Frequency Therapeutics — Hearing Loss Regeneration

Technical question: anyone have any insight if cochlear hair cells can only be regenerated a certain amount of times before the therapy loses effectiveness altogether? For example if I suffer NIHL and have it treated with FX-322, then I am exposed to additional NIHL that's out of my control afterwards and have to be treated again.

 

I believe that not only does FX-322 regrow the hair cell, but first multiplies the supporting cell so you don't deplete them.

 

It could get awfully crowded in there. I wonder about hearing quality and how 'natural' hearing will feel, with all these hair cells propagating all over the place.

 

Could the Martians that crashed at Roswell many years ago possibly help us cure tinnitus? Judging by the size of their head they have to be intelligent beings I would think.

 

Well Stephen Hawking predicted that we will make alien contact by the year 2025. Maybe then we can ask them for tinnitus and hearing loss cure.

 

Find out... next on The History Channel.

 

I do know that the size and structure of the cochlea is such that it probably wouldn't support detecting frequencies above 22 kHz at the very max in the most healthy young person.

Unless someone went in there and physically made space for more hairs, or tried implanting additional cells (more than the estimated 15000-16000 naturally occurring cells), I don't see any possibility of "super hearing" and I personally wouldn't want it especially with certain types of digital audio containing very high frequency artifacts, or music that is mixed with the highs boosted because of an incompetent audio engineer.

At least not until we can merge with bats...

 

Too bad they don’t have ears :-(
They talk telepathically. More efficient than soundwaves.

 

Citation required.

 

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372587






So they are looking at tinnitus, which would be obvious.

They know something that they need to share with the world.

 

Their advanced anal probing technologies could be the solution to our problem.

 

Wait a second, does the cochlear fluid in the cochlea also circulate into the vestibular system? If so, then this may cure vertigo.

 

They have a presentation video up on YouTube, which shows Pro's and Con's of their and others' approaches. One of their Pro's was keeping supporting cells alive and well.

 

What are the cons?

 

If it works really well they won't be able to keep charging us day after day after month after year like most other drug companies do.

 

Doesn't this greatly increase the risk of creating a tumor in the area?

 

¯\_(ツ)_/¯

 

It is a risk well worth taking.

 

That's what they're doing these trials for, to see if that happens.

 

https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728

Dear David - thank you for your nice email and sorry to hear about your hearing loss.

Frequency is working to develop a therapy to combat noise-induced hearing loss in this initial study. While we are still some time away from a commercially available treatment, we are working hard to move as quickly as possible to that outcome. The clinical trials will be conducted in 3 separate stages as explained by the National Institutes of Health, but the overall time frame will be dependent on the trial design. You may find further information on how trials are crafted and conducted here: https://clinicaltrials.gov/ct2/about-studies
The cause of tinnitus is not clear in all cases, but this condition is almost always accompanied by hearing loss due to damaged cells within the inner ear. Because of this, regenerating hair cells may be helpful in patient suffering from tinnitus.

Also, in the meantime you can learn about existing clinical studies being performed around the world at the FDA website - here is a link: https://www.clinicaltrials.gov/ct2/results?term=hearing+loss&Search=Search

Please visit this link and enter your contact info to be part of Frequency’s outreach efforts and keep people informed of our progress: http://frequencytx.com/contact/index.php
and any questions you have about Frequency’s study should be sent directly to clinicaltrials@frequencytx.com

With warm regards,
Jeff
Jeff Karp B.Eng. PhD.
Professor of Medicine
Brigham and Women’s Hospital, Harvard Medical School
60 Fenwood Rd, Boston. 02115

 

Is that you @JohnAdams?

 

lol, no.

 

But they have a larger problem. They can telepathically send tinnitus to those they disagree with.

Most have a volume control behind the ear to turn this down.

 

Jeff Karp sure does spend a LOT of time on Twitter.

 

Are they starting Phase 3 next? Both studies show completed.

https://clinicaltrials.gov/ct2/show/NCT03616223?term=FX322&rank=1

https://clinicaltrials.gov/ct2/show/NCT03300687?term=FX322&rank=2

 

No they are starting Phase 2a by end of this year. And Phase 2b next year.

 

Saw on Reddit that Frequency Therapeutics is going for an IPO:

https://www.sec.gov/Archives/edgar/data/1703647/000119312519239976/d72917ds1.htm

 

From the document:

Quick summary:

- The Planned Phase 2a clinical trial will also explore the efficacy of the drug regarding tinnitus

- About 30% improved word recognition for treated patient versus about 5% for the placebo group (only 23 patients)

- About 20% improved word in noise recognition for treated patient versus about 5% for the placebo group

- Apparently no statistically significant improvements on the audiograms

- Worked well on mice

Comment from Reddit:

Some huge problems.

First, no change in audiogram is major. If the treatment worked, that is, if it regenerated hair cells, that is exactly where you would expect to see the difference.

Speech tests are difficult to interpret. First, they only saw significant changes in 4 patients. I also couldn’t find what speech test they used and how many items. This is critical. If you are performing in the mid percentages on word rec, a 30% change is likely not significant and is just test-retest reliability (see the Thornton and Raffin tables). So this result does not excite me at all.

Finally, their biggest claims are from post hoc statistical tests. Which, ew. Also, they aren’t explicit about their statistical models, but they should have used mixed effects for this which it doesn’t appear they did. So it’s likely that some of the variability their model “explained” is incorrectly assigned to a fixed rather than random effect, artificially driving down their p values.

If mouse models translated to human models we’d all be basically cancer free.

Still an interesting company, but these results aren’t promising.

 

Well, I'll invest once I have more money. Anything to support tinnitus research.