Frequency Therapeutics — Hearing Loss Regeneration

[BrStan@]

I've seen it help for some. Time will tell.

This means nothing.

 

[tarmaced]

I don't know if you suffer from hearing loss, but I do. My tinnitus is far worse in the quiet, because it is more obvious to perceive. The world is filled with background noises. If I can better perceive these I know my tinnitus will impact me less. We know there are many different types of tinnitus and I know mine is caused by hearing loss / hair cell damage. Hence I believe this will help my tinnitus Hopefully we can reference you some results in 60 days, though I don't think they will mention tinnitus.

We can point at well educated people and note their logical and well informed opinions that it will help in the meantime, but since you have stated you need solid proof I won't bother. I'm going to look into hearing aids soon, so will keep you informed. I also think this will 'mean nothing' to you, but others may find it of interest.

The proof you ask for is not out there yet and is not available in a format or standard that you will find acceptable. I think you know this.

 

[Earing]

I still can't understand. Can someone please post a link to the clinical trial or a study clearly proving that improving hearing will reduce tinnitus? It looks we hope for something that we wish to be true.

P!ease don't bother with quotes if you can't show proof.

No proof but if tinnitus is the static from no hair cells then hopefully new hair cells will result in reduced static.

 

[GregCA]

I still can't understand. Can someone please post a link to the clinical trial or a study clearly proving that improving hearing will reduce tinnitus? It looks we hope for something that we wish to be true.

That's pretty much the definition of hope: wishing for something to be true.

You can find some evidence yourself if you are willing and able to do a bit of research. Here's a study that shows positive results when improving hearing via hearing aids: https://www.ncbi.nlm.nih.gov/pubmed/31295199

There are more (look into cochlear implants too).

 

[Rb86]

This means nothing.

There's a success story on here where someone got a hearing aid and it reduced their tinnitus significantly.

In addition, my aunt had the same experience.

That's enough evidence to say yes, it certainly could help people, and maybe even eliminate it for mild cases.

 

[Don Tinny]

I still can't understand. Can someone please post a link to the clinical trial or a study clearly proving that improving hearing will reduce tinnitus? It looks we hope for something that we wish to be true.

P!ease don't bother with quotes if you can't show proof.

There are no certainties my friend. A member of Frequency Therapeutics said that "FX-322 probably helps reduce tinnitus" (or something like that).

My hearing seems to be worse since the concert. And my tinnitus is variable. I firmly believe that if my hearing improves the tinnitus symptom will also improve. We are not sure but it is not a crazy hypothesis.

I understand you are having a hard time with tinnitus. I am having a very bad day today too.

 

[Simon Czt]

Do you think this treatment will also help people with hidden hearing loss? In the sense that it might help reduce my tinnitus? I have tinnitus due to an acoustic trauma, but I recently did a hearing test again, and it turns out that my hearing is normal now (on the high frequencies I don't know yet, I'm going to see a specialist within a week who will do a new test on high frequencies for me)

 

[ChrisBoyMonkey]

There are no certainties my friend. A member of Frequency Therapeutics said that "FX-322 probably helps reduce tinnitus" (or something like that).

My hearing seems to be worse since the concert. And my tinnitus is variable. I firmly believe that if my hearing improves the tinnitus symptom will also improve. We are not sure but it is not a crazy hypothesis.

I understand you are having a hard time with tinnitus. I am having a very bad day today too.

Brother, we are on the same page. I feel like mine was improving, but yesterday I tried to find my tinnitus tone and maybe I had the volume to high or something because now my train brakes feel as bad as first day and had to raise the volume of my maskers to early onset level, maybe even higher.

I'm hoping it's just a temporary spike, and I'm also hoping this stuff will knock it out. If course we don't know, but we can hope.

 

[ChrisBoyMonkey]

Do you think this treatment will also help people with hidden hearing loss? In the sense that it might help reduce my tinnitus? I have tinnitus due to an acoustic trauma, but I recently did a hearing test again, and it turns out that my hearing is normal now (on the high frequencies I don't know yet, I'm going to see a specialist within a week who will do a new test on high frequencies for me)

Hidden hearing loss seems to be caused by damage to the nerves. A Stafford researcher has said that nerve endings miraculously reattach to new hair cells if they are restored (If I remember right he was referring to stem cells).

If the nerves do grow back, then it likely would happen here too, and fix the problem.

 

[BrStan@]

There's a success story on here where someone got a hearing aid and it reduced their tinnitus significantly.

In addition, my aunt had the same experience.

That's enough evidence to say yes, it certainly could help people, and maybe even eliminate it for mild cases.

I agree, with mild cases, yes.

 

[rsmcfar]

Frequency reports raising another $62 million in Series C financing.

 

[Lucifer]

https://endpts.com/frequency-follow...d-to-bankroll-phii-of-lead-regenerative-drug/

 

[Rb86]

That's great news. Now if they could just hurry up.

 

[tarmaced]

Thanks for the above; I am hoping that we might get an update on approval strategy at some point...

Especially since this site claims, amongst a few other interesting things, that:

Importantly, Fast Track designated drugs can been approved with phase II data, making robust, early phase trials a more important part in the development process.

Any news in this sense?

With phase 1, 1/2, 2a and 2b(?) it seems Frequency Therapeutics are being robust possibly with the aim of a phase 2 approval?

 

[zhiyuan]

Can someone explain why phase 2 will be split into a / b / c sub phases?

And I found CGF-166 has reached phase 2c, why does it get little attention?

 

[Lucifer]

Can someone explain why phase 2 will be split into a / b / c sub phases?

And I found CGF-166 has reached phase 2c, why does it get little attention?

At this stage we are not too sure what will be after Phase 2a but what I do know is that Regain/Audion is ahead of the game. They are currently on Phase 2 and will have results published in January 2020. I would assume they would go straight to Phase 3.

 

[tarmaced]

Can someone explain why phase 2 will be split into a / b / c sub phases?

And I found CGF-166 has reached phase 2c, why does it get little attention?

I hope this is the case because they are intending to go fast track and get approval (possibly subject to periodical review) with phase 2 data. According to the article I linked above companies will often produce very extensive phase 2 data when they intend to do this. I hope that the difference is they can perform phase 2b before fully processing the results for phase 2b, speeding things up.

 

[JohnAdams]

And I found CGF-166 has reached phase 2c, why does it get little attention?

The technique to deliver that gene therapy is absurd. They surgically remove the eardrum, drill a hole in the cochlea with a laser and then inject the reprogrammed virus into the hole in the cochlea and then reattach the ear drum. Then the virus injects the stem cells in the cochlea with ATOH1.

 

[zhiyuan]

At this stage we are not too sure what will be after Phase 2a

So if phase 2a goes super well, the company will skip into phase 3 directly? I give huge confidence in FX-322 due to its theory. Did such things happen in past?

 

[tarmaced]

So if phase 2a goes super well, the company will skip into phase 3 directly? I give huge confidence in FX-322 due to its theory. Did such things happen in past?

We can't know. The link above suggests this is a possibility...

 

[85dB T]

Another new article just released in Pharma Technologist:

Astellas licenses Frequency's lead drug for $625m
By Ben Hargreaves

22-Jul-2019 - at 14:26 GMT

https://www.in-pharmatechnologist.com/Article/2019/07/22/Astellas-licences-Frequency-drug-for-625m

 

[Rb86]

To me the positive is that we now have a global collective attempt at testing and bringing this therapy to market. Hopefully this gets us through any politics, redundancy, and red tape that prolong drug development in the USA. This is not to say "rush it", because careful testing is necessary, but 10-12 years to bring a drug to market is a little absurd in my opinion.

 

[ChrisBoyMonkey]

To me the positive is that we now have a global collective attempt at testing and bringing this therapy to market. Hopefully this gets us through any politics, redundancy, and red tape that prolong drug development in the USA. This is not to say "rush it", because careful testing is necessary, but 10-12 years to bring a drug to market is a little absurd in my opinion.

Absurdly long? If that's the case I agree; these guys are moving so fast I'm guessing within 3 years. They already have another bigger company helping with globalization!

 

[JohnAdams]

I guess there has to be enough conviction that this is the right way, most people/investors aren't convinced thus far, otherwise there would be more capital. I know you're sold but yeah, that means nothing, have to convince the smart money, and not just a bunch of yahoos on Tinnitus Talk that think they have found the cure.

You think the smart money skipped this over? Time to get a grip on reality maybe?

Now what? What's half a billion dollars to you?

 

[ChrisBoyMonkey]

Now what? What's half a billion dollars to you?

I was just thinking of him when we got news about that too haha.

 

[spedgas]

I hope this doesn't turn into another Theranos.

 

[Striveon]

What phase is this on? How many more phases needed?

 

[Telis]

Now what? What's half a billion dollars to you?

To me personally, a lot.

 

[d'Wooluf]

I hope this doesn't turn into another Theranos.

Look up the resumes of the principals. Is there a chance that it will not work? Yes. Is there a chance of outright fraud? I'd say close to zero.

 

[JohnAdams]

Look up the resumes of the principals. Is there a chance that it will not work? Yes. Is there a chance of outright fraud? I'd say close to zero.

They already said it worked so wouldn't the chance that it will not work be zero?