Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

@brokensoul, you rock for transcribing all of that. Thank you!

 

[d'Wooluf]

Hope you appreciate the work. I tried to transcribe to the best of my abilities

You did an outstanding job. None of the speakers would win awards for their diction. I found one mistake only. 'daughter' cell, not 'dotter' cell. Thank you.

 

[brokensoul]

You did an outstanding job. None of the speakers would win awards for their diction. I found one mistake only. 'daughter' cell, not 'dotter' cell. Thank you.

Thanks!

I was wondering about that one (dotter cell).

Hearing damage confirmed! I need FX-322

 

[IAmCalifornia]

All I want to know is when will this treatment be available (like legit available), and more importantly is if us commoners will actually be able to afford it.

I just read this heart breaking story of this family in Canada, whose daughter has a rare spine disorder (https://ca.gofundme.com/f/foreva-strong).

There's a treatment available, a drug, but the drug costs 3 million dollars. THREE MILLION.

 

[MRItechssuck]

My apologies, but has anyone on the forum gotten into this trial?

Thanks for the transcription.

 

[d'Wooluf]

Hearing damage confirmed! I need FX-322

It would help if Americans learnt how to speak English.

 

[Enclave]

I think it would be really great if we had the Tinnitus Talk Podcast reach out to Jeff Karp. He's extremely receptive and a kind human being and I think it would be awesome if our community here was able to put a list together of 10 or so solid questions to ask him about.

Just a thought.

 

[brokensoul]

All I want to know is when will this treatment be available (like legit available), and more importantly is if us commoners will actually be able to afford it.

I just read this heart breaking story of this family in Canada, whose daughter has a rare spine disorder (https://ca.gofundme.com/f/foreva-strong).

There's a treatment available, a drug, but the drug costs 3 million dollars. THREE MILLION.

Hearing loss is not a rare health problem. As discussed in the presentation, we're talking about a double digit million population. That should allow them to set a reasonable price while still being very profitable.

Truth is we don't know how much it will cost, as it will still be a novelty therapy drug that must be transtympanically injected (thus by an expert). It may be a bit costly, but if it really works for hearing loss, everyone will be glad to fork out the cash.

In either case it won't be crazy expensive.

 

[brokensoul]

I think it would be really great if we had the Tinnitus Talk Podcast reach out to Jeff Karp. He's extremely receptive and a kind human being and I think it would be awesome if our community here was able to put a list together of 10 or so solid questions to ask him about.

Just a thought.

That would be great, but they are probably only talking to scientists, researchers and potential investors and some media perhaps here and there to promote the company.

We are also not really their primary target group of patients. So they would likely avoid being directly regarded as a (potential) drug therapy for tinnitus.

I think we should all be grateful that they did indeed add tinnitus as one of their secondary end points for phase 2a.

Let's hope their small molecules (in higher doses and later perhaps with an improved hydrogel) work well for hearing loss and, this obviously being the million dollar question, if it can actually help to reduce or alleviate the tinnitus signal(s).

 

[d'Wooluf]

I think it would be really great if we had the Tinnitus Talk Podcast reach out to Jeff Karp.

I'm pretty sure that @Hazel has asked Frequency Therapeutics and they've declined.

 

[John Queen]

All I want to know is when will this treatment be available (like legit available), and more importantly is if us commoners will actually be able to afford it.

I just read this heart breaking story of this family in Canada, whose daughter has a rare spine disorder (https://ca.gofundme.com/f/foreva-strong).

There's a treatment available, a drug, but the drug costs 3 million dollars. THREE MILLION.

I can't think of a time frame till it will be available, but with all the recent developments (the partnership with Astellas, FDA Fast Track, new drugs legislation both in US and Japan etc.), I hope not too late. My guess is: around 2 years from now if everything works fine in the trials. But I might be wrong. Might be earlier, might be later.

With regard to the cost, they shouldn't charge millions of dollars for this, that's clear. What that little girl needs for SMA is gene therapy, which is much more difficult to develop and manufacture at the moment. Frequency Therapeutics uses small molecules, i.e., conventional drugs.

 

[brokensoul]

@FGG, it seems to me that their answer on the question about improvements on secondary end points ("we saw trends across the population") likely did not refer to the secondary end points that they added now to the phase 2a study (tinnitus, ...). It's a bit confusing, but it seems too vague to me to get a good feeling on that answer in regards to tinnitus.

However, they did add it now as a secondary end point, do you suspect they may have gotten some feedback from participants and therefore added it to phase 2a?

We will need to wait until September (?) 2020 when they publish their results, before we can get our hopes up or start crying.

 

[FGG]

I'm pretty sure that @Hazel has asked Frequency Therapeutics and they've declined.

I think there would be little chance any publically traded company would do this while still in trial, unfortunately.

 

[FGG]

@FGG, it seems to me that their answer on the question about improvements on secondary end points ("we saw trends across the population") likely did not refer to the secondary end points that they added now to the phase 2a study (tinnitus, ...). It's a bit confusing, but it seems too vague to me to get a good feeling on that answer in regards to tinnitus.

However, they did add it now as a secondary end point, do you suspect they may have gotten some feedback from participants and therefore added it to phase 2a?

We will need to wait until September (?) 2020 when they publish their results, before we can get our hopes up or start crying.

But the question was the moderately severe population benefited more in word scores than the mild, do you think that will be true w secondary measures and they answered that the trends were the same across both groups. Vague or not, I don't know another way to interpret that.

And yes, the one piece of data they haven't released is patient testimonials. Adding tinnitus to the extended arm adds time and cost. I don't think it's a coincidence.

 

[d'Wooluf]

I think there would be little chance any publically traded company would do this while still in trial, unfortunately.

They seemed happy to give a presentation to and answer questions from a bunch of hedge fund managers?

 

[patorjk]

All I want to know is when will this treatment be available (like legit available), and more importantly is if us commoners will actually be able to afford it.

I just read this heart breaking story of this family in Canada, whose daughter has a rare spine disorder (https://ca.gofundme.com/f/foreva-strong).

There's a treatment available, a drug, but the drug costs 3 million dollars. THREE MILLION.

Frequency Therapeutics has always been really ambitious. My guess is as soon as they can get it to market, they will. Drugs can go to market during the Phase III trials, so we could see it as soon as late this year or early next year. But there are a lot of variables in play.

As for cost, they will want to maximize their profit. So what the final cost will be will depend on a number of things. One important thing will be if there's any competition. If Audion's LY3056480 drug fails, then FX-322 will be the only game in town and they'll be able to charge a lot. If LY3056480 is a big success, FX-322 will have to price their drug competitively. There are also other companies that have drugs in the pipeline, but for now it really looks like a race between LY3056480 and FX-322.

Last night I got a bill for a heart monitor I wore for 2 weeks. The bill was for $7,500, though insurance knocked it down so I only had to pay around $700. I was still pretty annoyed though. There has to be good competition for heart monitors, and mine was "mostly" covered by insurance. I fear a drug like FX-322 won't be covered as much (if at all - sort of like how laser eye surgery isn't typically covered by insurance).

At this point everything is speculation, but I would imagine a drug that could restore hearing and cure tinnitus costing around $10-20k. They may even charge by dose if it's discovered that additional doses help (maybe $5k per dose?).

 

[Chriscom]

I think there would be little chance any publically traded company would do this while still in trial, unfortunately.

True, and my impression is that Frequency Therapeutics has been among the least interested, period, in interacting with Tinnitus Talk.

 

[rei]

About ten and a half minutes into this video cost is addressed.

 

[brokensoul]

At this point everything is speculation, but I would imagine a drug that could restore hearing and cure tinnitus costing around $10-20k. They may even charge by dose if it's discovered that additional doses help (maybe $5k per dose?).

I'd happily spend all my money if it was sure that it cures tinnitus. However since there are likely different types of damage that can result in tinnitus, I feel we would never be sure until we try and that would then of course be a high cost for something that may not do anything to cure tinnitus.

If there was a growing track record that it helps many people with their tinnitus, but not all, I would go for it. Even if it only partly reduces tinnitus for some people I would still go for it. It would be a gamble, but still worth it in my opinion.

This shit has wrecked my life, money has little meaning left to me.

Luckily we will have a reasonable insight into what this drug can do for tinnitus after phase 2a, without having to shell out that amount of cash.

I'm not worried whatsoever about the potential cost, I'm worried it won't do anything for tinnitus.

 

[brokensoul]

As for cost, they will want to maximize their profit. So what the final cost will be will depend on a number of things. One important thing will be if there's any competition. If Audion's LY3056480 drug fails, then FX-322 will be the only game in town and they'll be able to charge a lot. If LY3056480 is a big success, FX-322 will have to price their drug competitively. There are also other companies that have drugs in the pipeline, but for now it really looks like a race between LY3056480 and FX-322.

Frequency Therapeutics already know their method has a clear advantage to Audion's. Even if Audion succeeds, I suspect many people will wait for FX-322.

We will see. Competition is good for sure.

 

[FGG]

I'd happily spend all my money if it was sure that it cures tinnitus. However since there are likely different types of damage that can result in tinnitus, I feel we would never be sure until we try and that would then of course be a high cost for something that may not do anything to cure tinnitus.

If there was a growing track record that it helps many people with their tinnitus, but not all, I would go for it. Even if it only partly reduces tinnitus for some people I would still go for it. It would be a gamble, but still worth it in my opinion.

This shit has wrecked my life, money has little meaning left to me.

Luckily we will have a reasonable insight into what this drug can do for tinnitus after phase 2a, without having to shell out that amount of cash.

I'm not worried whatsoever about the potential cost, I'm worried it won't do anything for tinnitus.

Well if it was say a million dollars, it just wouldn't be affordable to me and most everyone else no matter what. But I don't think that it is remotely possible.

 

[brokensoul]

Well if it was say a million dollars, it just wouldn't be affordable to me and most everyone else no matter what. But I don't think that it is remotely possible.

It won't be a million dollars. Would be a very bad pricing strategy on their part. You know that of course.

It's too soon to worry about the price.

 

[Coleoptere]

Frequency Therapeutics aims at the masses. That's why they partnered with Astellas. They will somehow compete with hearing aids I assume. So I do not expect a million dollar price tag.

 

[mrbrightside614]

Personal info and a theory, if anyone is interested.

Just got an extended frequency audiogram done, tested up to 20 kHz. My right ear has bat-like hearing; -5 to -15 dB at ranges of 12 kHz+. My left ear (tinnitus ear) is good enough to not even be considered to have mild hearing loss at the extended frequencies, but is within +20 dB difference when compared to the right.

I think an important measure may be dB comparison between ears at each respective pitch (hearing symmetry). Although my left ear doesn't qualify as even mild hearing loss, it could be seen as "loss compared to personal standard" (my right ear). I've also noted many times that my issue is not exactly with the volume of the tinnitus, but with the pitch. If 20d B at the right frequency can mask it, I think it's reasonable to believe the asymmetrical loss is enough to account for hair cell death and tinnitus genesis.

Further, I don't think extended audiograms are the be-all/end-all of measuring hearing loss. Within each measurement, there are an additional 999 Hz which are untested. When I've tested myself with a tone generator app, I've noticed variations in perceived volume intensity between certain parameters (e.g. 5350 Hz-5550 Hz).

My theory is that FX-322 may fill in these unmeasured gaps that deviate from 1 kHz to the next.

My speech-in-noise tests were also great so it is not likely that cochlear synaptopathy is my issue.

Of course I could be wrong and this could be related to TBI, but that doesn't explain why the hyperacusis that was immediately present post-airbag deploy was only in my left ear, and why when I woke up the following month on that fateful day of July 18th, that I perceived the EEEEEE to be distinctly coming from my left ear. I would think TBI tinnitus would occur bilaterally.

 

[FGG]

Personal info and a theory, if anyone is interested.

Just got an extended frequency audiogram done, tested up to 20 kHz. My right ear has bat-like hearing; -5 to -15 dB at ranges of 12 kHz+. My left ear (tinnitus ear) is good enough to not even be considered to have mild hearing loss at the extended frequencies, but is within +20 dB difference when compared to the right.

I think an important measure may be dB comparison between ears at each respective pitch (hearing symmetry). Although my left ear doesn't qualify as even mild hearing loss, it could be seen as "loss compared to personal standard" (my right ear). I've also noted many times that my issue is not exactly with the volume of the tinnitus, but with the pitch. If 20d B at the right frequency can mask it, I think it's reasonable to believe the asymmetrical loss is enough to account for hair cell death and tinnitus genesis.

Further, I don't think extended audiograms are the be-all/end-all of measuring hearing loss. Within each measurement, there are an additional 999 Hz which are untested. When I've tested myself with a tone generator app, I've noticed variations in perceived volume intensity between certain parameters (e.g. 5350 Hz-5550 Hz).

My theory is that FX-322 may fill in these unmeasured gaps that deviate from 1 kHz to the next.

My speech-in-noise tests were also great so it is not likely that cochlear synaptopathy is my issue.

Of course I could be wrong and this could be related to TBI, but that doesn't explain why the hyperacusis that was immediately present post-airbag deploy was only in my left ear, and why when I woke up the following month on that fateful day of July 18th, that I perceived the EEEEEE to be distinctly coming from my left ear. I would think TBI tinnitus would occur bilaterally.

I think it is the suddenness of the loss that contributes to the maladaptive plasticity, too. But yes, I wouldn't expect a 20 dB difference between your ears to be a natural occurrence esp since your "good ear" is not the one with tinnitus. I think your damage is cochlear and FX-322 will help.

Also agree notch testing would tell us more as well as better ways to assess for IHC damage and synaptopathy. I passed the speech in noise test perfectly but can't understand movies/TV without captions unless it's the News and there is no background music.

 

[mrbrightside614]

Also agree notch testing would tell us more as well as better ways to assess for IHC damage and synaptopathy. I passed the speech in noise test perfectly but can't understand movies/TV without captions unless it's the News and there is no background music.

Fascinating—an anecdotal report possibly substantiating Frequency's claim about extended frequencies affecting speech clarity perception.

Now that my qualification for phase 3 is likely out the window with this audiogram, pinning some hope on unbelievable efficacy data in regards to their tinnitus experimental arm to warrant conditional approval.

 

[FGG]

Fascinating—an anecdotal report possibly substantiating Frequency's claim about extended frequencies affecting speech clarity perception.

Now that my qualification for phase 3 is likely out the window with this audiogram, pinning some hope on unbelievable efficacy data in regards to their tinnitus experimental arm to warrant conditional approval.

The FDA prob won't look at extended arm data for approval (even if fantastic) because that's not the indication they filed their IND application under (unless there is a precedent for this I have never heard of) but if their word scores continue to amaze, that would be enough anyway imo.

 

[brokensoul]

Further, I don't think extended audiograms are the be-all/end-all of measuring hearing loss. Within each measurement, there are an additional 999 Hz which are untested. When I've tested myself with a tone generator app, I've noticed variations in perceived volume intensity between certain parameters (e.g. 5350 Hz-5550 Hz).

It's my main critique of pure tone audiometries. They use large intervals and then conclude that it must all be good in between the intervals. I don't know how valid this reasoning is, but I have some very serious doubts about it.

Is it not possible to have notches between these intervals if both adjacent measuring points revealed no hearing damage? It does not make any sense to assume there is no damage possible in between. These tests are completely archaic and insufficient in my opinion.

I've challenged all the audiologists on this point and they all seemed to imply it was not required. I can understand it's not practical to do all 20,000 frequencies with a pure tone audiometry, but to assume that every non-tested frequency must be ok then, that just seems strange to me.

On the other hand I'm not an audiologist and perhaps there is a valid reason to state that doing several intervals is sufficient.

If anyone has deeper knowledge on this, please share, I've been wondering about this for 9 months already.

PS: I've tried these HD hearing tests on YouTube which loop through all frequencies, but it's not easy to do a proper test at home or come to a conclusion.

 

[serendipity1996]

Bear with me here - I don't have a scientific background so apologies if this doesn't make sense but given that Frequency Therapeutics is obviously targeting hair cell regeneration, how do they differentiate between the Inner Hair Cells and the Outer Hair Cells? Is it assumed that using this method would regenerate both types of hair cells? From reading the data from the slides, it seems like it given that the results appear to indicate increased clarity of sound, which is a function of the OHCs?

 

[brokensoul]

Perhaps Tinnitus Hub could someday attract an audiologist to volunteer support for TinnitusTalk.com. There has got to be an audiologist out there with tinnitus that is willing to participate.