Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

One question: what is the speed of action of the drug? I mean, once we get the injection, how quickly would the ear cells grow back? How long before we notice benefits? Are we talking hours, days, weeks. months? The experiment on the removed cochlea from a cancer patient was mentioned, what was the speed of growth there?

Thanks.

I think they said a few weeks at some point but I can't remember where that was (JP Morgan presentation)?

 

[mrbrightside614]

One question: what is the speed of action of the drug? I mean, once we get the injection, how quickly would the ear cells grow back? How long before we notice benefits? Are we talking hours, days, weeks. months? The experiment on the removed cochlea from a cancer patient was mentioned, what was the speed of growth there?

Thanks.

Based on their corporate presentation, improvements in clarity continued 3-months post-intervention, but improvements were noticed as early as day 15. Between those two points in time there continued to be modest improvements in speech clarity. Word in noise recognition improved by 10% at day 15 and by another 10% by day 90.

 

[Chinmoku]

Based on their corporate presentation, improvements in clarity continued 3-months post-intervention, but improvements were noticed as early as day 15. Between those two points in time there continued to be modest improvements in speech clarity. Word in noise recognition improved by 10% at day 15 and by another 10% by day 90.

Thank you, and this was with a reduced dosage, right?

 

[Sevv]

Based on their corporate presentation, improvements in clarity continued 3-months post-intervention, but improvements were noticed as early as day 15. Between those two points in time there continued to be modest improvements in speech clarity. Word in noise recognition improved by 10% at day 15 and by another 10% by day 90.

And that was just a small dose.

 

[Lucifer]

For Phase 2a are the participants receiving 4 doses, getting a shot each week? I would assume the effects will be quicker if they get a shot each week for a month?

 

[FGG]

For Phase 2a are the participants receiving 4 doses, getting a shot each week? I would assume the effects will be quicker if they get a shot each week for a month?

It's not each week but it is 4 shots. I can't remember if it was every 2 weeks or once a month.

 

[mrbrightside614]

For Phase 2a are the participants receiving 4 doses, getting a shot each week? I would assume the effects will be quicker if they get a shot each week for a month?

Probably better results, which could be seen as "faster" but would not necessarily mean that the drug is working quicker. It's just doing more. I'm splitting hairs here, but yeah.

Thank you, and this was with a reduced dosage, right?

Safety dose, yep. I'm going to do a major dive back into all of this very soon and get absolutely everything sorted out.

 

[Lucifer]

It's not each week but it is 4 shots. I can't remember if it was every 2 weeks or once a month.

Probably better results, which could be seen as "faster" but would not necessarily mean that the drug is working quicker. It's just doing more. I'm splitting hairs here, but yeah.

Safety dose, yep. I'm going to do a major dive back into all of this very soon and get absolutely everything sorted out.

I know with Audion/Regain they are doing 4 shots, 1 each week. I thought Frequency Therapeutics would be the same.

 

[Diesel]

From the P2a page:

"Dosing occurs once weekly for 4 consecutive weeks."

 

[Lucifer]

From the P2a page:

"Dosing occurs once weekly for 4 consecutive weeks."

Cheers @Diesel for letting me know. I knew it had to be similar or the same as Regain/Audion dosing. The only thing we don't know is how much they use for each dose. I hope we find out once Phase 2a results are available.

 

[FGG]

From the P2a page:

"Dosing occurs once weekly for 4 consecutive weeks."

Do you have a link to that?

I remember during my interview that i said it might be hard to come back every week if selected and she said it wasn't every week. I specifically remember her saying that. Unless she somehow thought I meant for the entirety of the trial...

 

[Lucifer]

Do you have a link to that?

I remember during my interview that i said it might be hard to come back every week if selected and she said it wasn't every week. I specifically remember her saying that. Unless she somehow thought I meant for the entirety of the trial...

Maybe she meant, for example, say you got the first shot on the 1st week Monday but then got another shot on the 2nd week Thursday. I guess it depends on their schedule and they can't possibly have you in on the Monday each week.

 

[d'Wooluf]

I guess it depends on their schedule and they can't possibly have you in on the Monday each week.

It's a clinical trial, so if they say once a week I'd expect every Monday/whatever without fail.

 

[Serouj]

Do you have a link to that?

I remember during my interview that i said it might be hard to come back every week if selected and she said it wasn't every week. I specifically remember her saying that. Unless she somehow thought I meant for the entirety of the trial...

"Dosing occurs once weekly for four consecutive weeks."
https://clinicaltrials.gov/ct2/show/NCT04120116

 

[Serouj]

Update: Only 2 locations are still not recruiting. It was 4 last week.

 

[Lucifer]

Update: Only 2 locations are still not recruiting. It was 4 last week.

@Serouj thanks for letting me know. That's good news to hear. Maybe we will get the results in October.

I just had a look at the clinical trials information and I remember there was another New York location but they must have got rid of it. Virginia has started recruiting now so only Texas and Utah still remaining.

 

[Lucifer]

It's a clinical trial, so if they say once a week I'd expect every Monday/whatever without fail.

Well you would think so if they want to be accurate but you never know, it could be a public holiday on the 2nd week of Monday and would get the shot on a 2nd week Tuesday instead.

 

[Rayk]

Could FX-322 potentially work for people with Meniere's?

 

[Bartoli]

Has FX-322 a chance of regenerating frequencies in a cochlear dead region? I read that the auditory fibers innervating a dead region degrade over time.

 

[FGG]

Has FX-322 a chance of regenerating frequencies in a cochlear dead region? I read that the auditory fibers innervating a dead region degrade over time.

Frequency's FX-322 is reportedly for up to severe loss, I believe. Sound Pharmaceuticals have a drug in Pre-Clinical for profound loss but it seems they are behind on it. Maybe we could email Sound Pharmaceuticals and ask the status on that one.

 

[Bartoli]

Apparently even moderate hearing loss can indicate a cochlear dead region. There's a phenomenon where other hair cells take over and can detect frequencies other than the ones they're primarily designed for. A pure-tone audiogram would not fully reveal such a loss.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168936/

 

[FGG]

Could FX-322 potentially work for people with Meniere's?

Meniere's tends to result in very low frequency hearing loss. And frequency is targeting above 3500 Hz for the first version of the drug. As far as whether hydrops itself would interfere, not sure. You might have to get the hydrops at least temporarily under control first (again, not sure).

 

[GregCA]

Could FX-322 potentially work for people with Meniere's?

I would be suprised if it did, given the way Meniere's Disease (and Endolymphatic Hydrops) works.

 

[FGG]

I would be suprised if it did, given the way Meniere's Disease (and Endolymphatic Hydrops) works.

The permanent hearing loss (and hearing decline) is related to the hair cell death, though. I wonder if FX-322 in conjunction with a salt restricted diet and diuretics would help once the drug can reach the lower registers.

 

[FGG]

Apparently even moderate hearing loss can indicate a cochlear dead region. There's a phenomenon where other hair cells take over and can detect frequencies other than the ones they're primarily designed for. A pure-tone audiogram would not fully reveal such a loss.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168936/

Ah. Okay, I see what you mean. Looks like they are defining a "dead region" as complete IHC loss. I have seen other papers suggesting you start to get audiogram changes at 80-85% IHC loss but it generally stops at moderate to moderately severe on an audiogram (because other cells transmit the signal as you said) if your OHCs are mostly intact. As long as there were still support cells, I see no reason FX-322 wouldn't work since it appears to work on IHC as well as OHC.

 

[FGG]

@Serouj thanks for letting me know. That's good news to hear. Maybe we will get the results in October.

I just had a look at the clinical trials information and I remember there was another New York location but they must have got rid of it. Virginia has started recruiting now so only Texas and Utah still remaining.

There was only ever one NY location (Amherst).

 

[GregCA]

The permanent hearing loss (and hearing decline) is related to the hair cell death, though.

Is it? I thought it was related to the inability for hair cells to mechanically function, given the mechanical pressure they were subjected to, not that they were actually dead.

 

[FGG]

Is it? I thought it was related to the inability for hair cells to mechanically function, given the mechanical pressure they were subjected to, not that they were actually dead.

With active hydrops, that's exactly the case. This is the "fluctuating hearing loss" but over time, I believe there is permanent hearing loss from ischemia killing off hair cells (versus the effects of hydrops where hearing and tinnitus can get much better after an "attack").

 

[Bartoli]

Looks like they are defining a "dead region" as complete IHC loss.

I'm not very informed on the subject but it seems that without the IHC's no signal would go through, even when OHC's are still present.

 

[Bartoli]

Ah. Okay, I see what you mean. Looks like they are defining a "dead region" as complete IHC loss. I have seen other papers suggesting you start to get audiogram changes at 80-85% IHC loss but it generally stops at moderate to moderately severe on an audiogram (because other cells transmit the signal as you said) if your OHCs are mostly intact. As long as there were still support cells, I see no reason FX-322 wouldn't work since it appears to work on IHC as well as OHC.

But what about the degenerated nerve itself? Wouldn't it be like people who are born deaf that can't benefit from a cochlear implant in adult life because the neurological connections have never been made?