Frequency Therapeutics — Hearing Loss Regeneration

[asey20]

Facebook posts like that are exactly why people in trials sign NDAs. Just because probability says he likely got at least one shot does not mean he got at least one shot.

A successful trial will include persons who were successfully treated from the drug and persons unsuccessfully treated from the placebo.

Of course there are a lot of factors here to consider. We don't know how many shots of FX-322 he has gotten. We also don't know the time it takes for the drug to work and everyone may be different in the duration it takes to see improvements. It seems like he just recently finished receiving the last shot and hasn't yet completed testing. This means he could've received all placebo except for the last shot being FX-322, but that the drug hasn't had enough time to act yet.

This still doesn't change the fact that 75% of participants will receive the FX-322 drug in some dosage. Again, who knows. Maybe four doses is required and that 25% of participants will experience huge gains. Impossible to tell until the trial is over.

Still, this person hasn't seen improvements yet. Even though we don't know the reason why, I'm sure we would all be jumping in joy if someone reported huge improvements because that would indicate that the drug works. Even then, it could be the placebo effect. This is nothing to get down about and we can't really be disappointed until the trial is over and we know the results. It's just that people would rather hear about it working really well for that person.

 

[serendipity1996]

Is he even allowed to post that on Facebook...?!

 

[FGG]

Hi there - so is this thought to be bad news from a development perspective (independent of timelines)? Is there scope for them to modify a trial mid-trial in order to improve results if they don't look good?

They have said the delay is related to a recruitment delay due to COVID-19. Nothing about the trial has changed.

 

[Gb3]

Has anyone participated in the FX-322 clinical trials? Do you sign an NDA or not? What are the consequences if you do release information?

 

[Born To Slay]

Of course there are a lot of factors here to consider. We don't know how many shots of FX-322 he has gotten. We also don't know the time it takes for the drug to work and everyone may be different in the duration it takes to see improvements. It seems like he just recently finished receiving the last shot and hasn't yet completed testing. This means he could've received all placebo except for the last shot being FX-322, but that the drug hasn't had enough time to act yet.

This still doesn't change the fact that 75% of participants will receive the FX-322 drug in some dosage. Again, who knows. Maybe four doses is required and that 25% of participants will experience huge gains. Impossible to tell until the trial is over.

Still, this person hasn't seen improvements yet. Even though we don't know the reason why, I'm sure we would all be jumping in joy if someone reported huge improvements because that would indicate that the drug works. Even then, it could be the placebo effect. This is nothing to get down about and we can't really be disappointed until the trial is over and we know the results. It's just that people would rather hear about it working really well for that person.

It's be pretty much impossible for it to be placebo effect. As Carl said, you either hear or you don't.

 

[FGG]

Of course there are a lot of factors here to consider. We don't know how many shots of FX-322 he has gotten. We also don't know the time it takes for the drug to work and everyone may be different in the duration it takes to see improvements. It seems like he just recently finished receiving the last shot and hasn't yet completed testing. This means he could've received all placebo except for the last shot being FX-322, but that the drug hasn't had enough time to act yet.

This still doesn't change the fact that 75% of participants will receive the FX-322 drug in some dosage. Again, who knows. Maybe four doses is required and that 25% of participants will experience huge gains. Impossible to tell until the trial is over.

Still, this person hasn't seen improvements yet. Even though we don't know the reason why, I'm sure we would all be jumping in joy if someone reported huge improvements because that would indicate that the drug works. Even then, it could be the placebo effect. This is nothing to get down about and we can't really be disappointed until the trial is over and we know the results. It's just that people would rather hear about it working really well for that person.

The way dosing is set up, 75% get the drug with the first dosing. No one gets 3 placebo shots and then the drug last. By the final dosing, only 25% of people are getting the drug and they were the ones who got 3 other doses.

Anyway, 1 in 4 is not even close to rare or even very unlikely. I also tend to think people who didn't improve would care less if they influence the trial or recruitment in some way or ignore their NDA.

In other words, I could see there being a reporting bias towards the negative.

But it's also worth nothing just how much people overvalued single anecdotes, too. I'm not immune either. I felt reasonably sure OTO-313 was going to post bad results based on the fact that a member here worsened (and felt sure he got the drug). But then it came out that the adverse events were in the placebo group which means he likely got placebo and Otonomy posted good results with their drug for acute tinnitus after all.

The opposite happened with Audion. A friend of a forum member supposedly relayed that it cured his tinnitus and hyperacusis and he was able to tour as a musician again. Meanwhile, the CEO of Audion was completely unexcited about the drug and it sounds like they are reformulating the drug and never even posted any of their findings.

Lenire is different because data was pooled together on an aggregate of Tinnitus Talk members. If we had something like that for Frequency Therapeutics, I would find that credible. Of course, by then Phase 2 results would be out anyway (unlike Lenire who hasn't published anything like that).

 

[Rubenslash]

What's the time frame between the different shots?

 

[Lucifer]

What's the time frame between the different shots?

A week.

 

[NewLionel]

That's very discouraging...

I didn't need to start the week reading that.

 

[all to gain]

View attachment 40445

How come he's talking about it?

And how do we know he's not just bullshitting (for whatever reason)?

 

[Lucifer]

How come he's talking about it?

And how do we know he's not just bullshitting (for whatever reason)?

The likelihood of him bullshitting is quite low. I was talking to @Gb3 the other day asking him if he had more info about the poster and he was telling me that the guy who posted about getting the FX-322 shots had been in a Facebook chat group since October 2017 so I don't think he's lying.

I have a feeling his 4 shots were all placebo. The likelihood of the drug doing nothing is quite low.

 

[DebInAustralia]

How come he's talking about it?

And how do we know he's not just bullshitting (for whatever reason)?

Because I had a lengthy conversation with him today. I don't believe he's making it up.

 

[all to gain]

The likelihood of him bullshitting is quite low. I was talking to @Gb3 the other day asking him if he had more info about the poster and he was telling me that the guy who posted about getting the FX-322 shots had been in a Facebook chat group since October 2017 so I don't think he's lying.

I have a feeling his 4 shots were all placebo. The likelihood of the drug doing nothing is quite low.

I hope he did get the placebo.

How long ago did he get the shots? Maybe if he did get the real thing it hasn't had time to work?

 

[Lucifer]

I hope he did get the placebo.

How long ago did he get the shots? Maybe if he did get the real thing it hasn't had time to work?

I'm not sure.

@DebInAustralia could you give us more details on when he got the shots and what day was his last FX-322/placebo shot so we can figure out if he may still benefit from it? I remember that you can still benefit from the FX-322 up to 3 months.

 

[DebInAustralia]

I'm not sure.

@DebInAustralia could you give us more details on when he got the shots and what day was his last FX-322/placebo shot so we can figure out if he may still benefit from it? I remember that you can still benefit from the FX-322 up to 3 months.

He had his last shot at the end of June.

"Yes they said changes could happen up to 3 months from injection. My first one was on June 5th and I was injected every Friday in June."

Yes, he said he'd been told that he could still get some benefit at 3 months.

 

[xyz]

Now we have two anecdotes of not improving. Hopefully there will also be some positive leaks.

 

[Diesel]

He had his last shot at the end of June.

"Yes they said changes could happen up to 3 months from injection. My first one was on June 5th and I was injected every Friday in June."

Yes, he said he'd been told that he could still get some benefit at 3 months.

Who cares if he got placebo or not; I'm just happy to see they're getting people enrolled.

Also, as it relates to tinnitus and hearing loss... if you're going to bring up an anecdote; they should share their audiogram and describe/tone-match their tinnitus... Everyone's situation is completely different as it relates to both; and many have speculated that FX-322 (if they actually got the drug) may not help all cases of tinnitus in the first-go-round.

 

[Rubenslash]

Now we have two anecdotes of not improving. Hopefully there will also be some positive leaks.

What's the other one?

 

[GlennS]

But, they could also have received placebo.

They should probably tell participants after the trial is over whether it was placebo or not, otherwise if they aren't under NDA then these anecdotes could make them look worse than they should.

 

[tarmaced]

So at a random sample this would be 1/4 for two to get placebo.

But in my head people who it works for are more likely to stay quiet. They got what they wanted, so go with the NDA and don't make trouble, right?

So I don't think this is representative.

 

[asey20]

Now we have two anecdotes of not improving. Hopefully there will also be some positive leaks.

I believe there was but it was removed as unconfirmed from this thread. Can't give anymore details though, as I do not know.

 

[UHPTS]

View attachment 40445

I wonder if Tim Dunphy would agree to have his private message published on this forum.

 

[FGG]

Who cares if he got placebo or not; I'm just happy to see they're getting people enrolled.

Also, as it relates to tinnitus and hearing loss... if you're going to bring up an anecdote; they should share their audiogram and describe/tone-match their tinnitus... Everyone's situation is completely different as it relates to both; and many have speculated that FX-322 (if they actually got the drug) may not help all cases of tinnitus in the first-go-round.

I mean, he already publicly gave his name, so a before and after audiogram wouldn't reveal anything new about his identity. And I agree, he should tone match his tinnitus too.

Edit: or was that a private message that someone posted?

 

[asey20]

Yes, he said he'd been told that he could still get some benefit at 3 months.

Was looking on the web and found this:

A study among Australians who received a cochlear implant shows that speech perception improves markedly within a few months.

Adult cochlear implant recipients with a severe or profound hearing loss show marked improvements in their speech perception with a cochlear implant, an Australian study finds.

The study found rapid improvement in speech perception by 3 months and continuing improvement over 12 months after the cochlear implantation.

I'm sure this is the same with the regenerative drug approach. Seems like a full 3 months should be given before making any assumptions and conclusions. Even then, improvements probably can be seen after a year and more as the brain adjusts.

The best course of action is to just wait until the trials are done and see the results. Don't bother getting your hopes down until then!

Source: https://www.hear-it.org/speech-perception-improves-rapidly-cochlear-implants

 

[Diesel]

So at a random sample this would be 1/4 for two to get placebo.

But in my head people who it works for are more likely to stay quiet. They got what they wanted, so go with the NDA and don't make trouble, right?

So I don't think this is representative.

Totally agree. This is no different to Product/Service Review Bias where most often, people that give feedback which is typically negative, already have an axe to grind. Without more data, proof, or evidence, outside of an inappropriately shared screenshot; there's nothing tangible to draw any conclusion from...

 

[NewLionel]

Last week: FX-322 could be out next year.
This week: FX-322 doesn't even work.

"YOU ARE TEARING ME APART FX-322"

 

[Zugzug]

Are we overthinking this?

1) 1/4 chance of placebo is extremely high.
2) Even if it is the drug, it's not like it's going to help everyone. For reference, let's say it helps 50% of people with tinnitus (which is a lot, considering there are no other treatments). Then the probability of entering the trial and not seeing improvement is essentially
P(placebo) + P(drug)*P(no improvement, given drug) = 1/4 + 3/4 * 1/2 = 5/8 = 62.5%.
3) No way someone who is under NDA and enjoying the drug would muddy the results. They probably want it out and marketed ASAP.

I think FX-322 will very clearly be better than nothing, but it certainly won't end tinnitus.

 

[xyz]

What's the other one?

I think @tommyd87 had a contact who reported no improvements.

 

[serendipity1996]

Also if the drug is currently showing most benefit in the UHF regions, any differences may not be all that detectable by the person receiving the drug I'm guessing?

 

[patorjk]

What's the other one?

There were 2 unconfirmed reports that were posted to this forum last week. One positive and one negative. Both were deleted for being unconfirmed.

Single data points don't mean much on their own because we don't know if the person got the placebo or not. It's the data as a whole that will matter and we won't have that until next year.