthroughs forthcoming, any that would help with tinnitus? :-/

Yes, yes, yes and yes. Breakthroughs are forthcoming... reign in the cynicism... my tinnitus is fucking raging and torturous... be optimistic... be positive... there are great scientists working on multiple fronts.

Hang tight man... treatments are on the way... science has always been guess work, theories, and experimentation, analysis.

PeteJ, stay positive man, good things are coming... believe it.

 

[Jazzer]

One of the things that worries me and I wonder if it is a concern to others is how fragile and complicated the ear is, especially the cochlear nucleus (region). In saying that, I am especially talking about related nerves. Then you have this complicated relationship with the brain. Our understanding of it is limited and there is a lot of guess work and theories.

'Zakly!'

 

[Pero1234]

https://www.drugdevelopment-technology.com/news/frequency-fx-322-hearing-restoration-data/

Frequency's FX-322 improves hearing function in trial subjects

"Data also revealed improvements in hearing function, including audiometry and word scores, in multiple participants treated with the drug candidate."

"Based on the data from this trial, the company plans to launch a multi-dose Phase IIa trial later this year."


So they now know that one dose works. Maybe more doses provide even better results.

Holy moly!

This is big!

This is what we hoped to get for Christmas! Thanks @RB2014!

 

[Paulmanlike]

I wonder if they were obviously keeping an eye on hearing loss improvements, if they found any lessening of tinnitus as a secondary outcome. Still I suppose it's too early to draw any conclusions.

 

[Mr Mister]

Holy moly!

This is big!

This is what we hoped to get for Christmas! Thanks @RB2014!

If "improvement" means 2 dB then it is scientifically interesting, if it means 20 dB then the founders will become multi millionaires and get a Nobel Prize

 

[Aleksa Uzunovic]

Hey folks, didn't David Lucchino say that they will request fast track status if they find that this can be an effective treatment?

I think they 100% will, with these new results.

 

[RB2014]

Hey folks, didn't David Lucchino say that they will request fast track status if they find that this can be an effective treatment?

I think they 100% will, with these new results.

Yes, they have mentioned that, but it is still taking longer than we had hoped.

Mr. Mister - 2 dB wont give you better word scores...

Pero123 - This is huge.

The big take away is the improved word scores. So not only did it get people get better hearing, but people's understanding increased. This was the big question that everyone had and it seems like it will not only work, but work well.

The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast.

Paulmanlike - Tinnitus can be up and down in volume based on many factors, but most people do think that getting hearing back will proportionately decrease tinnitus loudness level.

 

[Mr Mister]

Yes, they have mentioned that, but it is still taking longer than we had hoped.

Mr. Mister - 2 dB wont give you better word scores...

Pero123 - This is huge.

The big take away is the improved word scores. So not only did it get people get better hearing, but people's understanding increased. This was the big question that everyone had and it seems like it will not only work, but work well.

The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast.

Paulmanlike - tinnitus can be up and down in volume based on many factors, but most people do think that getting hearing back will proportionately decrease tinnitus loudness level.

Could you clarify what you mean by "The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast."?

My understanding is that when granted a fast track status a drug developer still needs to complete ordinary phase II and III studies but the actual approval phase may be some months shorter. I tried to check (googled) that normally phase II and phase III take usually 18-24 months each. Does someone have better estimates?

It seems that the actual clinical studies don't take that long but it's the time lag between the actual studies like setting up the processes and choosing patients that is taking a lot of time.

 

[RB2014]

Could you clarify what you mean by "The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast."?

My understanding is that when granted a fast track status a drug developer still needs to complete ordinary phase II and III studies but the actual approval phase may be some months shorter. I tried to check (googled) that normally phase II and phase III take usually 18-24 months each. Does someone have better estimates?

It seems that the actual clinical studies don't take that long but it's the time lag between the actual studies like setting up the processes and choosing patients that is taking a lot of time.

https://brighamhealthhub.org/innovation/reversing-hearing-loss-with-new-cells

Not sure how accurate it is, but I saw it in this article. I agree and think it is going to take longer though, but this development is pretty huge.

 

[Aleksa Uzunovic]

Could you clarify what you mean by "The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast."?

My understanding is that when granted a fast track status a drug developer still needs to complete ordinary phase II and III studies but the actual approval phase may be some months shorter. I tried to check (googled) that normally phase II and phase III take usually 18-24 months each. Does someone have better estimates?

It seems that the actual clinical studies don't take that long but it's the time lag between the actual studies like setting up the processes and choosing patients that is taking a lot of time.

WTF... 24 months each???!!! That's not happening if the US wants to have a competitive medicine industry. The European Audion Therapeutics will mop the floor with Frequency Therapeutics in that case. That's waaaaaaaaay too inefficient.

 

[Deathtotinni]

See, I told you guys that they would know about efficacy and this was more than a safety study.
It would be completely ridiculous for them to not have tested efficacy.


Now we know it works in humans and I've been saying it would all along as did @Deathtotinni. Now the question is how well did it work and how many doses per amount of hearing loss will it take to iron out our good friend tinnitus.

I don't know if I'm happier about it working or that I get to know I was right and so many other skeptics were wrong?

 

[Pero1234]

"to iron out our good friend tinnitus."

I can't wait until the day we turn to YouTube, look for a tinnitus sample and tell our friends / kids:

"Look, this is what I had in my head for x years. There used to be no cure."

"No cure??"

"None, whatsoever. All we had was this amazing online community. They understood."

 

[Amv]

Bravo Frequency Therapeutics!

 

[Spiral]

*applause*
Still have to wait for the results of the Phase 2a, then there will be a Phase 3. Realistically, we are still looking at a few years to market if it works (unless they successfully fast track with the FDA).

 

[Deathtotinni]

*applause*
Still have to wait for the results of the Phase 2a, then there will be a Phase 3. Realistically, we are still looking at a few years to market if it works (unless they successfully fast track with the FDA).

Did someone say they were starting 2A in a couple of weeks?

 

[tomytl]

Yes indeed, we have to wait some more years. Nevertheless, if they really achieved some hearing enhancement it definitely would be a sensation. I guess everybody with hearing loss would take every single dB back that they can. While it probably won't make hard of hearing people normal hearing ones, it's probably still a big positive thing to be able to hear a little better, I would take it.

The evidence of hair cell regeneration being effective would be enough to open the race for investigating many other approaches.

 

[RichardGuy]

I'm kind of curious as to why they went to a 2A phase instead of a phase 3 if the option was available to them. Anyone want to shed some light?

I still think we are looking at a 3 year ETA at minimum.

 

[Mr Mister]

Here is my most humble effort to try to estimate how long it would take statistically to FDA approval and how the "fast lane" speeds it up:

Of drugs approved between 2012 and 2016, candidate medications with standard approval processes took between 6.5 and 10 years to proceed from the start of human trials to FDA approval, with a midpoint of eight years. -> So 8 years seems like the median years to approval.

Candidate medications evaluated under one of the four accelerated programs took between 5.1 and 10.1 years to cover the same ground, with a midpoint of 7.1 years. -> about a year less than normally.

Half of the drug candidates that got the breakthrough designation went from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of eight years for drug candidates with no expedited designation. To get a breakthrough status, treatment has to have advantages over existing options for patients with serious or life-threatening diseases. Examples of breakthrough status include treatments for breast cancer, HIV, retinopathy, leukemia, melanoma, etc. There are some 15-30 requests per year.

If Frequency Therapeutics gets a breakthrough status this is how long it would take statistically: Frequency Therapeutics started its first human trials May 30, 2017 so with a median start-to-finish of 4.8 years it would get approved by February, 2022. That's probably the best case scenario and depends on getting a breakthrough status among other.

 

[Aleksa Uzunovic]

Here is my most humble effort to try to estimate how long it would take statistically to FDA approval and how the "fast lane" speeds it up:

Of drugs approved between 2012 and 2016, candidate medications with standard approval processes took between 6.5 and 10 years to proceed from the start of human trials to FDA approval, with a midpoint of eight years. -> So 8 years seems like the median years to approval.

Candidate medications evaluated under one of the four accelerated programs took between 5.1 and 10.1 years to cover the same ground, with a midpoint of 7.1 years. -> about a year less than normally.

Half of the drug candidates that got the breakthrough designation went from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of eight years for drug candidates with no expedited designation. To get a breakthrough status, treatment has to have advantages over existing options for patients with serious or life-threatening diseases. Examples of breakthrough status include treatments for breast cancer, HIV, retinopathy, leukemia, melanoma, etc. There are some 15-30 requests per year.

If Frequency Therapeutics gets a breakthrough status this is how long it would take statistically: Frequency Therapeutics started its first human trials May 30, 2017 so with a median start-to-finish of 4.8 years it would get approved by February, 2022. That's probably the best case scenario and depends on getting a breakthrough status among other.

That's 3 freaking years??? Screw that crap, my money goes to Audion in that case.

 

[Spiral]

Did someone say they were starting 2A in a couple of weeks?

In their Twitter post link they mentioned that they would start Phase 2a later this year.

 

[ee9892]

That's 3 freaking years??? Screw that crap, my money goes to Audion in that case.

OK but Audion isn't going to be out for years either (if successful)... so I feel like you're going to be disappointed no matter what.

 

[Paulmanlike]

That's 3 freaking years??? Screw that crap, my money goes to Audion in that case.

I would be made up if it was all approved in 3 years. I can't see this medicine hitting the market til at least a decade away, if at all. Besides, we don't know the full extent how well it works or even if it would solve tinnitus.

 

[Street Novelist]

When they say later this year, do they mean starting in the summer (late July) like the last trial, or do they mean in the fall?

 

[Aleksa Uzunovic]

Jesus man, so many pessimistic people here.

 

[Bndsmheowqhe]

I would be made up if it was all approved in 3 years. I can't see this medicine hitting the market til at least a decade away, if at all. Besides, we don't know the full extent how well it works or even if it would solve tinnitus.

Based on the positive demeanor of the CEO and people associated with this my gut is telling me that they've really got something here. It's the complete opposite of what I'm seeing from a certain other tinnitus treatment company.

 

[GSC]

A decade what... Not at all... what...

 

[Spiral]

A decade what... Not at all... what...

I have a feeling that either this will come out in the next few years or it will not come out at all. But all indicators point to that it works.