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Frequency Therapeutics announces breakthrough small-molecule approach to regenerate inner ear sensory hair cells

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Yes, all the one’s that have been reported on the HAF had gone to clinical trials. I’ve been on the HAF for 8 years and in that time I think there has been at least 6 or 7 reports of breakthroughs in restoring lost hearing. So far none have made it through their trials.

Ok, I’ve kind of adopted this as my thing. Here’s their latest press release quoted verbatim. More importantly there’s a video from their Chief Scientific Officer explaining the concepts. Probably the most succinct explanation I’ve seen. Whether you believe it or not, it’s definitely interesting.

Frequency Therapeutics Initiates Phase 1/2 Single Dose Clinical Trial to...

SAN ANTONIO (PRWEB) August 09, 2018 -- Frequency Therapeutics today announced that the first patients have been treated in a Phase 1/2 clinical trial to...

https://www.businesswire.com/news/home/20190409005363/en/Frequency-Therapeutics-Announces-Positive-Phase-12-Data27

“In the Phase 1/2 study, FX-322 was safe and well tolerated following a single intratympanic injection with no serious adverse events. In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.”

Am I the only one who sees this as significant?

Am I the only one who sees this as significant?

Not at all - thank you for posting this update!

I don’t always have the time to keep up with all the biotech companies working on this stuff now so I really appreciate the update. Their work gives me tremendous hope that one day we won’t need to wear hearing aids anymore.

What an exciting announcement; I can’t wait to hear more in the coming months.

Even if FX-322 doesn’t make it to market for whatever reason, this result shows that some reversal of sensorineural hearing loss in humans is possible. Has it ever been done before? If you think of the possible improvements in quality of life for a large swathe of the population in developed countries, this has got to be front page news, surely?

Hi,

I’m equally excited like you, however, I have to ask myself who this drug will be able to help.
From the company’s website I take that it is designed to recover hearing for those who lost it due to damage like too much loud noise and alike.

Not sure how many people with hearing loss are in this category. Me for my part, I’m not, because my hearing loss has a genetic root cause. I’d love to find out if this drug can also help me, as the genetic disorder also leads to a degradation of hearing over time, but unfortunately no one can tell, not even this company…

Regards,
stedon81

@stefan.donath I don’t think even Frequency Therapeutics could say for sure. They are targeting the largest market segment and probably the least-complicated to test and treat. It may be that hair cell regeneration would reset the clock for people with a genetic basis for their hearing loss. So hearing would be restored but begin to degrade again. Maybe periodic treatments? I really don’t know. I guess the good knews is that viable gene therapy seems to be on the distant horizon. Fingers crossed.

I should think that genetic root causes would most "deaf"initely be helped with the drug! I’m in that category, too, with inherited sensorineural hearing loss (translation: BALD in those ear hair patches).

I’d so love to try a drug like this if it didn’t have severe side-effects. Now I’m hoping it won’t all go up in smoke like Theranos! Fingers crossed it hits the market and could be prescribed soon enough.

@1Bluejay said:

Fingers crossed it hits the market and could be prescribed soon enough

They are presenting the results of their phase 1/2 trial at a major conference in September. They have already said that ‘multiple’ subjects (that’s at least 2 out of 16 subjects who were giving the drug) showed improvements in hearing thresholds and word recognition scores. Presumably they are going to say how many and by how much at the conference. I’ll definitely be staying tuned for that one.

On a related note, there’s an anecdotal report that one of the participants in the Regain clinical trial in London has bent their confidentiality agreement a little and reported significant improvements in hearing and lowering of tinnitus.

It would be very nice if we had two drugs to treat hearing loss hitting the market (probably years away) at the same time. That would curb price gouging a little.

^^^^^ WOWIE! I’d take up drinking champagne again if this comes to pass!!!

To improve both hearing AND diminish tinnitus would be better than winning a lottery for me. I’m gonna have to live clean and healthy forever so I live long enough to benefit from such a drug.
:smile:

Definitely let us know here what the clinical trial results are after that conference.

Related to all this great news, I would LOVE to know how folks get accepted to clinical trials?!? I’d give my EARS to try a drug that could improve hearing and cure my 24x7 ringing ears. I just don’t know whose door to knock on.

Results:

No statistically significant results in audiometry scores, though 4 out of 6 participants with moderate-to-moderately severe hearing loss did show improvements of 10Db at 8000k.

Overall about 30% improvement in wrs. Four out of that same group of 6, “showed clinically meaningful” improvements in wrs. Those same four subjects also showed significant improments in speech in noise.

Reddit seems to find those results underwhelming. I’m unsure.

I agree. The highest frequencies are closest to the entrance to the cochlea (I believe), so they get the effects of the drug first. The next trial will have up to four injections at weekly intervals. Not sure if they’ll keep the same concentration of active ingredients or tweak it.

Improvements in wrs in 4 subjects were kind of impressive on paper. Depends how much creedence you place in word recognition scores I guess. Unsure how you can get improvements in wrs without the pure tone thesholds moving. Maybe someone can explain that to me.

I don’t have the details at hand, but wasn’t it a pretty small sample size? It’s possible the impact on was entirely random. It’s also feasible that there was some “training” going on.

Yep. Very small sample size. When done properly (and I’m not saying it was in this case- I don’t have the expertise to say), statistical significance takes account of sample size. So big effect with small sample size or small effect with big sample size can both be statistically significant. A p value of .05 (the value that’s usually used to decide whether the results are ‘statistically significant’) means that there’s a 5% chance or less that the results were random. The p on the word-recognition was .01. The placebo group showed 5% improvement- possibly training.

I’m still on the fence on this study. I think the validity and usefulness of word recognition scores is the biggest question. That and the lack of shift in hearing thresholds has dented my optimism by quite a lot.

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