Frequency Therapeutics — Hearing Loss Regeneration

[Gb3]

I don't know what you mean by larger? Looking at it, it won't be larger than the first single dosing trial in terms of numbers.

Larger meaning more people.

 

[Gb3]

This means barely anyone will qualify to enter, and the stock talk will start again, as the rich get richer.

Do you know how they get rich? If the drug works!

 

[Piney]

By "barely anyone will qualify to enter"... I think you mean, "patients that can show the drug is effective vs placebo will qualify to enter"...

Then we'll see how many on Tinnitus Talk enter when the time comes. Since everyone on here has tinnitus, one person will have good results, correct?

They've had some trials already, someone had to have gotten the drug, even the one which was botched while the company sold stock and made money.

 

[Gb3]

Then we'll see how many on Tinnitus Talk enter when the time comes. Since everyone on here has tinnitus, one person will have good results, correct?

They've had some trials already, someone had to have gotten the drug, even the one which was botched while the company sold stock and made money.

Do you even know what FX-322 is for? Honestly you come across as wicked dumb.

 

[Lukee]

Do you even know what FX-322 is for? Honestly you come across as wicked dumb.

I don't think he understands how stocks work or how trials work.

 

[Lucifer]

We can ask Will McLean some questions through podcast@frequencytx.com and he will answer them in episode #3 of Overheard at Frequency podcast.

Some of the questions I would like to ask him are about if future trials can be shortened from a year to 6 months or less, especially since they are using a single dose now compared to the multi-dosing trial.

 

[Street Novelist]

Can someone ask when the next trial will start and who will it be targeting? Mild? Moderate?

 

[Lucifer]

Can someone ask when the next trial will start and who will it be targeting? Mild? Moderate?

If the severe hearing loss results aren't good, then the Phase 2 repeat trial will be for mild-moderately severe hearing loss sufferers.

 

[Exit]

If the severe hearing loss results aren't good, then the Phase 2 repeat trial will be for mild-moderately severe hearing loss sufferers.

When will we get severe hearing loss results...?

Hugs.

 

[Lucifer]

When will we get severe hearing loss results...?

Hugs.

Someone stated October/November.

 

[Juan]

Trial and error is a part of science, yes, but Edison's ignorance meant he worked hard, not smart.

I'm reading a huge book on him, just starting, and the guy was obsessed with the phonograph, despite being quite deaf, and insisted on trusting what was left of his hearing to judge "quality" of sound. He hated radio when it was invented.

Deaf people can be "strange" according to my ENT, because hearing quality perception varies and there are deaf people who can perceive low sounds, but not understand language etc... How to assess the quality of sound must perceived (music, speech, sounds over noise, competing sounds, overlapping sounds etc) must be an interesting field.

But saying that, it seems foolish that a very deaf person like Edison was the one to judge the quality of sound produced by music equipment.

 

[RichieTheKid]

I must apologize Richie if I came across as abrupt. It was more a spontaneous reply. I got my tinnitus in 1992 so you can see that I had my abrupt answer off pat.

We gotta be gentler with one another -- and that's not easy.

Back in the 90's I heard that there's some academic paper out there titled: "The angry tinnitus patient". Well wouldn't you be impatient if you were waiting near on 30 years.

It's cool. I wasn't even offended or realised anything by it lol. Don't think too deep into it mate.

 

[Diesel]

View attachment 45947

We can ask Will McLean some questions through podcast@frequencytx.com and he will answer them in episode #3 of Overheard at Frequency podcast.

Some of the questions I would like to ask him are about if future trials can be shortened from a year to 6 months or less, especially since they are using a single dose now compared to the multi-dosing trial.

It's cool they're allowing audience questions. Just one piece of advice, anyone asking a question using the word "CURE" or a specific future date question, i.e. "WHEN will this be available?" will quickly be disappointed when they throw out your question.

Need to be more tactful. Like, "How do you see FX-322 being used as a treatment for tinnitus from NIHL?"

 

[El BUZZ]

Haven't the recent results shown that FX-322 has been found to be ineffective?

 

[GlennS]

Haven't the recent results shown that FX-322 has been found to be ineffective?

And so the thread circles back again.

 

[Piney]

Do you know how they get rich? If the drug works!

They get rich by selling their stock high through hype, getting money even though the drug doesn't work. Not a bad gig. Produce no cure, still get money.

Do you even know what FX-322 is for? Honestly you come across as wicked dumb.

I'm not so wickedly dumb; when I lived in Boston's north end; to see how arrogant some New England residents are, believing they're intellectually superior to others. Frequency Therapeutics should produce quality results before they start padding their pockets, that's just how I see it.

 

[Mentos]

It's cool they're allowing audience questions. Just one piece of advice, anyone asking a question using the word "CURE" or a specific future date question, i.e. "WHEN will this be available?" will quickly be disappointed when they throw out your question.

Need to be more tactful. Like, "How do you see FX-322 being used as a treatment for tinnitus from NIHL?"

It would be interesting to see though how they are prepared to answer these blunt questions.

 

[Joeseph Stope]

What's a body to do. I'm sure lots of people have hard uncomfortable questions, but that's the American way. They are fighting on our side.

 

[EkkoMusic]

Perhaps I just don't know enough about FX-322's mechanics, but is it accurate to say that the drug preferentially targets the extended high frequencies? Or (as I understood it previously) it seems to target the inner hair cells throughout the cochlea? A little confused, could someone clarify the role FX-322 plays in extended high frequencies compared to others?

I also ask because I'm sure many sufferers have tinnitus due to losses in their EHFs, and if FX-322 accesses that area effectively, this could be valuable for us (though I believe the outer hair cells are what would need to be repaired? I'm curious if Frequency Therapeutics has implemented EHF pure tone testing in their trials if they suspect this to be the area of greatest improvement, and what those results may be).

 

[Gb3]

Perhaps I just don't know enough about FX-322's mechanics, but is it accurate to say that the drug preferentially targets the extended high frequencies? Or (as I understood it previously) it seems to target the inner hair cells throughout the cochlea? A little confused, could someone clarify the role FX-322 plays in extended high frequencies compared to others?

I also ask because I'm sure many sufferers have tinnitus due to losses in their EHFs, and if FX-322 accesses that area effectively, this could be valuable for us (though I believe the outer hair cells are what would need to be repaired? I'm curious if Frequency Therapeutics has implemented EHF pure tone testing in their trials if they suspect this to be the area of greatest improvement, and what those results may be).

You're a little late to the party my dude.

 

[Joeseph Stope]

Perhaps I just don't know enough about FX-322's mechanics, but is it accurate to say that the drug preferentially targets the extended high frequencies? Or (as I understood it previously) it seems to target the inner hair cells throughout the cochlea? A little confused, could someone clarify the role FX-322 plays in extended high frequencies compared to others?

I also ask because I'm sure many sufferers have tinnitus due to losses in their EHFs, and if FX-322 accesses that area effectively, this could be valuable for us (though I believe the outer hair cells are what would need to be repaired? I'm curious if Frequency Therapeutics has implemented EHF pure tone testing in their trials if they suspect this to be the area of greatest improvement, and what those results may be).

How would I best put it?

You are worshipping at the Frequency Church.

A new mission has been set up called the Church of Otonomy.

And the very latest is Prof de Ridder.

 

[Christiaan]

How would I best put it?

You are worshipping at the Frequency Church.

A new mission has been set up called the Church of Otonomy.

And the very latest is Prof de Ridder.

I think we all feel a bit like Michael J. Fox in the movie Teen Wolf. Let's hope our story has the same happy ending as the 80's classic

 

[Chad Lawton]

So I recently sat down and watched the Q&A that Carl LeBel participated in last year with the HLAA. He made some VERY interesting remarks about drug delivery at the 27:28 mark. He says "We are confident that we'll be able to advance the field with respect to drug delivery and I could imagine a day where there is a drug designed specifically for low frequency hearing loss..."



I wonder if this is something they may reveal at R&D day...

Also, I'm firmly in the "it's not just a placebo effect" camp.

In their Phase 1/2 study they didn't have any placebo responders (okay, sure it was a small group) but then in their age related hearing loss study with 30 subjects, they didn't have any responders in either the drug group or the placebo group. If it were one giant placebo, surely we would have seen a couple responders in either the drug group or the placebo group in the age related study regardless of if the drug worked or not.

As for their Phase 2a study, the placebo arm was only 30% of the size of the drug recipient arm so it only took a few placebo responders to ruin the entire 90 person study. Out of the 64 participants that received at least one dose of FX-322 and completed the study, 30 saw a clinically significant improvement. Out of the placebo group that completed the study, 10 out of 21 saw a clinically significant improvement. So roughly 50% of both groups saw improvement and this is where we get the "it showed no benefit over placebo" statement from. If it was a 1:1 ratio of drug to placebo, I'd be more concerned about the results. I can believe the company's claims they've made about the placebo responders based on those numbers.

 

[Pete88]

So I recently sat down and watched the Q&A that Carl LeBel participated in last year with the HLAA. He made some VERY interesting remarks about drug delivery at the 27:28 mark. He says "We are confident that we'll be able to advance the field with respect to drug delivery and I could imagine a day where there is a drug designed specifically for low frequency hearing loss..."

I wonder if this is something they may reveal at R&D day...

Also, I'm firmly in the "it's not just a placebo effect" camp.

In their Phase 1/2 study they didn't have any placebo responders (okay, sure it was a small group) but then in their age related hearing loss study with 30 subjects, they didn't have any responders in either the drug group or the placebo group. If it were one giant placebo, surely we would have seen a couple responders in either the drug group or the placebo group in the age related study regardless of if the drug worked or not.

As for their Phase 2a study, the placebo arm was only 30% of the size of the drug recipient arm so it only took a few placebo responders to ruin the entire 90 person study. Out of the 64 participants that received at least one dose of FX-322 and completed the study, 30 saw a clinically significant improvement. Out of the placebo group that completed the study, 10 out of 21 saw a clinically significant improvement. So roughly 50% of both groups saw improvement and this is where we get the "it showed no benefit over placebo" statement from. If it was a 1:1 ratio of drug to placebo, I'd be more concerned about the results. I can believe the company's claims they've made about the placebo responders based on those numbers.

Thanks for the breakdown. I subscribe to the idea that the drug, in its current delivery form, does repair hearing to a limited but still remarkable extent. At least relative to what's currently available. Phase 2a wasn't a failure of the drug, just a failure of a trial.

 

[Chad Lawton]

Thanks for the breakdown. I subscribe to the idea that the drug, in its current delivery form, does repair hearing to a limited but still remarkable extent. At least relative to what's currently available. Phase 2a wasn't a failure of the drug, just a failure of a trial.

I agree. I've been following the company closely ever since the botched Phase 2a and have since started investing heavily in them so I'm always looking to soak up any new information I can on the company.

 

[tommyd87]

Thanks for the breakdown. I subscribe to the idea that the drug, in its current delivery form, does repair hearing to a limited but still remarkable extent. At least relative to what's currently available. Phase 2a wasn't a failure of the drug, just a failure of a trial.

It is inevitably possible that multi dosing could work. What would have to be identified first though would be how long it takes for a single dose to provide benefit if this treatment is successful and then once this is finished then look at proceeding to a subsequent dose.

 

[Pete88]

It is inevitably possible that multi dosing could work. What would have to be identified first though would be how long it takes for a single dose to provide benefit if this treatment is successful and then once this is finished then look at proceeding to a subsequent dose.

I've honestly never been super optimistic about the multi dosing hitting lower frequencies, it just never made sense to me. Full disclosure, I do not have any qualifications to even warrant an opinion that challenges the beliefs of the brilliant minds who are working on this drug.

 

[Chad Lawton]

It is inevitably possible that multi dosing could work. What would have to be identified first though would be how long it takes for a single dose to provide benefit if this treatment is successful and then once this is finished then look at proceeding to a subsequent dose.

Agreed. This isn't just regular medicine; its regenerative, its localized and it works on chemical messengers. It's completely believable to me that dosing too often could inhibit the process. You put a dose in the ear and tell the progenitor cells to start their mitotic regeneration, then you come back a week later and interrupt those same cells by telling them to start over when they barely have even got started. The analogy I used was it's like trying to bake a cake in the oven but every 5 minutes you open the oven door and add another egg and some extra flour rather than just leaving the cake alone and letting it does its thing.

 

[Damocles]

it's like trying to bake a cake in the oven but every 5 minutes you open the oven door and add another egg and some extra flour rather than just leaving the cake alone and letting it does its thing.

Mate, that's gonna be one disgusting cake.

 

[NewLionel]

Mate, that's gonna be one disgusting cake.

That cake has potential...