Frequency Therapeutics — Hearing Loss Regeneration

[all to gain]

Some of you are very optimistic, but I am a pessimist by nature. The only thing that means anything to me right now are the results that should hopefully be released at the end of September. It's excruciating waiting...

 

[Jorge1984]

Does anyone know if FX-322 will help with reactive tinnitus?

 

[Lucifer]

Some of you are very optimistic, but I am a pessimist by nature. The only thing that means anything to me right now are the results that should hopefully be released at the end of September. It's excruciating waiting...

Yea I know the feeling. I think we will only know if it works if someone in the clinical trials actually tells us it reduced their tinnitus and hyperacusis.

I know I'm being optimistic but I do believe FX-322 and Audion Therapeutics will be some of the drugs that would help us when they come out. I just hope they someone skip phases so it can be released quicker.

 

[Lucifer]

Does anyone know if FX-322 will help with reactive tinnitus?

I think it has a good chance. If it doesn't get rid of tinnitus I do believe it will stabilise the reactive tinnitus so it doesn't get worse to low to moderate sounds.

 

[GlennS]

Some of you are very optimistic, but I am a pessimist by nature. The only thing that means anything to me right now are the results that should hopefully be released at the end of September. It's excruciating waiting...

Speaking only for myself but I find it hard not to jump on the bandwagon because after stepping off the Lenire roller coaster there's nothing else out there that seems to be as far along.

 

[Bartoli]

It seems like it's mainly speculatory how much one's noise-induced hearing loss is hair cell death related and how much is synapse related.

I don't know as much as @FGG but I suspect that there is probably a fair amount of both at play.

My plan is to get FX-322 upon release, which gives new hair cells with their respective synapses. In theory this should at least improve the ratio if disconnected to connected synapses, which I see as a plus when it comes to synaptopathy.

When an actual synaptopathy treatment comes out, I'll do that as well to cover my bases.

Then it's going to be high fidelity earplugs anytime I'm in an environment louder than a movie theater, for the rest of the foreseeable future. I keep them on my keyring.

It baffles me that a potential treatment could be on the way before we have even found a way to reliably diagnose these auditory problems. I had good speech in noise scores, yet I have the feeling I often hear without understanding. Never mind acoustic reflex testing. I heard that's loud, so a no go for my moderate hyperacusis.

Whomever comes up with a treatment first, I'll take it as long as it comes with a free keyring.

 

[Lucifer]

It baffles me that a potential treatment could be on the way before we have even found a way to reliably diagnose these auditory problems. I had good speech in noise scores, yet I have the feeling I often hear without understanding. Never mind acoustic reflex testing. I heard that's loud, so a no go for my moderate hyperacusis.

Whomever comes up with a treatment first, I'll take it as long as it comes with a free keyring.

Even if it's Audion Therapeutics that comes out first I will most likely take it depending on what it gets rid of.

 

[xyz]

Frequency seem to be the first who can regenerate human hair cells. I have never read this anywhere else. Have they quantified how much hair cells they could regenerate? Probably our inner ears will not look like that of a ten year old after treatment. Maybe they have some figures from animal tests. What amazes me a bit is when I read hair cell regeneration articles from Harvard, Stanford, this sounds like: Practical treatments are years off in the future. And some US company has solved this on its own? But I am not a medical scientist and may be interpreting things wrong.

 

[FGG]

Frequency seem to be the first who can regenerate human hair cells. I have never read this anywhere else. Have they quantified how much hair cells they could regenerate? Probably our inner ears will not look like that of a ten year old after treatment. Maybe they have some figures from animal tests. What amazes me a bit is when I read hair cell regeneration articles from Harvard, Stanford, this sounds like: Practical treatments are years off in the future. And some US company has solved this on its own? But I am not a medical scientist and may be interpreting things wrong.

They have only published phase 1 data so far using a very small dose intended to test safely. It has been confirmed that they regrew hair cells. As to "how many", that's a difficult question to answer in a human without an autopsy but they did see word score increases and audiogram changes at 8000Hz. It should be even more rigorous after phase 2a data. That question may have been answered in the human explant study, though as a range. Not sure.

 

[all to gain]

Speaking only for myself but I find it hard not to jump on the bandwagon because after stepping off the Lenire roller coaster there's nothing else out there that seems to be as far along.

Oh, I'm all for Frequency, I really want this drug to work wonders. I would rather prefer myself for the worst though and then be pleasantly surprised. I have both hearing loss and tinnitus so hopefully it will do something for at least one of these. I can live with my current hearing loss, but it's the tinnitus that I really want sorting. Hopefully I'll get lucky and it will help both.

All the Lenire hype pretty much passed me by as it was going on just as my tinnitus started. Not impressed at all. Won't be taking up my option for an appointment.

 

[xyz]

Just read Audion expects the drug released in 7 years. Strongly hoping that Frequency comes before that.

 

[FGG]

Just read Audion expects the drug released in 7 years. Strongly hoping that Frequency comes before that.

Or at least opens up compassionate/expanded use much earlier. My hunch is that will happen before release once they scale up manufacturing enough.

 

[Lucifer]

Or at least opens up compassionate/expanded use much earlier. My hunch is that will happen before release once they scale up manufacturing enough.

Who would be considered for compassionate/expanded use?

 

[FGG]

Who would be considered for compassionate/expanded use?

Your (I believe has to be US doctor but I'm not positive) doctor would have to determine that your suffering warrants access to a drug not yet released and the drug company has to be willing to provide it. Each instance is petitioned separately for each individual.

Frequency has said they are not prepared to do that at this time and cited needing more results first (which makes sense since they are still trying to figure out dose) and not having to resources to meet demand at this time (they would need a factory and probably to hire more people just to review these requests as there will undoubtedly be thousands to even millions).

 

[grate_biff]

https://frequencytx.gcs-web.com/new...eutics-shares-clinical-data-exploratory-study

 

[all to gain]

Yea I know the feeling. I think we will only know if it works if someone in the clinical trials actually tells us it reduced their tinnitus and hyperacusis.

I know I'm being optimistic but I do believe FX-322 and Audion Therapeutics will be some of the drugs that would help us when they come out. I just hope they someone skip phases so it can be released quicker.

Talk about timing of my post.

Let's hope FX-322 doesn't go the same way.

I will admit, that's actually better results than I expected considering that I read a paper showing that compounds using their method produced cells that were phenotypically closer to vestibular hair cells. But I'm kind of an Audion skeptic.

@FGG I quoted this from the Audion thread, but in relation to FX-322, what results would you be happy with when they release their results in September? If I remember correctly the first phase showed 4 out of 15 had significant improvement.

 

[Sytex75]

Interesting... sounds like they are humming right along... appears to be a well run company with good visions.

 

[BBakkers]

https://frequencytx.gcs-web.com/new...eutics-shares-clinical-data-exploratory-study

So wait, can someone help me verify if I understand correctly? This is some really good news. This was an extra study done in Germany and they will present the result and Frequency intends to present the results from this study at an upcoming medical conference?

Quote:
"The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany."

Quote:
"In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."

 

[sssing]

https://frequencytx.gcs-web.com/new...eutics-shares-clinical-data-exploratory-study

Thanks @grate_biff, I was happy to read this It seems they did a repeat of their first Australian study with cochlear implant patients? Maybe this time they measured the concentration of FX-322? But I can't believe the didn't measure it in the other one?! I guess it's most likely from this German study where they got to know the drug diffuses up to 6kHz? I just hope the company doesn't just stop there and reformulate to go much further...

 

[FGG]

Talk about timing of my post.

Let's hope FX-322 doesn't go the same way.

@FGG I quoted this from the Audion thread, but in relation to FX-322, what results would you be happy with when they release their results in September? If I remember correctly the first phase showed 4 out of 15 had significant improvement.

Keep in mind that not all of the 15 had moderate to severe hearing loss so their word scores were fine to begin with. Frequency seems to be selecting criteria (i.e. your hearing has to be bad enough at several frequencies) that I predict will make their phase 2a results really rigorous and I predict they will be.

 

[FGG]

1st quarter 2020 update:

https://investors.frequencytx.com/n...utics-provides-business-updates-and-reports-1

 

[FGG]

So wait, can someone help me verify if I understand correctly? This is some really good news. This was an extra study done in Germany and they will present the result and Frequency intends to present the results from this study at an upcoming medical conference?

Quote:
"The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany."

Quote:
"In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."

Yes, the drug works and gets into the cochlea in appreciable amounts. Maybe they can give us hard numbers as to exactly how far down the first formulation reaches once the specific data is publically released.

 

[FGG]

Thanks @grate_biff, I was happy to read this It seems they did a repeat of their first Australian study with cochlear implant patients? Maybe this time they measured the concentration of FX-322? But I can't believe the didn't measure it in the other one?! I guess it's most likely from this German study where they got to know the drug diffuses up to 6kHz? I just hope the company doesn't just stop there and reformulate to go much further...

The 6kHz figure came from a single graphic that came out before this data was released. In other words, it's not a number that means anything unless they specifically declare that it does with current data because at the time the graphic was released, only phase 1 trial data was publically available.

The SEC prevents predictive statements based on unreleased data in a publically traded company.

So, thus far, only Frequency knows exactly how far their drug traveled in that study. Hopefully, they release that info at their next conference, though.

 

[BBakkers]

Does anyone know if the next conference is already planned?

 

[sssing]

The 6kHz figure came from a single graphic that came out before this data was released. In other words, it's not a number that means anything unless they specifically declare that it does with current data because at the time the graphic was released, only phase 1 trial data was publically available.

The SEC prevents predictive statements based on unreleased data in a publically traded company.

So, thus far, only Frequency knows exactly how far their drug traveled in that study. Hopefully, they release that info at their next conference, though.

Thanks @FGG you're right, only they know how far it has traveled...

 

[Enclave]

The 6kHz figure came from a single graphic that came out before this data was released. In other words, it's not a number that means anything unless they specifically declare that it does with current data because at the time the graphic was released, only phase 1 trial data was publically available.

The SEC prevents predictive statements based on unreleased data in a publically traded company.

So, thus far, only Frequency knows exactly how far their drug traveled in that study. Hopefully, they release that info at their next conference, though.

I'm not sure this will be addressed in their next conference. This study was based on a Safety dose, not a Therapeutic dose. They still had to play it safe at this point, so I doubt the amount they injected was the maximum volume with the maximum concentration of the drug in order to accurately measure whether or not they are able to reach 4khH or beyond.

I'm anticipating this study saying something along these lines: "based on the Safety dose we were required to inject, our model predicted it would reach X. We ended up reaching X, therefore, our model is correct".

I highly doubt they're going to come out and say the maximum distance they can reach.

 

[FGG]

I'm not sure this will be addressed in their next conference. This study was based on a Safety dose, not a Therapeutic dose. They still had to play it safe at this point, so I doubt the amount they injected was the maximum volume with the maximum concentration of the drug in order to accurately measure whether or not they are able to reach 4khH or beyond.

I'm anticipating this study saying something along these lines: "based on the Safety dose we were required to inject, our model predicted it would reach X. We ended up reaching X, therefore, our model is correct".

I highly doubt they're going to come out and say the maximum distance they can reach.

I agree, but they may talk about diffusion data from their recent Germany Cochlear Implant recipient perilymph analysis study.

 

[Lucifer]

I agree, but they may talk about diffusion data from their recent Germany Cochlear Implant recipient perilymph analysis study.

Quite surprised they did this in Germany. So this is definitely separate to the current trials in USA. What does this perilymph analysis study mean for the current clinical trials in USA?

 

[xyz]

Quote:
"In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study."

This sounds like dosage is not increased in the 2a trial. Wasn't this planned? Seems like Hannover is a nice city. You can get Lenire and FX-322

 

[FGG]

Quite surprised they did this in Germany. So this is definitely separate to the current trials in USA. What does this perilymph analysis study mean for the current clinical trials in USA?

Yes, it was separate. From the link:

"The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany. Results were based on an analysis of cochlear fluid, known as perilymph, obtained intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.

"When we consider these new findings, together with the hearing signal observed in our earlier Phase 1/2 study, we believe we have developed the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic. Through this study we have gained critical insight into the delivery properties of FX-322 and clinical confirmation that it reached the site of action in all study patients," said Carl LeBel, Ph.D., Frequency's Chief Development Officer."