Frequency Therapeutics — Hearing Loss Regeneration

That's not totally true. FX-322 first multiplies the supporting cells and then transdifferentiates them into hair cells. Audion's drug does the transdifferentiation without multiplying the supporting cell first.

They both cause the supporting cell to transform into a hair cell. FX-322 just does it with depleting the supporting cells. The main mechanism is the restoration of the hair cells.

FX-322 does not transdifferentiate new supporting cells into hair cells. It causes supporting cells to divide. Some of the new cells are hair cells, some of them are supporting cells. You're suggesting the new hair cells were supporting cells before they became hair cells. That's not the case.

Source:
http://www.cochlea.eu/en/research-lines/regeneration
 
Audion's drug does the transdifferentiation without multiplying the supporting cell first.

Has Audion confirmed that this is a one time treatment only.If you get a second acoustic trauma then your screwed?If so,I'd rather wait out for FX-322 or another similar treatment.Of course,as times goes on,and if Audion turns out to be a success,desperation may make me want to jump on ship.Time will tell I guess.
 
Has Audion confirmed that this is a one time treatment only.If you get a second acoustic trauma then your screwed?If so,I'd rather wait out for FX-322 or another similar treatment.Of course,as times goes on,and if Audion turns out to be a success,desperation may make me want to jump on ship.Time will tell I guess.
Yes, that's the downside of using only gamma secretase inhibitors: the number of supporting cells decreases, since those cells turn into hair cells. There was a study in mice (from 2013, I think) where they showed this reduction. The good thing was that the treatment indeed improved ABR scores at low frequencies for the treated mice, somehow proportionally to the number of hair cells regenerated -- at least that was my impression when I looked at the charts, I haven't read the whole study carefully. That's why I think Frequency is a few steps ahead of the others: in theory, if it works, you could use it multiple times; just in case you screw up your ears again after a treatment, you know...

PS: doesn't mean that it is a one-time treatment only, but certainly the number of supporting cells decreases with each injection.
 
Has Audion confirmed that this is a one time treatment only.If you get a second acoustic trauma then your screwed?If so,I'd rather wait out for FX-322 or another similar treatment.Of course,as times goes on,and if Audion turns out to be a success,desperation may make me want to jump on ship.Time will tell I guess.
The cochlea doesn't regenerate supporting cells as far as I know. So if you have hearing loss at let's say 4000-8000 Hz and the supporting cells at those frequencies become hair cells thus depleting the supporting cells located at those frequencies, I don't think you can repeat the treatment or at least it won't be as effective. We also don't know the exact function of supporting cells so depleting them might have effects we are not aware of yet.

On the other hand, should you get hearing loss at different frequencies than 4000-8000 Hz, I can imagine you could get the treatment again.

That's why I think FX-322 and Regain could work together nicely.
 
The Audion drug for the Regain project is essentially the exact same technology. It has been reported that a trial participant for that drug did in fact have their tinnitus and hyperacusis reduced. Hearing aids make many people's tinnitus go down or away entirely. If this does in fact improved hearing, the evidence is overwhelming that it will help.
Sometimes hearing aids help my tinnitus and sometimes they don't. The noise could be coming from my upper neck, hard to tell. I went to a chiro on Friday and seem worse today.
 
FX-322 does not transdifferentiate new supporting cells into hair cells. It causes supporting cells to divide. Some of the new cells are hair cells, some of them are supporting cells. You're suggesting the new hair cells were supporting cells before they became hair cells. That's not the case.

Source:
http://www.cochlea.eu/en/research-lines/regeneration
That article seems to state that the brain doesn't automatically calibrate the new hair cells by itself. However, I remember reading somewhere that the auditory nerve can detect when new hair cells grow. Can anyone clarify this?
 
Robert Jackler at Stanford University stated that when the hair cell regenerates that the nerve regrows and reconnects and called it a "miracle".
That phrase stuck with me too.

Still I do wonder how they could have observed this? In vivo? In vitro? What experiments were they doing? The video was from back in 2012 if I'm not mistaken.

I do hope he's right!
 
That article seems to state that the brain doesn't automatically calibrate the new hair cells by itself. However, I remember reading somewhere that the auditory nerve can detect when new hair cells grow. Can anyone clarify this?
Yeah, I don't think you should read that as "after the new hair cells are there, we need another treatment that grows the nerve endings". I think it reads as "new hair cells aren't enough, they need to be able to transmit a signal to the brain". That's exactly why Otonomy and Rinri Therapeutics are focused on regenerating the nerves (I think they focus on different missing nerves). We know there are people that have their hair cells, but are missing the nerve endings.

This is also why I don't think at all 2020 will be a fruitless year until Frequency publishes Phase 2a results. I think we'll get plenty of studies of other drugs that can answer these types of questions, even though they use different methods of regenerating hair cells. It's very easy: if Novartis announces, for example, a 10 dB gain in some patients that were treated with CGF-166, we'll know for pretty damn sure regrown hair cells are fully functioning.
 
Miracle implying doesn't usually happen or happens?
Miracle implying that it is a miracle of nature so positive that without it, this entire exercise wouldn't work. That kind of miracle. Thank goodness if introducing more hair cells that they reconnect to the brain.

The opposite of a miracle? That evolution has provided humans without the facility to regrow cochlear hair cells and hence only recourse is to make this happen biologically by chemical injection. Evolution has granted other animals this facility but not humans. Good news is humans are becoming smart enough to make this happen by studying animals that do it biologically.

Another example of a miracle? That peripheral nerves on humans grow back when injured... on some level. When a person suffers a bad concussion the nerves within the brain can regenerate on some level... or other nerves can 'stand in' to do the work.

The opposite of a miracle? The central nervous system does not regenerate. If a person gets their spinal cord severed, it doesn't grow back. Humans will figure out how to solve this as well.
 
Stock is back up to $14 per share right now. I wonder if it starts to take off as more people become aware of what they are doing.
 
Robert Jackler at Stanford University stated that when the hair cell regenerates that the nerve regrows and reconnects and called it a "miracle".
Saager & others (2017)
 

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It's smarter to short FREQ, then you win in both scenarios. If the therapy works, you will get hearing improvement/lower tinnitus and if it doesn't work, at least you made some money.

Timing the market on margin effectively would require you to know when they are reporting in H2 of next year. Until results are posted, the fluctuations are just speculative.

You could always buy long term puts (or calls) but those are expensive and if the timing of reporting changed for any reason, they could expire worthless either way.

Buying puts (or calls) based on if the therapy works is really far out/expensive at this point and involve additional risks that have nothing to do with the effectiveness of the drug at this point.
 
FX-322 in Adults With Stable Sensorineural Hearing Loss
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Recruitment Status: Recruiting
First Posted: October 9, 2019
Last Update Posted: October 9, 2019

Contacts
Contact: Clinical Trials Information Desk 800-839-9241 ClinicalTrialsInformation@FrequencyTx.com

Locations
United States, North Carolina

https://clinicaltrials.gov/ct2/show/NCT04120116
 
FX-322 in Adults With Stable Sensorineural Hearing Loss
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Recruitment Status: Recruiting
First Posted: October 9, 2019
Last Update Posted: October 9, 2019

Contacts
Contact: Clinical Trials Information Desk 800-839-9241 ClinicalTrialsInformation@FrequencyTx.com

Locations
United States, North Carolina

https://clinicaltrials.gov/ct2/show/NCT04120116
This is in my state! I hope I am eligible since my up to 8000 Hz audiogram is normal.
 
This is in my state! I hope I am eligible since my up to 8000 Hz audiogram is normal.
Are you? High frequency audiometry is one of the tests they will use, but high frequency hearing loss doesn't seem to fall in the inclusion criteria. Your PTA is probably not within 26-70 dB.
 
I thought they were going to have this in multiple states, not just one. How is this any better than the one in Texas? Plus, you could still be one of the people who receives nothing but the placebo.
 

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