Frequency Therapeutics — Hearing Loss Regeneration

[hopeful4future]

Should I try to apply if I have to drive about 60 miles to get to the trial? I wish they were doing it in Miami, Florida.

If I get accepted I'll be traveling about 600 miles round trip. So I'd say yes 60 miles once a week is not bad at all.

 

[1000]

Where are they doing the clinical trial for this phase?

 

[Aleksa Uzunovic]

We should have Audion Phase 2 results in the beginning of the next year right? If so that is very exciting...

 

[hopeful4future]

Do you guys think it's worth the risk to do the phase 2 trial without knowing if it's going to make things worse or what side effects could come of this?

Or is it a better idea to wait a few years for the drug to actually come to market to make sure it is actually safe and does not make hearing or tinnitus worse?

Thanks for the feedback.

 

[JohnAdams]

Where are they doing the clinical trial for this phase?

Down here in the south boway.

 

[JohnK]

Do we have any evidence that these chemicals are a risk when ingested? Like do they both a) not get broken down by the digestive system and b) get absorbed by the body and not simply urinated/defecated out?

 

[ChrisBoyMonkey]

That's what they do, that's how they know the sound is real, because it's handled through the auditory cortex and there are significant differences shown in tinnitus patients against control.

It's not "in the brain", the brain just processes the extra signaling (the tinnitus sound) it perceives, hence why the brain activity is increased, if a sound is heard, obviously the auditory cortex and other correlated portions of the brain have to process it, that said, the sound itself (or rather the signals the brain perceives and transcribes as sound) originates elsewhere, more often than not, in the case of somatosensory, that would be in the cochlea.

That extra signaling can also be caused by a lack of nerve/synapses input, as the auditory cortex expects a feedback from the cochlea (the information in between the cochlea and the cochlea and the auditory cortex is bidirectional), this is likely why you may still perceive "sound" when the auditory nerve is cut/disconnected.

Hey man, I'm telling you right now, I'm taking the researchers' words over yours. You have no credibility or evidence over them and their work. Even my own experiences falls in line with the research showing tinnitus in the brain.

"That extra signaling can also be caused by a lack of nerve/synapses input, as the auditory cortex expects a feedback from the cochlea"

- Which is caused by the brain. You said it yourself.

 

[Auron]

@JWJ I had this same question. But only with time, if FX-322 is to pass trials and is released, only then would we find out the dangers of it being injected into the blood or swallowed. Of course, I'm sure people participating in the trials would have been warned of such a scenario. I hope in worst case scenario it would not be concentrated enough to cause problems were it be swallowed or get injected into the blood.

Maybe if they are some side effects, I hope it will make me big, muscular and green with purple shorts.

 

[Don Tinny]

The trials will not show all the side effects. It requires years of application in the market to know it well. Many drugs end up affecting a percentage of users very badly. Maybe in 10 years there is a forum called "FX-322 Help" with users affected by the drug denouncing Frequency Therapeutics for harming them.

Sure, as we are desperate we will try it anyway (tinnitus is too ugly).

 

[ChrisBoyMonkey]

@JWJ I had this same question. But only with time, if FX-322 is to pass trials and is released, only then would we find out the dangers of it being injected into the blood or swallowed. Of course, I'm sure people participating in the trials would have been warned of such a scenario. I hope in worst case scenario it would not be concentrated enough to cause problems were it be swallowed or get injected into the blood.

Maybe if they are some side effects, I hope it will make me big, muscular and green with purple shorts.

This drug pretty much makes duplicates of cells. If those extra duplicates cells mutate as extra cells often do, then cancer could be a possibility, unless we live in Marvel, in which case this would be Hulk serum.

 

[hopeful4future]

This drug pretty much makes duplicates of cells. If those extra duplicates cells mutate as extra cells often do, then cancer could be a possibility, unless we live in Marvel, in which case this would be Hulk serum.

This right here is why I don't think I can move forward with the phase 2 trial. I don't know if the risks outweigh the benefits, I mean if it works it should be available in a few years. If I was 20 years older, maybe, but with 2 young kids at home, not sure I'd be able to forgive myself if I ended up in a worse way.

 

[ChrisBoyMonkey]

This right here is why I don't think I can move forward with the phase 2 trial. I don't know if the risks outweigh the benefits, I mean if it works it should be available in a few years. If I was 20 years older, maybe, but with 2 young kids at home, not sure I'd be able to forgive myself if I ended up in a worse way.

I can't say I blame you. It was shown to be safe and also some effectiveness from phase 1 but we can't be completely certain about any longterm effects of something that makes cells multiply.

I think after a few weeks if it isn't multiplying anymore it won't keep doing it, but that hasn't explicitly been proven yet.

 

[RingingBrother]

This right here is why I don't think I can move forward with the phase 2 trial. I don't know if the risks outweigh the benefits, I mean if it works it should be available in a few years. If I was 20 years older, maybe, but with 2 young kids at home, not sure I'd be able to forgive myself if I ended up in a worse way.

I'm thinking it would be safer to see if it passes phase 2 while still proving no safety issues and enroll in phase 3 trial instead.

 

[vttbx]

Do you guys think it's worth the risk to do the phase 2 trial without knowing if it's going to make things worse or what side effects could come of this?

Or is it a better idea to wait a few years for the drug to actually come to market to make sure it is actually safe and does not make hearing or tinnitus worse?

Thanks for the feedback.

If you are totally fine living with your tinnitus for maybe another five years, then wait.

 

[RingingBrother]

This drug pretty much makes duplicates of cells. If those extra duplicates cells mutate as extra cells often do, then cancer could be a possibility, unless we live in Marvel, in which case this would be Hulk serum.

Do you think the Audion/Regain drug would be a safer option since it doesn't multiply the cells?

 

[FGG]

Do you think the Audion/Regain drug would be a safer option since it doesn't multiply the cells?

This is pure speculation and would love to hear other ideas but it seems like if eustachian tube and throat cells (etc) would have divided in response to FX-322, they would have started to do so over the same time frame as the cochlear hair cells.

Keep in mind, too, that the original research for FX-322 came from discovering that intestinal mucosal cells divide and regenerate constantly in the body in response to local and specific small molecules--without systemic effects. There is a video from a Will McLean lecture that talks about how they used a very similar one to create FX-322 that they tweaked for the cochlea. Because of how specific this type of signaling is, my hunch is (esp in the small and local doses used) this is safe.

I also think rats would have likely shown a neoplastic effect to intratympanic injection too if there was one. You can never be sure without human trials though.

As far as REGAIN, I personally would be far less likely to participate in a trial because I would worry depleting supporting cells to make hair cells would result in less functional hair cells. Support cells are generally very important to neuron health and I don't see why in the cochlea, it would be any different.

So my thoughts are that REGAIN would potentially be less effective (I could see some hearing distortion--maybe mild--or early hair cell death of the regenerated cells being a problem) especially long term but likely "safer" in a systemic sense but FX-322 has the potential to properly restore hearing and function.

It's also possible that the percentage of support cells REGAIN turns over leaves enough to support the other hair cells. I would think they thought of that but my hesitation there is why I'm more excited for FX-322 and tried to get in that trial.

 

[swc5150]

But in the lab, didn't it just replace the dead cells, then stop? I didn't read anywhere that it continued to grow new cells uncontrollably, which is essentially what it would have to do to follow the "leading to cancer" argument.

Or maybe you swallow some of it and it regenerates dead or damaged cells you didn't even know you had, possibly preventing cancer somewhere in your body? Think positive

 

[Time4fix]

https://www.medpagetoday.com/meetingcoverage/aaohnsf/82242

Not sure if there is any new info in there, I've heard of most of it.

 

[hopeful4future]

This is pure speculation and would love to hear other ideas but it seems like if eustachian tube and throat cells (etc) would have divided in response to FX-322, they would have started to do so over the same time frame as the cochlear hair cells.

Keep in mind, too, that the original research for FX-322 came from discovering that intestinal mucosal cells divide and regenerate constantly in the body in response to local and specific small molecules--without systemic effects. There is a video from a Will McLean lecture that talks about how they used a very similar one to create FX-322 that they tweaked for the cochlea. Because of how specific this type of signaling is, my hunch is (esp in the small and local doses used) this is safe.

I also think rats would have likely shown a neoplastic effect to intratympanic injection too if there was one. You can never be sure without human trials though.

As far as REGAIN, I personally would be far less likely to participate in a trial because I would worry depleting supporting cells to make hair cells would result in less functional hair cells. Support cells are generally very important to neuron health and I don't see why in the cochlea, it would be any different.

So my thoughts are that REGAIN would potentially be less effective (I could see some hearing distortion--maybe mild--or early hair cell death of the regenerated cells being a problem) especially long term but likely "safer" in a systemic sense but FX-322 has the potential to properly restore hearing and function.

It's also possible that the percentage of support cells REGAIN turns over leaves enough to support the other hair cells. I would think they thought of that but my hesitation there is why I'm more excited for FX-322 and tried to get in that trial.

So would you do the Phase 2 trial if you qualified?

 

[FGG]

So would you do the Phase 2 trial if you qualified?

Yes. For sure. I tried to get in but my audiogram disqualified me.

 

[RB2014]

The 4 patients that improved has the more severe hearing loss. I think this is interesting and promising as well.

 

[JohnAdams]

Do you think the Audion/Regain drug would be a safer option since it doesn't multiply the cells?

No.

 

[hopeful4future]

Yes. For sure. I tried to get in but my audiogram disqualified me.

Did they tell you why your audiogram didn't work?

 

[FGG]

Did they tell you why your audiogram didn't work?

No but I have a normal audiogram to 8000 Hz and severe in the higher frequencies so my guess is they want someone more uniform.

 

[ChrisBoyMonkey]

Do you think the Audion/Regain drug would be a safer option since it doesn't multiply the cells?

It's hard to say. From how they're looking so far, maybe they're both safe, at least in the short term.

That's what these trials are for though, to establish safety of the drugs. We will see and hopefully both can become viable options. As @FGG said, FX-322 might be the better option in that you can have some peace of mind in knowing it won't completely deplete the supporting cells where REGAIN might. Hopefully they'll both be good options though.

 

[Jurger]

Do you think the Audion/Regain drug would be a safer option since it doesn't multiply the cells?

FX-322 mimics a process that's similar to what happens in the womb, when supporting cells start to proliferate, which leads to more supporting cells and the 15.000 hair cells per ear that (most) humans are born with. REGAINs method is more like what happens with birds when they get hearing damage, where supporting cells turn into something they aren't - hair cells. An interesting option would be that patients would follow a protocol of injections with FX-322 first, followed by REGAIN to put those new and fresh supporting cells to good use. That's speculation though.

 

[JohnAdams]

FX-322 mimics a process that's similar to what happens in the womb, when supporting cells start to proliferate, which leads to more supporting cells and the 15.000 hair cells per ear that (most) humans are born with. REGAINs method is more like what happens with birds when they get hearing damage, where supporting cells turn into something they aren't - hair cells. An interesting option would be that patients would follow a protocol of injections with FX-322 first, followed by REGAIN to put those new and fresh supporting cells to good use. That's speculation though.

Dude, FX-322 does what Audion's drug does, after the supporting cells divide. They both cause supporting cells to grow hair cells, FX-322 just doesn't deplete the supporting cells.

 

[HootOwl]

Damnit. They are actually having one of their trials right in my hometown. Why can't my hearing be affected just enough to qualify... I just want to try something that could give me some relief from the noise.

 

[Jurger]

Dude, FX-322 does what Audion's drug does, after the supporting cells divide. They both cause supporting cells to grow hair cells, FX-322 just doesn't deplete the supporting cells.

Again, FX-322 doesn't transdifferentiate new supporting cells to hair cells. I don't know why that's so hard to grasp. Bob Langer himself even said so. You're acting like FX-322 is REGAIN+. It's not. Different mechanisms, different origins.

 

[JohnAdams]

FX-322 doesn't transdifferentiate new supporting cells to hair cells

So you're saying FX-322 only divides supporting cells and doesn't grow new hair cells?