Frequency Therapeutics — Hearing Loss Regeneration

[Diesel]

Time to jumpstart the speculation engine:

Frequency Therapeutics is seeking to hire a VP of Quality.

Frequency Therapeutics Careers: Vice President/Senior Director, Quality

"...focus on CMC manufacturing readiness for Phase 3/NDA quality compliance including vendor qualification and regulatory authority inspection readiness..."

 

[Lucifer]

Time to jumpstart the speculation engine:

Frequency Therapeutics is seeking to hire a VP of Quality.

Frequency Therapeutics Careers: Vice President/Senior Director, Quality

"...focus on CMC manufacturing readiness for Phase 3/NDA quality compliance including vendor qualification and regulatory authority inspection readiness..."

This must mean really good news, that FX-322 works. I wonder why they are hiring early for this role? It tells me that there is a possibility of FX-322 coming out in the market by the end of 2021 or early 2022.

 

[Diesel]

This must mean really good news, that FX-322 works. I wonder why they are hiring early for this role? It tells me that there is a possibility of FX-322 coming out in the market by the end of 2021 or early 2022.

Assembling a team to manage manufacturing and supply chain of any product is a huge lift. It definitely shows confidence and readiness to release the drug. They probably want to get it all in place so there's a stockpile of drug ready at Phase 3 and approval time.

 

[Street Novelist]

When we find out the Day 90 results at the end of March, I will rest easy if I know the results are positive and that there is an improvement in efficacy with more doses of FX-322.

So, we are getting the results in March?

 

[Lucifer]

Assembling a team to manage manufacturing and supply chain of any product is a huge lift. It definitely shows confidence and readiness to release the drug. They probably want to get it all in place so there's a stockpile of drug ready at Phase 3 and approval time.

Yea true. I do hope they release the drug soon. If they can do that after Phase 2a is done, that would be good. I can't believe we got these conditions that we had no idea of. When I recover I will use this as motivation to achieve my goals without holding me back.

 

[tbuzz89]

When I recover I will use this as motivation to achieve my goals without holding me back.

And spread as much awareness as possible about the negative and life altering effects of using earbud headphones, attending loud concerts, etc. Let's say FX-322 is a cure-all for this condition, it doesn't negate the fact that more needs to be done to increase public awareness of hearing issues similar to what was done for smoking.

 

[Lucifer]

So, we are getting the results in March?

Yes day 90 results will be out at the end of March. Day 210 results will be out at the end of May.

 

[Lucifer]

And spread as much awareness as possible about the negative and life altering effects of using earbud headphones, attending loud concerts, etc. Let's say FX-322 is a cure-all for this condition, it doesn't negate the fact that more needs to be done to increase public awareness of hearing issues similar to what was done for smoking.

I agree. I was thinking about making a YouTube video one day to raise awareness. I will need to have a following before I do though to make sure I can impact a lot of people.

 

[TrevorSanders]

Yea true. I do hope they release the drug soon. If they can do that after Phase 2a is done, that would be good. I can't believe we got these conditions that we had no idea of. When I recover I will use this as motivation to achieve my goals without holding me back.

I literally can't wait for the day I can fully resume my life.

 

[Gb3]

Yes day 90 results will be out at the end of March. Day 210 results will be out at the end of May.

90 day results of which trial?

 

[Street Novelist]

Yes day 90 results will be out at the end of March. Day 210 results will be out at the end of May.

This is great news. Less waiting... I hope the FDA does something if the results are what we think they are.

 

[Lucifer]

Also do we know if FX-322 needs to be kept in a fridge or freezer before use?

 

[Billy_Shears]

Time to jumpstart the speculation engine:

Frequency Therapeutics is seeking to hire a VP of Quality.

Frequency Therapeutics Careers: Vice President/Senior Director, Quality

"...focus on CMC manufacturing readiness for Phase 3/NDA quality compliance including vendor qualification and regulatory authority inspection readiness..."

This is very good news! Frequency Therapeutics has yet, of course, to turn a profit but are investing in a highly intellectual individual to lead the way through the final phase and onto the market - very promising, to say the least.

 

[Philip83]

Regarding the "FX-322 Phase 1b Study for Age-Related Hearing Loss"- why would they need to do another safety trial just for changing the patients' age? Couldn't they just test for efficacy straight away?

 

[Lucifer]

90 day results of which trial?

Phase 2a.

 

[Lucifer]

Regarding the "FX-322 Phase 1b Study for Age-Related Hearing Loss"- why would they need to do another safety trial just for changing the patients' age? Couldn't they just test for efficacy straight away?

I think they want to see both types of hearing loss restored. If it works for both age and noise damage related hearing loss, it could mean a better chance for the FDA to approve Breakthrough Therapy Status.

 

[Philip83]

I think they want to see both types of hearing loss restored. If it works for both age and noise damage related hearing loss, it could mean a better chance for the FDA to approve Breakthrough Therapy Status.

Yes, I get that, but that's regarding efficacy. This trial is a safety trial.

 

[Danad]

Our expectations regarding tinnitus results from phase 2a need to be tempered with the fact that subjects are being treated unilaterally. Although tinnitus manifests a slight majority of time unilaterally, bilateral hearing loss sufferers may not have any reduction in their TFI scores. I can personally say that mine can translate from center to left to right and is equally annoying regardless of localization. The only way to truly gauge the drug's impact on tinnitus is to dose bilaterally. The untreated cochlea is still a liability; even one-sided hearing loss can evolve into bilateral tinnitus.

 

[Diesel]

Our expectations regarding tinnitus results from phase 2a need to be tempered with the fact that subjects are being treated unilaterally. Although tinnitus manifests a slight majority of time unilaterally, bilateral hearing loss sufferers may not have any reduction in their TFI scores. I can personally say that mine can translate from center to left to right and is equally annoying regardless of localization. The only way to truly gauge the drug's impact on tinnitus is to dose bilaterally. The untreated cochlea is still a liability; even one-sided hearing loss can evolve into bilateral tinnitus.

This is a good point. Carl LeBel did mention once or twice that patients opted to treat the "worse ear" with FX-322/Placebo. One can assume that the "worse ear" means the one with the greater hearing loss, which may or may not translate to worse tinnitus as well.

Carl LeBel also mentioned in the Tinnitus Talk Podcast that some patients noted that they had improvements in their tinnitus. So, this may be an indication that even though it might be an improvement in one side, the measure may improve slightly. We simply do not know what happens to one's tinnitus if the "worse ear" is treated with a regenerative drug.

Speaking anecdotally, my "worse ear" is the one with the louder/noisier tinnitus. Both have it, but the right is worse. So, if I noticed over the course of a clinical trial that the treated "worse ear" tinnitus got quieter, perhaps to where the left and right were "about the same" it would be reflected in my TFI score.

It is also unknown the severity of the tinnitus experienced by the patients in the trial. A 13-point reduction in the TFI score is considered clinically meaningful. If they go in with a low TFI score (under 25 is considered mild), then the results of a single treated ear won't look great at all. Unless it goes to zero. If patients starting at a moderate (25-50) or severe (50+) score receive treatment in one ear, a considerable "quieting" of tinnitus in one ear may lead to a meaningful reduction in TFI.

If someone could reference possibly a correlation between TFI score and hearing loss, that might be a good way to understand what the expectations should be.

I do agree that it may be a bit of a mixed bag of results. With a P-value that may not be significant (<0.05).

 

[Aaron91]

Yes, I get that, but that's regarding efficacy. This trial is a safety trial.

I can't pretend that I'm overly familiar with FDA procedures, but I think this is mostly a procedural thing. I think if the drug is not already on the market, it has to go through another safety trial as the terminology suggests that it's being used to treat a different kind of pathology (as far as the FDA is concerned, that is - in reality the pathologies are probably similar if not identical - there are old people in amazonian tribes with perfect hearing).

As someone else alluded to, this would then allow Frequency Therapeutics to combine age-related hearing loss into their phase 2b trial for noise-induced hearing loss. More numbers = more data = greater chance of expediting drug to market.

 

[tommyd87]

I can't pretend that I'm overly familiar with FDA procedures, but I think this is mostly a procedural thing. I think if the drug is not already on the market, it has to go through another safety trial as the terminology suggests that it's being used to treat a different kind of pathology (as far as the FDA is concerned, that is - in reality the pathologies are probably similar if not identical - there are old people in amazonian tribes with perfect hearing).

As someone else alluded to, this would then allow Frequency Therapeutics to combine age-related hearing loss into their phase 2b trial for noise-induced hearing loss. More numbers = more data = greater chance of expediting drug to market.

It is I think also much easier to meet the required number of participants with the age-related hearing loss cohort as well. What I reckon is that this is just as much about Frequency Therapeutics completing the trial quickly as it is about getting the requisite information for both groups.

This is a good point. Carl LeBel did mention once or twice that patients opted to treat the "worse ear" with FX-322/Placebo. One can assume that the "worse ear" means the one with the greater hearing loss, which may or may not translate to worse tinnitus as well.

Carl LeBel also mentioned in the Tinnitus Talk Podcast that some patients noted that they had improvements in their tinnitus. So, this may be an indication that even though it might be an improvement in one side, the measure may improve slightly. We simply do not know what happens to one's tinnitus if the "worse ear" is treated with a regenerative drug.

Speaking anecdotally, my "worse ear" is the one with the louder/noisier tinnitus. Both have it, but the right is worse. So, if I noticed over the course of a clinical trial that the treated "worse ear" tinnitus got quieter, perhaps to where the left and right were "about the same" it would be reflected in my TFI score.

It is also unknown the severity of the tinnitus experienced by the patients in the trial. A 13-point reduction in the TFI score is considered clinically meaningful. If they go in with a low TFI score (under 25 is considered mild), then the results of a single treated ear won't look great at all. Unless it goes to zero. If patients starting at a moderate (25-50) or severe (50+) score receive treatment in one ear, a considerable "quieting" of tinnitus in one ear may lead to a meaningful reduction in TFI.

If someone could reference possibly a correlation between TFI score and hearing loss, that might be a good way to understand what the expectations should be.

I do agree that it may be a bit of a mixed bag of results. With a P-value that may not be significant (<0.05).

I think that there is no issue if the benefit obtained for improving tinnitus is somewhat less due to the fact that only ear is getting treated. The outcome will be beneficial if Frequency Therapeutics can demonstrate that FX-322 assists with reducing tinnitus and that they can put forward a reasonable case or reasonable hypothesis that treatment with FX-322 will reduce tinnitus too.

That to me will be enough to demonstrate that FX-322 works for tinnitus and therefore we will get benefit from it.

 

[tiredofit]

I need some help, I suffer from mixed hearing loss (profound) due to ''Inner Ear Dysplasia.''

Basically my cochleas are kind of malformed.

Does that put me in the 10% that don't have hearing loss due to dead hair cells and therefore I would not benefit from FX-322?

How do I find out if it's my hair cells that caused my hearing loss?

 

[FGG]

I need some help, I suffer from mixed hearing loss (profound) due to ''Inner Ear Dysplasia.''

Basically my cochleas are kind of malformed.

Does that put me in the 10% that don't have hearing loss due to dead hair cells and therefore I would not benefit from FX-322?

How do I find out if it's my hair cells that caused my hearing loss?

There are many kinds of inner ear dysplasias. Do you know which one you have?

Mondini is one type of dysplasia, for instance, that causes mixed losses and if that's what you have, it would be hard to say if FX-322 would be effective or not because you would have an abnormally large bony canal which would contribute to further pressure injury.

Enlarged Vestibular Aqueducts and Childhood Hearing Loss

In the case of Mondini OHCs are involved because otoacoustic emissions (which measure a range of OHC response specifically) can be normal at birth and then decline rapidly.

My thought on this is that, on one hand, you maybe could regain some of the SNHL portion of your losses (would not help your conductive losses of course) but you might be continually damaging your hair cells and possibly also they wouldn't regenerate properly with the pressure of the enlarged aqueduct (but I am not really sure).

This could be completely irrelevant to your particular dysplasia as well if it's another kind.

Is there an expert in your particular malformation you could consult? Any of us would just be speculating.

I do want to add that a lot of dysplasia sufferers are still cochlear implant candidates and CIs are improving and will greatly improve with optic (vs electrical) CIs.

 

[bcplfan]

Does anyone know if FX-322 might treat hearing loss caused by a head trauma? I read somewhere that an impact to the head can cause additional damage to the cochlea besides dead/damaged hair cells.

A quick intro: I am a 57-year-old male and endured a car driving into the left side of my head whilst on a cycle 24 years ago. I have suffered moderate hearing loss and mild tinnitus since then up until 4 weeks ago when overnight my tinnitus increased in volume and a new tone (low hum) manifested itself.

 

[Padraigh Griffin]

A very good summary of the current position of FX-322 and the company. Apologies if already posted.

Enlarged Vestibular Aqueducts and Childhood Hearing Loss

 

[tommyd87]

There are many kinds of inner ear dysplasias. Do you know which one you have?

Mondini is one type of dysplasia, for instance, that causes mixed losses and if that's what you have, it would be hard to say if FX-322 would be effective or not because you would have an abnormally large bony canal which would contribute to further pressure injury.

Enlarged Vestibular Aqueducts and Childhood Hearing Loss

In the case of Mondini OHCs are involved because otoacoustic emissions (which measure a range of OHC response specifically) can be normal at birth and then decline rapidly.

My thought on this is that, on one hand, you maybe could regain some of the SNHL portion of your losses (would not help your conductive losses of course) but you might be continually damaging your hair cells and possibly also they wouldn't regenerate properly with the pressure of the enlarged aqueduct (but I am not really sure).

This could be completely irrelevant to your particular dysplasia as well if it's another kind.

Is there an expert in your particular malformation you could consult? Any of us would just be speculating.

I do want to add that a lot of dysplasia sufferers are still cochlear implant candidates and CIs are improving and will greatly improve with optic (vs electrical) CIs.

What is an optic CI?

 

[FGG]

What is an optic CI?

Optical CI. I use my phone and it autocorrects a lot:

Towards the optical cochlear implant: optogenetic approaches for hearing restoration

 

[L34]

Does anyone know if FX-322 potentially can help with both tinnitus caused by an acoustic trauma, and tinnitus caused by noice induced hearing loss?
(And what is the difference actually? Can it be shown on an audiogram?)

FWIW, English is not my first language, so it's not so straight forward for me to find out the difference...)

Thanks for any answers

 

[TrevorSanders]

Does anyone know if FX-322 might treat hearing loss caused by a head trauma? I read somewhere that an impact to the head can cause additional damage to the cochlea besides dead/damaged hair cells.

A quick intro: I am a 57-year-old male and endured a car driving into the left side of my head whilst on a cycle 24 years ago. I have suffered moderate hearing loss and mild tinnitus since then up until 4 weeks ago when overnight my tinnitus increased in volume and a new tone (low hum) manifested itself.

If it is dead/damaged hair cells, it will probably help. An OAE test can show the health of your hair cells.

 

[Lucifer]

Does anyone know if FX-322 potentially can help with both tinnitus caused by an acoustic trauma, and tinnitus caused by noice induced hearing loss?
(And what is the difference actually? Can it be shown on an audiogram?)

FWIW, English is not my first language, so it's not so straight forward for me to find out the difference...)

Thanks for any answers

Acoustic trauma and noise induced hearing loss are the same thing. So far in the clinical trials they have got positive results and it shows it can restore your hearing and this was with 1 dose of FX-322.

Results up to Day 90 will be coming out at the end of March and they will tell us whether additional doses of FX-322 will improve the outcome.

Results up to Day 210 will come out at the end of May.