Frequency Therapeutics — Hearing Loss Regeneration

[Steven__]

Complete

They are getting CIs because they need them and this treatment is not available. It is possible the treatment will help them though it is not knowable given they are having surgery and because it is not possible to image the inner ear.

No.

So it's at phase 2 when we'll know if this treatment actually works ?

 

[Aaron123]

So it's at phase 2 when we'll know if this treatment actually works ?

A phase 2 trial will provide evidence of efficacy. That isn't exactly evidence that it "works". If it were, then there wouldn't be a need for Phase 3 trials! The best evidence of that a treatment works is in phase 3 since it will have a larger sample. Importantly, the phase 2 results will help determine the design of the phase 3 trial.

 

[Contrast]

So I hate to nag with questions but when does stage 2 start? Somewhere ranging from Feb - May of 2018? I know this process is grueling slow

 

[Aaron123]

So I hate to nag with questions but when does stage 2 start? Somewhere ranging from Feb - May of 2018? I know this process is grueling slow

We don't know when it will start. The phase 1 trial stopped early so the February 28, 2018 date is wrong. However, it isn't the case that they can stop a Phase 1 trial one day and start a phase 2 trial the next day. it will take some time, but no one here knows how much time.

 

[Contrast]

The fact that Phase 1 ended earlier then expected seems like a positive thing and that Stage two might indeed start earlier then if it would have taken till mid 2018.

 

[Canadaman]

I think phase 1 did not end early. They "reached all endpoints", which means they know they can measure what they set out to measure (in this case, whether the drug is dangerous).

I'm pretty sure this really means, "we weren't forced to stop testing before the last patient." So there wasn't anything that immediately went obviously wrong.

The trial isn't over yet, since observations are still being collected. E.g. They have to wait to see if the drug causes a delayed adverse reaction. Maybe those people will have their cochleas dissolve in January, etc.

And of course, results need to get assembled and published.

 

[Aaron123]

I think phase 1 did not end early. They "reached all endpoints", which means they know they can measure what they set out to measure (in this case, whether the drug is dangerous).

I'm pretty sure this really means, "we weren't forced to stop testing before the last patient." So there wasn't anything that immediately went obviously wrong.

The trial isn't over yet, since observations are still being collected. E.g. They have to wait to see if the drug causes a delayed adverse reaction. Maybe those people will have their cochleas dissolve in January, etc.

Sorry, but no.

And of course, results need to get assembled and published.

True, but that has nothing to do with the end of the trial.

 

[Contrast]

Is the goal of FX-322 to regenerate hair cells within the middle ear, or inner ear or both?

From what I read the middle ear hair cells deal with amplification and the inner ear hair cells deal with specific frequencies. I'd imagine they are going for both but it could be more complicated. An unfortunate example would be if they have to make a separate drug for the middle and inner ear?


In this video discussing Frequency Therapeutics at 4:50 they mention a "2000 fold on what anyone has shown before" regarding the creation of progenitor cells which are suppose to create hair cells.

Do they mean 2000 possible new hair cells in designated areas, if so does that mean that if Frequency Therapeutics is successful that this could be capable of restoring our hearing to the point of perfection. IE the hearing we are given at birth. I don't expect to take frequencies claims as fact, but I want to know in detail what they are claiming. Sorry if I answered my own questions.

 

[Foncky]

There is no hair cells in the middle ear. It's all in the inner ear. The inner ear has outer hair cells and inner hair cells.

 

[lapidus]

Is the goal of FX-322 to regenerate hair cells within the middle ear, or inner ear or both?

The hair cells are inside the cochlea i.e inner ear. There are no hair cells in the middle ear.
EDIT: Oops. Second on the ball. Foncky was a tad faster.

 

[Contrast]

@Foncky Thank you for correcting my error. So my question remains about FX-322 being designed for both outer and inner hair cell regeneration and not just either or.

 

[Aaron123]

So my question remains about FX-322 being designed for both outer and inner hair cell regeneration and not just either or.

Both. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395286/ for more information.

Do they mean 2000 possible new hair cells in designated areas, if so does that mean that if Frequency Therapeutics is successful that this could be capable of restoring our hearing to the point of perfection. IE the hearing we are given at birth.

No. They mean that when growing hair cells for basic science research, they are able to grow 2000 times more than was previously possible. We have no information about the degree of restoration since nothing has been published on that, but it is very very (very) unlikely, given other damage, that hearing will be restored to "perfection".

 

[jeff W]

if so does that mean that if Frequency Therapeutics is successful that this could be capable of restoring our hearing to the point of perfection. IE the hearing we are given at birth. I don't expect to take frequencies claims as fact, but I want to know in detail what they are claiming. Sorry if I answered my own questions.

One can hear before birth. You would not want the hearing of an infant, it would place you in a most unnatural state. Hearing gently declines throughout childhood and this is normal. I would imagine the hearing of a teenager or thereabouts would be both more useful to us and realistic in terms of results.

 

[Berik]

On the one hand, this is a good thing in general and good business practice. On the other hand, exploring other indications necessarily takes resources away from hearing loss.

https://www.businesswire.com/news/h...ell-Leaders-Join-Frequency-Therapeutics’-PCA™

Well, even more resources it seems

 

[acufenero]

Breakthrough drugs offer hope for the 360 million people with hearing loss

Phase 2 is expected to start in the second half of the year:

In December the company announced the successful completion of a Phase 1 human study of FX-322, Frequency's lead progenitor cell activation drug, demonstrating its safety and tolerability. "We expect to start a Phase 2 clinical study in the second half of 2018," Lucchino said.

 

[Phendran]

Phase 2 is expected to start in the second half of the year:

That is still awfully late though. I'd like to see more speed. Mooooore.

Then again, if we get a cure before 2020 I'll be satisfied.

 

[grate_biff]

Breakthrough drugs offer hope for the 360 million people with hearing loss

Phase 2 is expected to start in the second half of the year:

So we wait... But I believe this is worth waiting for!

 

[Paulmanlike]

This is fast, hope it fixes tinnitus

 

[leledany]

Even if the first phase was conducted to see human tolerability the patients does take the drugs! So if there will be some improvement they could report, am I wrong?

 

[Mortzcent]

I would rather let them take time they need

 

[Aaron123]

So if there will be some improvement they could report, am I wrong?

Unfortunately, you are wrong. The individuals who received FX-322 also had inner ear surgery and received cochlear implants so it is not possible to know what effect, if any, that FX-322 had.

 

[Coleoptere]

Curious what they will do in the first half of this year. Phase 1 has been completed and FX-322 has been tested in animals and stays as it is so I suspect paperwork or test setup for phase-2?

 

[Rubenslash]

Curious what they will do in the first half of this year. Phase 1 has been completed and FX-322 has been tested in animals and stays as it is so I suspect paperwork or test setup for phase-2?

FDA needs to give approval etc, all takes a while.

 

[Jim51042]

FDA needs to give approval etc, all takes a while.

The FDA approval is a waste of time; they should start tomorrow

 

[Steven__]

"Although one or more drugs that might temporarily or permanently repair inner-ear damage and restore hearing loss is still several years away from commercial availability" 7 years is too long for me. 5 or less is better anyways I'm glad that I'll most likely won't have this all my life. Hopefully lmao

 

[Contrast]

I wonder if the US Federal Government paid more interest in science if there would be more advancements quicker.

 

[leledany]

Unfortunately, you are wrong. The individuals who received FX-322 also had inner ear surgery and received cochlear implants so it is not possible to know what effect, if any, that FX-322 had.

So the persons who took FX-322 are heroes? Which is the sense to take a novel drug if you cannot have benefits? Are they payed?

 

[Rubenslash]

So the persons who took FX-322 are heroes? Which is the sense to take a novel drug if you cannot have benefits? Are they payed?

Yes, as in all other clinicial trials.

 

[Jomo]

I wonder if the US Federal Government paid more interest in science if there would be more advancements quicker.

Not about money IMO. There are already plenty of people out there trying to figure our problem out. The reward is too big. Part of the problem is lack of understanding and awareness until the past 20 years and how complicated the brain and ear connection is.

 

[Contrast]

@Jomo I know some of the brightest scientist in the field of audiology neurology and regenerative science are truly devoted to trying to offer real solutions for Tinnitus but from what I am reading there isn't enough funding and awareness in general about tinnitus, as well as what you stated about Tinnitus being possibly an extremely complicated neurological issue. I am just suggesting that more Federal funding will speed up the process.