Frequency Therapeutics — Hearing Loss Regeneration

[Gb3]

@Gb3, did she also show improvements in the extended frequency tests where they test for sounds and not words?

"They" told me they improved in three frequency bands.

 

[Lucifer]

As in nothing at all happens in any individual? Then yeah, I would say it doesn't work or the delivery method is just atrocious considering it works in explants.

This sucks. I hope severe hearing loss participants show improvements. If severe hearing loss participants showed a bit of improvements, what would some of those little improvements be for them?

 

[Gb3]

@dan, now anecdotal reports aren't good enough for you. Isn't this what was stated in the Frequency Therapeutics interview on Tinnitus Talk Podcast that gave everyone hope?

 

[Lucifer]

"They" told me they improved in three frequency bands.

Ok so this is not word scores, this is actual improvements in the 3 frequency bands.

Do you know if the improvements for the 3 frequency bands were high, mid or low?

If she had positive results, I wonder if the Day 210 results will look even better. Maybe the patients will experience a similar thing to what she did.

I pray to God that severe hearing candidates show meaningful improvements which allow FX-322 to go to the pivotal phase early next year.

 

[mrbrightside614]

I feel so bad for everyone. This is obviously a major disappointment for various reasons and it's a massive delay, at minimum, to those of us who are just hanging on. But it is not a death knell.

@dan, I understand your skepticism. I understand your suffering. I understand the danger in believing in hope. Believe me, every single person on this forum just got the wind knocked out of them for the foreseeable future, and it feels like absolute shit. Just please hang on, everyone.

I pray to God

Me too bro, me too.

 

[FGG]

I'm so confused. How can someone have "stability" and lie about their screening scores to get in? Did they not include WR scores as a component of stability? Did they create a trail of lies (>=6 month session and screening)? This seems unlikely.

This is what the clinical trial inclusion criteria says

2. Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).​

Also, if the baseline scores were higher than screening, doesn't that sort of mean that there was less placebo cheating? In other words, they may have exaggerated to get in, but felt safe once in to do the baseline and rest of the tests correctly?

I can only speak from my trial interview but I only needed to show audiogram stability in the standard range over the longer term and then I had one extended audiogram from a few months prior to show them, too. I didn't qualify for other reasons (which I'm not going to lay out specifics for now especially obviously), though.

Word scores not being included in that because they just trusted people I guess was a huge mess up.

 

[Bambam0]

I listened to the entire webcast from this AM - it's here for those of you who haven't listened.

I'm the least intelligent person on this thread BUT F*** people, there are a few things that stand out after listening.

1. Remember that while they were measuring tinnitus, they aren't recruiting for it. How do we even know how many patients had it. What if there were only the two we've heard anecdotes from? Carl LeBel's answers about EHF audiogram and tinnitus were basically "we didn't get anything." Seemed very much an after thought. But it sounds like the entire Phase 2a data is pure trash. Not worried. Re: The FX-322-111 trial, it causes me a little concern but that was only 30 patients. Maybe not one had tinnitus.
2. They announced clinically significant results from the single-dose FX-322-111 trial that also came out today. Not from a previous trial.
3. They're moving forward with single-dose.
4. I bought 500 more shares.
5. Lucchino also mentioned they were combing 'social media' for conversations people were having about not being admitted to the trial based on not hitting the WR criteria.

I don't think this is dead at all. I'm long FREQ.

 

[Princebeyel]

"They" told me they improved in three frequency bands.

They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.

 

[Lucifer]

I feel so bad for everyone. This is obviously a major disappointment for various reasons and it's a massive delay, at minimum, to those of us who are just hanging on. But it is not a death knell.

@dan, I understand your skepticism. I understand your suffering. I understand the danger in believing in hope. Believe me, every single person on this forum just got the wind knocked out of them for the foreseeable future, and it feels like absolute shit. Just please hang on, everyone.

Me too bro, me too.

I'm still shocked that the Phase 2a trial was not successful. The irony is that we thought OTO-313 would fail due to the negative anecdote from someone on Tinnitus Talk, then out of the blue Otonomy posted that they had positive results.

I still believe FX-322 can succeed. We still don't know if the delivery method needs improving or spacing out the additional doses is required e.g. monthly.

If the severe hearing loss participants show improvement where they have improved in their frequency bands but also word scores then I see them going to the pivotal phase early next year.

Even if it's only 34% of participants improving like in the other Phase 1b trial, they can always fix the delivery method at a later date. They only need to do one trial. Why should they delay the pivotal phase even if it does not help with severe patients but works for those with mild and moderate hearing loss.

 

[dan]

You asked, I answered, you don't need to be a jerk; we're all in the same boat here.

I agree with your second statement, however, I believe in the PCA treatment. Science is trial and error. They aren't done.

Sorry, I apologize, I didn't mean it. Same boat, yes.

 

[reggie green]

I guess it's too early to email or call them to see what their next move is.

 

[FGG]

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

That's the thing that makes me really angry. The thought that say the drug worked, as Phase 1 showed, but enough people gamed the trial to get in. Infuriating beyond belief because a delay even could cost lives.

 

[Tezcatlipoca]

They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.

Please share the screenshots you posted a few months back, we really need them for a morale boost @Princebeyel.

 

[Gb3]

They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.

If I qualified for cochlear implants, I would get them.

 

[Lucifer]

They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.

If this person improved substantially with only two doses of FX-322 imagine if they got the doses monthly instead if it would have made the results better for them.

This goes to show that the drug works in it's current delivery method but surely they can make it better so it reaches deeper in the round window. How did this person experience improvements even though the Phase 2a trial failed with multiple doses.

Did this patient suffer from mild, moderate or severe hearing loss?

 

[dan]

Sooooooooooo... Are we waiting 10 more years for hearing regeneration?

 

[wwtsai]

That's the thing that makes me really angry. The thought that say the drug worked, as Phase 1 showed, but enough people gamed the trial to get in. Infuriating beyond belief because a delay even could cost lives.

I say this half jokingly, but they should offer Compassionate Use as a preventative measure from further gaming of future trials. If anything, doesn't this show just how far people are willing to go for some sort of relief?

 

[Tezcatlipoca]

Sooooooooooo... Are we waiting 10 more years for hearing regeneration?

We'll have real alternatives by 2025. I'm confident.

 

[FGG]

Sooooooooooo... Are we waiting 10 more years for hearing regeneration?

I hope not. It's not even like my life is stable in its suck. It just keeps getting worse and worse.

 

[FGG]

I say this half jokingly, but they should offer Compassionate Use as a preventative measure from further gaming of future trials. If anything, doesn't this show just how far people are willing to go for some sort of relief?

I doubt it but interesting thought.

 

[mrbrightside614]

I say this half jokingly, but they should offer Compassionate Use as a preventative measure from further gaming of future trials. If anything, doesn't this show just how far people are willing to go for some sort of relief?

I actually really like this solution... that's one hell of an uno reversal. If I get them on the Tinnitus Talk Podcast again I'll bring my deck.

**ethical disclaimer: don't weasel into clinical trials just to leverage compassionate use when you mess said trial up**

 

[dan]

We'll have real alternatives by 2025. I'm confident.

What year is it now? I've lost track lol.

Aaaaand in 2025 if I'm still around, if you're wrong, you owe me a 6-pack! Mmmm can't wait, free beeeeer...

 

[Jcmc]

Sooooooooooo... Are we waiting 10 more years for hearing regeneration?

I think it will take 20 years or more.

All these processes (preclinical and clinical trial phases) that it takes to test something to see if it works.

When you see that they can create a vaccine (COVID-19) in less than a year and put it on the market, you realize that everything is a bureaucracy that is only fast when it affects them.

 

[Lilah]

Is Frequency Therapeutics the only company involved in hearing loss regeneration?

 

[Lucifer]

That's the thing that makes me really angry. The thought that say the drug worked, as Phase 1 showed, but enough people gamed the trial to get in. Infuriating beyond belief because a delay even could cost lives.

I hope they can unbind the results and find out those who faked their results and those that didn't. I think Phase 2a can be salvageable if they can get rid of the fake hearing tests by the participants and see if the results look better. A long shot is that Day 210 results may look even better and may show improvements like the positive anecdote had.

@Gb3, do you know how long it took for him to know when he felt like he started to notice a difference in his hearing during the 5 months after he took his last dose of FX-322? When did he start to feel like he had some improvements in certain hearing bands and word scores?

Also just to add 5 months is roughly 152 days so there may be a chance that 210 days may show some meaningful improvements and Phase 2a can be salvageable and allow them to move on to the pivotal phase early next year.

 

[sensualmosquito]

I worry that my tinnitus will get worse over time. I hate that because of one event in my life I'll have to spend most or all of my 20s or more with this. Right now I can live with it but who knows what will happen later down the line. That really does scare the hell out of me. I'm scared that something loud, something bad will happen and it'll trigger a cascading escalation in symptoms.

I hope that their results were due more to an issue with their methods, not the drug itself. Or, at least, find out what isn't working and fix that.

I just don't want to live with this forever (and I'm lucky compared to some people. I can still live my life even with this frustrating condition).

 

[Bill Bauer]

There's no hope now, we're going to die with tinnitus.

What about Susan Shore's device? Isn't that the device that has actually made @kelpiemsp get over his tinnitus?

https://www.tinnitustalk.com/posts/416875/

 

[AliasM]

I have nothing worthwhile to add. I just want to say that I can absolutely see why they didn't announce results at the conference and I was afraid failure (somewhere along the line) may have been the reason why.

 

[frpp]

That's the thing that makes me really angry. The thought that say the drug worked, as Phase 1 showed, but enough people gamed the trial to get in. Infuriating beyond belief because a delay even could cost lives.

10000% it's effed if the trial got screwed due to selfish people trying to game the system.

 

[kiki]

We'll have real alternatives by 2025. I'm confident.

What is the alternative?

Is FREQ involved?