Frequency Therapeutics — Hearing Loss Regeneration

I dont think there is a limit, but 50db is moderate loss which is what they are saying will still work.

 

No, I don't believe so. If it works as advertised, supporting cells at particular locations will be restored and will restore the frequencies associated with particular hair cells.

 

That's depressing. That means that hair cells completely wiped out along with their supporting cells in upper frequencies, causing profound deafness in those regions, may mean that tinnitus will not be eliminated, if loss in those frequencies is its cause.

 

@Fabrikat Please don't get depressed. We're all just guessing here. Frequency Tx was able to get supporting cells to regenerate and divide in the lab, so they may be able to do the same in a person.

 

Here's a short radio interview with co-founder David Lucchino. Summary:

• They are still working on the drug.
• They're testing one single injection with "significant promise".
• It most likely won't work for "genetic hearing loss".
• The article published back in February included most but not all the preclinical intel they got. New paper is on the way with new data.
• He believes the drug could be on the market in three to five years if they can push FDA to approve it (I'm not English so this may not be accurate, please someone check min. 4:46).

 

Hoping is the only thing i can do
Its been three terrible months of my brain overloading all day long and i just wish i could wake up one day without T and have my solid stereo hearing back

Wish that for everybody

 

Guys, I have been thinking...for profound hearing loss, which therapy can work? I read in this thread only cochlear implants work for profound hearing loss. But implant for me hasn't achieved anything. Is it true by being implanted, the cochlea is destroyed and removing the implant surgically the cochlea cannot be returned to its form before implant surgery?

 

I wouldn't say "destroyed", but it does seem like the expectation is that the implantation is going to damage the cochlea to some extent. The doctors try to minimize this damage, but it's a difficult task.

 

I'm just having second thoughts whether to leave the electrode in or remove it. My surgery is due soon and I been debating with the idea. When I questioned the surgeon, he did say either way my cochlea is damaged. Don't know if he meant surgery wise but for hearing it is

 

I don't know if it's possible to find out what gets damaged in the process. Maybe whatever is damaged is something that some med treatment can try to "regrow" in the future.

 

Thanks Greg for the reassurance. Just worried at looking at the possible trials starting soon eg FXT and Horizon 2020; I can't find anything related to profound hearing loss. Sure, these might work for my other ear which has severe loss.

 

@Iliasp Let's just hope it works, period!!!

 

very interesting to listen

David Lucchino (Co - Founder Of Frequency Therapeutics) interview :

http://www.wrko.com/media/audio-channel/david-lucchino-co-founder-frequency-therapeutics

 

How much hearing loss do they expect to "regain" with this therapy? 10, 20, 50 db?

 

It's nice to hear someone so enthusiastic and intelligent about their research. I hope they make a lot of money off of this!

 

Question.

I know this product is to treat sensorial hearing loss primarily. What about for those people with tinnitus and no hearing loss where the suspected cause is noise over the years? Am I right to get excited about this product? Would I still be able to have the injection anyway to repair damage to see if it fixes the tinnitus? All these questions going through my mind and hoping one day tinnitus will no longer be an issue in my life.

 

1 to 50 (or more !) I believe

 

Be serious please, if they aim to regain only 20 db they wouldn't even bother to start clinical trials as hearing aids are usually more efficient.

 

There is no answer for now, so giving a number is impossible.

I don't agree with your statement though. They are focused on regenerative medicine. 20dB would mean it works, so it'd be totally worth a clinical trial before improving the technology and going further.

 

- They will be releasing a new paper with "data that will continue to capture the imagination of the scientific community"

- They hope to have something on the market in 3-5 years

- "Favourable interactions" with the FDA, so far

 

No, I have read somewhere before that it will only be approved by regulators if it is more efficient than hearing aids. I am not sure 20 db regeneration meets that definition.

 

It is no surprise that they are working on another paper. I will wait to see whether it captures the imagination of the scientific community. He is the CEO after all. What do you expect him to say?

Again, he is the CEO, what do you expect him to say?

I'd like to see the source for that statement.

You should look into Decibel Therapeutics. Frequency might be appropriate if you have high frequency hearing loss. Once it is on the market, the main issue you will face (in the US at least) is paying for it. It will likely be very expensive, and insurance will not pay "to see if it fixes tinnitus" because that will almost certainly be an off-label use.

 

Yep, fair enough, I'm just bulletpointing what he said

 

I know.

My takeaways were 1) he said the first paper contained most of the pre-clinical data which if true is disappointing and 2) the 3-5 year timeline which is aggressive and represents and absolute best-case scenario. A bit surprising that he would choose that time frame.

I take all of it with a grain of salt until we see results.

 

I believe we have a name for Frequency's drug: FX-322. interesting/odd to me that no one from the company is referring to it by name though I guess the name could change by trial time.

See for example, http://bciq.biocentury.com/products/fx-322, http://adisinsight.springer.com/drugs/800048613, and the picture in http://www.hartfordbusiness.com/article/20160815/PRINTEDITION/308129966/uconn

 

What do we know about FX-322 at this point (that isn't yet published)?

If you look closely at the picture at http://www.hartfordbusiness.com/article/20160815/PRINTEDITION/308129966/uconn, you see the slide discusses the restoration of hearing in mice. This work will presumably be at the heart of the next paper. It looks like the injection was done 24 hours after damage so a significant remaining question will be how effecting this is months or years after damage. Additionally, it obviously isn't clear from one slide how much hearing was restored.

Most interesting, the article is dated August 15, 2016. So this is well before the big paper in February. This is not surprising as they are not waiting for one paper to be published before starting on the next idea. Still interesting to know where they were well before August of last year.

 

First Frequency Therapeutics Trial in Humans

I debated about starting a separate thread, but since this seems more like preclinical work than an actual trial, it seems appropriate here.

If you look at the bottom of the page http://adisinsight.springer.com/drugs/800048613, they mention an Australian trial for sensorineural hearing loss. This would appear to be the first use of FX-322 in humans.

The trial registry page is https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372587

It's a little odd to me that this trial has not been mentioned in any of the interviews - perhaps because it is not a Phase 1 trial for hearing loss. In fact, it appears to be more pre-clinical than clinical.

The primary outcome is "To assess diffusion of FX-322 from the middle ear, across the oval and round window membranes, and into the cochlear fluid (perilymph). The concentration of FX-322 will be analysed from the perilymph fluid and blood plasma by standard laboratory methods." Recovery of hearing is not an outcome they are studying in this context.

It makes complete sense that Frequency would want to know these things, but it is less clear what is in it for the CI users as this adds an additional risk variable for them. It must be that FX-322 is viewed as essentially safe, and the appropriate IRB(s) must have agreed.

Anticipated first enrollment was 5/22/2017 with data collected expected to be complete by 9/18/2017. I suspect these dates will slip some. As I said, this looks almost more like a pre-clinical to determine dosing. I doubt we will see a paper out of this, but I suspect it will help inform the "real" trial. In fact, my guess is that this will need to be complete before the first trial to better understand dosing.

Interesting that it is being conducted in Australia.

 

Unless you're a military veteran. I can't see the government choosing to pay out over a billion a year, whilst a possible tinnitus treatment is out there, off label or not. Join the Army and save!

 

I suspect most of us would kill for a 20db improvement. Especially if it somehow corresponds to an equivalent reduction in tinnitus annoyance.

 

Bearing in mind they have claimed the trial to start in 12-18 for quite a while, maybe this 3-5 will last a while too, thus.......