Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

How is it even possible to have better word scores and no improvement in the extended audiogram? That's like having no increase in strength, but being able to lift heavier objects anyway.

Another thought I had. The EHF audiogram is not standard. Almost no one has years of data on this in their medical record. Most people likely got it specifically to be in the trial. As a result, this could be faked (unfortunately).

The other thing, too, is that they strongly recruited for sudden hearing loss based on my interview in the main study arm (I won't reveal what they asked me specifically because revealing things like this is part of the problem). This group does not necessarily have worse EHF (many people only get mid range notches with acoustic trauma, for instance). So these measurements could mostly reflect exaggerated/faked selection data.

This is different than age-related hearing loss where there is a much stronger tendency for the EHF area to wear down first.

 

[Koz]

Just finished reading through the last few pages. Seems like the people who still have faith and optimism are holding out hopes for better and more controlled future studies, a better delivery, getting more out of a single injection dose etc.

The single injection dose improvement on an audiogram from Phase 1 was tiny. The kind of improvement within an Audiologist's "you got to give or take -5 dB/+5 dB, -10 dB/+10 dB depending on multiple factors during testing", so that really doesn't say much. The only ever time it was going to be something worth shouting about is if it followed with more success from Phase 2 - it didn't, so I have to be honest about what it is - underwhelming and by the own admission of the company itself, cannot be fully trusted due to the inclusion criteria being dodgy.

For those who say Audiogram results don't matter, trust me, for those of us in the moderate/severe/profound ranges, they absolutely do. I am not someone with hidden hearing loss or only high frequency hearing loss, so I do not look at it from those specs.

Personally, my faith in Frequency Therapeutics is down the drain now. The results from the first iteration weren't ever going to be amazing prior to them coming out and then when they come out they come out so underwhelming. They are clearly not as advanced as I thought of them to be. I don't see much to hold on to to keep my hanging around for what I can at best describe as breadcrumbs of positive news drip fed over a long long time. It's just awful for my mental health, I applaud and salute those who are able to stay on top of things on a daily basis in terms of research/treatments etc., I personally can't, it just fucks with my mental health and now I have enough reason to let go of the one product that kept me attached - FX-322.

Sure, there are still others who are working on treatments but I don't think I'll be waiting forever. I probably will go down the cochlear implant route in a few years if nothing else pops up. I sincerely hope this company recovers from this but I have seen enough failures by now to never attach myself to something like this ever again.

Once something pops up, I will probably end up hearing about it after it's out and proven to be a success rather than having followed it like I have with this.

 

[HootOwl]

Quick thought: it would be tricky to fake a bad word score to get in. You would have to hear the word, recognize it, then quickly think of a word that it sounds similar to, without a suspicious/noticeable pause. The bluffing would be kind of obvious, in my opinion, unless you were a skilled improvisor.

Not necessarily. When I did my word score testing I said "I'm not sure" at several points and then my audiologist increased the decibel level so that I could hear it more clearly. I didn't have to actually come up with a different word.

This was for qualifying though, I'm not sure how they operated the WR trial at the testing centers. But if your audiologist was testing like mine, then faking your way into the trial at least would not have been difficult.

 

[Zugzug]

Holding onto my stock. My average purchase price was $23 USD.

I may even buy some more while they are low. FREQ was never so cheap, not even at IPO.

Although I admit it's really scary buying something that just crashed so hard... :-/

I do regret buying some more while they were at $48 USD. I did so against my own better judgement. The higher one buys, the harder One can get hit. I learned my lesson :-(

If they ever rise to those levels again, I will definitely refrain from doing so.

I invested a decent amount in the end. No regrets. My decision making was correct and I was prepared to lose it all. I'm holding. The pros from selling before the two Phase 1b trials don't outweigh the possible benefit if single dose pushes through, however unlikely without improved delivery.

 

[Jomo]

So sad... I don't even care that I lost a little money on this... It seemed so promising... Such a shame

 

[Pero1234]

That reminds me...

What is Audion Therapeutics up to these days?

They had Regain (LY3056480) tested successfully in Phase 1 back in 2019.

It says on regainyourhearing.eu that they started testing (pre-COVID-19) whether the drug affects the ability to hear (= Phase 2?)

 

[Rubenslash]

That reminds me...

What is Audion Therapeutics up to these days?

They had Regain (LY3056480) tested successfully in Phase 1 back in 2019.

It says on regainyourhearing.eu that they started testing (pre-COVID-19) whether the drug affects the ability to hear (= Phase 2?)

The study failed and they kind of abandoned the product.

Decibel Therapeutics, Otonomy and maybe in the future Stanford Initiative to cure hearing loss. I remember it was either Stanford or Decibel Therapeutics that were criticizing Frequency Therapeutics for rushing things and trying to bring an unfinished product to the market, it seems that they were right after all.

 

[Jcmc]

The truth is difficult to accept.

Unfortunately, the reality is that FX-322 does not work in vivo human cochlea.

The delivery method is where they have to focus on and this goes for all drugs that are injected intratympanic (OTO-313, OTO-413... etc).

 

[Aaron91]

I didn't mention this at the time, but I remember reading a few days ago that they were also carrying tympanometry tests at day 90. I found this somewhat surprising, as I personally consider this test to be somewhat dangerous to fully developed hair cells, nevermind developing ones. I wonder if they conducted it before or after they did the WR and audiogram tests.

 

[Tezcatlipoca]

Heartbroken.

 

[r34d1ng]

You should all take a break from Tinnitus Talk and researching info on Frequency Therapeutics or anything related to tinnitus. It is not doing you any good.

This is a massive setback, yes, but it is not the end of the line. Phase 2a was apparently biased and proved nothing. The drug is not dead yet by any means. Just wait until June for the full report on Phase 2a & Phase 1b and future plans.

 

[FGG]

I just can't get my head around how they had such solid pre-clinical evidence and the methodology is clearly far superior to other methods, e.g., transdifferentiation. It's interesting what @FGG mentioned about there being more LGR5+ support cells around IHCs than OHCs but then their pre-clinical work demonstrated efficacy in both.

It's possible in the in vivo cochlear environment, they target the area with more LGR5+ cells (i.e. inner row of inner hair cells) versus in culture.

 

[Born To Slay]

So guys, I'm a bit confused by all the comments saying everything from the Phase 2 showed FX-322 works as a single dose to having some people say flat out the drug is dead.

Can I get a summary of what actually happened?

 

[Rb86]

Word recognition as your sole measurement of efficacy is stupid anyway. Sure, it's a nice thing to improve on, but if the medicine outright improves your ability to hear higher frequencies, why not do a whole tone test of that? There's no faking it. You either hear it or you don't. They could do patterns and you replicate by pressing the button when you hear it.

 

[frpp]

Not necessarily. When I did my word score testing I said "I'm not sure" at several points and then my audiologist increased the decibel level so that I could hear it more clearly. I didn't have to actually come up with a different word.

This was for qualifying though, I'm not sure how they operated the WR trial at the testing centers. But if your audiologist was testing like mine, then faking your way into the trial at least would not have been difficult.

This is literally why the majority of this forum HATE audiologists. They are not doctors. They are not qualified human beings, nor qualified for anything other than being hearing aid salespeople. Going off this, any person on this forum could have ran this better than the audiologist you mentioned.

 

[Zugzug]

Not necessarily. When I did my word score testing I said "I'm not sure" at several points and then my audiologist increased the decibel level so that I could hear it more clearly. I didn't have to actually come up with a different word.

This was for qualifying though, I'm not sure how they operated the WR trial at the testing centers. But if your audiologist was testing like mine, then faking your way into the trial at least would not have been difficult.

Wow. When I read that, I thought you were just bashing audiologists in general. I never dreamed that would be related to the actual trial. That's insane.

 

[frpp]

You should all take a break from Tinnitus Talk and researching info on Frequency Therapeutics or anything related to tinnitus. It is not doing you any good.

This is a massive setback, yes, but it is not the end of the line. Phase 2a was apparently biased and proved nothing. The drug is not dead yet by any means. Just wait until June for the full report on Phase 2a & Phase 1b and future plans.

I agree, this is deflating to the highest degree. Time to take a news break. My mental health can't take much more of this for now.

 

[rid0871]

All of this has been nothing but smoke and mirrors. Now where is the HOPE?

Yesterday people were talking about a third trial starting, where did that come from?

 

[Aaron91]

Not necessarily. When I did my word score testing I said "I'm not sure" at several points and then my audiologist increased the decibel level so that I could hear it more clearly. I didn't have to actually come up with a different word.

This was for qualifying though, I'm not sure how they operated the WR trial at the testing centers. But if your audiologist was testing like mine, then faking your way into the trial at least would not have been difficult.

Jesus Christ.

The more I read these kind of stories the more I'm wondering whether audiologists have an ulterior motive to see this drug fail.

Frequency Therapeutics should be in complete control of the process from start to finish otherwise we will never know where we stand.

 

[WickedCarnival]

What are the odds that insiders from the hearing aid industry negatively influenced parts of the trial to turn it out negative? Like Slugworth from Willy Wonka but instead, convincing participants to lie for reward?

 

[FGG]

Jesus Christ.

The more I read these kind of stories the more I'm wondering whether audiologists have an ulterior motive to see this drug fail.

Frequency Therapeutics should be in complete control of the process from start to finish otherwise we will never know where we stand.

The only way to ensure reliable entry data in the EHF would be to only include the rare few patients that have long term EHF data.

In regards to word scores, I will be watching the severe group closely. Would be much harder to fake in that group.

 

[Sam99]

What are the odds that insiders from the hearing aid industry negatively influenced parts of the trial to turn it out negative? Like Slugworth from Willy Wonka but instead, convincing participants to lie for reward?

Let the conspiracy theories begin...

 

[Rajin]

Hopefully we get a cure for hearing loss soon.

It is about time.

This may just be a nice dip to invest and get some stock.

Have faith. It can still come back...

 

[Zugzug]

Maybe this is an absolutely nutty thing to say, but is it unreasonable to administer lie detecting tests with the hearing tests?

To be clear, the drug could have failed anyways. I'm not fully on the train of it only failed from lying. But this test seems, by nature, almost impossible to control without a test. If someone enrolls in the study, they are almost by default, desperate to get in and get the drug.

 

[Jurger]

The study failed and they kind of abandoned the product.

Decibel Therapeutics, Otonomy and maybe in the future Stanford Initiative to cure hearing loss. I remember it was either Stanford or Decibel Therapeutics that were criticizing Frequency Therapeutics for rushing things and trying to bring an unfinished product to the market, it seems that they were right after all.

The results were never officially published, but this is what the EU subsidy website (that financed the trial) says:

"Efficacy results demonstrated improvements in performance in several hearing tests in up to 35 % of patients, warranting further product evaluation."

A regenerative therapy for hearing loss | Result In Brief | CORDIS | European Commission (europa.eu)​

These results are better than what we have from FX-322 right now...

 

[Zugzug]

All of this has been nothing but smoke and mirrors. Now where is the HOPE?

Yesterday people were talking about a third trial starting, where did that come from?

Outcomes and decision making are not the same thing. I sure hope you don't live your life in such a way that doesn't involve probabilities of outcomes, but only retroactively basing things off of outcomes.

Actually, if anything, my non-outcome-based decision-making regret is not investing more. I went to bed last night wondering if I should have invested more.

What if it was a mega boom today? This is how life works...

 

[HootOwl]

Wow. When I read that, I thought you were just bashing audiologists in general. I never dreamed that would be related to the actual trial. That's insane.

I should clarify. My audiologist didn't know that this would be submitted as consideration for the FX-322 trial. It wasn't a deliberate withholding on my part - I was (and still am) in a really terrible mental state and just wanted to get in and out of that office as quickly as possible. So I simply asked for a WR test along with my audiogram.

Had he known it would be used as consideration for the trial, he might have done it differently. I can't say for sure.

For those unfamiliar with the recruitment process, the qualifying test is done through your own audiologist, then I believe a new baseline is conducted at the testing facility. But that first foot in the door is not standardized as far as I know.

 

[frpp]

The more I read these kind of stories the more I'm wondering whether audiologists have an ulterior motive to see this drug fail.

I wouldn't doubt it. I'm not a conspiracy theorist but this is highly likely. If you're making six figures and barely qualified to express canine rectal glands, and then something comes along threatening to take away your bread and butter, what would you do?

 

[NewLionel]

What are the odds that insiders from the hearing aid industry negatively influenced parts of the trial to turn it out negative? Like Slugworth from Willy Wonka but instead, convincing participants to lie for reward?

I'm going with the Slugworth theory, FX-322 isn't dead yet... something is on the way.

 

[Tezcatlipoca]

So where do we go from here? Which drugs do work and how far ahead in trials are they?