Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

If FX-322 works, do you see the severe hearing loss trial showing any improvements in word scores or do you think that with its current delivery method it will do nothing for severe hearing loss candidates?

I think they stand the best chance since their hearing (and word scores) is genuinely bad. It's definitely the arm I am watching.

 

[Jcmc]

There's no other way I can view this. I need to see hard data that proves beyond doubt that FX-322 is doing something inside the ear.

People, I have been saying all along that there is a serious issue with the delivery method to the cochlea. If they don't find a method to get the drug into the cochlea, all these IT drugs will be failures.

 

[Cernuto]

Totally get where you're coming from @Zugzug — and appreciate your valued input as always, especially taking a bearish approach — but maybe a 10 dB shift can have massive implications in terms of tinnitus reduction depending on type of damage and location of frequency.

We simply do not know how much regeneration is necessary to generate enough input that would result in a noticeable improvement of tinnitus since there's so much variation amongst individual cases.

It could be a godsend for those who have high-frequency tinnitus. We just don't know and it's frustrating because we have plenty of candidates here that I'm sure are willing to participate. I strongly believe this needs to be a university study (outside of the FDA) where we sign waivers, etc...

 

[Lucifer]

I think they stand the best chance since their hearing (and word scores) is genuinely bad. It's definitely the arm I am watching.

So say, if they got 5/50 words right at baseline and when they retest at 30 days or 90 days they get 10/50 words right, would you call this a meaningful improvement?

 

[Lucifer]

People, I have been saying all along that there is a serious issue with the delivery method to the cochlea. If they don't find a method to get the drug into the cochlea, all these IT drugs will be failures.

I agree but if the current delivery method works with mild-moderately severe hearing loss patients then they should continue with the same delivery method, and work on a new one once FX-322 is out in the market.

Why should they delay the release of FX-322 out in the market if the majority of people have mild-moderately severe hearing loss.

 

[Tezcatlipoca]

I find the "only 10 dB gains" argument laughable. No other drug has seen anything close to those numbers. The FDA knows this.

 

[FGG]

So say, if they got 5/50 words right at baseline and when they retest at 30 days or 90 days they get 10/50 words right, would you call this a meaningful improvement?

Speculating on what numbers people might get is not at all helpful. Just wait for the data.

 

[mrbrightside614]

I guess our best hope now is Susan Shore's device. Are we expecting anything from them in the next five years?

Nah man. There's still a lot of hope here. Once I distanced myself from the forum for a bit and cleared my head, I don't think this is such a major setback as I originally thought.

Dr. Shore basically worked her way off of my radar entirely with how incredibly, painstakingly slow her research/trials are moving. Also, look out for Ebselen and Thanos's drug (more selective Retigabine aka Trobalt).

 

[kiki]

I find the "only 10 dB gains" argument laughable. No other drug has seen anything close to those numbers. The FDA knows this.

Why did they say 0 dB?

Because it was three and a half months later?
Or 210 days later?
After 90 days, 5dB <10dB?

 

[Billy_Shears]

90 days may be enough time to develop hearing function within the womb prior to birth, but out here in the world to regenerate hearing in an adult without a doubt takes a little longer - it is complex but we are getting there.

Wait for the full readout, I am very confident there will be good news ahead.

 

[Lucifer]

I find the "only 10 dB gains" argument laughable. No other drug has seen anything close to those numbers. The FDA knows this.

This is why they should still go through to the pivotal phase if the age-related hearing loss trial shows meaningful improvements, even if the severe hearing loss category shows little to no improvements, as it seems to help those with mild-moderately severe candidates.

Let them work on a new delivery method after FX-322 is out in the market.

Why did they say 0 dB?

Because it was three and a half months later?

I think what he's trying to say is that no other drug has shown improvement in word scores like FX-322 did in the Phase 1b trials. The FDA will definitely be keeping a close eye on this. I feel they should advance to the pivotal phase if the age-related hearing loss trial shows meaningful improvement in word scores.

 

[weab00]

Why did they say 0 dB?

Because it was three and a half months later?

It was outside the timeframe to be considered clinically significant. They aren't able to count anything outside of the data parameters they set.

 

[Princebeyel]

I'm seriously about to flip a coin and see whether I should just get cochlear implants or not!

My quality of life is horrible not being able to understand what I hear!

I figure I'd ask some of you smarter guys what you would do. I just turned 33 in August and feel I'm losing everything. Is FX-322 something you would seriously wait on and be miserable, or would you just get cochlear implants? Please anyone give me some feedback here.

 

[Lucifer]

90 days may be enough time to develop hearing function within the womb prior to birth, but out here in the world to regenerate hearing in an adult without a doubt takes a little longer - it is complex but we are getting there.

Wait for the full readout, I am very confident there will be good news ahead.

I still have a bit of faith in the Day 210 readout for the patients that only received one or two doses of FX-322.

The reason why Frequency Therapeutics announced the bad news for Day 90 is that they took a more conservative approach and didn't want to say that patients experienced meaningful improvements when they only started getting improvements after Day 90 like the two positive anecdotes did. I think there may be more people like the two positive anecdotes that experienced meaningful improvements but only after Day 90.

If the theory of multiple doses of FX-322 reducing the benefit stands, I expect results at Day 210 to show improvements in those who only got one or two doses of FX-322.

 

[throwaway]

would you just get cochlear implants? Please anyone give me some feedback here.

Do it. Everybody here is a bit delusional.

 

[Lucifer]

I figure I'd ask some of you smarter guys what you would do. I just turned 33 in August and feel I'm losing everything. Is FX-322 something you would seriously wait on and be miserable, or would you just get cochlear implants? Please anyone give me some feedback here.

Me personally, I would honestly wait. There seems to be word score improvements using one dose of FX-322. Do you suffer from severe hearing loss?

 

[FGG]

I'm seriously about to flip a coin and see whether I should just get cochlear implants or not!

My quality of life is horrible not being able to understand what I hear!

I figure I'd ask some of you smarter guys what you would do. I just turned 33 in August and feel I'm losing everything. Is FX-322 something you would seriously wait on and be miserable, or would you just get cochlear implants? Please anyone give me some feedback here.

If you could wait until fall, you'd at least have the full data from these trials but my opinion is personally FX-322 works (and I have outlined in detail why I don't think the audiogram is fully representing what's going on here). However, I think they will have to repeat Phase 2a. This sets them back 18 months or so. So now instead of maybe 2 years, it could be 4 years.

That's a long time to have severe untreated hearing. I would consider the cochlear implant but maybe in one ear.

But that's just what I would do. This is a deeply personal decision.

 

[weab00]

I'm seriously about to flip a coin and see whether I should just get cochlear implants or not!

My quality of life is horrible not being able to understand what I hear!

I figure I'd ask some of you smarter guys what you would do. I just turned 33 in August and feel I'm losing everything. Is FX-322 something you would seriously wait on and be miserable, or would you just get cochlear implants? Please anyone give me some feedback here.

Wait until the day 210 readout. If it turns out to be effective, then great. If there are no clinically significant improvements, it's safe to say the drug is a bust. Otherwise, go for the CI; what's important is that you improve your quality of life with the tools you have available to you right now, and you don't want to be stuck waiting another 5-10 years for some ethereal drug that may never make it out of the lab.

 

[kiki]

It was outside the timeframe to be considered clinically significant. They aren't able to count anything outside of the data parameters they set.

10 dB is important.

If it is not 0 dB, you can improve it and aim for 20 dB and 30d B. Hope appears.

I think it is important that it is not 0 dB.

 

[Lucifer]

This is what I believe will happen when the Day 210 results come out. We all know weekly doses of FX-322 make it less effective.

The best scenario for us is that they can say that those who only got one or two doses of FX-322 experience meaningful word score improvements compared to those who got 3 or 4 doses of FX-322. So yes, technically multiple doses of FX-322 weren't effective, but if participants had word score improvements with one or two doses of FX-322 they can salvage it and prove to the FDA that their drug works but weekly dosing is unsuccessful.

If this happens, I don't see them having to repeat a Phase 2a.

 

[weab00]

10 dB is important.

If it is not 0 dB, you can improve it and aim for 20 dB and 30d B. Hope appears.

I think it is important that it is not 0 dB.

I was just explaining why Frequency Therapeutics could not have included that on the interim. 10 dB doesn't seem that great to me and could very well be a natural fluctuation in hearing or within the standard deviation for the test. Last time we got overly excited about anecdotes I'm pretty sure a few people lost $40k and everyone had their hopes and dreams crushed.

 

[Lucifer]

10 dB is important.

If it is not 0 dB, you can improve it and aim for 20 dB and 30d B. Hope appears.

I think it is important that it is not 0 dB.

I would have liked to know if any of the participants were between 7-9 dB. As long as it is not 0 dB, it would mean that there was an improvement in hearing.

 

[Ed209]

10 dB is important.

If it is not 0 dB, you can improve it and aim for 20 dB and 30d B. Hope appears.

I think it is important that it is not 0 dB.

It's because the test itself is not accurate enough to be certain within that window. It's the standard +- margin of error. Audiologists do not pay attention to jumps of this magnitude because they are meaningless. Have a look at my post above.

This is also a good reason why we need a better and more accurate way of measuring hearing loss. Audiology is largely stuck in the past and is in serious need of an update. The equipment that was used to conduct the audiograms in my previous post looked like it came straight from 1973.

 

[kiki]

I would have liked to know if any of the participants were between 7-9 dB. As long as it is not 0 dB, it would mean that there was an improvement in hearing.

Thank you.

For example, what if I give a 5 dB improvement with multiple injections with a reasonable period of one month or more?

I think the true 0 will remain 0 even if the delivery is improved.

No matter how many injections you give, 0 is 0.

 

[kiki]

Append.
Making "absence" into "existence" is a breakthrough.

 

[Bill Bauer]

Also, look out for Ebselen and Thanos's drug (more selective Retigabine aka Trobalt).

Trobalt is the drug that had visual snow as a side effect, right? And this new drug is similar to Trobalt and doesn't have that side effect?

 

[Cernuto]

It's because the test itself is not accurate enough to be certain within that window. It's the standard +- margin of error. Audiologists do not pay attention to jumps of this magnitude because they are meaningless. Have a look at my post above.

This is also a good reason why we need a better and more accurate way of measuring hearing loss. Audiology is largely stuck in the past and is in serious need of an update. The equipment that was used to conduct the audiograms in my previous post looked like it came straight from 1973.

The way they do the test is dumb and it has always been dumb.

 

[Tezcatlipoca]

It's because the test itself is not accurate enough to be certain within that window. It's the standard +- margin of error. Audiologists do not pay attention to jumps of this magnitude because they are meaningless. Have a look at my post above.

This is also a good reason why we need a better and more accurate way of measuring hearing loss. Audiology is largely stuck in the past and is in serious need of an update. The equipment that was used to conduct the audiograms in my previous post looked like it came straight from 1973.

And without approving drugs like these it will remain stuck there, that's why I think the FDA gave them FT status, their potential.

 

[ThomasC]

These are my before and after audiograms:

View attachment 44277

View attachment 44278

Look at the dates and then look at the difference at various frequencies. This could be construed as an improvement, but I didn't have a treatment of any sort. I took various vitamins and that's about it.

My right ear, in particular, went up by 15 dB at 8 kHz. This is the issue I have with results that show an improvement of 10 dB. It is clinically insignificant and means nothing. This was made clear by Frequency Therapeutics themselves when 4 people showed an improvement of 10 dB in phase I/II just like I did (except I didn't have FX-322).

I also think the WR scores are too marginal. It's very underwhelming.

An anecdotal experience of someone noticing an improvement in their tinnitus is common amongst the general population.

There's no other way I can view this. I need to see hard data that proves beyond doubt that FX-322 is doing something inside the ear.

I have the same kind of fluctuations on my audiograms. An improvement of 10 dB is really not impressive.

 

[chinup]

By the time you hear good news it's too late to buy. Pharma investing is all about believing in the company/drug before the results come out. It's the only way to make money on investment in pharma.

You're confusing getting in early with stubbornly holding after the news is bad and the stock has already crashed. Different points in time.