Frequency Therapeutics — Hearing Loss Regeneration

[RichieTheKid]

Something I'm wondering about is synapses. What if FX-322 on its own may not show statistical improvements as much as a combination of hair cell and synapse restoration? I may be wrong but I'll wait for the smart guys to get on this.

Anyone think this is a valid point? I'm honestly just wondering if most people with hearing loss have synapse damage too and for more statistical improvements both would be needed?

 

[annV]

I'm still so pissed off that people faked word scores to get in the trial.

People also faked stuff to get into the AM-101 and AUT00063 trials.

When you suffer a certain amount, it clouds some people's judgment and can't see the harm they're doing.

 

[MadsWithT]

• "When you seed the lawn, stay off the gras" - overdosing
• "We believe in the technology"
• "Additional studies"
• "People lowered their word recognition score to get into the study" - serious bias introduction
• "Multiple injection created unfavourable environment in the ear"
• "Minor adverse events"
• "More injections - more adverse events"
• "Mitigation - more accurate measures"
• "Lack of efficacy" -
• "2 datasets show improvements" - other studies

Serious presentation - The company seems trustworthy.

The German stock guy was right.
If Frequency Therapeutics gets FX-322 to work, it will take at least 10 years.

 

[Piet]

It still works, just multi-dosing doesn't give more additional benefits. Not the result we wanted but still improvement in WR scores across all groups. Heading only with a single injection will also reduce trial times and FX-322 might even get to the market quicker. It is still positive news so I don't know why people are freaking out about it.

And also I'm very curious about the extended audiograms. Anybody has info on that?

 

[FGG]

Anyone think this is a valid point? I'm honestly just wondering if most people with hearing loss have synapse damage too and for more statistical improvements both would be needed?

That's apparently not the problem they encountered. Apparently, the placebo group also improved word scores and their audiologist consultant said flat out it's because he believes many people faked worse word scores to get in the trial.

 

[r34d1ng]

They are saying that they are pretty sure that people faked their inclusion as they found inconsistencies when analyzing the data. So results are most likely biased and garbage.

Phase 2a is officially ruined.

 

[Gee82]

What a nightmare. I was dreaming good results would open up the chance for compassionate use, but now... Do you guys think it's still worth approaching Frequency Therapeutics for it?

 

[FGG]

People also faked stuff to get into the AM-101 and AUT00063 trials.

When you suffer a certain amount, it clouds some people's judgment and can't see the harm they're doing.

I know .

I saw once on this site even a while ago someone saying "just fake your word scores" and I was like "no, please God don't do that..." I get it people want to end their suffering and that puts priority over others but they may have delayed treatment for themselves and everyone else now too.

 

[Gabriel5050]

I'm still so pissed off that people faked word scores to get in the trial. I realize people want a solution and are desperate but it's so selfish and if they end up being required to re-run Phase 2 as a result with more long term word score results, and it delays everything that's literally on them.

My hope is the severe group alone (which is much harder to fake word understanding) allows this to go pivotal.

Absolutely agree. But I'm the kind of person who loses sleep over way smaller lies. But think about this. The need for a treatment for hearing loss / tinnitus / hyperacusis is so unmet - that people are truly desperate. Speaks a lot about how neglected hearing is in medicine.

 

[Paulmanlike]

Still need information about:

• Extended hearing loss frequencies
• Tinnitus

First of I'm gutted for the patients like myself who very much wanted a solution to their tinnitus.

I lost nearly all of my savings. I knew the risks.

 

[Jack Straw]

Just my two cents here, I think everyone is focusing too much on the headlines rather than the details.

• Their single dose seems to be statistically significant at increasing word scores. Does this not matter to anyone? This may help a lot of people's tinnitus since it is regenerating some form of hearing.
• There may be an issue with the delivery method of the drug. Maybe they need to figure out a new method to get it in there.
• Their timing of administering the drugs seems to have been too short. With extended periods between administering the drug, the results may improve.
• Lastly, they even said the trials had biases and issues. This means we literally can't use this data. We need to wait for them to redo it. Does this suck? Yes! But at least it doesn't mean this is over.

On another note:

"Patients, our subjects, they desperately need hearing solutions," said Kevin Franck, Ph.D., senior vice president of strategic marketing and new product planning. "When we communicated there were entry criteria of a depressed word score, we may have induced an unconscious bias in subjects who wanted to get into the trial."​

He's saying he thinks some people faked word scores to get into the trial and may have muddied the results. If so, fuck those people...

If anyone has the opportunity to get in, PLEASE don't be a scumbag fucking piece of shit asshole dickhead cunt and try to wiggle your way into a study, or any study for that matter, if you don't qualify. Assholes like this have cost us significantly more time to get some type of treatment. We are all desperate for something, but this is HURTING people more than helping and is extremely selfish. Ultimately drug trials are not about you, it's about getting the drug out for everyone.

Lastly, we have other options for treatments like Lenire (hopefully improving), Susan Shore, and other drugs on the way. Just keep truckin' and we will get there eventually.

Money is the catalyst for innovation and BOOOOIIIIIIII there is a shit load of money going to whoever figures this hearing loss shit show out.

Keep on truckin'...

 

[Kam75]

So the results of Phase 2a are not good?

And as if that wasn't enough, we learn that some assholes deliberately lied about word recognition to be able to participate in the tests while millions of people around the world suffer from hearing problems?

Well, that's great news...

 

[r34d1ng]

Multiple doses in four weeks were "too much, too soon."

 

[Whice]

Seems they're better off injecting one person and one ear at a time and comparing the treated ear to the 'good' or placebo ear — in the same person. Averaging treated populations to placebo populations over time with the advertisement of 'you need poor word scores' — which was well known in this forum — caused the bias.

 

[ploughna]

That's apparently not the problem they encountered. Apparently, the placebo group also improved word scores and their audiologist consultant said flat out it's because he believes many people faked worse word scores to get in the trial.

But that means those that got the drug equally faked their scores, so all the data across all groups is suspect, not just that of the placebo recipients.

 

[tommyd87]

That's apparently not the problem they encountered. Apparently, the placebo group also improved word scores and their audiologist consultant said flat out it's because he believes many people faked worse word scores to get in the trial.

They referred to this expressly when they stated that the comparisons made between historical word scores and word scores in the trials tended to not match. I think that this is a pretty clear indication of faking to participate.

 

[Zugzug]

That's apparently not the problem they encountered. Apparently, the placebo group also improved word scores and their audiologist consultant said flat out it's because he believes many people faked worse word scores to get in the trial.

Sigh.

This is something that never even crossed my mind. We have been so focused on the fact that "effort" can't will people to hear words. We (at least I didn't) even think about the reality.

There's a 75%, by enrolling in the study, of receiving the drug. There's a lower percentage chance of the drug clearing the finish line. Also, time and desperation.

If someone was sinister enough to do this, the motivation is there. There's actually a lot of good faith belief in humanity to not do this.

I still stand by the fact that doubling words scores doesn't make any sense at all by chance.

It horrifically sucks because there are two competing issues. The drug probably helps people with moderate hearing loss more than severe, but it's easier for moderate people to be subjected to this conscious or unconscious bias. They are going to need a new design and a new delivery method. Extremely unfortunate.

 

[arcanesystem]

So, I'm trying to understand correctly what happened. It wasn't so much an issue with multi-dosing itself but spacing out the doses in such a short period of time which precipitated overdosing? That and the response bias.

I'm also curious to hear about any tinnitus-related results.

 

[Aaron91]

Not a single question yet about secondary endpoints. So frustrating.

 

[Sam99]

That's apparently not the problem they encountered. Apparently, the placebo group also improved word scores and their audiologist consultant said flat out it's because he believes many people faked worse word scores to get in the trial.

I am not sure but I read somewhere on this thread that perhaps the placebo clears the round window or something like that which improved their hearing?

 

[FGG]

Not a single question yet about secondary endpoints. So frustrating.

To be honest, if they faked word scores I think people could increase their TFI/THI too if they thought it would help them be selected for the trial. The only data on that that would be reliable would be the anecdotal data from the patent (before people knew tinnitus would be measured).

 

[r34d1ng]

They have observed no changes in tinnitus, though they don't have the full data yet.

 

[Piet]

They just answered questions about tinnitus and extended frequencies. No significant changes from the baseline observed. It's also too early to speculate what seems fair and they have data missing.

 

[FGG]

I am not sure but I read somewhere on this thread that perhaps the placebo clears the round window or something like that which improved their hearing?

Absolutely not. The round window doesn't get "dirty".

 

[d'Wooluf]

So they designed a study where everything was blinded to the nth degree but indicated to prospective subjects that they were looking for low word recognition scores - something that was within the conscious or unconscious control of the prospective subjects.

How clever was that?

 

[Aaron91]

No changes observed in the EHF audiogram, which was the thing I was still holding out for - either in Phase 2 or new Phase 1 study. This tells me the delivery issue argument no longer holds.

I think we have to accept that, for whatever reason we don't understand, this drug just doesn't work in humans in vivo.

I'm soul destroyed. No idea where we go from here. This is as good as over.

 

[asey20]

Unfortunately these are about the results I expected... It's not all bad news though!

 

[Philip83]

Still need information about:

• Extended hearing loss frequencies
• Tinnitus

First of I'm gutted for the patients like myself who very much wanted a solution to their tinnitus.

I lost nearly all of my savings. I knew the risks.

They stated in the webinar; no observed changes in tinnitus from baseline in Phase 2a, although they only had data from one patient for some reason, as I understood it.

The really bad part though that came up was that there were no improvement in the high frequency range in the single dose Phase 1b study. This sucks really bad imo.

 

[Pharz]

I cannot believe someone would fake their way into a study. I am frustrated.

The only factor that improved in that study was WR, and that is not even reliable.

 

[Aaron91]

So they designed a study where everything was blinded to the nth degree but indicated to prospective subjects that they were looking for low word recognition scores - something that was within the conscious or unconscious control of the prospective subjects.

How clever was that?

Completely retarded.