Frequency Therapeutics — Hearing Loss Regeneration

[GlennS]

You only have word score troubles when you lose a lot of IHCs.

I await evidence that regenerating IHCs alone (the straw you're clutching at to suggest FX-322 is still efficacious) will assist with tinnitus.

 

[Cernuto]

This looks similar to what you are suggesting:

Steady streaming as a method for drug delivery to the inner ear

There's also cochlear pumping, which looks more promising to me in the mechanical category:

Local Drug Delivery to the Entire Cochlea without Breaching Its Boundaries

That's better than what I was thinking because they actually did it? We probably already have the technologies although integrating them is a whole other story. With the pace of the FDA process, maybe in my lifetime, I will see something.

I still strongly believe this is better served by research from a university where we test subjects sign whatever piles of disclaimers needed for the purposes of accelerating the development.

 

[FGG]

I await evidence that regenerating IHCs alone (the straw you're clutching at to suggest FX-322 is still efficacious) will assist with tinnitus.

That's not even my position though. I think it prefers IHCs, not that it can only grow IHCs.

We have some tinnitus anecdotes. Look forward to hearing more.

 

[Gb3]

This is my audiogram. Do you think I would qualify for the severe hearing loss trial?

 

[Lucifer]

You only have word score troubles when you lose a lot of IHCs.

This is why I think they were inadvertently selecting for "the unconscious biasers". Because you need people not in the severe range on audiogram (OHCs) but who happen to have lost a lot of IHCs. That's not usually how it works naturally...

Words in noise is very correlated to synaptopathy btw, which is separate from IHC loss and OHC loss.

You could also have synaptopathy if you struggle a lot with speech in noise issues.

I'm fine with words in noise if I'm on the same table as the person talking to me but I probably would not be able to hear conversation across the room, maybe that would be normal for a person, so I don't have trouble with words in noise anyway.

I'm going to go with OHCs and synapses causing both pain and loudness hyperacusis for me. I do hope there were some OHC regrowth in the Phase 1b and that dosing monthly would be a better solution for OHC regrowth.

 

[Diesel]

You're not understanding how this works. If Phase 2a was a success, the doubters knew all along. If it was a failure, it's all your fault. If Phase 2a results were a slam dunk, it overrides Phase 1. Since it's not, Phase 1 is the real efficacy test. If an audiologist agrees with you, it means you're right. If they disagree with you, it's because they are trying to sabotage the regeneration medicine industry.

If it turns out all of the 3 super responders were legit, I'm going to pretend like I never questioned how it happened. If the second Phase 2 is successful, I'm going to say that I was intentionally a bear to challenge our beliefs -- please thank me. If it's a failure, I'm going to say that I was so smart.

Any placebo patients that improve are diabolic lunatics, plotting to destroy the operation. Any FX-322 patients that improve are choir boys, have never uttered a swear word before, and gleefully showed off their improved hearing signal that was cleaner than a baby's bottom.

If someone's tinnitus got better, it was from the drug, but if it got worse, it was from the evil clinician who injured their middle ear.

If people enjoy this post, it's because I'm clever. If not, it's because I wasn't being serious.

Everyone reading this right now...

 

[Diesel]

This is my audiogram. Do you think I would qualify for the severe hearing loss trial?

View attachment 44344

No, your blue ear doesn't average a PTA of 71-90 dB. But you probably would have gotten into the Phase 2A.

 

[Diesel]

This looks similar to what you are suggesting:

Steady streaming as a method for drug delivery to the inner ear

There's also cochlear pumping, which looks more promising to me in the mechanical category:

Local Drug Delivery to the Entire Cochlea without Breaching Its Boundaries

Did you read this? RIP to anyone with hyperacusis.

 

[Gb3]

No, your blue ear doesn't average a PTA of 71-90 dB. But you probably would have gotten into the Phase 2A.

Do you think my word score was bad enough for Phase 2a?

 

[Zugzug]

Everyone reading this right now...

View attachment 44345

It's going to suck if a repeat of Phase 2 approaches and I legitimately start believing in its success again. Right now, it's super easy to be a bear. I'm like a band wagon bear.

When things eventually start succeeding with hearing regeneration (who knows how long that will be?), I'm going to be against the world.

"Zugzug, how do you explain that that none of the placebos improved and 85% of the treated group has clinically meaningful improvements in WR, WIN, and PTA?"

I'll have to come back over if I am check mated and literally can't come up with a bear argument. I don't see this happening anytime soon though.

 

[Diesel]

Do you think my word score was bad enough for Phase 2a?

Obviously you could have faked it... pfffft.

 

[Diesel]

It's going to suck if a repeat of Phase 2 approaches and I legitimately start believing in its success again. Right now, it's super easy to be a bear. I'm like a band wagon bear.

When things eventually start succeeding with hearing regeneration (who knows how long that will be?), I'm going to be against the world.

"Zugzug, how do you explain that that none of the placebos improved and 85% of the treated group has clinically meaningful improvements in WR, WIN, and PTA?"

I'll have to come back over if I am check mated and literally can't come up with a bear argument. I don't see this happening anytime soon though.

Same people calling you names and saying "IT DOESN'T WORK!" will then be saying, "IT DOES WORK!" and still calling you names...

 

[FGG]

Do you think my word score was bad enough for Phase 2a?

They never published their criteria but apparently people weren't taking chances...

 

[RichieTheKid]

I think this is perfectly normal. Regeneration of hearing hasn't been attempted before. The anecdotal evidence and the Phase 1 and pre-clinical testing tells me they're on to something. Those support cells that are the same ones in the intestines aren't just there for show. What a massive discovery, to think all this time in human history they were just there all along. Shows me how much we do not know. I still think Frequency Therapeutics should investigate synapses though.

 

[Paulmanlike]

We have some tinnitus anecdotes. Look forward to hearing more.

Anecdotes.

If they were given sugar pills, with tinnitus, there would be anecdotes.

 

[FGG]

Anecdotes.

If they were given sugar pills, with tinnitus, there would be anecdotes.

Well until we get an objective measure of tinnitus, unfortunately all we have is patient input...

 

[Lucifer]

Well until we get an objective measure of tinnitus, unfortunately all we have is patient input...

Another 3-6 months of waiting trial results :'(

 

[Street Novelist]

This looks similar to what you are suggesting:

Steady streaming as a method for drug delivery to the inner ear

There's also cochlear pumping, which looks more promising to me in the mechanical category:

Local Drug Delivery to the Entire Cochlea without Breaching Its Boundaries

Why is this method not being utilized?

 

[RingingBrother]

By the way, they observed a significant higher rate of adverse events in higher injections cohorts. Phase 2a single injections were safer, but were also found to have more adverse events compared to Phases 1/1b/1-2 single injections.

They just said that multiple dosing is not a viable option, literally.

What were the adverse events?

 

[Lucifer]

What were the adverse events?

There were no side effects with the multi-dosing, just that it wasn't as effective as the single dosing in Phase 1b.

 

[FGG]

There were no side effects with the multi-dosing, just that it wasn't as effective as the single dosing in Phase 1b.

They didn't say that, only that no side effects were serious. They did say there were more side effects in the Phase 2a dosing though.

 

[Lucifer]

They didn't say that, only that no side effects were serious. They did say there were more side effects in the Phase 2a dosing though.

I didn't know they said that, my bad.

 

[Street Novelist]

Can someone explain what cochlear pumping is? I Googled it but couldn't get a definition.

 

[just1morething]

To some this means "the drug is dead". To others (including myself) it means "the drug is flawed. So let's fix it if we can".

I think you mean Frequency Therapeutics scientists fix it. I doubt if any of their scientists read this thread for any advice. If the drug isn't dead you should be loading up on FREQ stock at these low levels. It might be cheap for a reason. Time will tell.

 

[Cernuto]

Why is this method not being utilized?

Looks to me like it takes about 5 hours to reach the deep parts. You'd have to lay there for 5 hours with this thing in your ear. I would do it. Maybe they can knock you out first or they can refine the process to speed it up.

 

[Gb3]

I didn't know they said that, my bad.

No treatment-related serious adverse events were observed in the study.

Straight from the press release.

 

[Jaysterk]

Ok so I've been in and out of here since Frequency Therapeutics posted their trial results. I understand the results were less than favorable.

So for the not so bright like me, are they going to continue with their research? Is one shot potentially more beneficial perhaps if it penetrates deeper into the cochlea... or are we all going to die with tinnitus and hyperacusis? Timelines?

 

[Sunshine007]

You're not understanding how this works. If Phase 2a was a success, the doubters knew all along. If it was a failure, it's all your fault. If Phase 2a results were a slam dunk, it overrides Phase 1. Since it's not, Phase 1 is the real efficacy test. If an audiologist agrees with you, it means you're right. If they disagree with you, it's because they are trying to sabotage the regeneration medicine industry.

If it turns out all of the 3 super responders were legit, I'm going to pretend like I never questioned how it happened. If the second Phase 2 is successful, I'm going to say that I was intentionally a bear to challenge our beliefs -- please thank me. If it's a failure, I'm going to say that I was so smart.

Any placebo patients that improve are diabolic lunatics, plotting to destroy the operation. Any FX-322 patients that improve are choir boys, have never uttered a swear word before, and gleefully showed off their improved hearing signal that was cleaner than a baby's bottom.

If someone's tinnitus got better, it was from the drug, but if it got worse, it was from the evil clinician who injured their middle ear.

If people enjoy this post, it's because I'm clever. If not, it's because I wasn't being serious.

Good one

At the end of the day we let the data take us where we want to go or where we have to go

 

[Lucifer]

@FGG, I'm just looking at the previous Phase 1b trials that showed positive outcomes. I forgot what the answer is, but did they say if there were any improvements in the audiograms for the two Phase 1b trials?

 

[Lucifer]

I think you mean Frequency Therapeutics scientists fix it. I doubt if any of their scientists read this thread for any advice. If the drug isn't dead you should be loading up on FREQ stock at these low levels. It might be cheap for a reason. Time will tell.

If the age-related and severe hearing loss trials have positive outcomes, I expect the share price to go up to $20. If they announce a pivotal phase, the share price will go back up to $60 or more. At the current price the stock is a bargain.