Frequency Therapeutics — Hearing Loss Regeneration

[leledany]

I mentioned FX-322 to my ENT today. He said his co-worker at another location is running the trial in my area and offered to set up a meeting to discuss.

I'm technically not qualified as I have diagnosed hearing loss for only 4.5 months. (You need at least 6). But, we'll see.

I'm VERY cautious as I don't think I could emotionally handle getting worse.

In theory FX-322 should not make your tinnitus worse as the first phase ascertained the safety profile.

 

[Lucifer]

Has anyone given the clinical trial centers a ring to sign up for the trial?

 

[ChrisBoyMonkey]

Has anyone given the clinical trial centers a ring to sign up for the trial?

They may not be ready actually. I noticed all of them have the same number. I might try to call it during the weekday, I've got some questions for them.

 

[dmorg]

I applied last phase(1b) and was denied. Unfortunately for me, the same parameters apply this time (stable sensorineural loss, not me) so I won't qualify. It would be nice just to hear that some folks around here are actively participating in their recovery and know that at some point in the future we could discuss their experiences/results.

Doesn't help me now, but it's pretty cool to think that soon some people soon may be walking around with significantly improved hearing and can pack away their hearing aids (and tinnitus).

 

[Lucifer]

They may not be ready actually. I noticed all of them have the same number. I might try to call it during the weekday, I've got some questions for them.

I noticed that too. Let us know what they say when you call them.

 

[ajc]

It would be nice just to hear that some folks around here are actively participating in their recovery and know that at some point in the future we could discuss their experiences/results.

All of the trial participants have to sign non-disclosure agreements; they can't talk about their participation in the trial on the internet or anywhere else.

 

[Lucifer]

All of the trial participants have to sign non-disclosure agreements; they can't talk about their participation in the trial on the internet or anywhere else.

Well they can if they do it privately while making sure the other person keeps it to themselves.

 

[bell]

Has anyone given the clinical trial centers a ring to sign up for the trial?

I wrote to Astellas as a candidate in case they were doing clinical trials in Europe, and they emailed me saying that they were not aware of any trials of FX-322 in Europe...

 

[Daniel Lion]

All of the trial participants have to sign non-disclosure agreements; they can't talk about their participation in the trial on the internet or anywhere else.

Do you think they would let the placebo patients have a go on completion of the testing? Do you know what the protocol is like concerning this question and clinical trials?

 

[ajc]

Do you think they would let the placebo patients have a go on completion of the testing? Do you know what the protocol is like concerning this question and clinical trials?

It isn't clear what Frequency's policy is, seems it's not published online. Auris Medical let AM-101 clinical trial participants who had initially received placebo get the real thing at the end of the trial.

So it is possible Frequency might allow it, but it's not guaranteed, as not all clinical trials allow it.

 

[Daniel Lion]

It isn't clear what Frequency's policy is, seems it's not published online. Auris Medical let AM-101 clinical trial participants who had initially received placebo get the real thing at the end of the trial.

So it is possible Frequency might allow it, but it's not guaranteed, as not all clinical trials allow it.

Thanks.

 

[Jurger]

I wrote to Astellas as a candidate in case they were doing clinical trials in Europe, and they emailed me saying that they were not aware of any trials of FX-322 in Europe...

It doesn't make sense for Astellas to do a separate Phase 2 trial. What's the benefit? They're trying to figure out dosing now and for that one trial is enough.

The only scenario I can think of is a international Phase 3 trial for FX-322 in the US, EU and some Asian countries concurrently. And you don't even need that to get the drug approved, at least in the EU. You can use American trials as grounds for drug approval in the EU. I think it's the same the other way around.

 

[Caveman]

I wrote to Astellas as a candidate in case they were doing clinical trials in Europe, and they emailed me saying that they were not aware of any trials of FX-322 in Europe...

If they did clinical trials in Europe, would they be obliged to go through phase I again?

 

[Lucifer]

If they did clinical trials in Europe, would they be obliged to go through phase I again?

Probably not but I wonder if it's possible for Astellas to release the drug before Frequency Therapeutics.

 

[ChrisBoyMonkey]

It doesn't make sense for Astellas to do a separate Phase 2 trial. What's the benefit? They're trying to figure out dosing now and for that one trial is enough.

The only scenario I can think of is a international Phase 3 trial for FX-322 in the US, EU and some Asian countries concurrently. And you don't even need that to get the drug approved, at least in the EU. You can use American trials as grounds for drug approval in the EU. I think it's the same the other way around.

True. It doesn't matter where it's done, what matters is the results.

 

[JohnAdams]

True. It doesn't matter where it's done, what matters is the results.

 

[Heinrich_S7]

View attachment 32394

John are you going to try to get in the trials?

I'm hoping Canada doesn't have as much of a stick up its butt for approval after the US gets it.

 

[Jurger]

If they did clinical trials in Europe, would they be obliged to go through phase I again?

You can use American trial data for approval in Europe. I think that's the law in most countries. Otherwise you'd have to do a lot of trials in different countries to get worldwide approval.

Having said that, approval in Europe will probably go faster if Phase 3 design is also approved by the EMA. So I can imagine an international trial that's approved by both the FDA and EMA, with Astellas running the European part of Phase 3.

 

[JohnAdams]

John are you going to try to get in the trials?

I'm hoping Canada doesn't have as much of a stick up its butt for approval after the US gets it.

I have a "normal" audiogram. I wouldn't be admitted to the trial.

 

[Staceyyy]

Is anyone considering trying to get into these clinical trials? I seem to meet the criteria but I am also nervous it may make my situation even worse. I've reached out to a clinic, so I guess I will just wait and see what they say. Hopefully I can talk to an actual person and get more info about the clinical trial.

 

[Caveman]

I have a "normal" audiogram. I wouldn't be admitted to the trial.

Maybe you could try to get in the ongoing OTO-413 trial... have you got hidden hearing loss?

 

[Staceyyy]

Has anyone given the clinical trial centers a ring to sign up for the trial?

I did receive an email with the specific phone number and address to the clinic. I left a message. I am waiting for them to call me back.

 

[JohnAdams]

Maybe you could try to get in the ongoing OTO-413 trial... have you got hidden hearing loss?

 

[JohnK]

I have a "normal" audiogram. I wouldn't be admitted to the trial.

Same problem. I don't have hearing loss until 12 kHz or so.

 

[Caveman]

Same problem. I don't have hearing loss until 12 kHz or so.

Is faking a -30 dB audiogram so difficult?

 

[FGG]

Is faking a -30 dB audiogram so difficult?

Please don't do this. This could confound results and prevent the drug from even being released if enough people muddy results in this way.

Besides, I would imagine you need documented unchanged audiograms over a longer time frame anyway to be included.

I talked to someone today who said a normal 250-8000 Hz audiogram is not necessarily an exclusion if you have documented consistent hearing loss at 12000 Hz, you may also qualify depending on your medical history. I set up a meeting to find out if I do.

 

[JohnAdams]

Here's something stupid. Why can't they do multiple trials at the same time?

 

[F-u-T]

Probably not but I wonder if it's possible for Astellas to release the drug before Frequency Therapeutics.

Maybe in Europe or other countries.

Here's something stupid. Why can't they do multiple trials at the same time?

Because that would be too easy!

 

[Jurger]

Here's something stupid. Why can't they do multiple trials at the same time?

What would you propose to do? They have to figure out dosing first. They can't run a Phase 2b concurrently because that usually involves the highest dose of Phase 2a (probably four injections because I think this is safe and it will likely/hopefully be most effective).

 

[JohnAdams]

What would you propose to do? They have to figure out dosing first. They can't run a Phase 2b concurrently because that usually involves the highest dose of Phase 2a (probably four injections because I think this is safe and it will likely/hopefully be most effective).

They could have one phase for safety and initial efficacy.