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Frequency Therapeutics — Hearing Loss Regeneration

#15,543
Diesel said:
We'll see how they respond in the webinar at 8.30. They're going to disclose their interpretation. The stock will still not recover until there is a Phase 3 announced.
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What's the likelihood that they can still go to the pivotal phase early next year using one dose of FX-322? I feel like they should be able to go to the pivotal phase even though additional doses did not work but they have proved it again that one dose of FX-322 works. It will be a shame if they will be forced to repeat a Phase 2a where they have already shown one dose of FX-322 works.

If both trials this year are positive with one dose of FX-322, they should be able to go to the pivotal phase early next year. Why delay it if it's already been proven that one dose of FX-322 works and it's safe.
 
#15,544
Delivery was a total flop.

Still seeing odd things like word score doubling.

It's a bad sign that they aren't revealing more details.

The results are underwhelming, which was the worse case scenario. The drug still works, just that round window diffusion appears to be a Stone Age method.
 
#15,545
Zugzug said:
Delivery was a total flop.

Still seeing odd things like word score doubling.

It's a bad sign that they aren't revealing more details.

The results are underwhelming, which was the worse case scenario. The drug still works, just that round window diffusion appears to be a Stone Age method.
Click to expand...
I would not be taking too much notice of the content and/or the detail delivered in one of those releases. They are almost all actually usually succinct and direct in the information in which they provide and don't seem to go into detail.
 
#15,546
#15,547
Zugzug said:
Delivery was a total flop.

Still seeing odd things like word score doubling.

It's a bad sign that they aren't revealing more details.

The results are underwhelming, which was the worse case scenario. The drug still works, just that round window diffusion appears to be a Stone Age method.
Click to expand...
They can still proceed past this Phase 2A. They learned that a multi-dose across 1 week didn't show any efficacy. That means the Pivotal Phase can be a single dose design with 90-day follow-up. Might actually be quicker.

Now for recruiting... fuck... I'm not sure what they'll need to do.

I agree with what some have said... let's wait for the full trial data to be released.

This also validates that the delivery method is the problem, not the drug.
 
#15,548
r34d1ng said:
As per this interview:

"It's fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future," he added.
Click to expand...
Could this lowkey mean a pivotal phase with a single dose of FX-322 could still be happening early next year if the results for their other trials this year are positive?
 
#15,549
Diesel said:
They can still proceed past this Phase 2A. They learned that a multi-dose across 1 week didn't show any efficacy. That means the Pivotal Phase can be a single dose design with 90-day follow-up. Might actually be quicker.

Now for recruiting... fuck... I'm not sure what they'll need to do.

I agree with what some have said... let's wait for the full trial data to be released.

This also validates that the delivery method is the problem, not the drug.
Click to expand...
Fuck this is actually good for us, if it is a single dose for the pivotal phase it will be much quicker to come out in the market. You are right, that is a positive.
 
#15,550
"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."​

This is something I've been thinking about before. How can they keep desperate people from faking a bad word score to get into the trials?

I know that you needed a standard audiogram to match with one from 6 months ago to assure stable hearing loss, but the word score seems more problematic?
 
#15,551
More interesting quotes from Frequency Therapeutics regroups as hearing loss med falls short in phase 2:
  • "It's some of the first evidence we've got to indicate that maybe hitting the ear once a week for four consecutive weeks with these materials is just dampening the ability of the ear to demonstrate the benefit on could get from FX-322," LeBel said.
  • "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."
 
#15,553
Lucifer said:
Could this lowkey mean a pivotal phase with a single dose of FX-322 could still be happening early next year if the results for their other trials this year are positive?
Click to expand...
It looks like the two Phase 1b studies matter quite a lot now.
 
#15,554
Diesel said:
They can still proceed past this Phase 2A. They learned that a multi-dose across 1 week didn't show any efficacy. That means the Pivotal Phase can be a single dose design with 90-day follow-up. Might actually be quicker.

Now for recruiting... fuck... I'm not sure what they'll need to do.

I agree with what some have said... let's wait for the full trial data to be released.

This also validates that the delivery method is the problem, not the drug.
Click to expand...
It seems they're going to do another Phase 2. Here's what Carl LeBel said:

"It's fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future"​

I'm wondering also if this is our fault. We hyped this drug up so much throughout the hearing loss community. Here's what Kevin Franck had to say:

"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."​
 
#15,555
Philip83 said:
"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."​
This is something I've been thinking about before. How can they keep desperate people from faking a bad word score to get into the trials?

I know that you needed a standard audiogram to match with one from 6 months ago to assure stable hearing loss, but the word score seems more problematic?
Click to expand...
Yeah, I read that... if there is some validity that some patients faked their word scores to get drugs... that is really screwed up.
 
#15,556
r34d1ng said:
As per this interview:

"It's fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future," he added.
Click to expand...
"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...
 
#15,558
r34d1ng said:
More interesting quotes from Frequency Therapeutics regroups as hearing loss med falls short in phase 2:
  • "It's some of the first evidence we've got to indicate that maybe hitting the ear once a week for four consecutive weeks with these materials is just dampening the ability of the ear to demonstrate the benefit on could get from FX-322," LeBel said.
  • "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."
Click to expand...
So is the delivery method or the weekly dosing the problem?
 
#15,560
FGG said:
"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...
Click to expand...
I agree... I wrote it but I deleted it... W T -actual - F.
 
#15,563
Aaron91 said:
It seems they're going to do another Phase 2. Here's what Carl LeBel said:

"It's fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future"​

I'm wondering also if this is our fault. We hyped this drug up so much throughout the hearing loss community. Here's what Kevin Franck had to say:

"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."​
Click to expand...
Fuck, I feel like if the one dose of FX-322 clinical trials are positive, they should be able to go to the pivotal phase early next year without having to repeat Phase 2a.
 
#15,566
The first injection helped. It's just that subsequent ones didn't. Doesn't sound that bad to me. Better than the first one not helping at all. I'll take one dose, please, if you all don't mind.
 
#15,567
FGG said:
I'm the opposite. It would be much harder to fake word scores if you were in the severe category.
Click to expand...
I agree, but I'm worried that severe hearing loss results might not look as good as mild-moderate hearing loss, but if the results show that severe hearing loss also had improvements as well, this would be good and prove that FX-322 works.
 
#15,569
Gabriel5050 said:
The first injection helped. It's just that subsequent ones didn't. Doesn't sound that bad to me. Better than the first one not helping at all. I'll take one dose, please, if you all don't mind.
Click to expand...
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.
 
#15,570
By the way, they observed a significant higher rate of adverse events in higher injections cohorts. Phase 2a single injections were safer, but were also found to have more adverse events compared to Phases 1/1b/1-2 single injections.

They just said that multiple dosing is not a viable option, literally.
 

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