Frequency Therapeutics — Hearing Loss Regeneration

[ThomasF]

There's this Audiologist on YouTube that has spoken of Frequency Therapeutics in the recent past as well as how their medication is supposed to aid hearing as a whole. Something regarding inner cochlear hair cells being responsible for different things than outer hair cells. The medication is able to aid in the regeneration of at least one of those types of cells or, more accurately, it activates the progenitor cells inside the ear to replace the damaged hair cells. Supposedly the medication itself has been shown to work but there was something problematic about the delivery method. For people with hearing loss induced tinnitus, replacing the hair cells is a likely candidate for a cure.

Side-note: It feels like an evolutionary mess up that birds can replace their gosh darn hair cells and we (most if not all mammals) cannot. Boy I really hope someone got fired for that blunder.

 

[Lucifer]

Seems not great news from Frequency Therapeutics. If they are not able to recover that much of the hearing, there is no hope for us with tinnitus, right?

Maybe this may help people with very mild hearing loss.

Depends if your hearing loss is at the higher frequencies. From the previous trials it seems that the drug can travel down to 8 kHz due to the audiogram improvements at 8 kHz. Unfortunately they did not do an audiogram test higher than 8 kHz in the previous trial.

So basically in its current formula it can travel down to 8 kHz so that's like 50% it can restore. With FX-345 the theory is that it can get down to 4 kHz so that is 80% restoration.

 

[GregCA]

So basically in its current formula it can travel down to 8 kHz so that's like 50% it can restore.

We don't hear in linear Hertz, though. We hear logarithmically. Improving everything above 8 kHz is essentially improving your highest pitch octave (out of roughly 9 of them). So more like 10% coverage, not 50%.

 

[DimLeb]

Side-note: It feels like an evolutionary mess up that birds can replace their gosh darn hair cells and we (most if not all mammals) cannot. Boy I really hope someone got fired for that blunder.

Lol. It got messed up big time, when somewhere in evolution some mammals could still survive even with all these hearing disorders and broken ears...

 

[Diesel]

Ah, keep telling yourself that. I have 45-50 WRS and I can't hear shit out of my left ear.

Then it sounds like you can hear shit out of your left ear. You can hear 45 - 50 words.

 

[Jurger]

I listened to most of it. More of the same. Focused on word recognition again. No mention of actual hearing improvement or tinnitus.

I thought it was telling one of the questions was why they don't focus on FX-345...

 

[Keith Handy]

Then it sounds like you can hear shit out of your left ear. You can hear 45 - 50 words.

To be fair, though, they might have had to crank the volume for him on the tests. I wasn't aware for some time that they actually don't have a "set volume" for word tests and will adjust it to what you can hear.

 

[Diesel]

I thought it was telling one of the questions was why they don't focus on FX-345...

Absolutely. 7-10MM population can benefit from FX-322, why abandon it if they can get it through pivotal and start generating revenue?

 

[Chad Lawton]

I thought it was telling one of the questions was why they don't focus on FX-345...

Why is it telling? The smartest thing for them to do is get FX-322 to market as quickly as possible to unlock a revenue stream, otherwise they are on track to run out of cash by end of 2023. They've already spent enough money on it it that it doesn't cost that much more to take it to pivotal rather than abandon it. Otherwise if they shelf FX-322 it will add an extra 2 years to the timeline of bringing something to market. We are probably 3 to 4 years from seeing something on market, FX-345 will be 5 to 6.

 

[Gb3]

Then it sounds like you can hear shit out of your left ear. You can hear 45 - 50 words.

I can if I go in for an audiogram and it's inserted directly into my ear. I can't hear anything in noisy backgrounds. And if I take my hearing aid out, it's all muffled.

 

[Koz]

Ah, keep telling yourself that. I have 45-50 WRS and I can't hear shit out of my left ear.

Careful, the shills on copium don't like audiograms here.

 

[Lucifer]

I can if I go in for an audiogram and it's inserted directly into my ear. I can't hear anything in noisy backgrounds. And if I take my hearing aid out, it's all muffled.

I think with the severe hearing loss trial there were word improvements in noise.

 

[Chad Lawton]

Careful, the shills on copium don't like audiograms here.

I suppose us shills are just trying to balance out the Audiogram Eeyores

 

[d'Wooluf]

I suppose us shills are just trying to balance out the Audiogram Eeyores

I think you're winning.

 

[Survivor234]

Seems not great news from Frequency Therapeutics. If they are not able to recover that much of the hearing, there is no hope for us with tinnitus, right?

To be honest, based on what I understand, it won't even help people with tinnitus. If your tinnitus is caused by overexcited neurons and damaged hair cells, regrowing new ones won't fix those issues. Tinnitus is likely going to require multiple treatments which undoubtedly would make it a very lucrative and costly symptom to remove. And if your tinnitus is caused by TMJ, anxiety, or sinus infections then it's likely that it won't be dealt with at all by these treatments.

 

[Gb3]

If it does get approved, no one is going to use it if all it does is increase your word scores by 10%.

 

[Survivor234]

If it does get approved, no one is going to use it if all it does is increase your word scores by 10%.

That's just a problem with measurement rather than what it actually does. Word-in-noise scores was the metric the FDA wanted them to use for approval so they're using it. There is no reason to believe that it doesn't do exactly what it sets out to do which is activate progenitor hair cells in the inner ear.

Furthermore, the audiograms they were testing for Phase 1B trial was up to 8 kHz which FX-322 doesn't even fully reach to (FX-345, on the other hand, does). Phase 2B is testing up to 16 kHz so we should see more patients with improvements.

The only reason why it wouldn't work or fix tinnitus is if either A. your tinnitus is not noise or hearing loss induced or B. your tinnitus is caused by damaged hair cells. Other than that, it should, at the very least, help.

 

[Diesel]

If it does get approved, no one is going to use it if all it does is increase your word scores by 10%.

Consider the number of treatments for hearing loss that people willfully try that have no measurable benefit over placebo or are not FDA approved, IE: steroids, HBOT, Sulodexide, etc. None of these have a target patient group, yet people spend thousands of dollars gambling on hope. Add to that, the likelihood of health insurance coverage in the US is nil. This happens every day.

Then, consider that same population that has the option to try a drug that is FDA approved and shows a significant improvement for certain hearing loss conditions. And, their doctor can reliably prescribe and administer it. Also, by the sound of the recent Q&A, it might be covered under their health insurance.

Which one do you think patients will choose? Which one would a doctor recommend?

 

[Gb3]

That's just a problem with measurement rather than what it actually does. Word-in-noise scores was the metric the FDA wanted them to use for approval so they're using it. There is no reason to believe that it doesn't do exactly what it sets out to do which is activate progenitor hair cells in the inner ear.

Furthermore, the audiograms they were testing for Phase 1B trial was up to 8 kHz which FX-322 doesn't even fully reach to (FX-345, on the other hand, does). Phase 2B is testing up to 16 kHz so we should see more patients with improvements.

The only reason why it wouldn't work or fix tinnitus is if either A. your tinnitus is not noise or hearing loss induced or B. your tinnitus is caused by damaged hair cells. Other than that, it should, at the very least, help.

No, it was the only signal they were able to achieve so they discussed with the FDA a way for them to achieve clinical significance and pass trials.

 

[Survivor234]

No, it was the only signal they were able to achieve so they discussed with the FDA a way for them to achieve clinical significance and pass trials.

Do you have any evidence of that?

 

[Gb3]

Do you have any evidence of that?

Yes, they said it in there presentations.

 

[Gb3]

Consider the number of treatments for hearing loss that people willfully try that have no measurable benefit over placebo or are not FDA approved, IE: steroids, HBOT, Sulodexide, etc. None of these have a target patient group, yet people spend thousands of dollars gambling on hope. Add to that, the likelihood of health insurance coverage in the US is nil. This happens every day.

Then, consider that same population that has the option to try a drug that is FDA approved and shows a significant improvement for certain hearing loss conditions. And, their doctor can reliably prescribe and administer it. Also, by the sound of the recent Q&A, it might be covered under their health insurance.

Which one do you think patients will choose? Which one would a doctor recommend?

People don't even get hearing aids to help with their hearing. Why are they going to get a shot in their ear for a drug that doesn't do anything?

 

[Survivor234]

Yes, they said it in there presentations.

Where?

 

[Gb3]

Where?

I don't remember which specific presentation but I've been following them very closely. Do you own research.

 

[Diesel]

People don't even get hearing aids to help with their hearing. Why are they going to get a shot in their ear for a drug that doesn't do anything?

"...all it does is increase your word scores by 10%." - Gb3, Tinnitus Talk, 15 January, 2022.

That's why.

 

[Diesel]

Where?

There are a few places. Keep up with their website, full of current information.

Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint

 

[Chad Lawton]

I don't remember which specific presentation but I've been following them very closely. Do you own research.

People don't even get hearing aids to help with their hearing. Why are they going to get a shot in their ear for a drug that doesn't do anything?

It sounds like you haven't been following them very closely at all.

For starters, 10% is the bar for clinically significant improvements; it does not mean that patients are only improving 10%, it's just the number they have to hit to get FDA approval. The wording they use is "subjects achieved 10% OR GREATER absolute improvement"

Secondly, the 10% scale they use is an absolute measure on a 50 word test so a change of 5 words is 10%. The 10% is not relative to the patients starting score. Many patients have more than doubled their word scores which is life changing for those people.

Using the Phase 1/2 data for example, patient 1 went from hearing 14 words out of 50 to hearing 30 words out of 50 16 months later. That would be labeled as a 30% absolute improvement when it's actually a 100%+ relative improvement for that patient. That patient was functionally deaf before and was a candidate for cochlear implant surgery (which costs between $30,000 to $50,000.) but now that patient can get by with just a hearing aid. If you can't see the value in a drug that can do something like that, then nothing I can say will persuade you.

Kevin Franck is their Senior Vice President and a licensed audiologist who ran one of the largest audiology clinics in the world at Mass Eye & Ear/Harvard Medical School and he made this statement:

"To me, these early data from small exploratory trials are very encouraging. Each of our responders would have experienced a life-altering improvement and we're beginning to recognize characteristics about them. We've pushed these subjects up on the graph, something no one's been able to do before. As a clinician, I wouldn't hesitate to recommend a drug like this."​

You also seem to greatly underestimate the burden of hearing aids and the hassles that come with them. That is like saying why would someone be willing to get Lasik eye surgery if they aren't willing to wear glasses. FREQ has said that only 20% of people that could be using hearing aids are actually using them. I could see a lot of those remaining 80% of people who aren't willing to live with the hassles of hearing aids be willing to get a one time injection that takes less than 15 minutes to do. Using that same Phase 1/2 data, subject 4 improved enough that he/she could likely stop using hearing aids all together if they wanted and could get by with lifestyle modifications.

According to you that shot in the ear does nothing, but I can guarantee you it provided lifechanging results for those that responded in their trials.

 

[Jurger]

Careful, the shills on copium don't like audiograms here.

"Just crank your hearing aids up to 110 dB bro."

 

[Gb3]

It sounds like you haven't been following them very closely at all.

For starters, 10% is the bar for clinically significant improvements; it does not mean that patients are only improving 10%, it's just the number they have to hit to get FDA approval. The wording they use is "subjects achieved 10% OR GREATER absolute improvement"

Secondly, the 10% scale they use is an absolute measure on a 50 word test so a change of 5 words is 10%. The 10% is not relative to the patients starting score. Many patients have more than doubled their word scores which is life changing for those people.

Using the Phase 1/2 data for example, patient 1 went from hearing 14 words out of 50 to hearing 30 words out of 50 16 months later. That would be labeled as a 30% absolute improvement when it's actually a 100%+ relative improvement for that patient. That patient was functionally deaf before and was a candidate for cochlear implant surgery (which costs between $30,000 to $50,000.) but now that patient can get by with just a hearing aid. If you can't see the value in a drug that can do something like that, then nothing I can say will persuade you.

Kevin Franck is their Senior Vice President and a licensed audiologist who ran one of the largest audiology clinics in the world at Mass Eye & Ear/Harvard Medical School and he made this statement:

"To me, these early data from small exploratory trials are very encouraging. Each of our responders would have experienced a life-altering improvement and we're beginning to recognize characteristics about them. We've pushed these subjects up on the graph, something no one's been able to do before. As a clinician, I wouldn't hesitate to recommend a drug like this."​

You also seem to greatly underestimate the burden of hearing aids and the hassles that come with them. That is like saying why would someone be willing to get Lasik eye surgery if they aren't willing to wear glasses. FREQ has said that only 20% of people that could be using hearing aids are actually using them. I could see a lot of those remaining 80% of people who aren't willing to live with the hassles of hearing aids be willing to get a one time injection that takes less than 15 minutes to do. Using that same Phase 1/2 data, subject 4 improved enough that he/she could likely stop using hearing aids all together if they wanted and could get by with lifestyle modifications.

According to you that shot in the ear does nothing, but I can guarantee you it provided lifechanging results for those that responded in their trials.

I was very hopeful for them in the beginning as well but the data just isn't there. They don't even mention tinnitus anymore. I know people who were in the trials and nothing changed for them.

 

[Chad Lawton]

I was very hopeful for them in the beginning as well but the data just isn't there. They don't even mention tinnitus anymore. I know people who were in the trials and nothing changed for them.

They may not be talking about it but they are still measuring & tracking tinnitus in the currently enrolling Phase 2 trial. FX-322 may not work for everybody as it barely penetrates the first 15% of the cochlea. Some people's hearing loss may not be in that range. Also, do you know how many of those people you know received placebo?

If you hire a piano technician to come fix your piano but he only has the equipment and strings to work on 15% of it, do you expect him to be able to fix every piano he comes across?